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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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

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

The complex art of benefit-sharing0

 

In community-based participatory action programs (programs which have a research component but which are also focussed on community development and empowerment), it might be possible to identify a link between a research project and a benefit to the participating community. Over and above conducting the study, in research on domestic violence, studies have provided emotional and practical support for victims, offering information about, and organizing access to, formal and informal services, providing feedback to the study community and relevant agencies, and supporting or engaging in advocacy on behalf of abused (Usdin et al. 2000). Work on victims of state violence has also advocated for broader political change (Stanley 2012).

However, in other circumstances it may be far more likely that participants may contribute to research but gain very little direct or even no benefit from it. The lack of reciprocity may be particularly problematic if participants are drawn from vulnerable groups.

For example, members of poorer communities have a right to feel aggrieved if research undertaken in their communities is only likely to be of benefit to wealthier societies. This is most obviously the case where multinational pharmaceutical corporations trial drugs or procedures in the Global South that are in the end likely to be priced out of the reach of participant communities or which were never relevant to their needs. Not surprisingly, therefore, the concept of benefit-sharing has been most widely developed in discussions of health and genetic research.

In response, international agreements and statements related to biomedical research such as the Declaration of Helsinki (from 2000 onwards) and non-human genetic and bioprospecting research such as the legally-binding Convention on Biological Diversity (1992), formalised in the Nagoya Protocol (Convention on Biological Diversity, 2010), instituted obligations relating to benefit-sharing for projects that fell within their jurisdiction. These agreements recognised that:

Those who contribute to developments in science and technology ought to share in the benefits, so if those benefits are not shared with the contributors to scientific advancement, that advancement is exploitative. (Arnason and Schroeder, 2013, p. 21)

As a result, the Nagoya Protocol pointed to the principle that research projects should offer benefits to participants. Non-financial benefits might include: sharing research results; collaboration, cooperation and contribution in research and development programmes, education and training; institutional capacity-building; contributions to the local economy; research directed towards priority needs of the participating community; institutional and professional relationships that can arise from an access and benefit-sharing agreement and subsequent collaborative activities; livelihood security benefits; and, social recognition. It is easy to imagine how such benefits, in the context of biomedical research, can be applied to social research; or, at least, it would be if social researchers were funded at the same level as biomedical researchers.

Unfortunately, the art of benefit-sharing has proved to be complex.

First, it might not be straightforward to identify what constitutes a benefit, particularly at the beginning of a researcher’s engagement with a new community. In her recent critique of transnational Feminist researchers, Rajan (2018) portrayed some external attempts at intervening in support of women’s rights in the Global South as ‘unfairly patronizing, or alternatively… ill-advised and characterized by a lack of sufficient knowledge of local context and concerns’ (p.271).

Second, it may not always be easy to work out what a particular community might regard as a fair way of sharing benefits. Even those projects that have sought to implement formal benefit-sharing arrangements have struggled to achieve a just and equitable distribution of benefits. For example, there is evidence that women have been marginalized in the negotiation and implementation of benefit-sharing arrangements, despite (and indeed because of) their additional susceptibility to exploitation within vulnerable communities. In addition, it is possible that some benefits aimed at individual participants might undermine commitments to respond to injustice at a macro-level and might even cause intra-community conflict. For instance, providing a participant family with additional food in a village where food is scarce may cause resentment among neighbours.

Third, some disciplines are less likely than others to generate tangible benefits and, even if they can, researchers may not be able to assure that the intended benefits of a research project will flow to participants. They may be particularly powerless in the face of powerful institutions whose job it is to restrict the freedom of participants. Zion et al. (2010), for example, argued that researchers seeking to work on projects on self-harm by asylum seekers funded by the Australian Commonwealth government were likely to be compromised. As asylum seekers are subjected to indefinite mandatory detention in Australia, Zion and her colleagues concluded that even projects aimed at improving the mental wellbeing of detainees risk legitimizing a detention regime that inevitably breached human rights.

Finally, acceptance of the importance of benefit-sharing arrangements is not universal. In 2008, the United States effectively opted out of the provisions of the Declaration of Helsinki that relate to ensuring that research participants must be allowed access to tested clinical interventions that were found to be successful and that research in low and lower middle-income countries must be designed to benefit local communities. Even before that time, there was little evidence that Institutional Review Boards in the US were taking the requirement seriously (Macklin, 2004).

So, benefit-sharing offers a way of directing both the outcomes and the process of research towards the pursuit of global and social justice. Unfortunately, a broader range of disciplines need to do more to develop and share strategies of benefit-sharing before we can have confidence that it has found a place in across our research programs.

Acknowledgements:

This article further develops an argument that will appear in Israel, M. & Fozdar, F. (in press) The ethics of the study of ‘Social Problems’ . In Treviño, J. & Marvasti, A. (eds) Researching Social Problems. New York: Routledge.

Bibliography

Arnason, G. and Schroeder, D. (2013) Exploring Central Philosophical Concepts in Benefit Sharing: Vulnerability, Exploitation and Undue Inducement. In Schroeder, D. and Lucas, J.C. (eds.) Benefit Sharing: From Biodiversity to Human Genetics. Springer. pp.9-31

Convention on Biological Diversity (2010) Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity. http://www.cbd.int/abs/doc/protocol/nagoya-protocol-en.pdf

Macklin, R. (2004) Double Standards in Medical Research in Developing Countries. Cambridge: Cambridge University Press.

Rajan, H. (2018) ‘The Ethics of Transnational Feminist Research and Activism: An Argument for a More Comprehensive View’, Signs: Journal of Women in Culture and Society 43(2): 269-300.

Stanley, E. (2012) ‘Interviewing Victims of State Violence’ in Gadd, D., Karstedt, S. and Messner, S.F. (eds) The Sage Handbook of Criminological Research Methods. Sage: London. DOI: http://dx.doi.org/10.4135/9781446268285.n15

Usdin, S., Christfides, N., Malepe, L. and Aadielah, M. (2000) ‘The value of advocacy in promoting social change: implementing the new Domestic Violence Act in South Africa’, Reproductive Health Matters, 8(16): 55–65.

Zion, D., Briskman L. and Loff, B. (2010) ‘Returning to History: The Ethics of Researching Asylum Seeker Health in Australia’, The American Journal of Bioethics, 10(2): 48-56. DOI: 10.1080/15265160903469310

Contributor
Prof. Mark Israel
Senior consultant AHRECS – AHRECS Profile | mark.israel@ahrecs.com

This post may be cited as:
Israel M. (24 July 2018) The complex art of benefit-sharing. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/the-complex-art-of-benefit-sharing

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.

New resources coming soon from AHRECS0

 

AHRECS has always had two primary missions: to provide relevant and up-to-date information services on human research ethics and research integrity and to provide expert consultancy services in those areas. We have developed and maintain free services – the Research Ethics Monthly and the Resources Library – that feedback shows are increasingly used and valued. We actively maintain these by regular surveying relevant literature to identify items of interest and value. We have attracted a regular community of readers and user of our services.

We have come to the view that, in order to ensure that these are maintained, a subscriber or patronage arrangement is needed. This patrons’ area will provide additional online services and resources.

We plan to establish such a subscription/patron’s area on 1 July. Our aim is to make available to subscribers material that supplements what we continue to offer at no charge and so rewards those who commit to this way of supporting us.

There will be different financial levels of patronage, starting at 1USD a month. For research institutions, our expectation is that one (for example, the ethics manager) or two (the HREC Chair as well) would become patrons, but we would of course be delighted if members of the research ethics committees and researchers (from all disciplines and across career stages) who are an important intended audience for this new material, decide to become AHRECS patrons.

The kinds of things that will be available are:

(i) Vignettes on human research ethics/research integrity topics;

(ii) Commentaries (about 300 words) on breaking news and significant research outputs;

(iii) A few times a year a group Q&A session with one of the AHRECS consultants;

(iv) Booklets and resource papers; and

(v) Periodic webinars on topics nominated by patrons.

The information and resources will be shared on a non-commercial creative commons basis.

On the more fun side of things, patrons will be able to download images AHRECS have commissioned for use in professional development workshops and receive free mugs/desktop mice pads.

The base level of subscription will grant access to an exclusive behind the scenes feed from the AHRECS team.

The monthly payments will be via Patreon and Paypal and can be discontinued or modified at any time without losing the right to use already downloaded material.

We’re excited by this new way to engage with the human research ethics and research integrity communities.

Rest assured the Resource Library and Research Ethics Monthly will continue and remain free.

The Contributors
Gary Allen, Mark Israel and Colin Thomson – senior consultants AHRECS

This post may be cited as:
Allen G., Israel M. and Thomson C. (22 June 2018) New resources coming soon from AHRECS. Research Ethics Monthly. Retrieved from: https://ahrecs.com/ahrecs-admin/new-resources-coming-soon-from-ahrecs

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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