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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.

‘Except as required by law’: Australian researchers’ legal rights and obligations regarding participant confidentiality0

 

Anna Olsen, Research School of Population Health, ANU Julie Mooney-Somers, Centre for Values, Ethics and the Law in Medicine, University of Sydney
*Neither of us are lawyers and, as such, our interpretations are as social scientists and HREC members. Interested lawyers and legal scholars are encouraged to contribute!

Researchers’ promises of confidentiality are often easily and genuinely made. However, our experience in research ethics review (Julie through an NGO-run ethics review committee; Anna through formally constituted university and hospital human research ethics committees), in qualitative research and in teaching qualitative research ethics has led us to think about the limits of these promises.

Australian researchers generally rely on the National Statement (National Health and Medical Research Council, 2015) and Human Research Ethics Committees (HRECs) for guidance around ethical and legal conduct in research. For example, Chapter 4.6 in the National Statement notes that researchers may discover illegal activity and guides researchers and HRECs to consider what researchers might be obliged to disclose in a legal situation and how to best protect (and inform) participants of this threat to confidentiality.

The National Statement is currently under revision (National Health and Medical Research Council, 2016) and the review submitted for public consultation in late-2016 contains a proposal to include additional information on “Disclosure to third parties of findings or results” in Section 3 of the National Statement. Here the NHMRC explicitly state that: “There can be situations where researchers have a legal, contractual or professional obligation to divulge findings or results to third parties”. That is, researchers should concern themselves not only with the legal implications of revealing potential illegal activity, but any instance in which they may be asked to break participant confidentiality.

The recent review of the National Statement extends the NHMRC recommendations around potential data disclosure in a number of ways: it makes much more explicit that researchers (as opposed to HRECs or institutions) are responsible for understanding the risks to patient confidentiality: “researchers should be aware of situations where a court, law enforcement agency or regulator may seek to compel the release of findings or results”. Researchers are expected to anticipate legal risks to participant confidentiality by: identifying “(a) whether, to whom and under what circumstances the findings or results will be disclosed; (b) whether potential participants will be forewarned that there may be such a disclosure; (c) the risks associated with such a disclosure and how they will be managed; and (d) the rationale for communicating and/or withholding the findings or results and the relative benefits and/or risks to participants of disclosure/non-disclosure”. And, researchers should advise participants on legal risks to confidentiality and how they will be handled: “(a) have a strategy in place to address this possibility; (b) advise participants of the potential for this to occur; and (c) advise participants as to how the situation will be managed”.

For many researchers in health, legal risks are a very vague reality and legal intervention a remote threat. They may feel confident that their research does not and will not uncover illegal activity, or that their data would simply be irrelevant to a legal case. Or they may feel confident that they have taken sufficient steps to protect their participants’ confidentiality by following guidelines; researchers working in illicit drug use, for example.

Many Australian HRECs articulate the NHMRC guidelines on legal risks of disclosure to third parties by requiring that researchers inform participants that any data collected during research will kept confidential, “except as required by law”. In keeping with the ethical concept of informed consent, participants are thereby warned that researchers are not able to unconditionally offer confidentially. It has become clear to us that the intention of this phrase, to flag the legal limits of confidentiality, is not well understood by researchers (Olsen & Mooney-Somers, 2014).

The National Statement details some aspects of human research that is subject to specific statutory regulation however stresses that compliance with legal obligations is not within the scope of the National Statement: “It is the responsibility of institutions and researchers to be aware of both general and specific legal requirements, wherever relevant”. Moreover, in the document we are directed that it is not the role of a HREC to provide legal advice. It is relatively rare for Australian HRECs to provide explicit guidance on the relevant legal obligations for researchers, including: how they differ across jurisdictions; what protective strategies researchers could employ to better protect patient confidentiality; or how to best inform participants about the risks of legal action (Some useful HREC-produced resources are Alfred Hospital Ethics Committee, 2010; QUT Office of Research Ethics and Integrity, 2016) Criminology scholars have (unsurprisingly) considered these issues in their own field (Chalmers & Israel. 2005; Israel, 2004; Israel & Gelsthorpe, 2017; Palys & Lowman, 2014).

We believe there are real risks to participants, researchers and research institutions.

Recent international cases of research dealing with illegal activity becoming subject to legal action include The Belfast Project/The Boston Tapes (BBC News, 2014; Emmerich, 2016; Israel, 2014) and Bradley Garrett’s ethnographic work with urban explorers (Fish, 2014; Times Higher Education, 2014) (See also Israel & Gelsthorpe, 2017). On the whole, legal action was anticipatable in these cases as they involved illicit activities and the legal action was driven by law enforcement interest. In some instances, researchers took extensive steps to protect participant confidentiality. In other cases the promise of absolute confidentiality seems a little naïve (and in our opinion, perhaps negligent).

Perhaps of more concern are cases in which legal action was instigated by interested others, not law enforcement. Of particular interest to us are recent cases of tobacco companies using Freedom of Information laws in Australia to obtain research data from Cancer Council Victoria on young people’s attitudes to and use of tobacco, and an earlier attempt to seek data on adults from Cancer Council NSW (McKenzie & Baker, 2015; Schetzer & Medew, 2015). As these cases do not involve illegal activity, it is much less likely that researchers could have anticipated the specific legal actions that undermined participant confidentiality. (The tobacco industry has taken these actions in other countries (Hastings, 2015; McMurtrie, 2002)).

Our point here is that the promise of confidentiality should never be casually made. Researchers have an ethical obligation to think through what “except as required by law” may mean for each particular research project. Although it has been argued elsewhere that as professionals, researchers should be provided the same participant confidentiality rights as doctors and lawyers (Emmerich, 2016), the current state of affairs is that research data is not (necessarily) safe from legal, contractual or professional obligation to divulge findings or results to third parties.

References:

Alfred Hospital Ethics Committee. (2010, Updated September 2016). Alfred Hospital ethics committee guidelines: Research that potentially involves legal risks for participants and researchers. Retrieved from https://www.alfredhealth.org.au/contents/resources/research/Research-involving-legal-risks.pdf

BBC News. (1 May 2014). What are the Boston tapes? Retrieved from http://www.bbc.com/news/uk-northern-ireland-27238797

Chalmers, R., & Israel, M. (2005). Caring for Data: Law, Professional Codes and the Negotiation of Confidentiality in Australian Criminological Research. Retrieved from http://crg.aic.gov.au/reports/200304-09.pdf

Emmerich, N. (9 December 2016). Why researchers should get the same client confidentiality as doctors. Retrieved from https://theconversation.com/why-researchers-should-get-the-same-client-confidentiality-as-doctors-69839

Fish, A. (23 May 2014). Urban geographer’s brush with the law risks sending cold chill through social science. Retrieved from https://theconversation.com/urban-geographers-brush-with-the-law-risks-sending-cold-chill-through-social-science-25961

Hastings, G. (31 August 2015). We got an FOI request from Big Tobacco – here’s how it went. Retrieved from https://theconversation.com/we-got-an-foi-request-from-big-tobacco-heres-how-it-went-46457

Israel, M. (2004). Strictly confidential? Integrity and the disclosure of criminological and socio-legal research. British Journal of Criminology, 44(5), 715-740.

Israel, M. (6 May 2014). Gerry Adams arrest: when is it right for academics to hand over information to the courts? Retrieved from https://theconversation.com/gerry-adams-arrest-when-is-it-right-for-academics-to-hand-over-information-to-the-courts-26209

Israel, M., & Gelsthorpe, L. (2017). Ethics in Criminological Research: A Powerful Force, or a Force for the Powerful? . In M. Cowburn, L. Gelsthorpe, & A. Wahidin (Eds.), Research Ethics in Criminology and Criminal Justice: Politics, Dilemmas, Issues and Solutions. London: Routledge.

McKenzie, N., & Baker, R. (15 August 2015). Tobacco company wants schools survey for insights into children and teens. The Age. Retrieved from http://www.theage.com.au/national/tobacco-company-wants-schools-survey-for-insights-into-children-and-teens-20150819-gj2vto.html

McMurtrie, B. (8 February 2002). Tobacco companies seek university documents. Chronicle of Higher Education. Retrieved from http://www.chronicle.com/article/Tobacco-Companies-Seek/6959

National Health and Medical Research Council. (2015). National Statement on Ethical Conduct in Human Research (2007) Retrieved from https://www.nhmrc.gov.au/printpdf/book/export/html/51613

National Health and Medical Research Council. (2016). Public consultation on Section 3 (chapters 3.1 & 3.5), Glossary and Revisions to Section 5: National Statement on Ethical Conduct in Human Research (2007). Retrieved from https://consultations.nhmrc.gov.au/files/consultations/drafts/ns-section3-public-consultation.pdf

Olsen, A., & Mooney-Somers, J. (2014). Is there a problem with the status quo? Debating the need for standalone ethical guidelines for research with people who use alcohol and other drugs. Drug Alcohol Rev, 33(6), 637-642. doi:10.1111/dar.12140

Palys, T., & Lowman, J. (2014). Protecting research confidentiality: What happens when law and ethics collide. Toronto: Lorimer.

QUT Office of Research Ethics and Integrity. (10 Novembeer 2016). Participants and illegal activities. Retrieved from http://www.orei.qut.edu.au/human/guidance/illegal.jsp

Schetzer, A., & Medew, J. (20 August 2015). Cancer Council spends thousands fighting big tobacco over children’s survey data. The Sydney Morning Herald. Retrieved from http://www.smh.com.au/national/cancer-council-spends-thousands-fighting-big-tobacco-over-childrens-survey-data-20150820-gj3nh7.html

Times Higher Education. (5 June 2014). Place-hacker Bradley Garrett: research at the edge of the law. Retrieved from https://www.timeshighereducation.com/features/place-hacker-bradley-garrett-research-at-the-edge-of-the-law/2013717.article

Contributors

Anna Olsen is a Senior Lecturer at the Research School of Population Health, Australian National University. She leads a number of qualitative and mixed methods public health research projects, teaches qualitative research methods and supervises post-graduate students. Dr Olsen is an experienced member of formally constituted university and hospital human research ethics committees. https://researchers.anu.edu.au/researchers/olsen-phd-am

Julie Mooney-Somers is a Senior Lecturer in Qualitative Research in the Centre for Values, Ethics and the Law in Medicine, University of Sydney. She is the director of the Masters of Qualitative Health Research at the University of Sydney. An experienced qualitative researcher, teacher and supervisor, she has taught qualitative research ethics and sat on a NGO-run ethics review committee for six years. http://sydney.edu.au/medicine/people/academics/profiles/julie.mooneysomers.php and http://www.juliemooneysomers.com

This post may be cited as:
Olsen A, and Mooney-Somers J. (2017, 24 February) ‘Except as required by law’: Australian researchers’ legal rights and obligations regarding participant confidentiality. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/except-required-law-australian-researchers-legal-rights-obligations-regarding-participant-confidentiality

Abuse of prisoners in the United States0

 

Mike Adorjan and Rose Ricciardelli’s edited collection, Engaging with Ethics in International Criminological Research, was recently published by Routledge. Of course, the book examines the likely suspects – ethical practices in relation to studies of policing, imprisonment and vulnerable populations. However, there are more unusual pieces on illuminating the Dark Net, carceral tours, and working in Hong Kong and China. My own contribution (Israel, 2016) examined the sad history of abuse of consent in research involving prisoners and prisons in the United States. It is an account of the exploitation of prisoners and a failure of criminologists to have any impact on the regulation and review of prison-based research.

Consent procedures have been created by research ethics regulators to protect research participants from abuse. In the United States, prisoners have been particularly vulnerable to the exploitative practices of researchers. However, contemporary consent procedures also stop researchers from uncovering institutional practices that exploit non-autonomous individuals. In doing so, research ethics regulation forms part of a broader strategy of self-protection established by public and private correctional services. Some scholars outside the United States have used covert research to evade prison protectionism. However, few have sought to link criminology’s understanding of state and state-corporate violence to the abuse of prisoners by researchers or extend their critique of protectionism to the work of research ethics regulators… I explore how requirements to obtain consent have been systematically evaded within prison-based research in the United States to the detriment of prisoners, but also how responses to scandal have led to the overprotection of institutions at the expense of prisoners’ ability to exercise autonomy, access justice, and benefit from the research process. Sadly, this chapter also demonstrates the apparent irrelevance of criminologists to the reform of regulation of research ethics in American prisons.

References

Israel, M (2016) A Short History of Coercive Practices: the Abuse of Consent in Research involving Prisoners and Prisons in the United States, in Adorjan, M and Ricciardelli, R (eds) Engaging with Ethics in International Criminological Research. London: Routledge. pp69-86. https://www.routledge.com/products/9781138938403

Contributor
Mark Israel is a senior consultant with AHRECS, adjunct professor of law and criminology at Flinders University and a visiting academic at The University of Western Australia.

This post may be cited as:
Israel M. (2016, 19 September) Abuse of prisoners in the United States. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/abuse-prisoners-united-states

A Note on the Importance of Sensitising the Novice Researcher to the Realities of Ethics in Practice0

 

Discussions of research ethics have begun to centre increasingly on how research guidelines translate into ethical practice during the research process. In the paper which prompted the invitation to contribute to this blog (McEvoy, Enright & MacPhail, 2015), my experiences as a novice researcher conducting focus group interviews with a group of young people are illustrated and discussed. The consequence of a limited experiential base in research and not having previously read deeply on the topic of research ethics was that I encountered difficulties in recognising or determining the best course of action when faced with what Guillemin and Gillam (2004, p. 263) refer to as ‘ethically important moments’ in the research situation.

It is clear that unless researchers are sensitised to how research practices such as confidentiality, informed consent, etc. manifest in research encounters, on-the-spot decisions can test the veracity of a research project’s ethical promises. I am certainly not suggesting that experienced researchers hold the monopoly on research ethics, or that it is not possible for novice researchers to behave ethically. Rather, due to the immediacy of ethically important moments it is often a researcher’s instincts or reflexes which are operative. Therefore, just as when we learn any skill and certain elements become automatic with experience, it is important that researchers starting out on their careers are given every opportunity to develop and challenge their ethical practice in a way that ensures that those elements of their practice which become ingrained have the best chance of being ethically sound.

In reflecting upon the ethically important moments I encountered, and in reading the associated literature, I certainly improved my ethical sensitivity and understanding of how ethics are enacted in practice. However, from the perspective of the research participants in the given project, it was far from ideal that my learning was the product of ethical difficulties in the field. So how might novice researchers hone their skills and reflexes without exposing research participants to the possibility of ethical breaches borne of inexperience? We may certainly begin by providing research students with a wealth of examples of ethical dilemmas, discussing our research encounters with them, what we did or didn’t do, said or didn’t say, and prompting them to question what they would do or say in the given situation. Further, we can ensure that we educate novice researchers regarding the deeper thinking behind the principles of research ethics and the various ethical stances that abound (e.g. virtue ethics, relational ethics, feminist ethics, situational ethics, etc.) so that when faced with a less clear-cut ethical dilemma they will have the resources to adapt to the context by upholding the spirit of a given principle. The immediacy of the research situation requires instant decisions but that same immediacy results in the likelihood that such decisions are in fact the result of that which comes before the research situation itself. It is perhaps in the preparation that ethics is won or lost.

References:

Guillemin, M., and Gillam, L., (2004). Ethics, reflexivity, and “ethically important moments” in research. Qualitative Inquiry, 20, 261.

McEvoy, E., Enright, E., & MacPhail, A. (2015). Negotiating ‘ethically important moments’ in research with young people: Reflections of a novice researcher, Leisure Studies, doi: 10.1080/02614367.2015.1119877

Eileen Mcevoy
PhD student at the University of Jyväskylä, Finland and also works as a research co-ordinator in Ireland. She has co-ordinated research projects at the Physical Education, Physical Activity and Youth Sport (PEPAYS Ireland) Research Centre, as well as various other Irish educational institutions.
epmcevoy@gmail.com

This blog may be cited as:
Mcevoy, E. (2016, 22 April) A Note on the Importance of Sensitising the Novice Researcher to the Realities of Ethics in Practice. Research Ethics Monthly. Retrieved from https://ahrecs.com/human-research-ethics/note-importance-sensitising-novice-researcher-realities-ethics-practice

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