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Australian Code for the Responsible Conduct of Research, 2018

The  Australian Code for the Responsible Conduct of Research, 2018  (the 2018 Code) establishes a framework for responsible research conduct that provides a foundation for high-quality research, credibility and community trust in the research endeavour.  

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The 2018 Code is a principles-based document that articulates the broad principles and responsibilities that underpin the conduct of Australian research.

Developed jointly by the National Health and Medical Research Council, the Australian Research Council and Universities Australia, the 2018 Code has broad relevance across all research disciplines.

Adherence to the 2018 Code is a prerequisite for the receipt of funding by the National Health and Medical Research Council.

Guidance to support the Code

The 2018 Code should be read alongside the Guide to Managing and Investigating Potential Breaches of the Australian Code for the Responsible Conduct of Research , 2018 (the Investigation Guide) – see 'Download' below. This guide outlines a model process for institutions to use to manage and investigate potential breaches of the 2018 Code.

The 2018 Code is also supported by guides on specific topics to encourage responsible research conduct. The co-authors have released guides on:

• Managing and investigating potential breaches of the Australian Code for the Responsible Conduct of Research
• Authorship (see download below)
• Management of data and information in research (see download below)
• Peer review (see download below)
• Disclosure of interests and management of conflicts of interest (see download below)
• Supervision (see download below)
• Collaborative research (see download below)
• Publication and dissemination of research (see download below)
• Research Integrity Advisors Guide (see download below)

NHMRC recognises the critical contribution that consumers can make to research, as well as their right to participate in research. The Statement on consumer and community involvement in health and medical research (the Statement) complements the Code, by guiding research institutions, researchers, consumers and community members in the active involvement of consumers and community members in all aspects of health and medical research. The Code, together with the Statement establishes a framework for credibility and community trust in publically funded research.

For further information please refer to the following webpage about the release of the 2018 Code .

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National Health and Medical Research Council (NHMRC)

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NHMRC, GPO Box 1421, Canberra, Australian Capital Territory, ACT,2601, Australia Tel: (61) 2 6217 9000 Fax: (61) 2 6217 9100 Email: [email protected] Website: www.nhmrc.gov.au Contact: Executive Director

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The National Health and Medical Research Council (NHMRC) (Australia) consolidates within a single national organization the often independent functions of research funding and development of advice. One of its strengths is that it brings together and draws upon the resources of all components of the health system, including governments, medical practitioners, nurses and allied health professionals, researchers, teaching and research institutions, public and private programme managers, service administrators, community health organizations, social health researchers and consumers.

Biomedical (C J Martin) Fellowships

Subjects: Biomedical sciences.

Purpose: To enable fellows to develop their research skills and work overseas on specific research projects within the biomedical sciences under nominated advisers.

Eligibility: Open to Australian citizens or graduates from overseas with permanent Australian resident status who are not under bond to any foreign government. Candidates should hold a Doctorate in a medical, dental or related field of research, be actively engaged in such research in Australia and have no more than 2 years postdoctoral experience at the time of application.

Level of Study: Postdoctorate

Type: Fellowship

Value: An allowance of Australian $5,000 per year is payable for research support, including conference travel, for the 2 year Australian portion of the Fellowship. Please check website for full detail

Length of Study: 4 years, the first 2 of which are to be spent overseas and the final 2 in Australia

Frequency: Annual

Study Establishment: Institutions approved by the NHMRC, such as teaching hospitals, universities and research institutes

Country of Study: Any country

No. of awards offered: Varies

Application Procedure: Application forms available from the website.

Closing Date: July 7th

Funding: Government

No. of awards given last year: 31

No. of applicants last year: 79

Additional Information: Please check website for more details.

Biomedical (Dora Lush) and Public Health Postgraduate Scholarships

Subjects: Biomedical sciences and public health.

Purpose: To encourage science Honours or equivalent graduates of outstanding ability to gain full-time health and medical research experience.

Eligibility: Open to Australian citizens who have already completed a science Honours degree (or equivalent) at the time of submission of the application, science Honours graduates and unregistered medical or dental graduates from overseas, who have permanent resident status and are currently residing in Australia. The scholarship shall be held within Australia.

Level of Study: Postgraduate

Type: Scholarship

Value: Varies

Length of Study: 1 year, renewable for up to 2 further years

Country of Study: Australia

Application Procedure: Applicants should visit the website at https://www.nhmrc.gov.au/grants-funding/apply-funding/postgraduate-scholarships/postgraduate-scholarships-categories-award for details.

Closing Date: Varies

No. of awards given last year: 51

No. of applicants last year: 133

For further information contact:

Centre for Research Management & Policy, NHMRC, GPO Box 9848, Canberra, Australian Capital Territory

Biomedical Australian (Peter Doherty) Fellowship

Purpose: To provide full-time training in basic biomedical sciences research in Australia.

Eligibility: Open to Australian citizens or graduates from overseas with permanent Australian resident status who are not under bond to any foreign government. Candidates should hold a Doctorate in a medical, dental or related field of research or have submitted a thesis for such by December in the year of application, be actively engaged in such research in Australia or overseas and have no more than 2 years postdoctoral experience at the time of application.

Value: Fellowship salary packages at the Training Support Package level 1 is $62,250. An allowance of $5,000 per year is payable for research support, including conference travel

Length of Study: 4 years

No. of awards given last year: 30

No. of applicants last year: 100

Career Development Fellowship

Subjects: Any human health-related research area.

Purpose: To help researchers to conduct research that is internationally competitive and to develop a capacity for independent research.

Eligibility: Open to Australian citizens or permanent residents, normally between 3 and 9 years postdoctoral experience.

Value: Australian $96,040–106,230 per year

Length of Study: 5 years

Study Establishment: Institutions approved by NHMRC, such as teaching hospitals, universities and research institutes

Application Procedure: Application forms available from the website www.nhmrc.gov.au .

Closing Date: March 19th

No. of awards given last year: 54

No. of applicants last year: 434

Clinical (Neil Hamilton Fairley) Fellowship

Subjects: All health-related fields.

Purpose: To provide training in scientific research methods.

Eligibility: Open to Australian citizens or graduates from overseas with permanent Australian resident status who are not under bond to any foreign government. Candidates should hold a Doctorate in a health-related field of research or have submitted a thesis for such by December of the year of application, be actively engaged in such research in Australia and have no more than 2 years postdoctoral experience at the time of application.

Value: Fellowship salary packages at the Training Support Package level 1 is currently at $62,250 and if appropriate, clinical loadings will be paid

Application Procedure: Application form available from the website.

No. of awards given last year: 4

No. of applicants last year: 10

Additional Information: For more information check website.

NHMRC Early Career Fellowship

Subjects: Scientific research, including the social and behavioural sciences, that can be applied to any area of clinical or community medicine.

Purpose: To undertake research that is both of major importance in its field and of benefit to Australian health.

Eligibility: Open to Australian citizens or graduates from overseas with permanent Australian resident status, who are not under bond to any foreign government. Candidates should hold a Doctorate in a health-related field of research or have submitted a thesis for such by December of the year of application, be actively engaged in such research in Australia or overseas and have no more than 2 years postdoctoral experience at the time of application.

Value: Funding is for 4 years at TSP1 Level, which currently is $67,508

Application Procedure: Application forms are available from the website.

Closing Date: May 1st

No. of awards given last year: 9

No. of applicants last year: 21

Additional Information: For more information check website www.nhmrc.gov.au/grants-funding/apply-funding/early-career-fellowships .

NHMRC Medical and Dental and Public Health Postgraduate Research Scholarships

Subjects: Medical, dental and public health research.

Purpose: To encourage medical and dental and public health graduates to gain full-time research experience.

Eligibility: Open to Australian citizens who are medical or dental and public health research graduates registered to practice in Australia, with the proviso that medical graduates can also apply during their intern year and that dental postgraduate research scholarships may be awarded prior to graduation provided that the evidence of high quality work is shown. Also open to medical and dental graduates from overseas who hold a qualification that is registered for practice in Australia, who have permanent resident status and are currently residing in Australia.

Study Establishment: Institutions approved by the NHMRC such as teaching hospitals, universities and research institutes

Application Procedure: Available from the website at www.nhmrc.gov.au/grants-funding/apply-funding/postgraduate-scholarships/postgraduate-scholarships-categories-award .

No. of awards given last year: 6

No. of applicants last year: 12

Additional Information: The award is divided into two categories: Medical and Dental Public Health Postgraduate Research Scholarships and Public HealthPostgraduate Research Scholarships.

NHMRC/INSERM Exchange Fellowships

Purpose: To enable Australian Fellows to work overseas on specific research projects in INSERM laboratories in France and vice versa.

Eligibility: Open to Australian citizens and permanent residents, who are not under bond to any foreign government, who hold a Doctorate in a medical, dental or related field of research or have submitted a thesis for such by December in the year of application, are actively engaged in such research in Australia and have no more than 2 years postdoctoral experience at the time of application.

Value: Fellowship stipend Australian $62,250. A maintenance allowance for research support of $5,000 per year For more information please check website www.nhmrc.gov.au/_files_nhmrc/file/grants/apply/training/insermfy.pdf

Length of Study: 4 years, the first 2 of which are to be spent in France and the final 2 in Australia

Study Establishment: Institutions approved by the NHMRC, such as teaching hospitals, universities and research institutes, and INSERM laboratories in France

Country of Study: France or Australia

No. of awards offered: 1

Application Procedure: Applications forms available from the website.

No. of awards given last year: 1

Additional Information: This fellowship is awarded in association with I’Institut National de la Santé et de la Recherche Médicale (INSERM), France.

Public Health Australian Fellowship

Subjects: Public health.

Purpose: To provide full-time training in public health research in Australia.

Eligibility: Applicants should hold a Doctorate in a health-related field of research or have submitted a PhD by December in the year of application and have no more than 2 years postdoctoral experience. Applicant must also, for years 1 and 2, nominate a department [preferably institution] and research group other than that where the applicant’s doctoral qualifications were obtained. Open to Australian citizens or permanent residents.

Value: Australian $67,508 and $5,000

No. of awards given last year: 17

No. of applicants last year: 61

Public Health Overseas (Sidney Sax) Fellowships

Purpose: To provide full-time training overseas and in Australia in public health research.

Eligibility: Applicants should hold a Doctorate in a health-related field of research or have submitted a PhD by December in the year of application and have no more than 2 years postdoctoral experience. Open to Australian citizens or permanent residents.

Value: Fellowship salary support packages at the Training Support Package level 1, that is $62,250, will be paid. Minimum cost airfares for the Fellow and dependants will be provided for direct travel to, and return from, the overseas centre. Additional overseas and Australian allowances are also payable

No. of awards given last year: 3

No. of applicants last year: 11

Training Scholarship for Indigenous Health Research

Subjects: Indigenous Australian Health Research.

Purpose: To provide support for research training or training leading to research areas of particular relevance to Indigenous Australians.

Eligibility: Applicant must be an Australian citizen or Australian permanent resident, have made prior arrangements with the Head of Department or Institution in which they propose to study, provide a specific study plan within a clearly defined area and conduct research of potential benefit to Australia.

Value: Depends on the qualification and current registration. Please check website

Length of Study: 1 year, renewable up to further 2 years

Application Procedure: Available from the website at www.nhmrc.gov.au/grants-funding/directory-previous-nhmrc-grants/training-scholarships-indigenous-health-research .

Closing Date: August 4th

No. of applicants last year: 6

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© 2018 Macmillan Publishers Ltd.

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(2018). National Health and Medical Research Council (NHMRC). In: The Grants Register 2018. Palgrave Macmillan, London. https://doi.org/10.1007/978-1-349-94186-5_833

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DOI : https://doi.org/10.1007/978-1-349-94186-5_833

Published : 10 January 2018

Publisher Name : Palgrave Macmillan, London

Print ISBN : 978-1-137-59209-5

Online ISBN : 978-1-349-94186-5

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Australasian human research ethics consultancy services pty ltd (ahrecs).

Research Ethics Monthly | ISSN 2206-2483

Release of the national statement on ethical conduct in human research 2007 (updated 2018) – with interview.

The revised National Statement on Ethical Conduct in Human Research 2007 (updated 2018) was released on 9 July 2018.

. Content of the updated National Statement

The National Statement consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act 1992 and is subject to rolling review. This means that parts of the National Statement are updated as needed, in accordance with strategic planning, or in response to user feedback or national or international developments in research or ethics.

Since 2007, Section 3 of the National Statement has addressed ethical considerations specific to research methods or fields. The 2018 revision provides a new structure for Section 3, based on the elements of a research project (from conception to post-completion). The revised Section 3 begins with a chapter that addresses ethical issues in all research, followed by specialised guidance for research involving human biospecimens, genomics and xenotransplantation.

While significant changes have been made to all aspects of the guidance provided in Section 3, we note, in particular, the additional guidance that has been provided in relation to collection, use and management of data and information and to management of the findings or results arising from genomic research.

As part of this update, changes have also been made to Chapters 5.1, 5.2 and 5.5 in Section 5, the Glossary and the Index as a consequence of the revisions to Section 3.

Revisions to the National Statement were informed by working committees and through public consultation in accordance with requirements of the National Health and Medical Research Council Act 1992.

Currency and effective date

All users of the National Statement, including HRECs, research offices and researchers are expected to ensure that the current version of the National Statement is being used in developing research proposals, making submissions for ethics review and undertaking ethics review. However, as a consequence of the scope of the revisions to Section 3, we expect that users of the National Statement will gradually integrate these revisions into their proposals, submissions and review over the period from July to December 2018, with full implementation expected by 1 January 2019.

This timeline is intended to give researchers and HRECs an opportunity to familiarise themselves with the new guidance prior to the revocation of the version of the National Statement updated, most recently, in 2015. To facilitate this transition, both the current version of the National Statement and the updated version are available on the NHMRC website at http://nhmrc.gov.au/guidelines/publications/e72 .

Use of the National Statement is also linked to the Human Research Ethics Application (HREA), released in December 2016 to replace the National Ethics Application Form.

To coincide with the release of the revised National Statement, questions in the HREA will require revision and users of the HREA will be advised when the revised HREA is online.

Institutions and HRECs are encouraged to allow a transition period for researchers while the revisions to the HREA take effect. The provision of a transition period, how it will be managed and its timeframe are at the discretion of individual Institutions/HRECs.

Australia’s research integrity framework is underpinned by three national standards developed by NHMRC and its co-authors, the Australian Research Council (ARC) and Universities Australia (UA). Together these three standards provide guidance on responsible and ethical research conduct for both humans and animals.

The overarching document is the Australian Code for the Responsible Conduct of Research, 2018. The Code is the leading reference for researchers and institutions across all disciplines about the expectations for responsible research conduct and the handling of investigations into research misconduct. After 10 years in operation, the Code has been reviewed and the 2018 edition was released in June 2018. The other two documents are the National Statement and the Australian code for the care and use of animals for scientific purposes (also endorsed by CSIRO).

AHRECS (While we know it predated the recent work on s3) What drove the decision to conduct a rolling review, rather than a review of the entire document?

NHMRC During the revision of the National Statement that was completed in 2007, it was determined that a more flexible, more efficient approach to revising the document would be a good innovation. We wanted to be able to both respond to the needs of users for more limited changes – from a word, to a paragraph, to a single chapter – without having to review the whole document and to be able to integrate or modify the content in response to changes nationally or internationally in research, research ethics or government regulation. Review of the 1999 National Statement took three years from start to finish and we thought we could improve on that timeline! We have found that this approach has, in practice, enabled us to make both minor changes and significant changes to single chapters of the document, as well as to review one of the five sections of the document, as we have just done.

AHRECS Are there downsides to that approach?

NHMRC Yes, there are. The major downside is that the document is ‘of a piece’ and changes to any one part of the document invariably require consideration of changes to the other parts, not just in terms of cross-referencing, but in terms of the content itself. This issue of ‘consequential effect’ manifests itself in the need to ensure consistency in our guidance and to consider the impact on the whole document of more philosophical or conceptual changes that have been introduced by the changes. An example in the most recent revision of Section 3 is that our approach to interventional research in Section 3 had a ‘flow on’ effect to Section 5 in terms of where certain guidance belonged, how that guidance should reflect changes in the clinical research sector since 2007 and how it should reflect other guidance documents (e.g. related to safety reporting) that NHMRC has published in the last 12 months.

AHRECS What were you hoping to accomplish with the changes to section 3 (and Section 5 + the Glossary)? Was it achieved?

NHMRC Principally, we were hoping to facilitate a re-thinking on the part of users (researchers and HRECs, primarily) regarding how they conceptualise and address ethical issues in the design, review and conduct of the research. We began with a decision to abandon the idea of ‘categories’ or ‘types’ of research as the main way to package this guidance and to focus on the reality that most ethics guidance applies to ALL research, thereby requiring ALL researchers to consider it, rather than just going to their specialised chapter of the document and, potentially, ignoring the broader issues. We then settled on the ‘life cycle’ of a research project as the best structure – that is, from conception to post-completion stages of a research project. This also enabled us to see more clearly what was not general guidance and encapsulate that extra guidance in separate, specialised chapters that each required consideration of the general guidance as a prerequisite to fully understanding and implementing the specialised guidance content.

The changes that we made to Section 5 and the Glossary were a direct consequence of the revision of Section 3 and we purposefully did not introduce changes to those parts of the document that were independent of the Section 3 revision, even though it was pretty tempting to do so sometimes.

We do think that we achieved our objectives and we are very satisfied with the results of the review process.

AHRECS If you could say just one thing about the work to date what it be?

NHMRC Review of the National Statement, while challenging, involves very stimulating and satisfying dialogue with lots of researchers, reviewers and other users of the document. We are so committed to it that we are almost immediately taking on the review of Section 4 and Section 5 – so, watch this space!

AHRECS When someone says they would have liked examples to better illustrate the new concepts in the update how do you respond?

NHMRC A weaselly response would be: it depends on which new concepts you are talking about; but, to use one example, a good look at Chapter 3.3: Genomic research and the Decision tree for the management of findings in genomic research and health care that we included (on page 52) to address this complex issue provides just such an attempt to illustrate by example. The main impediment to using examples or case studies to illustrate concepts is the difficulty of deciding which concepts to illustrate and with how many examples, as well as potentially expanding the size of the document exponentially in order to do the examples justice.

AHRECS When will a html version be available online?

At present, the 2007 version of the National Statement (updated May 2015) is available in both PDF and HTML format; whereas the version updated 2018 is only available in PDF. We are not 100% sure when the HTML version of the National Statement (updated 2018) will be available, but we anticipate within the next two to three months. Please also note that the current address ( https:// beta .nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018#block-views-block-file-attachments-content-block-1 ) is only temporary, which means that you’ll need to update your bookmarks/links again when the final version of the new NHMRC website is released in late August or early September.

This post may be cited as: NHMRC (31 July 2018) Release of the National Statement on Ethical Conduct in Human Research 2007 (updated 2018). Research Ethics Monthly . Retrieved from: https://ahrecs.com/human-research-ethics/release-of-the-national-statement-on-ethical-conduct-in-human-research-2007-updated-2018-with-interview

We invite debate on issues raised by items we publish. However, we will only publish debate about the issues that the items raise and expect that all contributors model ethical and respectful practice.

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The ARC is committed to the highest standards of integrity in all aspects of research it supports. This includes ensuring that ARC-funded research is conducted according to appropriate ethical, legal and professional frameworks, obligations and standards; as well as the development and support of a research environment that is underpinned by a culture of integrity. To encourage responsible research practices, all Proposals and ARC-funded research Projects are either recommended or required to conform to the principles outlined in the following and their successor documents, as stipulated within the scheme-specific funding rules:

• The Australian Code for the Responsible Conduct of Research (2018) 

Supplementary Guides supporting implementation of the Code

Arc research integrity policy, national principles of intellectual property management for publicly funded research, the national statement on ethical conduct in human research (2007)—updated 2018, the national statement on ethical conduct in human research (2023)—effective 1 january 2024, ethical conduct in research with aboriginal and torres strait islander peoples and communities: guidelines for researchers and stakeholders.

• AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research (the AIATSIS Code)

The Australia Council for the Arts, Indigenous Cultural Protocols for Producing Indigenous Australian Music, Writing, Visual Arts, Media Arts and Performing Arts (2007)

• The Australian Code For The Care And Use Of Animals For Scientific Purposes 8th edition ( 2013)

Other guidelines relating to the use of animals for scientific purposes, as promulgated by the NHMRC

The australian code for the responsible conduct of research (2018)  .

In June 2018, the ARC, National Health and Medical Research Council (NHMRC) and Universities Australia (the co-authors) issued the  Australian Code for the Responsible Conduct of Research 2018  (the Code) and the  Guide to Managing and Investigating Potential Breaches of the Code  (the Investigation Guide).

• Message from the co-authors about the release of the revised Australian Code for the Responsible Conduct of Research 

The Code articulates the broad principles that characterise an honest, ethical and conscientious research culture. It outlines the expectations for the conduct of research in Australia or research conducted under the auspices of Australian institutions. The new Investigation Guide will assist institutions to manage, investigate and resolve complaints about potential breaches of the Code.

The 2018 Code and Investigation Guide replace the 2007 version of the Code. NHMRC, ARC and Universities Australia expect institutions to meet the requirements of the 2018 Code and Investigation Guide by no later than 1 July 2019.

• Further information relevant to the implementation of the 2018 Code and Investigation Guide is available on the NHMRC website.  

The ARC, NHMRC and Universities Australia are developing a series of supplementary guides designed to support institutions and researchers to implement and comply with the Australian Code for the Responsible Conduct of Research (the Code).

The following guides have been released and can be downloaded from the  NHMRC’s website :

• Authorship 
• Management of Data and Information in Research 
• Peer Review 
• Disclosure of Interests and Management of Conflicts of Interest
• Research Supervision
• Collaborative Research
• Publication and Dissemination of Research
• Research Integrity Advisors

The policy outlines requirements for institutions, and individuals engaged in ARC business, to report to the ARC research integrity matters, and the action the ARC may take in response to reported breaches of the Code. It also describes how the ARC can refer concerns or complaints to research institutions, who, in accordance with the Code, are responsible for managing and investigating potential breaches of the Code.  

The National Principles of Intellectual Property (IP) Management for Publicly Funded Research (the National Principles) were developed by a working party of the Australian Government’s Coordinating Committee on Innovation .

The National Principles were developed to assist researchers, research managers and research institutions develop best practice in identifying, protecting and managing IP, thus ensuring appropriate commercial outcomes from publicly funded research.

The intention of the National Principles is simply to improve the commercial outcomes from publicly funded research where a commercial outcome is appropriate. The National Health and Medical Research Council (NHMRC) publicly announced the adoption of these National Principles in April 2013.  

Jointly developed by the ARC, the NHMRC and UA, the  National Statement on Ethical Conduct in Human Research  consists of a series of guidelines on ethical conduct in human research and is intended for use by:

• any researcher conducting research with human participants;
• any member of an ethical review body reviewing that research;
• those involved in research governance; and
• potential research participants.  

The National Statement on Ethical Conduct in Human Research 2023 was issued on 29 June 2023. The 2023 National Statement will take effect, and replace, the 2007 National Statement from 1 January 2024. Co-authored by NHMRC, the Australian Research Council (ARC) and Universities Australia (UA), the National Statement is Australia’s principal human research guideline setting out the requirements for the ethical design, review and conduct of human research in Australia.

The 2023 National Statement and a summary of amendments can be found on NHMRC's website. The major changes in this update are to Chapter 2.1 and Section 5.  

Developed by NHMRC, Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders provides a set of principles to ensure research is safe, respectful, responsible, high quality, of benefit to Aboriginal and Torres Strait Islanders people and communities.  

AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research

The  Guidelines for Ethical Research in Australian Indigenous Studies  embody the best standards of ethical research and human rights. It is essential that Indigenous people are full participants in research projects that concern them, share an understanding of the aims and methods of the research, and share the results of this work. At every stage, research with and about Indigenous peoples must be founded on a process of meaningful engagement and reciprocity between the researcher and Indigenous people.  

• Music: Protocols for Producing Indigenous Australian Music
• Writing: Protocols for Producing Indigenous Australian Writing
• Visual Arts: Protocols for producing Indigenous Australian Visual Arts
• Media Arts: Protocols for Producing Indigenous Australian Media Arts  
• Performing Arts: Protocols for Producing Indigenous Australian Performing Arts

The ARC recognises that the Protocols may also have much broader application, and, as applicable, advises that any researchers accessing, using or reproducing music, literature, arts, images or ceremonies of Indigenous peoples, or Indigenous cultural materials conduct their research in accordance with these protocols.  

The Australian Code For The Care And Use Of Animals For Scientific Purposes 8 th edition ( 2013)

Endorsed by the NHMRC, the ARC, the Commonwealth Scientific and Industrial Research Organisation (CSIRO) and UA the purpose of the  Australian code for the care and use of animals for scientific purposes  is to promote the ethical, humane and responsible care and use of animals used for scientific purposes. The ethical framework and governing principles set out in the Code provide guidance for investigators, teachers, institutions, animal ethics committees and all people involved in the care and use of animals for scientific purposes. The Code encompasses all aspects of the care and use of animals for scientific purposes where the aim is to acquire, develop or demonstrate knowledge or techniques in any area of science.  

NHMRC provides additional guidelines and information for Animal Ethics Committees and researchers, relating to particular fields of research or types of animals. These guidelines should be read in conjunction with the  Australian code for the care and use of animals for scientific purposes  8th edition (2013) . They are available on NHMRC’s website and include, but are not limited to:

• Guidelines to promote the wellbeing of animals used for scientific purposes: The assessment and alleviation of pain and distress in research animals (2008) ; and
• A Guide to the care and use of Australian native mammals in research and teaching (2014) . 

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Ending structural racism.

May 14, 2024

Enhancing Transparency and Accountability for NIH Minority Health and Health Disparities Research

UNITE Co-Chairs’ Corner

The UNITE N Committee is charged with enhancing the transparency, accountability, and equitable conduct of NIH-supported health disparities (HD) and minority health (MH) research. The goal is to mitigate the impact of structural racism on health, improve the health of racial and ethnic minority populations, and promote health equity for all.

In 2021, the UNITE N Committee established the UNITE N Data Working Group to enact part of the UNITE N Committee charge. The Working Group focused on assessing the data available to characterize the HD/MH research portfolios and to facilitate analyses of HD/MH grant applications and awards. Once established, the Working Group evaluated NIH’s previous approach to capturing and reporting investments in HD/MH research, with an eye toward enhancing accuracy, transparency, and accessibility.

Definitions:

• Health disparities are preventable differences in health that adversely affect disadvantaged populations. Health disparities research examines the influence of individual behavior and biology, health care, physical and interpersonal environment, adverse social determinants, and other underlying mechanisms that lead to modifiable differences in health outcomes.
• Minority health refers to the distinctive health characteristics and attributes of racial and/or ethnic minority groups that can be socially disadvantaged due in part to potential discriminatory acts. Minority health research is the scientific investigation of distinctive health characteristics and attributes of minority racial and/or ethnic groups who are usually underrepresented in biomedical research to understand health outcomes in these populations. Racial and ethnic minority populations are defined by the federal government as American Indian or Alaska Native, Asian, Black or African American, Latino or Hispanic, Native Hawaiian or Pacific Islander persons.

Since 2009, NIH has relied on the Research, Condition, and Disease Categorization (RCDC) reporting system to inform the public about how tax dollars are spent to support biomedical research. RCDC provides estimates of total NIH funding for more than 300 categories of diseases, conditions, or research areas. While almost all RCDC categories use an automated process to identify relevant applications and awards, some categories use a manual process until analyses to address unique reporting requirements for these categories can be completed and they can be converted to automated ones. Until 2022, the Health Disparities and Minority Health RCDC categories relied on manual coding.

After extensive analysis and consideration of alternative strategies to characterize the research of HD/MH portfolios, the N Data Working Group, in collaboration with the National Institute on Minority Health and Health Disparities (NIMHD), RCDC staff in the Office of Extramural Research (OER), and other NIH colleagues, recommended converting the manual HD/MH categories into automated categories. Shifting to automated categories offers increased rigor, accuracy, and transparency by:

• applying the same classification methodology across all applications and awards, eliminating inconsistencies inherent with individual interpretation of coding standards;
• capturing unfunded applications for internal purposes, which was too burdensome for manual assessment, thereby enhancing NIH’s analytical capabilities to assess application rates, award rates, and other metrics; and
• enhancing NIH’s ability to track progress of the NIH Minority Health and Health Disparities Strategic Plan goals.

NIH is pleased to share that it has converted the two manual categories of Health Disparities and Minority Health into five automated categories that better distinguish research funding from workforce diversity and capacity building funding (the previous manual HD/MH categories included funding for HD/MH research as well as workforce diversity and capacity building):

• Health Disparities Research
• Racial and Ethnic Minority Health Research
• This category is the union of “Racial and Ethnic Minority Health Research” and “Health Disparities Research” with duplicate projects removed. Most research projects in the “Racial and Ethnic Minority Health Research” category are also represented in the “Health Disparities Research” category since the projects involve both research areas.
• Workforce Diversity and Outreach
• Building Research Capacity at Institutions with Limited NIH Funding

These new categories will be used to report NIH funding in these areas beginning with fiscal year 2023 and moving forward. Importantly, actual total funding numbers have not changed: only the reporting methodology has been revised to increase rigor, accuracy, and transparency.

NIH has a longstanding commitment to supporting health disparities research, minority health research, workforce diversity and outreach, and research capacity building at institutions with limited NIH funding. This commitment is what prompted NIH to improve its reporting methodologies.

Our goal is to continuously improve the accuracy and transparency of reporting NIH investments in these critical areas and to better track progress toward the NIH Minority Health and Health Disparities Strategic Plan goals, which include mitigating the impact of structural racism on health and promoting health equity for all.

Authored by N Committee Co-chairs

National Institute on Drug Abuse

Monica Webb Hooper, Ph.D.

Deputy Director, National Institute on Minority Health and Health Disparities

Xinzhi Zhang 

National Heart, Lung, and Blood Institute

This page last reviewed on May 14, 2024

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• 15 May 2024

Neglecting sex and gender in research is a public-health risk

• Sue Haupt 0 ,
• Cheryl Carcel 1 &
• Robyn Norton 2

Sue Haupt is an honorary senior research fellow at Peter MacCallum Cancer Centre in Melbourne, Australia, and a research associate at The George Institute for Global Health, Women’s Health Program, Centre for Sex and Gender Equity in Health and Medicine, University of New South Wales (UNSW) Sydney, Australia.

You can also search for this author in PubMed   Google Scholar

Cheryl Carcel is the head of the brain health programme at The George Institute for Global Health UNSW Sydney, Australia.

Robyn Norton is a founding director of The George Institute for Global Health, a professor of public health at UNSW Sydney and chair of global health at Imperial College London, UK.

Illustration: Sophi Gullbrants

You have full access to this article via your institution.

In 2022, clinical trials indicated that a drug called lecanemab could slow cognitive decline in people with Alzheimer’s disease; soon after the results were published, the global Alzheimer’s community heralded lecanemab as a momentous discovery. However, closer inspection of the data by independent investigators revealed that the drug might significantly help men, but not women 1 .

The finding is a reminder that, even though tremendous advances are being made in the clinical application of cutting-edge technologies, such as gene editing and artificial intelligence (AI), there is a remarkable lack of understanding about how many aspects of human health are affected by variables as seemingly basic as sex and gender.

Sex and gender in science

Over the past decade or so, funders and publishers have made extensive efforts to encourage researchers to address the effects of sex and, in human studies, gender where appropriate. Thanks in part to these efforts, more insights are beginning to emerge. For Alzheimer’s and many other diseases that are common causes of death, including cardiovascular diseases, cancer, chronic respiratory conditions and diabetes, a person’s sex and gender can influence their risk of developing the disease, how quickly and accurately they are diagnosed, what treatment they receive and how they fare.

But even for the most-studied conditions, many questions remain. Few investigators have begun to probe the interrelationships between sex and gender , for example. And in cases in which researchers are managing to unpick the multifaceted effects of sex, this knowledge is not being sufficiently incorporated into the design of clinical trials or adequately changing the practice of medicine.

The consideration of sex and, where appropriate, gender in biological research must become routine — especially as molecular genetics, biomedical engineering and AI open up possibilities for treatments that are better tailored to the needs of individuals. Likewise, the culture of medicine must be transformed so that approaches to treatment evolve in response to the data. This will require further engagement from funders and publishers, but action from many other players, too. Pharmaceutical companies and intergovernmental organizations, among others, must acknowledge three things: how sex and gender can have huge effects on health outcomes; how these effects are often disregarded in basic research and clinical trials; and that change can come only through increasing awareness among all stakeholders of the importance of shifting the dial.

Health outcomes affected

In most human clinical records so far, sex is reported by physicians or participants in studies ticking one of two boxes: ‘female’ or ‘male’. In those clinical studies in which data are collected on chromosomes, hormone levels, reproductive anatomy or other sex characteristics, these features will frequently reflect a person’s sex assigned at birth. But this is not always the case. Added to this, sex and gender have often been used interchangeably, but they are not the same and they do not always align. Current definitions of gender include the social, psychological, cultural and behavioural aspects of being a man or woman (whether cisgender or transgender), non-binary or identifying with one or more other evolving terms 2 .

In several countries, new recommendations about how researchers should obtain data on people’s sex and gender should mean that, in the future, investigators will be able to more-accurately probe the roles of both in human health. But in general, there has been incomplete capture of information for sex and gender so far, including for individuals whose sex characteristics and/or gender identities don’t fall into a binary categorization scheme.

Women are more likely to die after a severe heart attack than are men. Credit: Simon Dawson/Reuters

In this article, consistent with much of the published population-wide data, we refer to a woman as someone who identifies with that gender and was assigned female sex at birth (a cis woman), and a man as someone who identifies with that gender and was assigned male sex at birth (a cis man). But we recognize that participants in the studies we describe might not have been asked about both their gender and their sex.

For all sorts of non-communicable diseases, there are differences between men and women in the average age at which they are diagnosed, the average age at which they die and even in their rates of death.

We need more-nuanced approaches to exploring sex and gender in research

Such variations, from the earlier onset of cardiovascular diseases in men to the more frequent occurrence of Alzheimer’s disease in women, might stem from differences in biology, which can affect people’s likelihood of developing a disease and how they respond to treatment. Or these discrepancies might stem from variation in people’s exposure to the environmental factors that trigger the disease, how they manage their condition, how they are treated by carers and so on, all of which can be influenced by a person’s gender. Often, a combination of factors will be at work.

Take heart attacks. Studies conducted over the past decade have revealed extensive sex differences in the expression of certain genes in heart tissue, which in turn affect the type and function of the cells that make up the heart.

Such variation could help to explain why men are likely to have a heart attack for the first time around six years earlier than women — in the United States, at 65.6 years old in men compared with 72 years old in women 3 — and why (in Australia, at least) heart attacks are at least twice as common in men relative to women of comparable ages (see go.nature.com/3qbvrxq ). Likewise, although mechanisms are yet to be fully understood, it is plausible that differences in people’s biology help to explain why women are more likely to experience pain between their shoulder blades, nausea or vomiting and shortness of breath during a heart attack; why men are more likely to experience chest pain and increased sweating; and why women are nearly twice as likely as are men to die after a severe heart attack.

Yet, when it comes to the risk of dying, social and environmental factors — shaped by gender — also seem to be important.

Tobacco consumption increases a person’s risk of having a heart attack, and smoking is much more common among men globally. Worldwide, around 37% of men smoke compared with around 8% of women . Also, in part because health-care professionals and others are more familiar with the heart attack symptoms commonly seen in men, when women have a heart attack, they are more likely to delay seeking help, and carers are often slower to intervene 4 . In fact, in a study of more than 500,000 people who experienced a heart attack and were admitted to hospital in the United Kingdom between 2004 and 2013, women were 37% more likely to receive an incorrect initial diagnosis after a severe heart attack than were men 5 . Even when women tell their physicians that they have chest pain, they are two to three times less likely to be referred to a cardiologist than are men 6 .

A similarly complicated picture has been emerging in relation to strokes 7 — another cardiovascular disease — and, in the past few years, in relation to cancer.

Smoking is more common among men than women globally. Credit: Behrouz Mehri/AFP/Getty

Most cancers that occur in non-reproductive organs develop earlier in men than they do in women. In the United States, oesophageal cancer is 4.5 times more likely to occur and cause death in men than in women, for example, and lung cancers, the most common drivers of cancer-associated deaths worldwide, kill around 40% more men than women 8 .

Just as with heart disease and stroke, some of this variation seems to stem from behavioural differences. Tobacco consumption increases a person’s risk of developing several cancers 7 . For thyroid cancers, however, women are more likely to develop the disease than are men — three times more likely in some places — which suggests that other factors might drive the different rates of this particular cancer in women and men 9 . But tumours typically arise because of problems with cells’ genetic-repair systems, together with inadequate damage clearance, and genetic differences between men and women that affect cancers are beginning to emerge.

Male–female comparisons are powerful in biomedical research — don’t abandon them

Much more research is needed to understand how sex affects the rate at which genes mutate, cells’ capacities to repair and clear damaged DNA, and when genetic damage starts causing disease. Yet research led by one of us (S.H.) on lung adenocarcinoma, the most common type of lung cancer, suggests that women can survive for longer than men after they are diagnosed, in part thanks to cancer-defence genes in women driving more-robust immune responses 10 . X chromosomes encode many genes that are linked to immunity, and women with two X chromosomes might express these genes at higher levels than men with XY chromosomes.

Responses to cancer treatments also differ between men and women. Chemotherapies tend to work better in women than in men. This could be because it can take longer for women’s bodies to clear certain drugs, which could partly explain why women are also 34% more likely than men to experience harmful side effects 11 . Moreover, women with lung cancer typically have better outcomes after surgery, which they undergo more often than men 8 . This is probably due, at least in part, to women having less advanced disease when they are diagnosed than men do 12 . But the generally stronger immune responses in women might also help their recovery 8 .

Too often ignored

Despite these compelling indications that sex and gender matter, when it comes to many diseases that are leading causes of death, many researchers and health practitioners still fail to adequately take sex and gender into account. They might also be influenced by conscious or unconscious bias.

In the case of heart disease, the differences in gene expression and cellular make-up and activity found in men and women’s hearts highlight the need for sex-specific cardiac tissue models, sustained by sex-appropriate vasculature 13 . (Women on average have smaller hearts with narrower vessels compared with men.) Currently, researchers tend to construct heart models using either animal or human cells, but without necessarily ensuring that cells are sourced from individuals of only one sex per model. In fact, identifying sex disparities in basic heart biology is crucial to engineering relevant heart models with stem cells, for example, which investigators are now developing to aid the study of heart disease 13 .

For both heart disease and stroke, because of decades of under-representation of women in clinical trials, many of today’s standard treatments are based on studies of what happens in men who weigh around 70 kilograms. In clinical trials conducted for stroke and heart conditions between 2010 and 2017, women worldwide were under-enrolled relative to the prevalence of these diseases in the general population — by around 20% 14 . There is also significant underfunding of research for many conditions that are more prevalent in women compared with those that are more common in men (see ‘Disparities in health and disease’).

Source: A. A. Mirin J. Womens Health 30 , 956–963 (2021).

Basic research on cancer is similarly riddled with problems. Take the sex of the cell lines that are stored in commercial cell banks, which have been studied for decades and are the source of much of today’s textbook knowledge. For lung cancers, male lines outnumber female lines by two to one. For liver cancers, the ratio is seven to one. Until a few years ago, few researchers studying cancer in cultured cells in the lab even considered the sex of the cells they were studying. Also, the standard media in which cells are grown is frequently supplemented with fetal calf serum from a mixture of male and female calves, and so contains both male and female sex hormones. And phenol red, a dye commonly used to monitor the pH of tissue culture media mimics the hormone oestrogen 8 .

To add to the difficulties, research findings that emerge from the use of these cell lines are often tested in mice of only one sex. The results of these studies are then used to guide human trials that include both men and women participants. And in oncological clinical trials, just as with stroke and heart disease, women are still under-enrolled relative to the burden of disease they experience 7 .

Inclusivity in human trials will ensure the best possible outcomes for all participants, including cis and trans women and men, gender-diverse and intersex people (see ‘Inclusivity in practice’). Studies are showing, for example, that circadian rhythms — which can affect heart function and might impact how drugs are metabolized — differ between men and women 15 . So how might they compare in non-binary or transgender people? Likewise, knowledge about the immune responses of people with atypical numbers of sex chromosomes is likely to be crucial when it comes to the use of immune checkpoint inhibitors and other immune therapies for treating cancer. Those with Klinefelter syndrome, for example, who, similar to cis women, are at a higher risk of developing breast cancer than are cis men, have multiple X chromosomes that are rich in genes involved in the immune response.

Inclusivity in practice

How researchers include diverse groups of people in clinical trials with enough participants to be able to uncover between-group differences is a challenge.

Women represent nearly half of the population, but they are still under-represented in many clinical trials for numerous diseases, even in cases in which disease prevalence for women has been measured. For smaller population groups, such as transgender people, there are not enough data to even know what representative inclusion looks like. In fact, even if participation does reflect the prevalence of disease in the broader population in any one trial, teasing out effects might require combining the results of multiple studies in meta-analyses.

Advisory governing boards for pharmaceutical companies, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, funders and regulatory agencies could help with this by ensuring that terminology is adequately and consistently defined, and that populations are properly profiled.

Heightened awareness

Routinely taking sex and gender into account in research and using that knowledge to change health care could benefit billions of people. So what’s needed to make this happen?

Policy changes — such as the US National Institutes of Health’s 2016 call for the inclusion of male and female sexes in studies involving cells, tissues and animals — are crucial. But for many researchers, such calls seem burdensome, especially because studying more than one sex can increase costs. ( Sample sizes might need to be increased to achieve sufficient statistical power when comparing groups.)

Alongside initiatives from funders and publishers, awareness must be built — among students, researchers, clinicians, medical ethics committees, research governance bodies and community groups — of the ramifications of failing to consider sex and gender, and how to correct the problem.

Accounting for sex and gender makes for better science

Efforts led by the Canadian Institutes of Health Research (CIHR) are encouraging. Even though the permeation of knowledge from research to health care has been glacial, between 2011 and 2019, the proportion of all research grant applications submitted to the CIHR that took sex into consideration increased from around 22% to 83%. Gender as a variable is now also included in many of the human studies funded by the CIHR .

Several initiatives have contributed to this. As an example, as well as asking grant applicants to include a section in their research proposals on whether they are considering sex and gender and how they will do so, or why this is not considered applicable, the CIHR has provided training for scientists and organized workshops involving researchers and specialists in sex and gender. Applicants are more likely to receive funding if they provide a satisfactory rationale for their choices.

Convincing people in leadership roles — in governments, laboratories, medical ethics boards, education and so on — of the importance of including sex and gender in research is especially crucial. More studies demonstrating the financial costs of not doing so could help. Between 1997 and 2000, for instance, eight prescription drugs were retracted from the US market because inadequate clinical testing in women had failed to identify that the drugs put women at greater risk of developing health problems than men. This error cost pharmaceutical companies and taxpayers an estimated US$1.6 billion per drug 16 .

The scale of transformation needed will also require more engagement from global players.

Even as far back as 2007, the 60th World Health Assembly — the decision-making body of the World Health Organization (WHO) — passed a resolution to urge researchers to split their data according to sex and to include gender analyses where appropriate. Steps to improve care for transgender people or those with diverse genders are also starting to be taken; in December last year, the WHO established a Guideline Development Group, to provide recommendations on how to address the health of transgender and gender-diverse people . But more extensive efforts, comparable to all United Nations member states committing to target 5.b of the 2015 Sustainable Development Goals by 2030, will be crucial. (This target is to “enhance the use of enabling technology, in particular information and communications technology, to promote the empowerment of women”.)

Lastly, under the guidance of regulatory bodies such as the European Medicines Agency and the scientific entrepreneur community, the pharmaceutical industry must do more to ensure that preclinical work is robust, and that products are tested on enough people of different sexes and genders. Many leading pharmaceutical companies acknowledge on their websites the importance of including diverse groups in clinical trials , but evidence of actions to address the issue is only just emerging.

Awareness of the problems around sex and gender is growing fast. And although many are concerned that medical applications of AI will perpetuate already existing biases 17 , promising developments are emerging in the use of machine learning to make diagnoses that are appropriate for people’s sex and gender.

For decades, for instance, physicians worldwide have been determining whether a person has had a heart attack by using the Global Registry of Acute Coronary Events (GRACE) score, which was derived from trials mainly involving men. In 2022, the application of machine learning to data that had been split for men and women refined the predictors for women. And these revised predictors did a better job of matching individuals to appropriate interventions 18 .

Greater awareness, the wealth of data now emerging and the possibilities presented by new tools, from AI to gene editing, could mean a new era for research and medicine.

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Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome

Collaborators.

• International PCOS Network : Marianne Andersen ,  Ricardo Azziz ,  Adam Balen ,  Estifanos Baye ,  Jacqueline Boyle ,  Leah Brennan ,  Frank Broekmans ,  Preeti Dabadghao ,  Luigi Devoto ,  Didier Dewailly ,  Linda Downes ,  Bart Fauser ,  Stephen Franks ,  Rhonda M Garad ,  Melanie Gibson-Helm ,  Cheryce Harrison ,  Roger Hart ,  Rachel Hawkes ,  Angelica Hirschberg ,  Kathleen Hoeger ,  Femke Hohmann ,  Samantha Hutchison ,  Anju Joham ,  Louise Johnson ,  Cailin Jordan ,  Jayashri Kulkarni ,  Richard S Legro ,  Rong Li ,  Marla Lujan ,  Jaideep Malhotra ,  Darren Mansfield ,  Kate Marsh ,  Veryan McAllister ,  Edgar Mocanu ,  Ben W Mol ,  Ernest Ng ,  Sharon Oberfield ,  Sasha Ottey ,  Alexia Peña ,  Jie Qiao ,  Leanne Redman ,  Raymond Rodgers ,  Luk Rombauts ,  Daniela Romualdi ,  Duru Shah ,  Jane Speight ,  Poli Mara Spritzer ,  Elisabet Stener-Victorin ,  Nigel Stepto ,  Juha S Tapanainen ,  Eliza C Tassone ,  Shakila Thangaratinam ,  Mala Thondan ,  Chii-Ruey Tzeng ,  Zephne van der Spuy ,  Eszter Vanky ,  Maria Vogiatzi ,  Angela Wan ,  Chandrika Wijeyaratne ,  Selma Witchel ,  Jane Woolcock ,  Bulent O Yildiz

Affiliations

• 1 National Health and Medical Research Council Centre for Research Excellence in PCOS, Monash University, Melbourne, Victoria, Australia; National Health and Medical Research Council Centre for Research Excellence in PCOS, University of Adelaide, Adelaide, South Australia, Australia; Monash Centre for Health Research and Implementation, Monash Public Health and Preventive Medicine, Monash University and Monash Health, Melbourne, Victoria, Australia. Electronic address: [email protected].
• 2 National Health and Medical Research Council Centre for Research Excellence in PCOS, Monash University, Melbourne, Victoria, Australia; National Health and Medical Research Council Centre for Research Excellence in PCOS, University of Adelaide, Adelaide, South Australia, Australia; Monash Centre for Health Research and Implementation, Monash Public Health and Preventive Medicine, Monash University and Monash Health, Melbourne, Victoria, Australia.
• 3 University of New South Wales, Sydney, New South Wales, Australia.
• 4 Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania, U.S.A.
• 5 Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynaecology, Erasmus Medical Centre, Rotterdam, The Netherlands.
• 6 Obstetrics and Gynecology, PEDEGO Research Unit, Medical Research Centre, Oulu University Hospital, Oulu, Finland.
• 7 National Health and Medical Research Council Centre for Research Excellence in PCOS, Monash University, Melbourne, Victoria, Australia; National Health and Medical Research Council Centre for Research Excellence in PCOS, University of Adelaide, Adelaide, South Australia, Australia; Robinson Research Institute, University of Adelaide and Fertility SA, Adelaide, South Australia, Australia.
• PMID: 30033227
• PMCID: PMC6939856
• DOI: 10.1016/j.fertnstert.2018.05.004

Study question: What is the recommended assessment and management of women with polycystic ovary syndrome (PCOS), based on the best available evidence, clinical expertise, and consumer preference?

Summary answer: International evidence-based guidelines including 166 recommendations and practice points, addressed prioritized questions to promote consistent, evidence-based care and improve the experience and health outcomes of women with PCOS.

What is known already: Previous guidelines either lacked rigorous evidence-based processes, did not engage consumer and international multidisciplinary perspectives, or were outdated. Diagnosis of PCOS remains controversial and assessment and management are inconsistent. The needs of women with PCOS are not being adequately met and evidence practice gaps persist.

Study design, size, duration: International evidence-based guideline development engaged professional societies and consumer organizations with multidisciplinary experts and women with PCOS directly involved at all stages. Appraisal of Guidelines for Research and Evaluation (AGREE) II-compliant processes were followed, with extensive evidence synthesis. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied across evidence quality, feasibility, acceptability, cost, implementation and ultimately recommendation strength.

Participants/materials, setting, methods: Governance included a six continent international advisory and a project board, five guideline development groups, and consumer and translation committees. Extensive health professional and consumer engagement informed guideline scope and priorities. Engaged international society-nominated panels included pediatrics, endocrinology, gynecology, primary care, reproductive endocrinology, obstetrics, psychiatry, psychology, dietetics, exercise physiology, public health and other experts, alongside consumers, project management, evidence synthesis, and translation experts. Thirty-seven societies and organizations covering 71 countries engaged in the process. Twenty face-to-face meetings over 15 months addressed 60 prioritized clinical questions involving 40 systematic and 20 narrative reviews. Evidence-based recommendations were developed and approved via consensus voting within the five guideline panels, modified based on international feedback and peer review, with final recommendations approved across all panels.

Main results and the role of chance: The evidence in the assessment and management of PCOS is generally of low to moderate quality. The guideline provides 31 evidence based recommendations, 59 clinical consensus recommendations and 76 clinical practice points all related to assessment and management of PCOS. Key changes in this guideline include: i) considerable refinement of individual diagnostic criteria with a focus on improving accuracy of diagnosis; ii) reducing unnecessary testing; iii) increasing focus on education, lifestyle modification, emotional wellbeing and quality of life; and iv) emphasizing evidence based medical therapy and cheaper and safer fertility management.

Limitations, reasons for caution: Overall evidence is generally low to moderate quality, requiring significantly greater research in this neglected, yet common condition, especially around refining specific diagnostic features in PCOS. Regional health system variation is acknowledged and a process for guideline and translation resource adaptation is provided.

Wider implications of the findings: The international guideline for the assessment and management of PCOS provides clinicians with clear advice on best practice based on the best available evidence, expert multidisciplinary input and consumer preferences. Research recommendations have been generated and a comprehensive multifaceted dissemination and translation program supports the guideline with an integrated evaluation program.

Study funding/competing interest(s): The guideline was primarily funded by the Australian National Health and Medical Research Council of Australia (NHMRC) supported by a partnership with ESHRE and the American Society for Reproductive Medicine. Guideline development group members did not receive payment. Travel expenses were covered by the sponsoring organizations. Disclosures of conflicts of interest were declared at the outset and updated throughout the guideline process, aligned with NHMRC guideline processes. Full details of conflicts declared across the guideline development groups are available at https://www.monash.edu/medicine/sphpm/mchri/pcos/guideline in the Register of disclosures of interest. Of named authors, Dr Costello has declared shares in Virtus Health and past sponsorship from Merck Serono for conference presentations. Prof. Laven declared grants from Ferring, Euroscreen and personal fees from Ferring, Euroscreen, Danone and Titus Healthcare. Prof. Norman has declared a minor shareholder interest in an IVF unit. The remaining authors have no conflicts of interest to declare. The guideline was peer reviewed by special interest groups across our partner and collaborating societies and consumer organizations, was independently assessed against AGREEII criteria and underwent methodological review. This guideline was approved by all members of the guideline development groups and was submitted for final approval by the NHMRC.

Keywords: GRADE; Polycystic ovary syndrome; assessment; evidence-based; guideline; management.

Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Publication types

• Research Support, Non-U.S. Gov't
• Australia / epidemiology
• Disease Management*
• Evidence-Based Medicine / methods
• Evidence-Based Medicine / standards*
• Internationality*
• Polycystic Ovary Syndrome / diagnostic imaging
• Polycystic Ovary Syndrome / epidemiology
• Polycystic Ovary Syndrome / therapy*
• Practice Guidelines as Topic / standards*
• Reproductive Medicine / methods
• Reproductive Medicine / standards*
• Young Adult

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May 14, 2024

NIH Improves Reporting of Minority Health and Health Disparities Research Categories

NIH has a longstanding commitment to supporting health disparities research, minority health research, workforce diversity and outreach, and capacity building. It is with this commitment that I am pleased to share recent changes to NIH’s reporting of minority health and health disparities research as part of the NIH Research, Condition, and Disease Categorization (RCDC) reporting system . These updates will improve the accuracy and transparency of minority health and health disparities research investments and better track progress towards the goals of the NIH Minority Health and Health Disparities Strategic Plan . Leading this effort is a major responsibility of the National Institute on Minority Health and Health Disparities (NIMHD) and this change to the RCDC reporting methodology will facilitate that effort.

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These new categories will be used beginning with Fiscal Year 2023 funding and moving forward. It is important to note that actual funding numbers and NIH priorities have not changed. The reporting methodology has simply been revised to facilitate a harmonized approach to data collection and reporting for these critical research areas.

As the lead institute at NIH on policy, planning, and monitoring of minority health and health disparities research, NIMHD oversees numerous programs to increase the scientific knowledge base and design of interventions to improve minority health and reduce health disparities. We believe that enhancing NIH’s reporting methodology is one additional step towards better understanding our progress towards ultimately advancing health equity across all communities.

Best regards, Eliseo J. Pérez-Stable, M.D. Director, National Institute on Minority Health and Health Disparities

Page published May 14, 2024

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