ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)
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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Get access to some great resources (two examples included in this post) and support events like the Constructive Voices panels0

 

Every month we add at least two items to the subscribers’ area. These include vignettes and other resources to use in your internally delivered professional development workshops. They are shared on a creative commons basis, so a nominated person can download selected material, load it onto a local server and use it within his or her own institution multiple times.(as long as they adhere to the CC license). Included here is a example pf a discussion item. We are currently working on a library of 26+ research integrity short audio snippets that could be incorporated into your internal research integrity workshops (example also attached). A library of these will be available from the subscribers’ area.

In addition to getting access to these great material, patrons are helping AHRECS cover the costs of events like the Australian Code= and National Statement Constructive Voices panel discussions webinars.

A Gold sponsorship (which costs US15/month) provides access to all materials. Subscriptions are paid via PayPal. We can provide a payment receipt after each monthly payment.

Too become a patron visit https://www.patreon.com/ahrecs.

Feel free to contact us on patron@ahrecs.com to discuss.

Are you attending the ‘Constructive voices’ panel discussions in November about the 2018 changes to the Australian Code and National Statement on Ethical Conduct in Human Research?0

 

Just a reminder these online discussions are free, but you will need to RSVP. Details below. Recordings of the sessions will be available from our subscribers area (https://www.patreon.com/ahrecs).


Australian Code (2018) – 8 November 2018
https://www.nhmrc.gov.au/guidelines-publications/r41

New South WalesThursday, 8 November at 2:30:00 pm AEDT UTC+11 hours
Western Australia Thursday, 8 November at 11:30:00 am AWST UTC+8 hours
Australian Capital TerritoryThursday, 8 November at 2:30:00 pm AEDT UTC+11 hours
QueenslandThursday, 8 November at 1:30:00 pm AEST UTC+10 hours
South AustraliaThursday, 8 November at 2:00:00 pm ACDT UTC+10:30 hours
Northern TerritoryThursday, 8 November at 1:00:00 pm ACST UTC+9:30 hours
Victoria Thursday, 8 November at 2:30:00 pm AEDT UTC+11 hours
New Zealand Thursday, 8 November at 4:30:00 pm NZDT UTC+13 hours

Moderator: Prof. Mark Israel
Guests: Jillian Barr (NHMRC) and Kandy White (Expert Working Committee and Director, Research Ethics and Integrity, Macquarie University)
Voices: Prof. Colin Thomson AM
Rapporteur: Dr Gary Allen

To RSVP:
Yes.AC_081118@ahrecs.com



National Statement (Updated 2018) – 22 November 2018

https://www.nhmrc.gov.au/_files_nhmrc/file/publications/national-statement-2018.pdf

New South WalesThursday, 22 November at 2:30:00 pm AEDT UTC+11 hours
Western Australia Thursday, 22 November at 11:30:00 am AWST UTC+8 hours
Australian Capital TerritoryThursday, 22 November at 2:30:00 pm AEDT UTC+11 hours
QueenslandThursday, 22 November at 1:30:00 pm AEST UTC+10 hours
South AustraliaThursday, 22 November at 2:00:00 pm ACDT UTC+10:30 hours
Northern Territory Thursday, 22 November at 1:00:00 pm ACST UTC+9:30 hours
Victoria Thursday, 22 November at 2:30:00 pm AEDT UTC+11 hours
New Zealand Thursday, 22 November at 4:30:00 pm NZDT UTC+13 hours

Moderator: Prof. Colin Thomson AM
Guests: Jeremy Kenner (NHMRC), Professor Wendy Rogers (Chair National Statement Review Working Group, Macquarie University) and Associate Professor Pamela Henry (Newly appointed Chair of the ECU, Human Research Ethics Committee)
Voices: Dr Gary Allen

To RSVP:
Yes.NS_221118@ahrecs.com



PROFILES:

Dr Gary Allen (AHRECS)

Gary is a member of the National Statement Review Working Group and chaired the committee that drafted the revision to NS Chapter 3.1. He is the Managing Director of, and a Senior Consultant with, AHRECS. Gary has worked in the human research ethics and research integrity spheres since 1997. He was formerly a member of the NHMRC’s Australian Health Ethics Committee. Gary holds a social science doctorate and a bachelor of education.
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Jillian Barr (NHMRC)

Jillian Barr is the Director of Ethics and Integrity NHMRC. Jillian’s work involves developing a range of ethics guidelines and research standards including the recently released 2018 Australian Code for the Responsible Conduct of Research, the National Statement on Ethical conduct in Human Research and animal ethics guidelines. Jillian’s team is responsible for providing policy and guidance for Human Research Ethics Committees in Australia and for supporting the Australian Health Ethics Committee. Jillian is also responsible for research integrity matters that relate to research involving NHMRC funding.
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Associate Professor Pamela Henry

Associate Professor Pamela Henry is the Director of the Sellenger Centre for Research in Law, Justice and Social Change at ECU. She is also a newly appointed Chair of the ECU, Human Research Ethics Committee. Her role as the Director of the Sellenger Centre has seen her develop an extensive body of research in policing focused on integrity, use of information management systems, human source recruitment and management, use of force, policing those experiencing mental illness, and other programs of research examining the effectiveness of police operational deployment models. She also holds a PhD in Psychology.
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Professor Mark Israel (AHRECS)

Mark provides advice to higher education institutions, research agencies, government and non-government organisations in Australia, Hong Kong, New Zealand, Taiwan, the United Kingdom and acts as an ethics reviewer and rapporteur for the European Research Council

As an Executive Director of and Senior Consultant with Australasian Human Research Ethics Consultancy Services, he works on institutional policy and practice in relation to research ethics and research integrity. Mark was a member of the Australian National Health and Medical Research Council’s Working Party responsible for revision of Section 3 of the National Statement. He was professor of law and criminology at Flinders University and University of Western Australia

He has a degree in law and postgraduate qualifications in sociology, criminology and education from Oxford (DPhil), Cambridge (MA, MPhil) and Flinders Universities (MEdStudies) respectively. He has over 90 publications in the areas of criminology and socio-legal studies, higher education policy and practice, and research ethics and integrity. His recent books include Research Ethics and Integrity for Social Scientists: Beyond Regulatory Compliance (Sage, 2015).
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Jeremy Kenner (NHMRC)

Jeremy is Expert Advisor for Ethics at NHMRC. At NHMRC, he contributes to the development of guidelines and advice on matters related to health and research ethics, research integrity and governance and clinical trials. Jeremy’s experience includes ethics administration at Peter Maccallum Cancer Centre, multiple roles in education and law practice. His various loyalties extend to Melbourne, Tasmania, Canada and the U.S
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Professor Wendy Rogers (Professor of Clinical Ethics, Macquarie University)

Wendy Rogers is Professor of Clinical Ethics at Macquarie University and Deputy Director of the Macquarie University Research Centre on Agency, Values and Ethics, with strong interests in healthcare policy and practice. During her first term on the Australian Health Ethics Committee she served on the working party responsible for the 2007 revision of the National Statement. Since 2010, she has been Chair of the working party on the current rolling revision of the National Statement. Her research interests include over diagnosis, ethics of surgical practice and research, transplant abuse and vulnerability.
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Professor Colin Thomson AM (AHRECS)

Colin Thomson AM is a senior consultant with Australasian Human Research Ethics Consultancy Services Pty. Ltd. (AHRECS) and a former Professor in Health Law and Ethics in Graduate Medicine, University of Wollongong and positions in law faculties at the Australian National University and the University of Wollongong.

He was a member of the Medical Research Ethics Committee of the National Health and Medical Research Council (NHMRC), a member and chair of the Australian Health Ethics Committee and Consultant in Health Ethics to the NHMRC.

As a consultant, he conducted training for human research ethics committees (HRECs) in State Health departments in Queensland, NSW, Victoria and Tasmania and in universities in all States and territories; certification assessments for the NHMRC National Certification Scheme and advised government departments in the Commonwealth, NSW and Victoria.

He has been a member and chair of multiple HRECs in universities, local health districts, government departments and public sector agencies.

In 2018, he was made a Member of the Order of Australia for services to medical research and research ethics.
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Dr Karolyn (Kandy) White

Kandy is the Director, Research Ethics and Integrity at Macquarie University. Kandy has taught research ethics to undergraduate and postgraduate student both in Australia and overseas as well as to ethics committee members. She Chairs a Social Science and Humanities Human Research Ethics Committee. Kandy has been the Chair of the AEN Advisory Group, co-convenor of ARMS Research Ethics and Integrity SIG, a member of the national Code Review Committee established to revise the Australian Code and Chair of the Better Practice Guides (BPG) working group responsible for developing the Investigation Guide.
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Release of the National Statement on Ethical Conduct in Human Research 2007 (updated 2018) – With interview0

 

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

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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.

This approach emphasises that researchers, Human Research Ethics Committees (HRECs) and other users of the National Statement must take account of the principles and major themes in research ethics addressed in Sections 1 and 2 of the document as the foundation of the guidance in Section 3 and then, in turn, consider the guidance provided in Chapter 3.1 as a base for the guidance provided in the other chapters included in this section.

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.

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Context

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).


INTERVIEW

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.

Research Ethics in Australia: A Story0

 

Have you ever needed to find a history of human research ethics, whether for personal study or for use in professional development work with human research ethics committee members or researchers?

Motivated perhaps by George Santayana’s often paraphrased ‘those who cannot remember the past are condemned to repeat it’, we at AHRECS have often needed to refer to the history of the emergence of ethics in human research but have found repeatedly that the readily available histories focus on international, European and (predominantly) United States events. Conventionally, they begin in the 18th century and recount a litany of unethical research and, apparently consequential, increases in regulation, whether in the form of revised and strengthened guidelines, additional review processes or even legislation.

A typical pattern is to begin with Edward Jenner’s smallpox work in the late 18th century, Claude Bernard’s early 19th-century cautions about avoiding harm, Walter Reid’s yellow fever study in Havana in the early 1900s, the start of the Tuskegee syphilis study in the early 1930s, the Nuremberg experiments and the Code (and the mere lip-service paid to it in the US Army’s atomic energy studies in the 1950s) and, sometimes, the Japanese Unit 731 biological and chemical warfare studies in the 1940s. Then, in the 1960s, Henry Beecher’s New England Journal of Medicine article, Maurice Papworth’s human guinea pigs article and book, what Martin Tolich referred to as the ‘unholy trinity’ of Stanley Milgram’s authority study, Laud Humphrey’s tearoom trade study and Philip Zimbardo’s Stanford prison experiment, and the Declaration of Helsinki.  Then the 1970s brings disclosure and cessation of the Tuskegee syphilis study, the US National Research Act, the first common rule regulations, the President’s Commission and the Belmont Report.  Sentinel events in the 1990s include the Pfizer Trovan study in Nigeria, the clinical trial deaths of Jesse Gelsinger and, since 2000, the death of Ellen Roche, the Northwick Park TGN 1412 study and the disclosure of the Guatemalan sexually transmitted disease studies, and controversy over Napoleon Chagnon’s Amazon bioprospecting and the US military’s Human Terrain System.  There are of course other US and international events that could be added, but, in our experience the ones mentioned tend to recur most.

There are a number of difficulties with this ‘schooled by scandal’ history. First, the implicit (and simplistic) assumption of causality between examples of unethical (as seen with the benefit of hindsight) research and the subsequent tightening of regulations, guidelines or standards. Second, the unrepresentative importance accorded to the “scandals” can conceal the fact that most human research at the time was ethically acceptable.  Nonetheless, we accept that the so-called scandals are important at least in the fact that they reveal points of time at which the ethical and social acceptability of prevailing practices in human research was being questioned from new perspectives whose sources are historically and socially complex.  Third, the assumption that regulations have evolved and that all changes in regulation have benefited both research and research participants. Finally, the most important difficulty is that the history is simply not representative of our part of the world.

Australia has its own story to tell.  It is likely that this story has been influenced at identifiable points by events in other parts of the world but it is equally important to recognise that those influences find an Australian expression. We at AHRECS think that we do need to know – and tell – our own story.

An Australian account could include

DateEventSource Material/urls
1920s and 1930searly physiological research conducted in South Australia with Aboriginal men
1930s to the 1950svaccine studies on children in orphanages in Queensland and Victoria
1950s to the 1970ssecret strontium 90 pathology studies of bones
1950satomic energy experiments at Maralinga
1950searly confrontation between Aboriginal mission administrators and researchers at Haast’s Bluff
1966the first statement on human experimentation from the NHMRC (on which the influence of the 1964 Declaration of Helsinki is likely)
1970srepetition of Stanley Milgram’s authority study at Latrobe University
1976 to 1999ongoing revision of and additions to the statement on human experimentation
1986the confrontational conference on Aboriginal and Torres Strait Islander health research in Alice Springs
1991NHMRC Interim guidelines on Aboriginal and Torres Strait Islander health research
1987development by the Australian Research Council of a discussion paper on human research ethics
1992radical revision of ethical review and approval of clinical trials
1994 to 1996ministerial review of human research ethics system
1997-99development the first National Statement, including joint working party of ARC, UA & scholarly academies
2002-03guidelines on Aboriginal and Torres Strait Islander research from the Australian Institute of Aboriginal and Torres Strait Islander Studies in and from the NHMRC
2002defamation litigation about a Sydney doctor’s clinical trial approval and conduct practices
2006public disclosure of the Latrobe University lifestyle study
2006development of a national approach to shared ethical review
2007revision of the National Statement
2007 to daterolling revision of the National Statement
2007public controversy about a study entitled ‘laughing at disabled’
2013the Brisbane bus driver racial discrimination study

Accordingly, there is, in our view sufficient material from Australia to constitute a local, well documented story that is as valuable for study and professional development purposes as any of the conventional international and American accounts.

However, we are aware that stories of this kind are rarely complete. Accordingly, with this article, we are commencing the Research Ethics in Australia: A Story Project as a process of developing a more comprehensive Australian account which we propose to make available to AHRECS subscribers in formats that can be readily deployed for presentations or study resources.

A next step in that process is to invite our readers to add events that will fill out that history.  Please send us at australianstoryproject@ahrecs.com any publicly available resources, documented anecdotes or other material that can be used to fill out the emerging story.  The tabular format in which we have listed Australian events would be a suitable form in which to do this, accordingly please provide:

  1. Dates
  2. A description of the event/episode
  3. Sources, references, urls,
  4. Any multimedia material (images, video or audio files…) that might be used for teaching or presentations
  5. First-hand accounts if you were part of the story and are free to share that account#.

# If you are free, legally and ethically, to do so, let us know if you have any personal accounts of any item.  Don’t send us the account yet, we’ll seek ethics approval before asking you about your experience.

We would especially welcome accounts of the achievements of ethical human research in Australia.  This could address the second difficulty, referred to above, with typical histories and inform a balanced and fairer Australian story of human research ethics

A final version will be in the form of a resource, suitable for presentation, supported with links to the sources of the events and accompanied by notes and advice on its use.  Consistent with our mission, we firmly encourage the use of these past events in a constructive manner – how knowledge and understanding of them can inform better design, review and conduct of human research.

As you will be aware, we are delighted to have New Zealand colleagues among our consultants and know that that country has its own human research ethics story.  Indeed, our colleagues, Martin Tolich and Barry Smith, have started telling the history of New Zealand research ethics. We are interested in developing a parallel New Zealand account and will invite contributions to this as well later on.

Our proposed final resource will include both narrative and presentation formats that embed links to source materials about events, procedures or documents. We will offer guidance about using the resource constructively, consistent with AHRECS’ mission, so that the underlying message is how to design, review and conduct human research well.

Contributor
Prof. Colin Thomson
Senior Consultant, AHRECS
AHRECS profile | colin.thomson@ahrecs.com

This post may be cited as:
Thomson C. (30 July 2018) Research Ethics in Australia: A Story. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/research-ethics-in-australia-a-story

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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