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INFORMATION SHEET

Institutional Review Boards Frequently Asked Questions Guidance for Institutional Review Boards and Clinical Investigators January 1998

The following is a compilation of answers to questions asked of FDA regarding the protection of human subjects of research. For ease of reference, the numbers assigned to the questions are consecutive throughout this section. These questions and answers are organized as follows.

• IRB Organization
• IRB Membership
• IRB Procedures
• IRB Records
• Informed Consent Process
• Informed Consent Document Content
• Clinical Investigations
• General Questions

I. IRB Organization

1. What is an Institutional Review Board (IRB)?

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

2. Do IRBs have to be formally called by that name?

No, "IRB" is a generic term used by FDA (and HHS) to refer to a group whose function is to review research to assure the protection of the rights and welfare of the human subjects. Each institution may use whatever name it chooses. Regardless of the name chosen, the IRB is subject to the Agency's IRB regulations when studies of FDA regulated products are reviewed and approved.

3. Does an IRB need to register with FDA before approving studies?

As published in the Federal Register on January 15, 2009, (74 FR 2358), 21 CFR Part 56, Institutional Review Boards, was amended with regard to IRB registration (21 CFR 56.106). This amendment requires each IRB in the United States (U.S.) that reviews FDA-regulated studies to register. IRB registration information is entered into an Internet-based registration system maintained by the Department of Health and Human Services (HHS). (See Guidance for Institutional Review Boards (IRBs) Frequently Asked Questions – IRB Registration ).

4. What is an "assurance" or a "multiple project assurance?"

An "assurance," is a document negotiated between an institution and the Department of Health and Human Services (HHS) in accordance with HHS regulations. For research involving human subjects conducted by HHS or supported in whole or in part by HHS, the HHS regulations require a written assurance from the performance-site institution that the institution will comply with the HHS protection of human subjects regulations [45 CFR part 46]. The assurance mechanism is described in 45 CFR 46.103. Once an institution's assurance has been approved by HHS, a number is assigned to the assurance. The assurance may be for a single grant or contract (a "single project assurance"); for multiple grants ("multiple project assurances" - formerly called "general assurances"); or for certain types of studies such as oncology group studies and AIDS research group studies ("cooperative project assurances"). The Office for Human Research Protection (OHRP) is responsible for implementing the HHS regulations. The address and telephone number for OHRP are: 1101 Wootton Parkway, The Tower Building, Suite 200, Rockville, MD 20852; Toll-Free Telephone within the U.S.: (866) 447-4777, Telephone: (240) 453-6900, FAX: (240) 453-6909.

5. Is an "assurance" required by FDA?

Currently, FDA regulations do not require an assurance. FDA regulations [21 CFR parts 50 and 56] apply to research involving products regulated by FDA - federal funds and/or support do not need to be involved for the FDA regulations to apply. When research studies involving products regulated by FDA are funded/supported by HHS, the research institution must comply with both the HHS and FDA regulations. [A table of significant differences between 45 CFR Part 46, Subpart A and 21 CFR Parts 50 and 56 is available on the FDA website.]

6. Must an institution establish its own IRB?

No. Although institutions engaged in research involving human subjects will usually have their own IRBs to oversee research conducted within the institution or by the staff of the institution, FDA regulations permit an institution without an IRB to arrange for an "outside" IRB to be responsible for initial and continuing review of studies conducted at the non-IRB institution. Such arrangements should be documented in writing. Individuals conducting research in a non-institutional setting often use established IRBs (independent or institutional) rather than form their own IRBs. Also see the information sheets entitled "Non-local IRB Review" and "Cooperative Research."

7. May a hospital IRB review a study that will be conducted outside of the hospital?

Yes. IRBs may agree to review research from affiliated or unaffiliated investigators, however, FDA does not require IRBs to assume this responsibility. If the IRB routinely conducts these reviews, the IRB policies should authorize such reviews and the process should be described in the IRB's written procedures. A hospital IRB may review outside studies on an individual basis when the minutes clearly show the members are aware of where the study is to be conducted and when the IRB possesses appropriate knowledge about the study site(s).

8. May IRB members be paid for their services?

The FDA regulations do not preclude a member from being compensated for services rendered. Payment to IRB members should not be related to or dependent upon a favorable decision. Expenses, such as travel costs, may also be reimbursed.

9. What is the FDA role in IRB liability in malpractice suits?

FDA regulations do not address the question of IRB or institutional liability in the case of malpractice suits. FDA does not have authority to limit liability of IRBs or their members. Compliance with FDA regulations may help minimize an IRB's exposure to liability.

10. Is the purpose of the IRB review of informed consent to protect the institution or the subject?

The fundamental purpose of IRB review of informed consent is to assure that the rights and welfare of subjects are protected. A signed informed consent document is evidence that the document has been provided to a prospective subject (and presumably, explained) and that the subject has agreed to participate in the research. IRB review of informed consent documents also ensures that the institution has complied with applicable regulations.

11. Does an IRB or institution have to compensate subjects if injury occurs as a result of participation in a research study?

Institutional policy, not FDA regulation, determines whether compensation and medical treatment(s) will be offered and the conditions that might be placed on subject eligibility for compensation or treatment(s). The FDA informed consent regulation on compensation [21 CFR 50.25(a)(6)] requires that, for research involving more than minimal risk, the subject must be told whether any compensation and any medical treatment(s) are available if injury occurs and, if so, what they are, or where further information may be obtained. Any statement that compensation is not offered must avoid waiving or appearing to waive any of the subject's rights or releasing or appearing to release the investigator, sponsor, or institution from liability for negligence [21 CFR 50.20].

II. IRB Membership

12. May a clinical investigator be an IRB member?

Yes, however, the IRB regulations [21 CFR 56.107(e)] prohibit any member from participating in the IRB's initial or continuing review of any study in which the member has a conflicting interest, except to provide information requested by the IRB. When selecting IRB members, the potential for conflicts of interest should be considered. When members frequently have conflicts and must absent themselves from deliberation and abstain from voting, their contributions to the group review process may be diminished and could hinder the review procedure. Even greater disruptions may result if this person is chairperson of the IRB.

13. The IRB regulations require an IRB to have a diverse membership. May one member satisfy more than one membership category?

Yes. For example, one member could be otherwise unaffiliated with the institution and have a primary concern in a non-scientific area. This individual would satisfy two of the membership requirements of the regulations. IRBs should strive, however, for a membership that has a diversity of representative capacities and disciplines. In fact, the FDA regulations [21 CFR 56.107(a)] require that, as part of being qualified as an IRB, the IRB must have "... diversity of members, including consideration of race, gender, cultural backgrounds and sensitivity to such issues as community attitudes ...."

14. When IRB members cannot attend a convened meeting, may they send someone from their department to vote for them?

No. Alternates who are formally appointed and listed in the membership roster may substitute, but ad hoc substitutes are not permissible as members of an IRB. However, a member who is unable to be present at the convened meeting may participate by video-conference or conference telephone call, when the member has received a copy of the documents that are to be reviewed at the meeting. Such members may vote and be counted as part of the quorum. If allowed by IRB procedures, ad hoc substitutes may attend as consultants and gather information for the absent member, but they may not be counted toward the quorum or participate in either deliberation or voting with the board. The IRB may, of course, ask questions of this representative just as they could of any non-member consultant. Opinions of the absent members that are transmitted by mail, telephone, telefax or e-mail may be considered by the attending IRB members but may not be counted as votes or the quorum for convened meetings.

15. May the IRB use alternate members?

The use of formally appointed alternate IRB members is acceptable to the FDA, provided that the IRB's written procedures describe the appointment and function of alternate members. The IRB roster should identify the primary member(s) for whom each alternate member may substitute. To ensure maintaining an appropriate quorum, the alternate's qualifications should be comparable to the primary member to be replaced. The IRB minutes should document when an alternate member replaces a primary member. When alternates substitute for a primary member, the alternate member should have received and reviewed the same material that the primary member received or would have received.

16. Does a non-affiliated member need to attend every IRB meeting?

No. Although 21 CFR 56.108(c) does not specifically require the presence of a member not otherwise affiliated with the institution to constitute a quorum, FDA considers the presence of such members an important element of the IRB's diversity. Therefore, frequent absence of all non-affiliated members is not acceptable to FDA. Acknowledging their important role, many IRBs have appointed more than one member who is not otherwise affiliated with the institution. FDA encourages IRBs to appoint members in accordance with 21 CFR 56.107(a) who will be able to participate fully in the IRB process.

17. Which IRB members should be considered to be scientists and non-scientists?

21 CFR 56.107(c) requires at least one member of the IRB to have primary concerns in the scientific area and at least one to have primary concerns in the non-scientific area. Most IRBs include physicians and Ph.D. level physical or biological scientists. Such members satisfy the requirement for at least one scientist. When an IRB encounters studies involving science beyond the expertise of the members, the IRB may use a consultant to assist in the review, as provided by 21 CFR 56.107(f).

FDA believes the intent of the requirement for diversity of disciplines was to include members who had little or no scientific or medical training or experience. Therefore, nurses, pharmacists and other biomedical health professionals should not be regarded to have "primary concerns in the non-scientific area." In the past, lawyers, clergy and ethicists have been cited as examples of persons whose primary concerns would be in non-scientific areas.

Some members have training in both scientific and non-scientific disciplines, such as a J.D., R.N. While such members are of great value to an IRB, other members who are unambiguously non-scientific should be appointed to satisfy the non-scientist requirement.

III. IRB Procedures

18. The FDA regulations [21 CFR 56.104(c)] exempt an emergency use of a test article from prospective IRB review, however, "... any subsequent use of the test article at the institution is subject to IRB review." What does the phrase "subsequent use" mean?

FDA regulations allow for one emergency use of a test article in an institution without prospective IRB review, provided that such emergency use is reported to the IRB within five working days after such use. An emergency use is defined as a single use (or single course of treatment, e.g., multiple doses of antibiotic) with one subject. "Subsequent use" would be a second use with that subject or the use with another subject.

In its review of the emergency use, if it is anticipated that the test article may be used again, the IRB should request a protocol and consent document(s) be developed so that an approved protocol would be in place when the next need arises. In spite of the best efforts of the clinical investigator and the IRB, a situation may occur where a second emergency use needs to be considered. FDA believes it is inappropriate to deny emergency treatment to an individual when the only obstacle is lack of time for the IRB to convene, review the use and give approval.

19. Are there any regulations that require clinical investigators to report to the IRB when a study has been completed?

IRBs are required to function under written procedures. One of these procedural requirements [21 CFR 56.108(a)(3)] requires ensuring "prompt reporting to the IRB of changes in a research activity." The completion of the study is a change in activity and should be reported to the IRB. Although subjects will no longer be "at risk" under the study, a final report/notice to the IRB allows it to close its files as well as providing information that may be used by the IRB in the evaluation and approval of related studies.

20. What is expedited review?

Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. The Agency's IRB regulations [21 CFR 56.110] permit, but do not require, an IRB to review certain categories of research through an expedited procedure if the research involves no more than minimal risk. A list of categories was last published in the Federal Register on January 27, 1981 [46 FR 8980].

The IRB may also use the expedited review procedure to review minor changes in previously approved research during the period covered by the original approval. Under an expedited review procedure, review of research may be carried out by the IRB chairperson or by one or more experienced members of the IRB designated by the chairperson. The reviewer(s) may exercise all the authorities of the IRB, except disapproval. Research may only be disapproved following review by the full committee. The IRB is required to adopt a method of keeping all members advised of research studies that have been approved by expedited review.

[See Conditions for IRB Use of Expedited Review - Federal Register: November 9, 1998 (Volume 63, Number 216), Notices ]

21. The number of studies we review has increased, and the size of the package of review materials we send to IRB members is becoming formidable. Must we send the full package to all IRB members?

The IRB system was designed to foster open discussion and debate at convened meetings of the full IRB membership. While it is preferable for every IRB member to have personal copies of all study materials, each member must be provided with sufficient information to be able to actively and constructively participate. Some institutions have developed a "primary reviewer" system to promote a thorough review. Under this system, studies are assigned to one or more IRB members for a full review of all materials. Then, at the convened IRB meeting the study is presented by the primary reviewer(s) and, after discussion by IRB members, a vote for an action is taken.

The "primary reviewer" procedure is acceptable to the FDA if each member receives, at a minimum; a copy of consent documents and a summary of the protocol in sufficient detail to determine the appropriateness of the study-specific statements in the consent documents. In addition, the complete documentation should be available to all members for their review, both before and at the meeting. The materials for review should be received by the membership sufficiently in advance of the meeting to allow for adequate review of the materials.

Some IRBs are also exploring the use of electronic submissions and computer access for IRB members. Whatever system the IRB develops and uses, it must ensure that each study receives an adequate review and that the rights and welfare of the subjects are protected.

22. Are sponsors allowed access to IRB written procedures, minutes and membership rosters?

The FDA regulations do not require public or sponsor access to IRB records. However, FDA does not prohibit the sponsor from requesting IRB records. The IRB and the institution may establish a policy on whether minutes or a pertinent portion of the minutes are provided to sponsors.

Because of variability, each IRB also needs to be aware of State and local laws regarding access to IRB records.

23. Must an investigator's brochure be included in the documentation when an IRB reviews an investigational drug study?

For studies conducted under an investigational new drug application, an investigator's brochure is usually required by FDA [21 CFR 312.23(a)(5) and 312.55]. Even though 21 CFR part 56 does not mention the investigator's brochure by name, much of the information contained in such brochures is clearly required to be reviewed by the IRB. The regulations do outline the criteria for IRB approval of research. 21 CFR 56.111(a)(1) requires the IRB to assure that risks to the subjects are minimized. 21 CFR 56.111(a)(2) requires the IRB to assure that the risks to subjects are reasonable in relation to the anticipated benefits. The risks cannot be adequately evaluated without review of the results of previous animal and human studies, which are summarized in the investigator's brochure.

There is no specific regulatory requirement that the Investigator's Brochure be submitted to the IRB. There are regulatory requirements for submission of information which normally is included in the Investigator's Brochure. It is common that the Investigator's Brochure is submitted to the IRB, and the IRB may establish written procedures which require its submission. Investigator's Brochures may be part of the investigational plan that the IRB reviews when reviewing medical device studies.

24. To what extent is the IRB expected to actively audit and monitor the performance of the investigator with respect to human subject protection issues?

FDA does not expect IRBs to routinely observe consent interviews, observe the conduct of the study or review study records. However, 21 CFR 56.109(f) gives the IRB the authority to observe, or have a third party observe, the consent process and the research. When and if the IRB is concerned about the conduct of the study or the process for obtaining consent, the IRB may consider whether, as part of providing adequate oversight of the study, an active audit is warranted.

25. How can a sponsor know whether an IRB has been inspected by FDA, and the results of the inspection?

The Division of Scientific Investigations, Center for Drug Evaluation and Research, maintains an inventory of the IRBs that have been inspected, including dates of inspection and classification. The Division recently began including the results of inspections assigned by the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health. This information is available through Freedom of Information Act (FOIA) procedures. Once an investigational file has been closed, the correspondence between FDA and the IRB and the narrative inspectional report are also available under FOI.

26. If an IRB disapproves a study submitted to it, and it is subsequently sent to another IRB for review, should the second IRB be told of the disapproval?

Yes. When an IRB disapproves a study, it must provide a written statement of the reasons for its decision to the investigator and the institution [21 CFR 56.109(e)]. If the study is submitted to a second IRB, a copy of this written statement should be included with the study documentation so that it can make an informed decision about the study. 21 CFR 56.109(a) requires an IRB to "... review ... all research activities [emphasis added] ...." The FDA regulations do not prohibit submission of a study to another IRB following disapproval. However, all pertinent information about the study should be provided to the second IRB.

27. May an independent IRB review a study to be conducted in an institution with an IRB?

Generally, no. Most institutional IRB have jurisdiction over all studies conducted within that institution. An independent IRB may become the IRB of record for such studies only upon written agreement with the administration of the institution or the in-house IRB.

28. Could an IRB lose its quorum when members with a conflict of interest leave the room for deliberation and voting on a study?

Yes. "The quorum is the count of the number of members present. If the number present falls below a majority, the quorum fails. The regulations only require that a member who is conflicted not participate in the deliberations and voting on a study on which he or she is conflicted. The IRB may decide whether an individual should remain in the room."

29. Does FDA expect the IRB chair to sign the approval letters?

FDA does not specify the procedure that IRBs must use regarding signature of the IRB approval letter. The written operating procedures for the IRB should outline the procedure that is followed.

30. Does FDA prohibit direct communication between sponsors and IRBs?

It is important that a formal line of communication be established between the clinical investigator and the IRB. Clinical investigators should report adverse events directly to the responsible IRB, and should send progress reports directly to that IRB. However, FDA does not prohibit direct communication between the sponsor and the IRB, and recognizes that doing so could result in more efficient resolution of some problems.

FDA does require direct communication between the sponsors and the IRBs for certain studies of medical devices and when the 21 CFR 50.24 informed consent waiver has been invoked. Sponsors and IRBs are required to communicate directly for medical device studies under 21 CFR 812.2, 812.66 and 812.150(b). For informed consent waiver studies, direct communication between sponsors and IRBs is required under 21 CFR 50.24(e), 56.109(e), 56.109(g), 312.54(b), 312.130(d), 812.38(b)(4) and 812.47(b).

IV. IRB Records

31. Are annual IRB reviews required when all studies are reviewed by the IRB each quarter?

The IRB records for each study's initial and continuing review should note the frequency (not to exceed one year) for the next continuing review in either months or other conditions, such as after a particular number of subjects are enrolled.

An IRB may decide, to review all studies on a quarterly basis. If every quarterly report contains sufficient information for an adequate continuing review and is reviewed by the IRB under procedures that meet FDA requirements for continuing review, FDA would not require an additional "annual" review.

32. 21 CFR 56.115(a)(1) requires that the IRB maintain copies of "research proposals reviewed." Is the "research proposal" the same as the formal study protocol that the investigator receives from the sponsor of the research?

Yes. The IRB should receive and review all research activities [21 CFR 56.109(a)]. The documents reviewed should include the complete documents received from the clinical investigator, such as the protocol, the investigator's brochure, a sample consent document and any advertising intended to be seen or heard by prospective study subjects. Some IRBs also require the investigator to submit an institutionally-developed protocol summary form. A copy of all documentation reviewed is to be maintained for at least three years after completion of the research at that institution [21 CFR 56.115(b)]. However, when the IRB makes changes, such as in the wording of the informed consent document, only the finally approved copy needs to be retained in the IRB records.

33. What IRB records are required for studies that are approved but never started?

When an IRB approves a study, continuing review should be performed at least annually. All of the records listed in 21 CFR 56.115(a)(1) - (4) are required to be maintained. The clock starts on the date of approval, whether or not subjects have been enrolled. Written progress reports should be received from the clinical investigator for all studies that are in approved status prior to the date of expiration of IRB approval. If subjects were never enrolled, the clinical investigator's progress report would be brief. Such studies may receive continuing IRB review using expedited procedures. If the study is finally canceled without subject enrollment, records should be maintained for at least three years after cancellation [21 CFR 56.115(b)].

V. Informed Consent Process

34. Is getting the subject to sign a consent document all that is required by the regulations?

No. The consent document is a written summary of the information that should be provided to the subject. Many clinical investigators use the consent document as a guide for the verbal explanation of the study. The subject's signature provides documentation of agreement to participate in a study, but is only one part of the consent process. The entire informed consent process involves giving a subject adequate information concerning the study, providing adequate opportunity for the subject to consider all options, responding to the subject's questions, ensuring that the subject has comprehended this information, obtaining the subject's voluntary agreement to participate and, continuing to provide information as the subject or situation requires. To be effective, the process should provide ample opportunity for the investigator and the subject to exchange information and ask questions.

35. May informed consent be obtained by telephone from a legally authorized representative?

A verbal approval does not satisfy the 21 CFR 56.109(c) requirement for a signed consent document, as outlined in 21 CFR 50.27(a). However, it is acceptable to send the informed consent document to the legally authorized representative (LAR) by facsimile and conduct the consent interview by telephone when the LAR can read the consent as it is discussed. If the LAR agrees, he/she can sign the consent and return the signed document to the clinical investigator by facsimile.

36. 21 CFR 50.27(a) requires that a copy of the consent document be given to the person signing the form. Does this copy have to be a photocopy of the form with the subject's signature affixed?

No. The regulation does not require the copy of the form given to the subject to be a copy of the document with the subject's signature, although this is encouraged. It must, however, be a copy of the IRB approved document that was given to the subject to obtain consent [21 CFR 50.27(a) or 21 CFR 50.27(b)(2)]. One purpose of providing the person signing the form with a copy of the consent document is to allow the subject to review the information with others, both before and after making a decision to participate in the study, as well as providing a continuing reference for items such as scheduling of procedures and emergency contacts.

37. If an IRB uses a standard "fill-in-the-blank" consent format, does the IRB need to review the filled out form for each study?

Yes. A fill-in-the-blank format provides only some standard wording and a framework for organizing the relevant study information. The IRB should review a completed sample form, individualized for each study, to ensure that the consent document, in its entirety, contains all the information required by 21 CFR 50.25 in language the subject can understand. The completed sample form should be typed to enhance its readability by the subjects. The form finally approved by the IRB should be an exact copy of the form that will be presented to the research subjects. The IRB should also review the "process" for conducting the consent interviews, i.e., the circumstances under which consent will be obtained, who will obtain consent, and so forth.

38. The informed consent regulations [21 CFR 50.25 (a)(5)] require the consent document to include a statement that notes the possibility that FDA may inspect the records. Is this statement a waiver of the subject's legal right to privacy?

No. FDA does not require any subject to "waive" a legal right. Rather, FDA requires that subjects be informed that complete privacy does not apply in the context of research involving FDA regulated products. Under the authority of the Federal Food, Drug, and Cosmetic Act, FDA may inspect and copy clinical records to verify information submitted by a sponsor. FDA generally will not copy a subject's name during the inspection unless a more detailed study of the case is required or there is reason to believe that the records do not represent the actual cases studied or results obtained.

The consent document should not state or imply that FDA needs clearance or permission from the clinical investigator, the subject or the IRB for such access. When clinical investigators conduct studies for submission to FDA, they agree to allow FDA access to the study records, as outlined in 21 CFR 312.68 and 812.145. Informed consent documents should make it clear that, by participating in research, the subject's records automatically become part of the research database. Subjects do not have the option to keep their records from being audited/reviewed by FDA.

When an individually identifiable medical record (usually kept by the clinical investigator, not by the IRB) is copied and reviewed by the Agency, proper confidentiality procedures are followed within FDA. Consistent with laws relating to public disclosure of information and the law enforcement responsibilities of the Agency, however, absolute confidentiality cannot be guaranteed.

39. Who should be present when the informed consent interview is conducted?

FDA does not require a third person to witness the consent interview unless the subject or representative is not given the opportunity to read the consent document before it is signed, see 21 CFR 50.27(b). The person who conducts the consent interview should be knowledgeable about the study and able to answer questions. FDA does not specify who this individual should be. Some sponsors and some IRBs require the clinical investigator to personally conduct the consent interview. However, if someone other than the clinical investigator conducts the interview and obtains consent, this responsibility should be formally delegated by the clinical investigator and the person so delegated should have received appropriate training to perform this activity.

40. How do you obtain informed consent from someone who speaks and understands English but cannot read?

Illiterate persons who understand English may have the consent read to them and "make their mark," if appropriate under applicable state law. The 21 CFR 50.27(b)(2) requirements for signature of a witness to the consent process and signature of the person conducting consent interview must be followed, if a "short form" is used. Clinical investigators should be cautious when enrolling subjects who may not truly understand what they have agreed to do. The IRB should consider illiterate persons as likely to be vulnerable to coercion and undue influence and should determine that appropriate additional safeguards are in place when enrollment of such persons is anticipated, see 21 CFR 56.111(b).

41. Must a witness observe the entire consent interview or only the signature of the subject?

FDA does not require the signature of a witness when the subject reads and is capable of understanding the consent document, as outlined in 21 CFR 50.27(b)(1). The intended purpose is to have the witness present during the entire consent interview and to attest to the accuracy of the presentation and the apparent understanding of the subject. If the intent of the regulation were only to attest to the validity of the subject's signature, witnessing would also be required when the subject reads the consent.

42. Should the sponsor prepare a model informed consent document?

Although not required by the IND regulations, the sponsor provides a service to the clinical investigator and the IRB when it prepares suggested study-specific wording for the scientific and technical content of the consent document. However, the IRB has the responsibility and authority to determine the adequacy and appropriateness of all of the wording in the consent, see 21 CFR 56.109(a), 111(a)(4) and 111(a)(5). If an IRB insists on wording the sponsor cannot accept, the sponsor may decide not to conduct the study at that site. For medical device studies that are conducted under an IDE, copies of all forms and informational materials to be provided to subjects to obtain informed consent must be submitted to FDA as part of the IDE, see 21 CFR 812.25(g).

43 . Is the sponsor required to review the consent form approved by the IRB to make sure all FDA requirements are met?

For investigational devices, the informed consent is a required part of the IDE submission. It is, therefore, approved by FDA as part of the IDE application. When an IRB makes substantive changes in the document, FDA reapproval is required and the sponsor is necessarily involved in this process.

FDA regulations for other products do not specifically require the sponsor to review IRB approved consent documents. However, most sponsors do conduct such reviews to assure the wording is acceptable to the sponsor.

44. Are there alternatives to obtaining informed consent from a subject?

The regulations generally require that the investigator obtain informed consent from subjects. Investigators also may obtain informed consent from a legally authorized representative of the subject. FDA recognizes that a durable power of attorney might suffice as identifying a legally authorized representative under some state and local laws. For example, a subject might have designated an individual to provide consent with regard to health care decisions through a durable power of attorney and have specified that the individual also has the power to make decisions on entry into research. FDA defers to state and local laws regarding who is a legally authorized representative. Therefore, the IRB should assure that the consent procedures comply with state and local laws, including assurance that the law applies to obtaining informed consent for subjects participating in research as well as for patients who require health care decisions."

Alternatives 1 and 2 are provided for in the regulations and are appropriate. Alternative 3 allows a designated individual to provide consent for a patient with regard to health care decisions and is appropriate when it specifically includes entry into research. FDA defers to state and local laws regarding substituted consent. Therefore, the IRB must assure itself that the substituted consent procedures comply with state and local law, including assurance the law applies to obtaining informed consent for subjects participating in research as well as for patients who require health care decisions.

45. When should study subjects be informed of changes in the study?

Protocol amendments must receive IRB review and approval before they are implemented, unless an immediate change is necessary to eliminate an apparent hazard to the subjects (21 CFR 56.108(a)(4)). Those subjects who are presently enrolled and actively participating in the study should be informed of the change if it might relate to the subjects' willingness to continue their participation in the study (21 CFR 50.25(b)(5)). FDA does not require reconsenting of subjects that have completed their active participation in the study, or of subjects who are still actively participating when the change will not affect their participation, for example when the change will be implemented only for subsequently enrolled subjects.

VI. Informed Consent Document Content

46. May an IRB require that the sponsor of the study and/or the clinical investigator be identified on the study's consent document?

Yes. The FDA requirements for informed consent are the minimum basic elements of informed consent that must be presented to a research subject [21 CFR 50.25]. An IRB may require inclusion of any additional information which it considers important to a subject's decision to participate in a research study [21 CFR 56.109(b)].

47. Does FDA require the informed consent document to contain a space for assent by children?

No, however, many investigators and IRBs consider it standard practice to obtain the agreement of older children who can understand the circumstances before enrolling them in research. While the FDA regulations do not specifically address enrollment of children (other than to include them as a class of vulnerable subjects), the basic requirement of 21 CFR 50.20 applies, i.e., the legally effective informed consent of the subject or the subject's legally authorized representative must be obtained before enrollment. Parents, legal guardians and/or others may have the ability to give permission to enroll children in research, depending on applicable state and local law of the jurisdiction in which the research is conducted. (Note: permission to enroll in research is not the same as permission to provide medical treatment.) IRBs generally require investigators to obtain the permission of one or both of the parents or guardian (as appropriate) and the assent of children who possess the intellectual and emotional ability to comprehend the concepts involved. Some IRBs require two documents, a fully detailed explanation for parents and older children to read and sign, and a shorter, simpler one for younger children. [For research supported by DHHS, the additional protections at 45 CFR 46 Subpart D are also required. The Subpart D regulations provide appropriate guidance for all other pediatric studies.]

On April 24, 2001, FDA issued an interim final rule, Additional Protections for Children, as subpart D to 21 CFR Part 50. Assent by children is addressed in subpart D. This interim final rule and its preamble are available at Additional Protections for Children . 

48. Does FDA require the signature of children on informed consent documents?

As indicated above, researchers may seek assent of children of various ages. Older children may be well acquainted with signing documents through prior experience with testing, licensing and/or other procedures normally encountered in their lives. Signing a form to give their assent for research would not be perceived as unusual and would be reasonable. Younger children, however, may never have had the experience of signing a document. For these children requiring a signature may not be appropriate, and some other technique to verify assent could be used. For example, a third party may verify, by signature, that the assent of the child was obtained.

As noted in the previous answer, on April 24, 2001, FDA issued an interim final rule, Additional Protections for Children, as subpart D to 21 CFR Part 50. Informed consent of children who participate in clinical trials is addressed in subpart D. This interim final rule and its preamble are available at Additional Protections for Children . 

49. Who should be listed on the consent as the contact to answer questions?

21 CFR 50.25(a)(7) requires contacts for questions about the research, the research subject's rights and in case of a research-related injury. It does not specify whom to contact. The same person may be listed for all three. However, FDA and most IRBs believe it is better to name a knowledgeable person other than the clinical investigator as the contact for study subject rights. Having the clinical investigator as the only contact may inhibit subjects from reporting concerns and/or possible abuses.

50. May the "compensation" for participation in a trial offered by a sponsor include a coupon good for a discount on the purchase price of the product once it has been approved for marketing?

No. This presumes, and inappropriately conveys to the subjects, a certainty of favorable outcome of the study and prompt approval for marketing. Also, if the product is approved, the coupon may financially coerce the subject to insist on that product, even though it may not be the most appropriate medically.

51. Must informed consent documents be translated into the written language native to study subjects who do not understand English?

The signed informed consent document is the written record of the consent interview. Study subjects are given a copy of the consent to be used as a reference document to reinforce their understanding of the study and, if desired, to consult with their physician or family members about the study.

In order to meet the requirements of 21 CFR 50.20, the consent document must be in language understandable to the subject. When the prospective subject is fluent in English, and the consent interview is conducted in English, the consent document should be in English. However, when the study subject population includes non-English speaking people so that the clinical investigator or the IRB anticipates that the consent interviews are likely to be conducted in a language other than English, the IRB should assure that a translated consent form is prepared and that the translation is accurate.

A consultant may be utilized to assure that the translation is correct. A copy of the translated consent document must be given to each appropriate subject. While a translator may be used to facilitate conversation with the subject, routine ad hoc translation of the consent document may not be substituted for a written translation.

Also see FDA Information Sheets: "A Guide to Informed Consent Documents" and "Informed Consent and the Clinical Investigator"

52. Is it acceptable for the consent document to say specimens are "donated"?

What about a separate donation statement? It would be acceptable for the consent to say that specimens are to be used for research purposes. However, the word "donation" implies abandonment of rights to the "property". 21 CFR 50.20 prohibits requiring subjects to waive or appear to waive any rights as a condition for participation in the study. Whether or not the wording is contained in "the actual consent form" is immaterial. All study-related documents must be submitted to the IRB for review. Any separate "donation" agreement is regarded to be part of the informed consent documentation, and must be in compliance with 21 CFR 50.

53. Do informed consent forms have to justify fees charged to study subjects?

FDA does not require the consent to contain justification of charges.

VII. Clinical Investigations

54. Does a physician, in private practice, conducting research with an FDA regulated product, need to obtain IRB approval?

Yes. The FDA regulations require IRB review and approval of regulated clinical investigations, whether or not the study involves institutionalized subjects. FDA has included non-institutionalized subjects because it is inappropriate to apply a double standard for the protection of research subjects based on whether or not they are institutionalized.

An investigator should be able to obtain IRB review by submitting the research proposal to a community hospital, a university/medical school, an independent IRB, a local or state government health agency or other organizations.

55. Does a clinical investigation involving a marketed product require IRB review and approval?

Yes, if the investigation is governed by FDA regulations [see 21 CFR 56.101, 56.102(c), 312.2(b)(1), 361.1, 601.2, and 812.2]. Also, see the information sheet entitled " 'Off-label' and Investigational Use of Marketed Drugs and Biologics" for more information.

VIII. General Questions

56. Which FDA office may an IRB contact to determine whether an investigational new drug application (IND) or investigational device exemption (IDE) is required for a study of a test article?

For drugs, the IRB may contact the Center for Drug Evaluation and Research (CDER), Office of Communications, Division of Drug Information at (301) 796-3400.

For biological products, contact the Center for Biologics Evaluation and Research (CBER), Office of Communication, Outreach and Development, at (800)-835-4709 or (301) 827-1800.

For medical devices, contact the Investigational Device Exemption (IDE) Staff, Office of Device Evaluation, Center for Devices and Radiological Health (CDRH), at (301) 796-5640.

57. What happens during an FDA inspection of an IRB?

FDA field investigators interview institutional officials and examine the IRB records to determine compliance with FDA regulations. Also, see the information sheet entitled "FDA Institutional Review Board Inspections" for a complete description of the inspection process.

58. Does a treatment IND/IDE [21 CFR 312.34/812.36 ] require prior IRB approval?

Test articles given to human subjects under a treatment IND/IDE require prior IRB approval, with two exceptions. If a life-threatening emergency exists, as defined by 21 CFR 56.102(d), the procedures described in 56.104(c) ("Exemptions from IRB Requirement") may be followed. In addition, FDA may grant the sponsor or sponsor/investigator a waiver of the IRB requirement in accord with 21 CFR 56.105. An IRB may still choose to review a study even if FDA has granted a waiver. For further information see the information sheets entitled "Emergency Use of an Investigational Drug or Biologic," "Emergency Use of Unapproved Medical Devices," "Waiver of IRB Requirements" and "Treatment use of Investigational Drugs and Biologics."

59. How have the FDA policies on enrollment of special populations changed?

On July 22, 1993, the FDA published the Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs, in the Federal Register [58 FR 39406]. The guideline was developed to ensure that the drug development process provides adequate information about the effects of drugs and biological products in women. For further information, see the information sheet entitled "Evaluation of Gender Differences in Clinical Investigations."

On December 13, 1994, FDA published a final rule on the labeling of prescription drugs for pediatric populations [59 FR 64240]. The rule [21 CFR 201.57] encourages sponsors to include pediatric subjects in clinical trials so that more complete information about the use of drugs and biological products in the pediatric population can be developed.

60. What is a medical device?

A medical device is any instrument, apparatus, or other similar or related article, including component, part, or accessory, which is: (a) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them; (b) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals; or (c) intended to affect the structure or any function of the human body or in animals; and does not achieve any of its principal intended purposes through chemical action within or on the human body or in animals and is not dependent upon being metabolized for the achievement of its principal intended purposes.

Approximately 1,700 types of medical devices are regulated by FDA. The range of devices is broad and diverse, including bandages, thermometers, ECG electrodes, IUDs, cardiac pacemakers, and hemodialysis machines. For further information, see the information sheets entitled "Medical Devices," "Frequently Asked Questions about IRB Review of Medical Devices" and "Significant Risk and Nonsignificant Risk Medical Device Studies."

61. Are in vitro diagnostic products medical devices?

Yes. The definition of a "device" includes in vitro diagnostic products - devices that aid in the diagnosis of disease or medical/physiological conditions (e.g., pregnancy) by using human or animal components to cause chemical reactions, fermentation, and the like. A few diagnostic products are intended for use in controlling other regulated products (such as those used to screen the blood supply for transfusion-transmitted diseases) and are regulated as biological products.

62. What are the IRB's general obligations towards intraocular lens (IOL) clinical investigations?

An IRB is responsible for the initial and continuing review of all IOL clinical investigations. Each individual IOL style is subject to a separate review by the IRB. This does not, however, preclude the IRB from using prior experience with other IOL investigations in considering the comparative merits of a new lens style. All IOL studies are also subject to FDA approval.

63. Considering the large number of IOL studies, how does an IRB approach the review of a new IOL style?

Full IRB review is required for all new IOLs that exhibit major departures from available lenses. Minor changes to existing lenses may be approved through expedited review. FDA designates new IOL styles as either major or minor changes based upon a predetermined classification scheme and advises the sponsor of its determination. The sponsor, through the investigator, should provide the IRB with the investigational plan which indicates the FDA study requirements, as well as the informed consent document and other comparative information on the proposed lens that describes its characteristics. It is the IRB's prerogative to request any relevant information on a new IOL to arrive at a decision or to be more rigorous in its evaluation than FDA considers minimally required.

64. Must a manufacturer comply with 21 CFR 50 and 56 when conducting trials within its own facility using employees as subjects?

Yes. This situation represents a prime example of a vulnerable subject population.

65. Do Radioactive Drug Research Committees (RDRCs) have authority to approve initial clinical studies in lieu of an IND?

No. An IND is required when the purpose of the study is to determine safety and efficacy of the drug or for immediate therapeutic, diagnostic or similar purposes. RDRCs are provided for in 21 CFR 361.1 Radioactive Drugs for Certain Research Uses . Radioactive drugs (as defined in 21 CFR 310.3(n)) may be administered to human research subjects without obtaining an IND when the purpose of the research project is to obtain basic information regarding the metabolism (including kinetics, distribution, and localization) of a radioactively labelled drug or regarding human physiology, pathophysiology, or biochemistry. Certain basic research studies, e.g., studies to determine whether a drug localizes in a particular organ or fluid space and to describe the kinetics of that localization, may have eventual therapeutic or diagnostic implications, but the initial studies are considered to be basic research within the meaning of 21 CFR 361.1. Such basic research studies must be conducted under the conditions set forth in 21 CFR 361.1(b).

All RDRC approved studies must also be approved by an IRB prior to initiation of the studies.

66. Does FDA approve RDRCs?

Yes. An RDRC must obtain and maintain approval by the Food and Drug Administration, as outlined in 21 CFR 361.1(c). RDRCs must register with the Division of Medical Imaging Products, Center for Drug Evaluation and Research (CDER), FDA, 5901-B Ammendale Road, Beltsville, MD 20105-1266, Attn: RDRC. The FDA contact for compliance issues is the Human Subject Protection Team, Division of Scientific Investigations (DSI),CDER, FDA,10903 New Hampshire Avenue, WO51, Room 5342, Silver Spring, MD 20993.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852

All comments should be identified with the title of the guidance.

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NIH Inclusion Outreach Toolkit: How to Engage, Recruit, and Retain Women in Clinical Research

• Institutional Review Board

An institutional review board (IRB) is the institutional entity charged with providing ethical and regulatory oversight of research involving human subjects, typically at the site of the research study. NIH does not require IRB approval before NIH peer review of proposed research; however, the appropriate IRB approval(s) must be in place to implement the research protocol. This review must be conducted by an IRB approved by the HHS Office of Human Subjects Protection; this can include approval by a single or central IRB in the case of multisite studies. Both local and single IRBs must follow the same Federal regulations about human subjects protections provided in 45 CFR 46, Subpart A  and 21 CFR Part 50 (for studies that must also meet Food Drug Administration requirements). IRBs also ensure compliance with relevant local and State regulations.

Each IRB follows its own operational policies. Contact your local IRB to learn how it can work with you to help protect human subjects in your clinical research. IRB staff may be able to offer recommendations on writing the protocol, consent forms, and other documents and on the appropriate training to provide your research staff.

NIH Single Institutional Review Board Policy

NIH Single IRB policy affects multi-site studies involving non-exempt human subjects research funded by NIH and applies to grant applications with due dates on or after January 25, 2018, and R&D contracts in response to solicitations issued on or after January 25, 2018.

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ORI  Introduction  to RCR: Chapter 3. The Protection of Human Subjects

• risks to subjects are minimized;
• risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result;
• selection of subjects is equitable;
• informed consent will be sought from each prospective subject or the subject’s legally authorized representative;
• informed consent will be appropriately documented;
• when appropriate, the research plan makes adequateprovision for monitoring the data collected to ensure the safety of subjects; and
• when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
• respect for persons and their right to make decisions for and about themselves without undue influence or coercion from someone else (the researcher in most cases);
• beneficence or the obligation to maximize benefits and reduce risks to the subject; and
• justice or the obligation to distribute benefits and risks equally without prejudice to particular individuals or groups, such as the mentally disadvantaged or members of a particular race or gender.

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Do You Need IRB Review... and Why?

Why do irbs exist.

Simply stated, egregious human experimentation such as that conducted by Nazis during World War II and during the Tuskegee Syphilis Study resulted in the creation of regulatory and ethical safeguards designed to protect the rights and dignity of participants in clinical trials and research studies. IRBs were the ultimate result and are in place to ensure research is conducted ethically and in accordance with various sets of regulations.

Review the set of infographics Protecting Research Volunteers ( https://www.hhs.gov/ohrp/education-and-outreach/about-research-participation/protecting-research-volunteers/index.html ) to get an overview of the Federal system of protections. These provide an easy-to-follow introduction to human subjects’ research protections that covers topics such as why we have regulations to protect human research participants and the framework for protecting human research participants in the U.S.

Watch the video Evolving Concern: Protection for Human Subjects  ( https://www.youtube.com/watch?v=_8Ku4b1fW18 ) to understand the historical events that provoked public concerns and led to the development of regulations and policies to protect human research participants in the U.S

Where do regulations around human subjects research come from?

At the highest level, they are governed by the United States Department of Health & Human Services' Office of Human Research Protections (OHRP) at 45 CFR part 46 and the Food and Drug Administration’s regulations at 21 CFR part 50 and 21 CFR part 56 .

The Belmont Report sets forth guidelines to be followed by researchers, based on three fundamental ethical principles:

• Respect for persons : Protect autonomy, ensure respect, and allow for informed consent without deception.
• Beneficence : "Do no harm" while maximizing research benefits and minimizing participant risks.
• Justice : Ensure reasonable, non-exploitative, and well-considered procedures involve the fair and equal distribution of costs and benefits to potential research participants.

Researchers must also be aware of and adhere to any applicable state, local, and institutional regulations.  

FDA regulations differ from OHRP. Please see Is Your Research FDA Regulated? for further guidance.  

Ohrp has specific definitions of "research" and "human subject" provided below, if your project meets both definitions, you are conducting "regulated research" and irb review is needed..

• Is It Research?
• Is It Human Subjects?

How Do the Federal Regulations Define Research?

“a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”  .

A systematic investigation   involves a methodical procedure and plan, is theoretically grounded, and specifies a focused and well-defined research problem or question, is informed by the empirical findings of others, is analytically robust, and provides a detailed and complete description of data collection methods.

Generalizable knowledge   is information that is expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following:

• Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied.
• Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study.
• Note that publication or other dissemination of findings does not in and of itself make the activity “research”. It has been a long-standing myth that if you publish, IRB review is required.

What is Not Generalizable?

• A quality assurance/quality improvement/organizational effectiveness study   where the   intent   is to assess, improve, or develop programs or services for an organization. Outcomes will remain specific to the organization, programs or services, although other organizations may use the results for their own programs.
• An oral history or journalistic piece . These are published materials that are limited to only documenting or reporting on events, situations, policies, institutions, or systems without the intent to form hypotheses, draw conclusions, or generalize findings. It will   not   involve stories that will or may draw broad conclusions about the population, cultures, norms, and practices.
• A note about class/educational “research” activities –   Class projects and research methods classes may involve data collection activities for training purposes that do not require IRB review and oversight because the intent is to teach methods, not to contribute to generalizable knowledge. The intent of other class projects may be to provide the student with real world experiences, information gathering techniques, and report writing. However, when the primary focus and initial intent of the class activities are to collect data to be used by students or other researchers beyond the classroom thereby contributing to “generalizable knowledge,” IRB review may be needed.
• A note about student internships –   Students within many departments or schools of the University are involved in internships or practica. Some student practica/internships may include research activities that are designed to contribute to generalizable knowledge and, thus, involve research that requires IRB review.
• Please note   --  even though a research activity may not qualify as "regulated research" now, this does not mean that you may not use these data for future "regulated research" activities. The use of data that was initially collected for non-research purposes is known as “secondary use of data not initially collected for research”.

How do the Federal Regulations Define Human Subject?

“A living individual about whom an investigator conducting research obtains (1) information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens”   (45 CFR 46.102(f)(1)(2)) .”                     

• Living individual   refers to data (information or specimens) collected from living subjects. For example, research using data from the 1880 Census would not be human subjects research.
• About whom   refers to the fact that the information collected must be personal information about an individual. For example, a survey that collects data about the activities of an organization, rather than its members, is not human subjects research.
• Intervention   includes physical procedures and manipulations of the subject or the subject's environment for research purposes. For example, taking a saliva or blood sample from a subject or having a subject view a video would be considered a research intervention.
• Interaction  refers to communication between the researcher and the subject. For example, research that includes face‐to-face, mail, internet and phone interactions (e.g. surveys), as well as other modes of communication would be considered an interaction.
• Identifiable private information or biospecimen  means the identity of the subject is or may be readily ascertained by the researcher or others or associated with the information. For example, research with a de‐identified data set is not research with human subjects because the data are not individually identifiable.
• Private information   includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, or information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable in order to be considered information to constitute research involving human subjects. Examples of private information include medical or academic records or personal journals.

With these definitions in mind, there are several possible next steps.  See below to learn more about your study.

If you are faculty, staff, or other non-undergraduate researcher.

If your study:

What if you are not sure? The IRB office would be more than willing to help you determine whether your activity requires IRB review or not.

Find your IRB contact person  !

If You Are An UNDERGRADUATE Researcher

All undergraduate research starts with the Undergraduate Research Training Program

Preparing for Your IRB Application    

As the nation’s largest public research university, the Office of the Vice President for Research (OVPR) aims to catalyze, support and safeguard U-M research and scholarship activity.

The Office of the Vice President for Research oversees a variety of interdisciplinary units that collaborate with faculty, staff, students and external partners to catalyze, support and safeguard research and scholarship activity.

ORSP manages pre-award and some post-award research activity for U-M. We review contracts for sponsored projects applying regulatory, statutory and organizational knowledge to balance the university's mission, the sponsor's objectives, and the investigator's intellectual pursuits.

Ethics and compliance in research covers a broad range of activity from general guidelines about conducting research responsibly to specific regulations governing a type of research (e.g., human subjects research, export controls, conflict of interest).

eResearch is U-M's site for electronic research administration. Access: Regulatory Management (for IRB or IBC rDNA applications); Proposal Management (eRPM) for the e-routing, approval, and submission of proposals (PAFs) and Unfunded Agreements (UFAs) to external entities); and Animal Management (for IACUC protocols and ULAM).

Sponsored Programs manages the post-award financial activities of U-M's research enterprise and other sponsored activities to ensure compliance with applicable federal, state, and local laws as well as sponsor regulations. The Office of Contract Administration (OCA) is also part of the Office of Finance - Sponsored Programs.

Ethics & Compliance

• eResearch IRB NextGen Project
• Class Assignments & IRB Approval
• Operations Manual (OM)
• Authorization Agreement Process
• ORCR Policies and Procedures
• Self-Assessment Tools
• Resources and Web Links
• Single IRB-of-Record (sIRB) Process
• Certificate of Confidentiality Process
• HRPP Education Resources
• How to Register a Clinical Trial
• Maintaining and Updating ClinicalTrial.gov Records
• How to Report Clinical Trial Results
• Research Study Participation - FAQ
• International Research
• Coordinated Services & Practices (CSP)
• Collaborative Research: IRB-HSBS sIRB Process
• Data Security Guidelines
• Research Incentive Guidelines
• Routine fMRI Study Guidelines
• IRB-HSBS Website Directory and Guidance
• Waivers of Informed Consent Guidelines

IRB Review Process

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• Human Subjects
• IRB Health Sciences and Behavioral Sciences (HSBS)

U-M HRPP Operations Manual References

IRB approval criteria: Part 3, Section III, C 6

Regulated/not regulated research: Part 4, Section V  

Exempt research policy: Part 4, Section VI

Using the U-M IRB System

IRB staff and board members have access to the IRB application and posted correspondence via the eResearch Regulatory Management (eRRM) system.  The system facilitates the IRB review process by:

• Providing regulatory checklists that guide IRB staff review
• Routing submissions to ancillary committees (e.g., COI-UMOR), as applicable
• Re-routing submissions to a different U-M IRB, if applicable

IRB-HSBS Turnaround Times

"Turnaround" is the estimated time it takes to complete the IRB review and determination process.

Full-board :  4 - 8 weeks

Expedited :  2 - 4 weeks

Exempt :  < 1 week

The U-M Institutional Review Boards (IRBs) fulfill their goals to protect human research participants and support the design and conduct of sound research by reviewing and approving IRB submissions for new applications, amendments, and continuing reviews.

All projects that meet the definition of research with human subjects ( 45 CFR 46.102 ) must be reviewed and approved by an IRB, or receive an exempt determination,  prior  to beginning the research.  The IRB staff initially screens submissions to determine the completeness and the appropriate type of review.  Submissions may be returned to the study team for changes before the review type is assigned.  The review type may be reassessed at any time during the review process.

Types of IRB Review

The basic types of IRB Review are: Comprehensive , Exempt , and Not Regulated .  The type of IRB review and the associated review process (e.g., full board , expedited , limited IRB review , system-generated ) are determined by the:

• Level of risk to research participants
• Type of research being conducted (e.g., an educational intervention, a survey, an ethnographic observation, etc.)
• Sensitivity of the research questions or complexity of the research design
• Involvement of vulnerable populations as research participants
• Use of identifiable information or indentifiable biospecimens
• Applicability of one or more of the criteria for exempt or expedited review

Research Requiring Comprehensive IRB Review

The IRB may conduct either an  expedited or full board review for IRB-regulated research proposed in the  Interaction/Intervention or   Secondary Use   application types  to ensure:

• Risks to the subjects are minimal, and are reasonable in relation to anticipated benefits
• The subject selection is equitable
• Privacy and confidentiality are protected
• Informed consent processes meet federal regulatory and U-M requirements 

Full Board Review

Federal regulations and institutional policy require a review by the IRB Full Board for applications where the research involves  more than minimal risk  to human subjects, does not meet the criteria for one of the categories of expedited review , or has been referred to the committee by an expedited reviewer or the Chair.  Regardless of risk level, IRB-HSBS may require full board review when the research involves: 

• Vulnerable populations, particularly prisoners
• Sensitive topics, including illegal behaviors which may require an NIH  Certificate of Confidentiality  (CoC) to protect subject data from compelled disclosure
• Research involving genetic/genomic analyses
• A complex research design requiring the expertise of multiple board members to evaluate

The IRB posts submission deadlines for upcoming IRB meeting dates. If an application is “board ready”, meaning that it contains all of the information and materials necessary for the full board to conduct its review, the application will be assigned to the next IRB meeting date (see Related Information to the right for schedule links), except where the agenda is already full or a reviewer with the necessary expertise is not available for that meeting. IRB staff assign submissions to a primary and secondary IRB reviewer for presentation at the full board meeting. Investigators may be invited to attend the meeting to answer questions from the board. At the conclusion of the meeting, the board votes and issues a determination for the submission.

IRB Full Board Determinations 

Approved : the application is approved as submitted.  The approval date is the date of the IRB review.

Approved with Contingencies : the application is approved, contingent on submission of specified changes to the protocol, informed consent document(s) and/or other supporting materials.  Final approval status is granted when the IRB has reviewed and approved all requested changes. The date of the "approved with contingencies" determination is deemed the date of approval.

Action Deferred : the IRB needs additional information from the investigator before the IRB can make all of the determinations found at 45 CFR 46.111  necessary to approve the study. The principal investigator must submit the requested additional information before the IRB will consider the application for further review.

Disapproved :  the protocol does not provide adequate protection to human participants, and it is unlikely that it can be modified to provide such protection. The IRB notifies the principal investigator of the disapproval in writing, including a statement of the reasons for its decision, and provides the opportunity for the investigator to respond to the IRB in person or in writing.

Tabled :  the IRB full board did not have time to review the application at the convened board meeting. The application is placed on the agenda for the next convened meeting.

Expedited Review

Federal regulations ( 45 CFR 46.110 ) authorize the use of an expedited review process for:

• Minimal risk  human research that meets one or more of the OHRP  Expedited Review Categories   
• Minor  changes to research  previously approved by the full board

Applications qualifying for expedited review are assigned to an expediting reviewer, an experienced IRB member appointed to the role by the IRB Chair.  The expediting reviewer has the authority to make a determination or to refer a submission for full board review for multiple purposes (e.g., clarification, expertise), including in cases of disapproval.  Only the full board has the authority to disapprove a study.  Most studies that qualify for the expedited review process do not require annual Continuing Review .

IRB Expedited Review Determinations

In addition to the  Approved  and  Approved with Contingencies  determinations ( described above ) reviewer may issue a Changes Requested  determination, when substantial changes to the application and/or materials are required before the expediting reviewer can approve the study. 

Exempt Research Review

Per university policy, investigators must submit an IRB application for determination of exemption before research begins. Applications are routed for exempt review through the Interaction/Intervention application or the Secondary Use application types.  IRB-HSBS recommends using the Brief Protocol for Exempt Research Projects (download) to provide an overview of you exempt project or as a data entry guide when completing the IRB application.

Projects that meet the criteria for a  federal exemption category  (45 CFR 46.104) or for a  U-M exemption #5  may be granted a  determination of exemption  by the IRB, or where applicable, through the system-generated review process.  The review determination, whether conducted by the IRB or system-generated, is limited in scope to the information necessary to determine if the proposed exemption applies.  The IRB does not review informed consent documentation or recruitment materials for proposed exempt studies.  Exemptions may be granted by the IRB Chair, expedited reviewers, or (in most cases) qualified IRB staff members.

Projects receiving an exempt determination are not subject to the Continuing Review process .  Amendments are required only if the changes to the project would alter the exemption criteria.  An exempt determination does not lessen the researcher's ethical obligations to participants as articulated in the Belmont Report or to the codes of conduct for specific disciplines.

Limited IRB Review

The Common Rule provides a Limited IRB Review process, which is a required expedited review of recruitment and consent materials as well as plans to maintain participant privacy and data confidentiality for exempt 2 and 3 projects that collect or use sensitive and identifiable data .  An exempt determination is issued once the expediting reviewer confirms that these protections are acceptable.

Not Regulated Review

Not all research-related activities that involve people, their data, or their biospecimens are covered by the regulations governing human research. However, investigators may wish to submit a brief eResearch IRB application for a formal “not regulated” determination for funding or publication purposes; or, the investigator may be able to issue a system-generated determination letter without submission to the IRB.

Submission to the IRB is not required for the following activities:

• Case studies
• Class activities
• Journalism/documentary activities
• Oral history
• Quality assurance and quality improvement activities
• Research on organizations
• Research using deidentified data or biospecimens
• Research using publicly available data sets

Some categories require IRB review for the purpose of assessing compliance with HIPAA or other regulations. These include:

• Research involving existing information or biospecimens that have been coded before the researcher receives them, but identifiers exist
• Research involving deceased individuals only
• Pre-review of clinical data sets preparatory to research
• Standard public health surveillance or prevention activities

For a complete list of not regulated research activities, see the HRPP Operations Manual, Part 4 .

If you can answer "yes" to the following questions, you need to submit an IRB application in eResearch for IRB review:

1.  Is it research?

Research is a systematic investigation (including research development, testing, and evaluation) designed to develop or contribute to generalizable knowledge   ~ Federal definition,  45 CFR 46.102 (l)

• Activities such as the  practice  of public health, medicine, counseling, or social work are not research. 
• Studies for internal management purposes (e.g., program evaluation, quality assurance, or quality improvement) are not research because the intent is not to provide generalizable knowledge but to apply findings only to the program or activity.

2.  Does the research involve human subjects?

Human subjects research is a project that involves a living individual about whom the investigator (whether student or professional) (i) obtains information or biospecimens through interaction/intervention with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses studies, analyzes, or generates identifiable private information or indentifable biospecimens.  ~  Federal definition  45 CFR 46.102 (e)(1) 

3.  Is the university engaged in the conduct of the research?​​

The university is "engaged" when the research is conducted by U-M faculty, staff, trainee, or other agent acting in connection to their university responsibilities.  See OHRP's Guidance on Engagement of Institutions for more information and examples.

• Direct awards from federal sponsors that meet criteria #1 and #2 are always reviewed by a U-M IRB, whether or not the university is engaged in the research.  
• If you answer "no" to any of these questions, you may have other obligations than IRB review.  See the U-M HRPP Operations Manual Part 4, Section V for more information about regulated/non-regulated research.

IRB Health Sciences and Behavioral Sciences Phone: (734) 936-0933 Fax: (734) 936-1852 [email protected]

• Human Subjects Protections

Human Research Protection Program and Institutional Review Board

• For Researchers
• For External Partners
• Research Impact
• Research Annual Report
• OSU Advantage
• Office of Research Integrity (ORI)
• Research Integrity Forums
• Research Security
• Report Concerns

What is the Institutional Review Board (IRB)?

The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.

The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants. The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, exempt, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy. The IRB shall have at least five members of varying backgrounds in order to provide complete and adequate review of human research and its institutional, legal, scientific, and social implications. The Board will also include at least one member who is not affiliated with the institution and one member who is not a scientist. The IRB has several consultants who advise the Board and are periodically involved in protocol review.

Human Research Protection Program, Institutional Review Board B308 Kerr Administration Corvallis, OR 97331-2140 [email protected] Phone: (541) 737-8008

• Education and Advising
• New Applications
• Post Approval
• Ethical Principles, Regulations, and Policies
• Guidance for Researchers
• Informed Consent Guidance and Templates

Contact Info

Division of Research and Innovation A312 Kerr Administration Corvallis, OR  97331-2140 Phone 541-737-3467

Institutional Review Board (IRB)

The Institutional Review Board (IRB) reviews research involving human participants to ensure that the rights and welfare of human participants are protected. The IRB has the authority to approve, require modifications, disapprove, suspend, terminate and observe the consenting process for research that falls within its scope of review, as specified by federal regulations and institutional policy. UT Austin has two IRBs: a Social Behavioral and Educational Research IRB (SBERIRB) and a Health Sciences IRB (HSIRB).

The HRPP and the UT IRBs have been accredited by the Association for the Accreditation of Human Research Participants (AAHRPP) since 2006.

Activities Requiring IRB Review

UT’s IRB’s provide ethical oversight to all activities that meet the regulatory definitions of research involving human subjects conducted by UT faculty, staff or students.

Research requires IRB review under Department of Health and Human Services (DHHS) regulations if the project is a systematic investigation designed to develop or contribute to generalizable knowledge AND involves living individuals about whom an investigator:

• Obtains information or biospecimens through intervention or interactions with the individuals, and uses, studies or analyzes the information or biospecimens
• Obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens

Additionally, research requires IRB review under FDA regulations if the project meets the definition of a clinical investigation — any experiment that involves one or more human subjects and an FDA-regulated test article (drug, device, biologic, human food additive, electronic product) other than in the course of standard medical practice — AND involves a human subject defined as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may either be a healthy individual or a patient.

If a research project meets either two scenarios above, IRB review and determination is required prior to beginning any research activities involving human subjects.

If an activity does not meet the regulatory definition of “research,” no IRB review is required. Similarly, if an activity is research, but it does not involve human subjects, the research does not require IRB review. Failure to meet either definition means that the activity is not human subjects research.

For help determining if research meets these regulatory definitions before submitting to the IRB, contact the IRB staff at [email protected] or online chat.

Determining When to Submit Activities to the IRB

Examples of activities that may or may not be human subjects research NIH Decision Tool: Am I Doing Human Subjects Research? HRP-310 – Worksheet:  Human Research Determination

PI Eligibility

The principal investigator (PI) of a human research study is the individual with ultimate responsibility for the conduct of the activities described in the IRB submission and for protecting the rights and welfare of human participants involved in the research. The PI must be available to devote adequate time and attention to the study to ensure its responsible conduct.

• Tenure-track faculty
• Research assistant, associate or full professor
• Non-tenure-track faculty who are paid UT employees
• Directors, chairs, deans, VPs or AVPs
• Affiliate of clinical faculty when all of the research will be conducted in a UT, Dell or Seton facility
• Research scientists
• Research associates
• Faculty instructors
• Emeritus faculty
• Adjunct faculty
• Visiting faculty and scholars
• Postdoctoral fellows
• Research assistants
• Graduate students
• Undergraduate students

Faculty Sponsors

A faculty sponsor, who is eligible to serve as a PI, is required for all students conducting human subjects research and should oversee the conduct of student conducted research. Students and their faculty sponsors are responsible for human subjects protections. The faculty sponsor is typically the student’s dissertation or thesis chair; however, this is not always the case. The sponsor will provide valuable recommendations about experimental designs aimed at reducing the risk to human subjects.

In the UTRMS-IRB system, the faculty sponsor will be listed as the PI and the student investigator should be designated as the PI Proxy. The PI Proxy will be able to submit actions in the UTRMS-IRB system.

Review Process

In the UT Research Management Suite – IRB Module, researchers can see at a glance where their submission is within the review process. At the top of the study action workspace is the workflow.

The RMS system uses “states” to classify where a submission is in the process. The following table defines the possible study states for a new study submission during the course of its review.

Pre-Submission The application is under preparation by the PI/submission preparer. The study will remain in this state until the PI/PI Proxy clicks Submit.

Pre-Review The submission is in the queue / is being reviewed by the assigned IRB Analyst.

Clarifications Requested Pre-Review The IRB Analyst has requested changes or clarification. The PI, PI Proxy and Primary Contact will receive an email notification advising them of the request. Details regarding the request can be found in the study workspace.

IRB Review The submission is currently being reviewed by an IRB member.

Clarifications Requested IRB Review The IRB member has requested changes or clarifications regarding the submission under review.

Post Review The IRB letter advising the PI of the IRB member or IRB committee’s decision is being prepared.

Modifications Required The IRB has requested additional modifications to secure final approval. The PI, PI Proxy and Primary contact will receive an email notification advising them of this request.

Review Complete The PI will receive the final approval/determination letter and IRB review is complete.

Departmental Review 

Some academic areas have a departmental review process for research submitted to the IRB. Researchers must follow all departmental requirements for review and approval, if applicable. For questions about the rules and procedures for departmental review or the applicability of this information to a submission, please contact the appropriate department.

IRB Review Types

Depending on the type of research conducted, it may be exempt, expedited or require full board review. The type of review is determined by risk level and categories as defined by federal regulations. Minimal risk is defined by federal regulations as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [45 CFR 46.102(j)].

Federal regulations identify several different categories of minimal risk research as being exempt from the regulations. This does not mean that they are exempt from IRB review, only that some of the federal requirements that apply to non-exempt studies are not applicable to studies deemed exempt. For example, exempt studies are not required to obtain written informed consent and are not required to submit modifications prior to implementation (unless they may affect the exempt status of the study).

Exempt reviews are performed administratively by the IRB Minimal Risk Research Team. For detailed information on the exempt categories and exempt submissions, refer to the IRB Policies and Procedures Section 5.4 Exempt Research . FDA regulated studies are not eligible for exemption under these categories.

Unlike exempt review, expedited review falls under the full scope of the regulations and is reviewed by a designated IRB member reviewer. Expedited studies must fall into one of the Expedited Review Categories .

All expedited studies must adhere to the requirements for informed consent or its waiver or alteration. Expedited studies may or may not be required to undergo continuing review. All modifications must be approved by the IRB prior to implementation, unless they are necessary for the immediate safety of participants.

Studies that are not eligible for expedited review (do not meet the definition of minimal risk and/or do not fit into an expedited category) must be reviewed by the convened IRB.

All full board studies must adhere to the requirements for informed consent or its waiver or alteration. Full board studies must undergo continuing review at least annually. All modifications must be approved by the IRB prior to their implementation, unless they are necessary for the immediate safety of participants.

Please email [email protected] with questions or to set up a consultation. Include information about the proposed research study or UT IRB Study Number (if available) along with questions to facilitate an efficient response.

Electronic Submission

All new human subjects research applications must be submitted electronically via the UT Research Management Suite – IRB Module (UTRMS-IRB) . If a study was originally approved in the legacy system, historical study documents and IRB determinations can be accessed in IRBaccess .

Submitting to the IRB

All new human subjects research must be reviewed by the IRB prior to the commencement of any study activity. The IRB Application Guide will assist UT Austin faculty, staff and students who are planning to conduct research involving human subjects.

Once IRB approval or determination has been granted, researchers must follow IRB Policies and Procedures for follow-on submissions during the course of their research study to remain in compliance. Examples of follow-on submissions include modifications, continuing reviews (when applicable), and reportable new information reports.

• See the step-by-step instructions on submitting new studies via UTRMS.
• Forms and templates are available for download via the UTRMS-IRB Library, “Templates” tab .
• Guidance documents help with questions during the submission process.

IRB Dates, Deadlines and Fees IRB Reliance Frequently Asked Questions

City of Philadelphia

• An official website of the City of Philadelphia government
• Here's how you know
• An official website
• Feedback and support

Mental & physical health

• Medical professionals

Submit a research study to the Institutional Review Board (IRB)

The Department of Public Health participates in research to improve services and care for the public. Research studies that involve human subjects must be reviewed by the Institutional Review Board (IRB) before and during the study.

Required reviews for research studies

Research studies require different levels of review based on the criteria outlined in this section.

Institutional Review Board (IRB) review

Research must be submitted to the IRB when it involves people receiving services from, or funded by/through, these City entities:

• Department of Behavioral Health and Intellectual disAbility Services (DBHIDS)
• Department of Human Services (with limited exceptions; ask for guidance)
• Department of Public Health
• Office of Homeless Services
• Prison Health Services .

Research must also be submitted to the IRB when it:

• Involves data, staff, or specimens from the Medical Examiner’s Office
• Is submitted with a request for review by other City departments.

This applies whether or not the study is a multi-site study or has been approved by another IRB.

Health Commissioner’s Office (HCO) Review Committee

Some studies must be submitted to the HCO Review Committee in addition to the IRB. This includes all research that:

• Involves Department of Public Health data
• Involves people receiving services from the department
• Involves people receiving services funded by the department
• Will result in a publication or conference presentation involving the department.

These studies must include an investigator or collaborator working for the Department of Public Health.

For details, see the Health Commissioner’s Office Review Committee Submission Form .

Data License Agreements (DLA)

You must get a DLA from the Law Department if any of the following apply:

• The principal investigator or co-principal investigator (applicant) works at a non-City entity
• The principal investigator or co-principal investigator (applicant) will share City data with any non-City entity
• The principal investigator or co-principal investigator (applicant) intends to publish the results of the study.

The Law Department must approve all DLAs. Applicants should submit a request through the City’s privacy review portal . For questions about the process, email [email protected] . Applicants should be prepared to provide an application to use City data for research . You will also need to include:

• Your IRB application materials
• The IRB’s approval or waiver letter
• A list of all data points or variables sought
• A narrative description of the study (if not included with the IRB application materials)
• A letter of support from all City departments contributing data
• Any state- or federal-level approvals, if necessary.

If a DLA is required, the Department of Public Health will not release data unless and until the DLA is fully executed.

Special regulations and requirements for research involving prisoners

Research involving prisoners is subject to additional federal and state regulations and requirements. The Pennsylvania Criminal History Records Information Act (PDF) severely limits access to prisoner health records, even with the prisoner’s consent. Researchers proposing studies involving prisoners or data about prisoners are urged to learn about these requirements.

If your study will involve prisoners in City facilities, you must get approval from the Philadelphia Department of Prisons  before applying for IRB approval.

Deadlines and meeting dates

Most new studies that require IRB approval must be reviewed by the full committee at a regularly scheduled meeting. Minimal-risk studies that involve  only  materials collected for non-research purposes may be eligible for expedited review, and can be submitted at any time. Please review the requirements on the proposal submission application.

For studies requiring full review, application submission deadlines are generally one month before a scheduled meeting of the IRB.

To confirm a meeting date, call the IRB office at (215) 685-0869 .Investigators are encouraged to attend the IRB meetings at which their applications will be reviewed.

Submitting your study for review

You must submit your study to the IRB before it begins. To submit a new study, complete a proposal submission application . Your application must include:

• An executive summary
• Consent forms and, if children are involved, assent forms
• Materials for participant recruitment or distribution
• The full research protocol or grant proposal
• Any data collection instruments (surveys, measurement scales, etc.)
• Conflict of interest forms for key personnel .

Investigators must also submit proof that they have taken human subjects research training within the last three years. City employees can access training through the City’s Learning Management System (LMS) . The course is listed as “PDPH IRB – NIH Human Subjects Training.” Investigators without access to this site can email the IRB office for a link to the course.

Managers of the City unit(s) involved must approve all studies. You may submit a  unit approval form  or a letter from the unit manager.

The PDPH IRB does not accept routine exclusion of potential research participants who do not speak English. Investigators must provide justification for exclusions based on language proficiency.

Be sure to number the pages on all study documents for review.

Informed consent

All consent and assent forms must adhere to  informed consent requirements .

You must inform all participants that they are being included in research, except for studies that qualify for a waiver. They must receive all pertinent information about that research and their rights. Please use or refer to the informed consent template .

Federal requirements for informed consent changed in 2019. To learn more, visit the U.S. Department of Health and Human Services regulations for the protection of human subjects in research .

Waiver or alteration of informed consent and waiver of Health Insurance Portability and Accountability Act (HIPAA) authorization

Federal regulations allow limited human subjects research without written informed consent. An IRB may also approve a waiver of HIPAA authorization under specific situations. The Law Department’s HIPAA Privacy Unit will review HIPAA waiver requests. Refer to the  summary information sheet  for information on what waivers the IRB may permit. Complete section 5 of the proposal submission application, as appropriate. Be sure to provide justification for any requested waiver or alteration.

We recommend that you get a third party opinion from a children’s rights advocate when requesting waiver of parental consent for minors participating in research. This person should not be involved in the project. They should review the study requirements for the child and determine if there is any extra risk to the child by their participation without parental consent.

You should submit any requests for an exempt study determination with the  proposal submission application . We recommend that you submit the exemption request at least two weeks before an application submission deadline. This allows time to make a full IRB study submission if the IRB determines that the study is not exempt.

Submitting documentation throughout your study

You’ll also need to submit documentation to the IRB throughout your study.

Continuing review of approved studies

All approved studies require a continuing review by the IRB. Investigators should submit update reports to the IRB between 20 to 60 days before the study is scheduled to expire.

Revisions to approved studies

The IRB will approve a study for a specific period of time (usually one year). During the period of your study, you may choose to submit revisions based on the study’s progress or other factors. Proposed revisions must be reviewed and approved before they go into effect.

Closure reports

Upon completion of an approved study, the principal investigator should submit a closure report to the IRB.

Forms & instructions

• Forms for studies submitted to the Institutional Review Board (IRB)
• Philadelphia Department of Prisons data disclosure protocol
• Health Commissioner’s Office Review Committee Submission Form
• City of Philadelphia Privacy Review Portal

Related content

Federal regulations.

• Federal Policy for the Protection of Human Subjects (‘Common Rule’)
• 21 CFR Part 50, Protection of Human Subjects
• 21 CFR Part 56, Institutional Review Boards

Other resources

• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
• U.S. Department of Health and Human Services, Office for Human Research Protection
• U.S. Food and Drug Administration, Clinical Trials and Human Subject Protection

Office of Science Policy

Clinical Research

Of NIH’s more than $17B investment, clinical trials (~$7B ) reflect the point at which the public is most directly engaged in NIH’s clinical research activities, either as dedicated volunteer research participants or users of the resulting data and health interventions. Successful management and oversight of the clinical trial enterprise remains essential to NIH’s mission to translate basic biomedical discoveries into improved health outcomes. OSP works to ensure that NIH’s clinical trial policies enhance the design, conduct and oversight of clinical trials.

Clinical Trials

• Clinical Trials E-Protocol Tool

Informed Consent

Nih single irb (sirb) policy, data and safety monitoring, protections for participants in research (human subjects research protections), privacy and confidentiality in research, return of research results.

• sIRB Policy Implementation

NIH Definition of Clinical Trial

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

• Notice of Revised NIH Definition of “Clinical Trial” Revised NIH Clinical Trial Definition
• NIH’s Clinical Trial Definition
• Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial?

Sharing Clinical Trial Information

HHS Final Rule for Clinical Trials Registration and Results Information Submission

• Federal Register Notice of Final Rule for Clinical Trials Registration and Results Submission
• NPRM Clinical Trials Registration and Results Submission (November 2014)
• Summary of the Final Rule and NIH Policy
• Key Elements of Final Rule and NIH Policy
• Summary Table of Changes from Current Practice Described in the Final Rule
• Federal Register Notice for NIH Policy on the Dissemination of NIH-Funded Clinical Trials
• NIH Guide Notice
• Federal Register Notice
• Compendium of Comments

GCP Training for NIH Awardees Involved in NIH-funded Clinical Trials

• Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials
• FAQs_on_NIH_GCP_Policy

Clinical Trial Enrollment Workshop (July 2015)

NIH Workshop on the Enrollment and Retention of Participants in NIH-funded Clinical Trials July 25, 2014

• Poster Abstracts
• Poster Abstract for Poster Presentation
• Proceedings

Presentations:

• Moon Chen Ph.D.,M.P.H, University of California, Davis
• Jonathan Ellen M.D., John Hopkins University
• Maria Freire Ph.D., FNIH
• Joseph Unger Ph.D., Fred Hucthinson Cancer Research Center
• Jeffrey Vigne, Friends of NIH
• Mary Woolley, Research! America
• ClinicalTrials.gov
• Clinical Trial Requirements for Grants and Contracts
• ICH E6 (R2) Good Clinical Practice (GCP) Integrated Addendum to ICH E6 (R1)
• New Review Criteria for Research Project Applications Involving Clinical Trials
• NIH ClinRegs
• NIH Clinical Trials and You
• NIH Stem Cell Clinical Trials & Other Information
• Regulations: Good Clinical Practice and Clinical Trials 
• Research Methods Resources
• OSP-OER Blog “Improving Visibility of NIH-Supported Clinical Trial Activities and Results Information”
• OSP-OER Blog “Building Better Clinical Trials through Enhanced Stewardship and Transparency”
• JAMA Article “Toward a New ERA of Trust and Transparency in Clinical Trials”
• NEJM Article “The Final Rule of U.S Clinical Trials Registration and Results Information Submission”

Clinical Trial E-Protocol Tool

Clinical trial e-protocol tool and template documents.

The  electronic protocol writing tool  aims to facilitate the development of two types of clinical trials involving human participants.  The first type of trials are Phase 2 and 3 clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) application.

NIH developed a second protocol template to help behavioral and social science researchers prepare research protocols for human studies measuring a social or behavioral outcome or testing a behavioral or social science-based intervention.

Both templates found in the electronic protocol tool meet the standards outlined in the  International Council on Harmonisation (ICH) Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance (ICH-E6) . These are international standards of good clinical practice that apply to all clinical trials, and their goals are to ensure research integrity and protect human subjects. In addition, use of the electronic protocol tool allows researchers to interface directly with clincialtrials.gov.

Take me to the Web-based e-Protocol Writing Tool

• Word Version of Final Template
• NIH Director’s Statement
• Under the Poliscope  blog
• Under the Poliscope  Blog

As a steward of the nation’s biomedical research enterprise, NIH is dedicated to ensuring that data and biospecimens are shared for research ethically, securely, and with respect for the privacy, autonomy, and well-being of research participants and the communities to which they belong. Responsible sharing of data and biospecimens derived from human participants relies on robust informed consent practices that uphold the principles of autonomy and trust in biomedical research. Fundamental to these practices are clear, efficient, and transparent communication strategies for conveying potential risks and benefits of sharing, enabling individuals to make informed decisions to participate in research, retain autonomy in decision making, and understand potential uses and contributions of their data and specimens.

OSP works to ensure robust informed consent practices are understood and in place across NIH, with the goal of protecting research participants altruistically donating data and specimens to advance the scientific enterprise.

Relevant Documents and Resources

• Informed Consent for Secondary Research with Data and Biospecimens: Points to Consider and Sample Language for Future Use and/or Sharing
• Request for Information: Developing Consent Language for Future Use of Data and Biospecimens
• Public Comments

The NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the National Institutes of Health (NIH) will use a single Institutional Review Board (sIRB) for all U.S. sites to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects. If you have any questions about this policy, please contact us  here .

• NIH Single IRB Policy
• Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
• Federal Register Notice on the Final NIH sIRB policy
• Federal Register Notice on sIRB Effective Date Extension
• NIH Guide Notice on the Final sIRB policy
• NIH Guide Notice on sIRB Effective Date Extension
• NIH Director’s Statement on the NIH sIRB policy
• OSP-OER Blog on the sIRB policy
• NCATS SMART IRB Reliance Platform
• Frequently Asked Questions about the Implementation of the sIRB policy
• NIH Guide Notice on Scenarios Illustrating the Use of Direct and Indirect Costs for Single IRB Review Under the sIRB Policy
• NIH Policy on the Use of a Single IRB for Multi-Site Research FAQs on Costs
• Request for Comments on the Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
• Public Comments on the Draft Policy
• New Federal Register Notice regarding the extension of the effective date for the Single IRB policy

Single IRB Review for Multi-Site Research Resource and Infrastructure Development Workshop (September 2018)

On September 12, 2018, NIH held a Workshop on Single IRB Resource and Infrastructure Development.  The workshop focused on successful strategies and lessons learned for modifying and enhancing institutional IRB infrastructure for single IRB review of multi-site studies.

Agenda Biographies Relevant Information and Resources

Presentations: SESSION I – Customizing eIRB Systems to Review Multisite Studies Using a Single IRB Model, Medical University of South Carolina SESSION I –  Models for Institutions Serving as sIRB of Record, Washington University SESSION I –  Single IRB Standard Best Practices, New York University SESSION II –  Models for Assisting Institution Relying on sIRB – Partnership and Innovation Exploring Single IRB Models to Support Clinical and Translational Research, Yale University SESSION II –  Models for Assisting Institutions Relying on sIRB – Incorporating sIRB Procedures into an Existing Research Network, University of Rochester SESSION III –  Facilitating Single IRB Review for Multi-site Research:The OneIRB IT Platform, University of Penslyvania SESSION III –  Administrative Supplements for CTSA Awardees: Development of Resources to Facilitate Single IRB Review for Multi-Site Research, University of Cincinnati Webcast

Clinical trials must be conducted with a high standard of quality that assures the research question is answered in a reliable, valid, and unbiased manner, and that the rights and welfare of human subjects are protected.

In 1998, NIH issued a  policy  and further  guidance  was published in 2000. The NIH Data and Safety Monitoring policy states that each NIH Institute and Center (IC) should have a system for appropriate oversight and monitoring of clinical trials in order to ensure the safety of participants and the validity and integrity of the data. The 1998 and 2000 policies provide guidance on when monitoring should be conducted by a Data and Safety Monitoring Board (DSMB). The NIH requirement for data and safety monitoring –at a level commensurate with the risks, size and complexity of the trial–is separate and distinct from the requirement for protocol review and approval by an Institutional Review Board (IRB).

• Healthcare Research and Quality (AHRQ) Data and Safety Monitoring Policy
• Office for Human Research Protections (OHRP): Guidance on IRB Continuing Review of Research
• FDA Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
• NIH Policy for Data and Safety Monitoring, June 10, 1998
• Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials, June 5, 2000
• Guideline on Data Monitoring Committees (European Medicines Agency, July 27, 2005)
• Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards (World Health Organization)

Participants in NIH-funded clinical research studies receive a robust set of protections in accordance with standards established by the U.S. Department of Health and Human Services (HHS) in 45 Code of Federal Regulations (CFR) part 46 (“the Common Rule”), and, when applicable, Food and Drug Administration (FDA) Regulations for 21 CFR Part 50 and 56. Additional protections for research participants are also established under Section 2012 and 2013 of the 21st Century Cures Act, the NIH Certificates of Confidentiality policy, the Privacy Act, and the HIPAA Privacy Rule. Protections provided by the Common Rule ensure the safety, rights, and welfare of participants in research (what the Common Rule calls “human subjects”) under a framework that prioritizes the ethical principles enshrined in the Belmont Report (i.e., respect for persons, beneficence, and justice). These protections include oversight of research by Institutional Review Boards (IRBs), as well as requirements for informed consent, confidentiality, and privacy.

OSP serves as a resource for and advisor to the NIH research community with respect to the implementation of regulations, laws, and policies impacting the protection of participants in NIH research. OSP advises on harmonization and optimization, works with NIH Institute, Center, and Office (ICO) partners to identify and resolve policy issues, and recommends and develops new policies as needed. OSP works closely with colleagues across NIH and HHS, including NIH ICOs as well as FDA, the Department of Defense (DOD), the Department of Veteran’s Affairs (VA), the HHS Office for Human Research Protections (OHRP), and the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP).

• Common Rule: 45 CFR Part 46
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Privacy and confidentiality are essential components of a robust research enterprise. NIH takes seriously the obligation to ensure privacy and confidentiality for individuals who have altruistically provided data and samples for research. Some of the obligations for these protections are outlined in the Common Rule, which describes a framework for protecting the privacy and confidentiality of sensitive, private information. Additional protections are provided by Section 2012 and 2013 of the 21st Century Cures Act and the NIH Certificates of Confidentiality Policy, which ensure appropriate protections for research when identifiable, sensitive information is collected or used. The Privacy Act and HIPAA Privacy Rule outline further protections for when individual data subject to these laws can be released.

OSP serves as a resource and advisor to the NIH research community on privacy and confidentiality regulations, laws, and policies. OSP advises NIH ICOs on these protections and works with ICOs to identify and resolve any policy issues.

• Common Rule: 45 CFR Part 46
• 21 CFR part 50 and 56 FDA Regulations for the Protection of Human Subjects
• Section 2012 and 2013 of the 21st Century Cures Act Provision on Certificates of Confidentiality
• NIH Certificates of Confidentiality policy
• NIH Certificates of Confidentiality website
• Privacy Act
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• 2013 Privacy Rule Amendments
• HIPAA Privacy Rule and Its Impacts on Research (nih.gov)

NIH has long supported a movement in the research enterprise to engage participants as partners in research by informing research priorities and advising on clinical study designs to ensure that outcomes are meaningful to them. Research participants, for their part, have indicated the desire to have information returned to them about the studies in which they participate, including individual-level research results. In 2018, NIH co-sponsored a study by the National Academies of Sciences, Engineering, and Medicine (NASEM) to examine Returning Individual Research Results to Participants , specifically reviewing the current evidence on the benefits, harms, and costs of returning individual research results while considering the ethical, societal, regulatory, and operational issues related to the return of individual-specific research results generated from research on human biospecimens. In recognition of the evolving nature of research and the relationship between research participants and investigators, as well as the responsibility to uphold participant preferences, various programs and initiatives across NIH are moving towards creating a more participatory model of enabling greater return of individual-level research results.

OSP serves as a resource for and advisor to the NIH research community with regard to identifying and resolving policy issues and promoting best practices for the appropriate return of individual research results to participants.

Funding Opportunities Across NIH (updated 4/3/23)

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Select Return of Research Results Efforts at NIH

The below list of programs and initiatives is non-exhaustive and highlights select examples that include either a focus on returning research results from particular studies or promoting the development of tools and best practices to enable return of results.

• All of Us Research Program
• Return of Research Results webpage
• CLINSEQ®: A Large-Scale Medical Sequencing Clinical Research Pilot Study
• Clinical Sequencing Evidence-Generating Research (CSER) Consortium
• Electronic Medical Records and Genomics (eMERGE) Network

Select Resources

• Clinical Laboratory Improvement Amendments of 1988 (CLIA)
• The Secretary’s Advisory Committee on Human Research Protections (SACHRP) Recommendation for Return of Individual Research Results—Sharing Study Data and Results: Return of Individual Results
• OSP Blog: Recommendations for Moving to a Process for Returning Research Results
• OSP Blog: A Fresh Look at the Rules for Returning Research Results

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• v.8(10); 2016 Oct

A Framework for Navigating Institutional Review Board (IRB) Oversight in the Complicated Zone of Research

Gretchen e parker.

1 Ethics Review, Pearl IRB LLC

The treatment therapies and technologies currently emerging from the rapidly evolving health care industry must undergo full examination in a clinical setting if they are to be marketed to the public. All elements of clinical studies involving human subjects must undergo thorough IRB review before study activities can commence. Regulations regarding IRB oversight apply to all clinical studies—including retrospective examinations of private medical data and identifiable biological samples. It is not uncommon for researchers to be unsure whether, or on what level, IRB review and oversight are required for a particular project. Yet, if human subjects or their private medical data are utilized in a study, peer-reviewed journals will require relevant IRB approval information be provided as a requirement for publication. This article examines IRB processes and review types, offers insight into the IRB decision-making process, and emphasizes the importance of engaging an IRB consultant early in the clinical study design process.

Introduction

From Phase I through post-market analysis, clinical investigations are continually developed and implemented to test a product or intervention’s safety and effectiveness. The assessment of interventions related to human subjects typically begins by performing preclinical animal tests to determine how the drug and/or intervention works and if it will be safe enough to be tested in humans. Preclinical studies also assess product absorption, excretion, and metabolism, and aid in identifying the correct human dosage. A series of clinical trials in three phases is then performed to test if the product is effective and safe in humans. A fourth phase, post-market analysis, occurs following regulatory approval of the product. Safety and effectiveness data must be generated and assessed throughout a product’s total life cycle.

The Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) are two agencies regulating clinical investigations. When implementing an investigational protocol, a clinical study’s principal investigator (PI) is responsible for following and complying with all applicable federal regulations regarding human subject research [ 1 ]. These responsibilities include obtaining initial and continuing IRB review and approval of the proposed research study. This obligation is especially important if you want to use these data for an investigational product application or in a publication. IRBs were formed as a result of disasters occurring in the field of human research. Studies including the Milgram obedience study, the Willowbrook hepatitis experiments, the Jewish Chronic Disease Hospital study, the Public Health Service (Tuskegee) syphilis study, and the Nazi medical experiments are all examples where researchers severely mistreated study subjects [ 2 ]. In all these examples, the subjects were not offered the same considerations and protections as other populations. In fact, they would have been better off had they never been included in the studies.

The IRB has the power to approve, require modifications to (in order to secure approval), or disapprove human subjects research. An IRB must review and approve all research involving humans before the study begins. An IRB may not review projects retrospectively. This includes proposed research involving previously collected human fluid and tissue samples and existing data, as well as advertising and recruitment procedures. In order to approve research, an IRB must determine that risks to subjects are minimized and reasonable in relation to anticipated benefits, selection of subjects is equitable, subjects are adequately consented, data are appropriately monitored, the privacy of subjects is maintained and the resulting data kept confidential, and vulnerable subjects are protected [ 3 ]. In short, the objective of an IRB is to ensure, both in advance and by periodic review and monitoring, that the rights and welfare of humans participating as subjects in a research study are protected. To accomplish this goal, IRBs meet to assess research protocols and their associated materials (e.g., informed consent documents and advertisements). IRB oversight is complex and includes a number of activities with numerous levels of IRB review and supervision.

Technical report

Unfortunately, instances where clinical investigators fail to acquire proper IRB oversight have occurred. In these cases, the investigator is often dismayed to find out an IRB cannot retrospectively review their study and, because of such, they cannot publish results in a peer-reviewed journal or use the data in a regulatory submission. Questions that arise often include:

- Does an IRB need to oversee my research study?

- Will my project require continual IRB oversight?

- What level of IRB review does my investigation require?

- Do I need to let the IRB know when my project is done?

There are a number of questions that an IRB reviewer must consider before these issues can be resolved. When determining the appropriate level of IRB oversight, an IRB reviewer must ask four basic questions about the study:

1. Is it research/are you engaged in research?

2. If yes, does the research involve human subjects?

3. If yes, is your research exempt?

4. If no, what level of IRB review is appropriate?

Is it research? What is a human subject? Are you engaged in research?

Definitions often differ between the FDA and DHHS/OHRP. Definitions of "research" are shown in Table ​ Table1. 1 . “Human subject” is defined in Table ​ Table2. 2 . If you believe your research meets the federal definition for human subjects research you must apply for IRB review and approval of your study prior to any commencement of intervention.

“Engaged in research” means that employees (or agents of an investigator or institution) are intervening or interacting with human subjects for research purposes or to obtain individually identifiable private health information for research purposes [ 4 - 5 ]. In brief, if your systematic investigation designed to develop or contribute to generalizable knowledge also interacts with human subjects or their private health information, you will need IRB approval and oversight. For example, you are considered “engaged in human subjects research” if you:

- Manipulate a human subject’s environment for research purposes (e.g., controlling environmental temperature, sound, or light; and coordinating social interactions).

- Interact with human subjects by participating in protocol-specified communication or personal contact (e.g., accruing specimens and administering questionnaires).

- Use invasive or noninvasive procedures for research purposes with human subjects.

- Are responsible for the informed consent process.

- Obtain private health information or identifiable biological specimens from any source for research purposes. In this case, one does not necessarily need to have direct interaction or intervention with the study subject.

- Receive an award (e.g., a grant or contract) directly from DHHS for non-exempt human subjects research. This is the case even if all research activities are carried out by another institution or individual.

For many clinical investigations, the role of some investigative team members might not meet the definition of being engaged in research. For example, if a technician receives a de-identified tissue specimen and they have no way to re-identify the tissue donor, the technician is not engaged in research. Therefore, under some circumstances, certain individuals may not be considered engaged in research even though study investigators elsewhere in their organization are.

In one example, de-identified tissue samples are sent to a laboratory for analysis. If laboratory personnel do not enroll subjects in the study, then the lab is not engaged in human subjects research. There is one exception: when the study is sponsored by DHHS and the PI is also from the lab performing the analysis, an IRB is required to review the study [ 6 ]. This is the case even when the PI is not personally engaged in the conduct of the study. DHHS rationalization for this is that the PI is ultimately responsible for oversight of the human subjects research being conducted at the site.

What types of studies might be considered exempt?

Research can be determined to be “exempt” if it is no more than “minimal risk” per 45 CFR §46.405 and fits one of the six federally designated exempt review categories listed in 45 CFR §46.101. Under this specific statute, studies that may qualify for exempt must still be submitted to the IRB for an exemption determination review prior to any intervention.

The six categories of human subjects research that is exempt from IRB oversight are:

1. Research conducted in established or commonly accepted educational settings, involving standard educational practices.

2. Research necessitating the use of educational tests, interview or survey procedures, or assessment of public behavior.

3. Research involving the use of educational tests, interview or survey procedures, or observation of public behavior when the human subjects are elected or appointed public officials or candidate for public office.

4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. This category applies only if these sources are publicly available or if the information is recorded by the investigator in such a way that the subject cannot be identified directly or through identifiers linked to the subject.

5. Research and demonstration projects which are conducted by, or subject to the approval of, department or agency heads, and which are designed to examine public benefit or service programs.

6. Taste and food quality evaluation and consumer acceptance studies.

But what if samples contain identifying donor information (the inverse of #4 above)? What level of review would be appropriate then? Expedited or full board? Since this is a minimal risk study, it could be expedited. However, if the study is greater than minimal risk (e.g., the investigator is prospectively collecting samples via invasive means) the study would need to go before the full board for review. These two types of review are discussed below.

What is an expedited review?

Expedited review allows the IRB chairperson or another experienced IRB reviewer designated by the chairperson to evaluate and approve minimal risk research. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not reject a study. When a reviewer cannot approve the research under expedited review, the study is referred to the full board for review.

To qualify for an expedited review, research must fall into one of nine federally defined, expedited categories [ 7 ]. These categories involve collection of non-anonymous samples and data in a manner that involves no more than minimal risk to subjects. Expedited categories include:

1. Clinical studies of drugs and medical devices only when certain conditions are met.

2. Collection of blood samples by heel/finger stick or venipuncture in certain patient populations and within certain amounts.

3. Prospective collection of biological specimens for research purposes by noninvasive means (e.g., placenta removed at delivery and nail clippings).

4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving X-rays or microwaves (e.g., magnetic resonance imaging and ultrasound).

5. Research involving materials that have been collected, or will be collected, solely for non-research purposes.

6. Collection of data from voice, video, digital, or image recordings made for research purposes.

7. Research on individual or group characteristics or behavior; or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methods.

8 and 9. Certain continuing reviews.

Some examples of expedited research are:

- Studies involving the prospective collection of hair or saliva samples.

- Collection of blood samples from healthy volunteers.

- Studies of existing pathological specimens with patient identifiers.

What is a full board review?

A full board review is necessary for any proposed human subject research that does not fall into either the exempt or expedited review categories. This research is deemed greater than minimal risk. Some examples of this type of research are:

- Studies involving the use of a drug for which an investigational new drug (IND) application is required.

- Studies involving vulnerable subjects. These may include children, pregnant women, prisoners, or employees.

- Studies involving the prospective collection of tissue samples via invasive means.

- Research involving general anesthesia or sedation.

- Some modifications to research initially approved by a convened IRB.

Once a PI has supplied an initial assessment, an IRB will verify or correct the level of review needed for a study before rendering a decision and forwarding approval documentation. Figure ​ Figure1 1 summarizes various levels of IRB oversight and Figure ​ Figure2 2 gives examples of situations which may be presented to an IRB for clarification.

Are changes to the regulations coming?

The short answer is yes. Changes are on the way. What is unclear is what will be changing or when the changes will take place. As a result of the technological advances currently impacting the clinical research industry, the DHHS has proposed changes to the Common Rule (45 CFR § 46) which could result in a major overhaul of human research regulatory requirements [ 8 ]. The DHHS proposed nineteen changes to the Common Rule; however, five major areas impacting clinical research could be affected. Briefly, these include: 

1. The harmonization of OHRP and FDA guidelines.

2. The simplification of informed consent requirements and forms.

3. Clinical research regulation changes: Research in which the subjects may be placed at risk and are identifiable could qualify for an exemption determination, thereby expanding the exempt category. Additionally, the existing six categories of research that are considered exempt may have new guidelines to follow.

4. Research involving biobanks: At present, residual biospecimens can be utilized for research purposes without individual consent by stripping the specimens of identifiers. The Notice of Proposed Rulemaking (NPRM) proposes written consent for research of this nature.

5. Changes to IRB scope: Currently, human subject federal protections only apply to studies that are funded by federal agencies or clinical investigations that involve products regulated by FDA. The NPRM proposes that regulations pertain to all studies conducted by U.S. institutions, regardless of funding source. As such, clinical studies that were not previously subject to IRB review may require IRB oversight.

To further complicate the issue, in 2016 at the request of Congress, the National Academy of Sciences (NAS) evaluated the effectiveness of the policies surrounding human subjects research and proposed recommendations for improving current regulations [ 9 ]. Citing the said problem of regulations lagging behind product development, the NAS made several suggestions, including withdrawing the aforementioned NPRM until several additional independent commissions are appointed to closely examine current regulations.

Clinical investigations are necessary to gather insight about medical treatments, strategies, and devices to determine whether they are safe and effective for use in humans. Investigators are legally required to follow all aspects of federal regulations and guidelines regarding human subject protections.

There are many groups which must be coordinated in order to effectively complete a clinical protocol. These include research sites, sponsors, contract research organizations (CROs), study volunteers, research institutions, and IRBs. IRBs can be valuable sources of information and provide guidance in implementing a clinical study that is in line with current regulations. This is of vital importance for those investigators who wish to conduct their study according to federal regulations, publish study findings, or apply for federal financial support.

At this time, regulations are in the process of being updated in an effort to keep up with the products currently being developed in the rapidly changing health care industry. Many of the proposed NPRM changes could provide clarity for researchers and possibly reduce regulatory burdens; however, other changes such as the biobank requirement to consent would add more regulatory burden to the exploding field of research. As such, an IRB should be consulted early in the study design process to ensure that study documents and procedures are in line with current requirements.

Conclusions

Researchers must effectively organize their resources to efficiently assess the many issues that arise during a clinical study. There are numerous ethical standards that govern research with human participants in the United States which are codified in the CFR. While regulations may evolve over time, the primary IRB responsibility of protecting the rights and welfare of humans participating in research studies will continue.

Acknowledgments

Gretchen Parker, PhD, RAC, CIP, serves as a co-chair at Pearl IRB. Pearl IRB is an AAHRPP-accredited, independent IRB that provides comprehensive IRB services. She can be reached at www.pearlirb.com, 317.899.9341, or [email protected].

The content published in Cureus is the result of clinical experience and/or research by independent individuals or organizations. Cureus is not responsible for the scientific accuracy or reliability of data or conclusions published herein. All content published within Cureus is intended only for educational, research and reference purposes. Additionally, articles published within Cureus should not be deemed a suitable substitute for the advice of a qualified health care professional. Do not disregard or avoid professional medical advice due to content published within Cureus.

The authors have declared that no competing interests exist.

Human Ethics

Consent was obtained by all participants in this study

Animal Ethics

Animal subjects: This study did not involve animal subjects or tissue.

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Kuali Research - Knowledge Base  - General documentation related to the Protocols module in Kuali Research

Forms and Templates

Starting Monday, March 21, 2022, create a new study application online in Kuali by selecting   IRB Application (Basic Study Information) Form (HRP-211) as the submission type. The same form is used for exemption requests, and there is no need to indicate a request for exemption or IRB review type.

All new studies submitted to the IRB will require the following documents:  protocol  (investigator study plan) and   any related study documents   (e.g., informed consent, survey instrument, recruitment materials). Submit related documents in   Word   format. Researchers should use the Protocol template HRP-503 (either in Word or build entirely in Kuali) to draft their investigator protocols. All study documents (consents, data collection instruments, recruitment materials, etc.) will continue to be attachments uploaded to Kuali by the researcher.

• HRP-503 Protocol Template Use this Word template (or build entirely in Kuali) 
• Consent_Form_12.20.22.doc *new logo*
• Consent_Form_recording_form_7.28.22.doc *new logo*
• Assent_Form_sample_7.28.22.doc *new logo*
• HIPAA Waiver request

After obtaining initial IRB approval, the PI is responsible for submissions to the IRB to amend, renew, request close, and report events for their study. For more information, visit our web page for  Managing an IRB Protocol . 

Reliance on External IRB Requests

• Starting Monday, March 21, 2022, requests to rely on an external IRB for review of a study can be submitted to the UMass Boston IRB online in Kuali by creating a new study and selecting   Request for External Reliance (form HRP-811)   as the submission type. The researcher should confirm with the external IRB that they are willing to be the reviewing IRB before submitting the request to UMass Boston IRB. IRB staff will review the request and assist with executing a reliance agreement. Reliance agreements are generally restricted to non-exempt human research (with some exceptions such as for exempt categories with limited IRB review).

Investigator Manual and HRPP Plan

Investigator Manual (HRP-103) A "one-stop shop" to guide investigators through the policies and procedures related to the conduct of human research at UMass Boston. 

Investigator Manual - Appendices (HRP-103a) Additional guidance and requirements to supplement the Investigator Manual.

Human Research Protection Program (HRPP) Plan (HRP-101) An overview of the mission and components of the HRPP at UMass Boston. 

IRB Guidance on GDPR Investigators planning to conduct research involving “personal data” about individuals located in European Union member states plus Norway, Iceland, Liechtenstein, and Switzerland need to be aware of these additional EU General Data Protection Regulations. We thank Brown University IRB for sharing this resource with us.

IRB Guidance on SONA Investigators using the SONA system for participant recruitment need to be aware of these additional reviews and considerations. We thank UMass Lowell IRB for sharing SONA guidance with us.

UMass Boston COVID-19 policies  If you have any questions, please reach out to the Office of Environmental Health and Safety (OEHS) at   [email protected] . 

IRB Checklists, Worksheets, and SOPs

IRB checklists, worksheets, and standard operating procedures (SOPs) are used by the IRB in making regulatory decisions. These tools offer researchers insight into what the IRB is reviewing in protocols. Researchers do not need to fill out these documents. They are for reference only.

Checklists:

• Waiver of Alteration of Consent Process Checklist (HRP-410)
• Waiver of Written Documentation of Consent Checklist (HRP-411)
• Prisoners Checklist (HRP-415)
• Children Checklist (HRP-416)
• Adults Lacking Decision Making Capacity Checklist (HRP-417)
• HIPAA Waiver of Authorization Checklist (HRP-441)

Worksheets:

• Human Research Determination Worksheet (HRP-310)
• Engagement Determination Worksheet (HRP-311)
• Exemption Determination Worksheet (HRP-312)
• Expedited Review Worksheet (HRP-313)
• Criteria for Approval Worksheet (HRP-314)
• Advertisements Worksheet (HRP-315)
• Payments Worksheet (HRP-316)
• Additional Federal Agency Criteria Worksheet (HRP-318)
• Limited IRB Review and Broad Consent Worksheet (HRP-319) Note:  Broad consent is not implemented at this institution
• Review of Information Items (HRP-321)
• FERPA Compliance Worksheet (HRP-331)
• Certificate of Confidentiality Worksheet (HRP-333)
• Definitions SOP (HRP-001)
• LARs, Children, and Guardians SOP (HRP-013)
• Informed Consent Process SOP (HRP-090)
• Written Documentation of Consent SOP (HRP-091)

What type of review does your study require?

Read below to learn the differences between exempt, expedited, and full Board review. Researchers themselves do   not   determine the type of IRB review -- only the IRB can make this determination. Formal IRB approval (or exempt determination) is required prior to conducting human research.

*Submissions received after 5 PM ET are considered received the next business day (excluding   holidays/campus closures ). The IRB operates year-round. Submissions are placed in queue to accommodate all applicants.  

Certain categories of human research are exempt from regulation but require initial IRB review. Ongoing IRB review and approval is not always needed after obtaining the initial exempt determination.

Some new exempt categories (i.e., category 2 iii) also require a type of expedited review called "limited IRB review" (see   Limited IRB Review Worksheet (HRP-319 )."

Note: Exempt human research is NOT the same as activities which are " not human research ."

Application deadline: None. Accepted and reviewed on a rolling basis.

Review timeframe: within about 3 weeks*

Certain categories of non-exempt human research may qualify for review using the expedited procedure, meaning that the study may be approved by a single designated IRB reviewer, rather than by the full Board.

Human research that poses minimal risk to human subjects and falls under one or more permissible expedited categories are eligible for expedited review.

Full Board:

Non-exempt human research that does not qualify for review using the expedited procedure (e.g., research presenting greater than minimal risk to participants and/or research procedures not all within the expedited review categories) must be reviewed at a convened meeting of the full Board.

Application deadline: See Deadlines And Meetings

Review timeframe: within about one week after the meeting date

Related Links

Clinical Trial Definition (NIH)

Clinical Trial Decision Tool (NIH)

Code of Federal Regulations (DHHS)

Data Protection & Export Control/International Travel (UMass Boston)

Data Security Services (UMass Boston IT/Research Computing)

FERPA Guidance (UMass Boston Office of the Registrar)

FERPA Guidance (U.S. Department of Education)

GDPR Compilation of Guidances (DHHS)

Gift Card Request Process (UMass Boston)

HIPAA Guidance (DHHS)

Human Subjects - Frequently Asked Questions (NIH)

Information Technology Services (UMass Boston IT)

Information Technology Services - Data Security Guidelines (UMass Boston IT)

International Research Guidance (DHHS)

OneDrive Online File Storage (UMass Boston IT)

Online Survey Protection References

Payment to Research Subjects (FDA)

Recruiting Study Subjects (FDA)

Social-Behavioral Research Standards (DHHS)

UMass Boston Research Home Page

Zoom Video Conferencing (UMass Boston IT)

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HSC IRB Calendar

Boards 3 & 4 irb meetings.

Event date: 5/13/2024 12:00 PM iCal Export Export event -->

IRB Meetings for Boards 3 and 4 on May 20th

A component of the Human Research Protection Program (HRPP), the Institutional Review Boards (IRB) mission is to protect the rights, safety, and well-being of people involved in research. The IRBs review human research to ensure that it meets the ethical principles and complies with federal regulations, state laws, and OU policies. 

The OUHSC IRB Office reviews human research conducted by faculty, staff, and students for OUHSC in Oklahoma City and Tulsa, and as well as medical and clinical research that is conducted by OU-Norman researchers. The HSC IRB Office also reviews human research for OU Health, Dean McGee Eye Institute, and VA Health Care System in Oklahoma City and Eastern Oklahoma.

Getting Started

Single IRB Review

Specific Resources For:

Researchers & Study Staff

Board Members

Request Consultation

Do you have a question about your application or study, iRIS, reliance agreements/single IRB, or something else?

Click to learn more and to request a meeting.

PI Self-Assessment Tools

Checklists are available to PIs and study teams to evaluate how well studies comply with regulations and policies, including record keeping.

Click to learn more.

Presenter & Training Requests

Would you like to request a member of HRPP staff present at your event or to your class or department? Click to learn more and to submit your request.

Phone: 405-271-2045

Main Email: [email protected]

Single IRB Email: [email protected]

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Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure (1998)

Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure [1]

Applicability

• Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
• The categories in this list apply regardless of the age of subjects, except as noted.
• The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects= financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
• The expedited review procedure may not be used for classified research involving human subjects.
• IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB.
• Categories one (1) through seven (7) pertain to both initial and continuing IRB review.

Research Categories

• (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
• Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
• (a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
• from other adults and children [2] , considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
• Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
• Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
• Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4) . This listing refers only to research that is not exempt.)
• Collection of data from voice, video, digital, or image recordings made for research purposes.
• Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
• where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
• where no subjects have been enrolled and no additional risks have been identified; or
• where the remaining research activities are limited to data analysis.
• Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

[1] An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110 .

[2] Children are defined in the HHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR 46.402(a) .

Source: 63 FR 60364-60367 , November 9, 1998.