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The seductive peril of precedent-based decision making1

Posted by Admin in Human Research Ethics on November 15, 2015 / Keywords: ,
 

Human research ethics committees face workloads that can very easily become crippling, consequently precedent-based decision making can appear to be a sensible survival strategy.

An HREC might decide to adopt such a strategy for several reasons:

• a desire to turnaround applications for research ethics review as quickly as possible;

• a commitment to being consistent and fair;

• to minimize the demands on committee members; and

• keep the discussion moving in meetings.

Typically such a survival strategy might relate to a component of a research design: ‘What do we normally do when researchers want to offer a prize-draw as an incentive to encourage participation?’. It might also be about the potential participant pool or context, ‘What did we do the last time an application related to research in China?’. Sometimes it can relate to the researchers, ‘Have we allowed counsellors to conduct research on their own clients before?’. Or, even more troublingly, it might pertain to an entire research discipline, methodology or research practice, ‘What did we do the last time we reviewed participatory action research?’.

There is a fair chance that the committee/other review body will not have specifically discussed adopting a precedent-based approach. It might be previously the Chair and/or ethics officer have previously been challenged by an applicant, ‘The last time you reviewed research like this you…’.

Making decisions by precedent has the allure of a legal approach which can seem to provide a decision authority, fairness and a degree of predictability that all might seem to make the work of the reviews more professional. It also looks deceptively like the philosophical approach of casuistry which uses reasoning by analogy to tackle complex ethical issues.

But, it is a seductive trap and Committee Chairs, members and ethics officers should be very wary.

Precedent-based thinking has a number of serious flaws:

a. Decisions should be based upon the specifics of individual projects – the research design, the question/objectives of the work, the potential participant pool, the context, the risks and benefits of the project, and the expertise of the researchers. In Australia, the National Statement is based on principles not rules and HRECs should not attempt to subvert the basis of the National Statement for their own convenience. Those countries that have adopted inflexible rules about research ethics have not had a happy experience and the United States is just taking the first steps away from this (Dingwall, 2015);

b. Applicants may well not have access to information about those precedents, so rather than the decision being seen as fair and consistent it might be seen as arbitrary and unfair;

c. Precedent-based decisions are likely to be conservative and risk averse; and

d. Such decision making encourages researchers to outsource their ethical responsibilities to the reviewers, ‘There is no way I can know all about research ethics review so I’ll just tell the reviewers what I want to do and they’ll tell me is it’s okay’. It also reinforces the message that the review is a one way communication, with edicts being issued, rather than an engaged and reflective discussion.

So what is the alternative?

Research ethics review bodies and research offices should work together to produce resource material for researchers and reviewers that identify ethical matters requiring attention, relate them to the principles and provisions of the National Statement (or relevant national framework) and provide the basis for the constructive approach to addressing those challenges.

Research ethics review decisions should reference the resource material, the national framework/institutional policy, and invite researchers to share their reflections on the given matter and explain why the propose approach is better/more appropriate for the specifics of the situation.

If a project is novel and/or applicants produce an elegant solution to an ethical challenge they should be congratulated (not beaten over the head with a precedent) and perhaps the solution included in the resource material.

The best solution to crippling workload might be to work smarter, rather than inflexibly.

Reference
Dingwall, R (2015) Deregulating Social Science Research Ethics – Clipping the Wings of IRBs? Social Science Space, blog posted 5 November http://www.socialsciencespace.com/2015/11/deregulating-social-science-research-ethics-clipping-the-wings-of-irbs/

Contributor
Gary Allen is the author of the Griffith University Research Ethics Manual a resource manual for researchers and research ethics reviewers.

This post may be cited as:
Allen, G (2015, 16 November) The seductive peril of precedent-based decision making. Research Ethics Monthly. Retrieved from https://ahrecs.com/human-research-ethics/the-seductive-peril-of-precedent-based-decision-making

Ethics and the privacy pendulum3

 

As the development of new technologies advances at a rapid pace, the ability to access, search and link information in new and different ways also continues to grow. Current legislative and governance frameworks regarding data privacy were developed at a time when these possibilities were not foreseen and are now an inadequate fit for this brave new world. Research ethics guidelines in particular struggle to accommodate not only the new mediums of communication, such as social media, but the ways in which this type of data can be harvested (often unknowingly) and connected to formerly disparate pieces of benign or de-identified data to create incredibly detailed pictures of peoples’ lives, views and aspirations. Ethics committees also grapple with assessing the risks and benefits of research at a time when the privacy pendulum has swung from what was a common central belief within the community (and indeed a human right) of the importance of protecting privacy at all costs to a more stratified set of values that include younger generations who actively seek out public connectedness and openly share almost all aspects of their lives in the public domain. How are the views of these generations and their sense of what constitutes risk and benefit captured in the deliberations of ethics committees whose membership often (although not exclusively) is made of Gen X-ers or baby boomers?

One of the real strengths of ethics committees is the diversity of experience and opinions they bring to bear on debating and resolving the ethical challenges of research that is driving new frontiers of technology and its exploration of all that it means to be human. Ensuring multi-generational membership of ethics committees that capture these stratified values can only add to this strength. However there is also a need for researchers and committees to stay engaged with public debate to understand evolving community values regarding privacy and our information. Why? Because one thing is for certain – a pendulum never stays at the peak of its swing for long and it already appears to be on the move again. This time the driving force is not a generational change but the rapid rise of big data and the associated realisation of the tangible market value of our information. Knowledge is power, and data, and the ability to harness and explore it in all its forms, is now big business. As individuals and enterprises join the new race to protect the IP associated with their data and mitigate against the risks that can arise from its misuse, they are also demanding their fair share of the benefits that can flow from its potential exploitation. Principles of privacy, justice and consent in this new context will require new considerations by researchers and ethics committees alike.

This blog may be cited as:
Pitkin, C (2015, 6 October) Ethics and the privacy pendulum. AHRECS Blog. Retrieved from https://ahrecs.com/human-research-ethics/ethics-and-the-privacy-pendulum

Cathy Pitkin
Manager Social Responsibility and Ethics CSIRO

Cathy Pitkin is responsible for the management of human and animal CathyPitkinresearch ethics for CSIRO. In this role she has led the development and implementation of a human research ethics framework for the organisation and manages the ethics review and associated support process for research scientists undertaking a diverse range of social, biophysical and interdisciplinary research. She has over 10 years experience working with researchers and research managers across multiple disciplines in considering the ethical dimensions of their research and ensuring that ethics principles are embedded as a core part of research design and implementation. This experience includes research that involves emergent technologies, privacy and other related social considerations. Cathy has an in-depth knowledge of current national ethics guidelines and related legislation and broader frameworks for research ethics governance. She regularly provides training to researchers and ethics committee members and has developed a suite of resources to support good research practice.

Prior to this role she was Director of Communication, Education and Training with CSIRO’s Social and Economic Integration Emerging Science Initiative which focussed on building capacity for and greater consideration of social and economic issues in biophysical research.

Before joining CSIRO Cathy worked in a range of community development, training, project management and communications roles in the private, government and NGO sectors. She has a Masters degree in community and international development and undergraduate degrees in social science and business.

Is human research ethics review a form of out of date, inefficient and ineffective regulation?3

Posted by Admin in Human Research Ethics on September 22, 2015 / Keywords: , ,
 

As I reached page 35 of the latest NEAF application for the next HREC meeting, I wondered, with some dismay, whether the system we are using is a form of regulation that has been rejected some decades ago in most other contexts. (I was dismayed because I had chaired the NHMRC working party that developed the NEAF!)

On 6 July 1988, the Piper Alpha North Sea oilrig was destroyed by a fire that killed 167 workers. This was in spite of a regulatory safety regime designed to prevent such disasters. The report of the inquiry into the disaster recommended significant changes in that regulatory scheme. Central was the proposal to no longer regulate by the imposition of prescriptive requirements but instead to require operators to submit a “safety case” to the regulating authority that showed how the operator would meet the safety requirements by reducing risks to as low as reasonably practical (ALARP) levels. No longer was compliance to be measured by pedantic and pernickety checklists related to prescriptive requirements because these had proved both inefficient and ineffective. Instead, compliance was measured by reliance on the operator’s innovation in meeting standards and commitment to safety.

Is this what we need to do in research ethics review? Are we at present, by relying on instruments like the NEAF (and others), burdening every applicant indiscriminately with prescriptive requirements of how to tell the reviewers what the researchers are planning to do? Granted, the requirements are all derived from the National Statement but is a focus on meeting those the only or the most important criterion for a good application?

We have little evidence that ethics review changes outcomes, although now there are only a few reported examples of unethical or scandalous research conduct, but perhaps this was always the case. The impact of these far outweighs their low frequency, but the fact that few do occur could be argued to be some evidence of ineffectiveness (it did not prevent these) or effectiveness (it only allowed these few) of ethical review. But there are other important effects. In recent years, there has been much discussion about the adversarial atmosphere in which human research ethics review is often conducted. Is this evidence of inefficiency and, if so, is inefficiency linked to ineffectiveness? In other contexts, such as oil exploration, extensive time given to filling out pedantic checklists, ever expanding work hours for teams of costly inspectors bred superficial compliance, corner cutting and workarounds. Can such resistance to, or rejection of the process because of its cost and burden lead to its ineffectiveness and, arguably, to disasters like Piper Alpha? Similarly, perhaps, with research ethics review: the time burdens of the application and review process that are seen to be unnecessary breed irritation, frustration, disdain and resistance which, in turn, mean ineffectiveness.

In oilrig safety, the renewed recognition was that measures of effectiveness need to include effects on operators’ attitudes. Greater safety could be demonstrated not only by a reduction of accidents but also by a change in the attitudes of operators. Their motivation for a safe operation was not from external compulsion – this is what I’ve been told to do – but from an internal conviction – this is the best way to conduct this operation.

So what could we do in human research ethics review? The model of responsive and smart regulation shows that the keys are:

* Giving more scope for regulatees to tell their story: to describe how they will meet and how they have met the relevant standards

* Relying more heavily on the motivation engendered in regulatees by forces other than regulation: public opinion, the market, industry, international standards and a sense of public responsibility

* Changing the function of the regulator to one of steering not rowing.

In human research ethics review, the application process could be changed to give far more scope for researchers to describe how they will meet a set of criteria derived from the National statement.

More radically, could we take the finality out of the initial review by instigating a system in which:

* The outcome of the first review is advice by reviewers, agreed to by researchers, on how to conduct the project,

* Progress reports that show that the advice is being followed • Agreements to adapt the advice when needed to respond to unforeseen or foreseen events,

* A completion report that demonstrates conformity with the agreed advice and that generates, in turn, approval from the reviewer, for publication and related purposes.

Currently, reviews of national human research guidelines are afoot in the USA and Australia. Now may be an opportune time to re-imagine a system of human research ethics review.

Colin Thomson
Professor, Academic Leader Health
Law and Ethics, Graduate School of Medicine, University of Wollongong,
Director, Houston Thomson Pt Ltd.
Colin’s AHEC profile

References

Healy, J., Braithwaite, J. Designing safer health care through responsive regulation MJA; May 15, 2006; 184-187: Baldwin, R and Black, J. Really Responsive Regulation MLR (2008) 71(1) 59-94

Gunningham, N. Environment Law, Regulation and Governance: Shifting Architectures, Journal of Environmental Law 21:2 (2009), 179 -212; Gunningham, N, Grabovsky, P and Sinclair, D. 1998. Smart Regulation: Designing Environmental Policy. Oxford: Oxford Univ. Press.

Sinclair, D. 1998. Smart Regulation: Designing Environmental Policy. Oxford: Oxford Univ. Press.

This blog may be cited as
Thomson, C (2015, 23 September) Is human research ethics review a form of out of date, inefficient and ineffective regulation?. AHRECS Blog. Retrieved from https://ahrecs.com/human-research-ethics/is-human-research-ethics-review-a-form-of-out-of-date-inefficient-and-ineffective-regulation

Do we need consent for the continued use of children’s biological samples and data in research – and what if the grown up children cannot be located?1

 

Parental consent is sufficient to authorize research involving infants and young children who do not have the capacity to take part in such decisions. But what happens when the children grow up and the research is ongoing?

According to the National Statement, where research is ‘complex or long-running, or participants are vulnerable’, consent ‘may need to be renegotiated or confirmed’ so that research participants are ‘given the opportunity to continue their participation or withdraw’. This suggests that at some point, researchers will need to get consent from the children themselves. The difficulty is that when children reach an age where they can consent for themselves and parental consent no longer applies, they may not know that they are involved in such research.

A study clarifying ethical responsibilities in the Australian paediatric biobanking context, reports that the responsibility to inform children when they are able to decide for themselves, belongs to no one: “Most children at 18 wouldn’t know about samples” and there is “no onus to inform people”. This state of affairs will likely cease to be a problem as new biobanks and studies get set up and better procedures are put in place. Currently though, we are left with questions about whether it is ethically acceptable for researchers to use samples and data, given with parental consent, from children who are now grown up and who cannot be located.

A U.S. study has addressed this very topic. It reports that most adults are not concerned about continued use of their samples and data collected during childhood but they want to be asked and they are generally willing to provide consent. Nevertheless there were 26% who think it is not acceptable to use their samples and data if they cannot be contacted. The authors conclude that adults have an interest in decision-making and that should be respected. Their consent for continuing research should be sought, but if they cannot be located, ‘it is generally acceptable to continue to conduct research’. The authors concede though that the scenario they use in the interviews lacked detail about things that would affect people’s attitudes – things such as risks, the type of study and identifiability.

So, how should researchers and Human Research Ethics Committees respond if the source of the sample cannot be found? Can researchers use the sample or should they throw it out?

The answer is – it depends. The National Statement reminds us that there is a need for researchers and HRECs to engage in ‘deliberation on the values and principles’, exercise their judgement, and have ‘an appreciation of context.’ What this means is that to arrive at an ethically defensible position for continuing without consent, researchers will need to explain their position, giving reasons for continued use without consent.

In order to justify using previously collected samples/data where the source cannot be located, researchers need good ethics based reasons for using this sample rather than a different sample from someone who has given consent or is willing to donate a new sample. There may be good reasons. For instance, good ethics based reasons may be to do with rare conditions and limited number of samples. Whatever the reasons, these reasons will be weighed against reasons for not using the sample without consent. Reasons in support of the need for consent after sources become adults, are autonomy based i.e. participation should be a reflection of that person’s own choices or reasons, not that of parents or researchers. A different but important reason is that proceeding without consent poses a threat to public trust and confidence in research – and the success of this type of research depends on the support of the public and their willingness to contribute. Reasons to continue without consent based simply on costs, time and inconvenience for researchers do not do the job.

References

Goldenberg, A. J., Sara, C. H., Botkin, J. R., & Wilfond, B. S. (2009). Pediatric Biobanks: Approaching Informed Consent for Continuing Research After Children Grow Up. The Journal of pediatrics, 155(4): 578-583

NHMRC (2007) National Statement on Ethical Conduct in Human Research. Accessed 4 September, 2015, from http://www.nhmrc.gov.au/guidelines-publications/e72

Spriggs, M., and C. Fry. 2015. Clarifying ethical responsibilities in paediatric biobanks. AJOB Empirical Bioethics Available early online at: http://www.tandfonline.com/eprint/QDVEzAwZsTqT9QkwvBjB/full

Dr Merle Spriggs BA (Hons), M.Bioeth., PhD
ARC Research Fellow
Children’s Bioethics Centre / Centre for Health Equity,
University of Melbourne.

This blog may be cited as:
Spriggs, M (2015, 4 September) Do we need consent for the continued use of children’s biological samples and data in research – and what if the grown up children cannot be located?. AHRECS Blog. Retrieved from https://ahrecs.com/human-research-ethics/do-we-need-consent-for-the-continued-use-of-childrens-biological-samples-and-data-in-research-and-what-if-the-grown-up-children-cannot-be-located

Dr Merle Spriggs (mspriggs@unimelb.edu.au) is a Research Fellow at the Children’s Bioethics Centre, Royal Children’s Hospital; the Centre for Health Equity, Melbourne School of Population and Global Health, University of Melbourne; and an Honorary Research Fellow at the Murdoch Childrens Research Institute. She has developed substantial educational resources about consent for Human Research Ethics Committees (HRECs) and researchers who conduct research involving children. Other recent research includes ethical issues and responsibilities in paediatric biobanking, e-health ethics, specifically the ethics of internet-based research and the ethical issues of electronic health records. Merle has over 20 years experience on hospital and university Human Research Ethics Committees and she has been an expert witness for two US law firms in cases involving child research. She is also a member of the Royal Children’s Hospital Clincical Ethics Committee and Clinical Ethics Response Group.

Current projects: Merle is part of a team working on an ARC Discovery Project: Involving children in social research: Balancing the risks and benefits; she is also leading a project titled: ‘Using research participants as co-researchers: Ethical considerations” funded by the University of Melbourne, Ethics and Integrigy Development Grant Scheme.

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