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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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.

Sprinting to the start line: concerns with expedited ethics review2

 

Allow me to start with a short story.

A recent conversation I had with an established academic evolved as follows. The academic had funding to explore how involvement with classical music impacted a child’s development. He planned to interview parents of children, aged 2-13, who played musical instruments. The interviews were exploring how music was involved in the children’s daily schedule. The questions were likely to centre around everyday activities and conversations the parents had with their family and friends, so he considered the research low risk. Expedited ethics review was gained, and the research was approved almost immediately. Upon ethics approval, the researcher then explained how he used the amendment process to include children in the research; something he had planned to do all along. The amendment involved a small submission explaining how the research was differing and what some of the new potential ethical issues might be. The interviews with the children would be about their experiences playing musical instrument. They were likely to mimic conversations the children had daily. This manipulative even blasé approach to ethics review concerned me. The researcher here took advantage of the low risk expedited review, using it as a short cut to dodge full ethics review which would have involved lengthy paperwork. When I asked him about his approach he claimed it was fairly common practice in his department. It saved time and avoided unnecessary ethical bureaucratic practices.

As a budding researcher and novice ethicist, I want to make it clear from the beginning that I am not against expedited ethics review process for low risk projects, nor do I think all projects involving children are high risk. After completing and submitting a handful of ethics applications for various projects in my postgraduate studies and research assistant work, I understand the benefits of expediting low risk projects. I do, however, have some concerns with what may be lost in the rush to expedited review, particularly if expedited review is being used as a loophole.

Typically ethics committees tend to be protective of groups deemed ‘vulnerable’, children included. So my curiosity grew when I heard the ethics committee not require the academic to resubmit a full ethics application. Many ethics committees would see red flags because of the children and require a completely new application. Ethics committees’ idiosyncrasies are discussed often enough in ethics literature, and perhaps magnified through their approaches to expedited review. Yet, little explanation around the decisions to accept or reject amendments is offered. Would other ethics committees have reacted differently to the amendment submitted?

I am apprehensive that expedited ethical review may render the primary purpose of ethics review secondary. Ethics review was originally created to protect participants from harm. Expedited ethical review has definite benefits for the researcher and ethics committee, decreasing the time review takes, and reducing the workload for committee members. But does it come at a cost to participant protection?

I have two main concerns: the level of ethical scrutiny applied during expedited review; and the temptation for expedited review to be used as a ‘shortcut’. One of the main benefits of full ethics review is that research proposals are scrutinised by multiple sets of eyes, and critiqued and examined by members with different skill sets, concerns, and expertise. I am unsure how during expedited review, one or two ethics committee members can ensure the same level of review is applied. In the past, expedited review of applications I have submitted certainly missed some key mistakes which I found after receiving ethics approval. Furthermore, I am unsure if just one member of the ethics committee can identify all the potential risks of low risk projects.

The second main concern I have with expedited review is that it may be used as a ‘shortcut’. Expedited review may be seen as a way to obtain ethics review quickly. “The identification of ‘doing ethics’ with ‘getting through ethics review’ creates a risk that ethics questions focus on data gathering, with the result that (re)use of data is either seen as ethically unproblematic or ignored” (Morrow et al 2004 p. 4). Israel (2015) argues qualitative researchers are frustrated with ethics procedures that do not understand qualitative methods. The researcher’s approach to ethics review above may be a result of this frustration. However, finding loopholes and using or abusing the expedited review process should not be the answer.

My short reflection of this expedited review process is not intended to criticise ethics committee members’ work. I simply cannot fathom the volume of work they undertake each month. Introducing systems such as expedited review may be a productive way to reduce the monthly workload ethics committees face. Rather, I have questioned how thoroughly expedited review can explore a complex project. Perhaps we should be asking not if projects reviewed through an expedited review process offer the same level of ethical scrutiny as a full review process, but rather how this shortened review process can ensure projects are still reviewed sufficiently?

References

Israel, M. (2015). Research ethics and integrity for social scientists: Beyond regulatory compliance (2nd ed.). London: Sage.

Morrow, V.; Boddy, J.; Lamb, R. The ethics of secondary data analysis: Learning from the experience of sharing qualitative data from young people and their families in an international study of childhood poverty. Institute of Education, University of London, UK (2014) 24 pp.

Amber Chambers
Otago University MA graduate
Research assistant at Griffith University
Centre for Governance and Public Policy, Nathan

This blog may be cited as:
Chambers, A (2015, 23 August) Sprinting to the start line: concerns with expedited ethics review. AHRECS Blog. Retrieved from https://ahrecs.com/human-research-ethics/sprinting-to-the-start-line-concerns-with-expedited-ethics-review

 

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