Survey on Personal Genomics, Privacy & Consent

Here's an announcement for a new "interactive" or "deliberative" survey that we are running, on Personal Genomics, Privacy & Consent. Anyone can participate. (We refer to the survey as "interactive" or "deliberative" because participants get to see each other's answers, and respond to them, while taking the survey.)

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Our research group (at University of British Columbia, Saint Mary’s University, & Ryerson University) has created an online, interactive survey to better understand values & attitudes related to Personal Genomics. We’d like to include input from readers of this blog because they represent important perspectives on ethical issues related to Personal Genomics.

The survey will take about 10-20 minutes.

To take the survey you will need to register. This requires entering your email address. This is so that we can make the survey safe from spammers & hackers. We will not be able to link your e-mail address with your answers, & we won’t give your details to any third party.

If you have questions or concerns, email us at chris.macdonald@smu.ca or nwalton@ryerson.ca.

You can access the ‘Personal Genomics & Privacy’ survey via this link: http://www.yourviews.ubc.ca.

Thank you. We value your input.

Chris MacDonald PhD. & Nancy Walton, Ph.D.

Moving Ethics Review Out of the institution: Are We Throwing Caution to the Wind?

There is a debate out there in the research ethics world about "outsourcing" research ethics review responsibilities. In other words, taking the (Research Ethics Board) REB from the University or hospital and situating it outside of the institution. For those of you not familiar with Canadian research ethics review processes, we use a fairly common "local model of review" standard as articulated in our federal guidelines, found in the Tri Council Policy Statement for the Ethical Conduct for Research Involving Humans (TCPS). The model of local review implies that research must be reviewed by multidisciplinary, independent local ethics review boards who apply both the national norms or guidelines (as outlined in the TCPS) and local interpretations of the guidelines as outlined in institutional ethical standards for research. Boiled down, this means that Universities and hospitals, along with other kinds of research-generating institutions, have local ethics review boards to review research conducted at their institution and by those affiliated with their institution. The current question is whether or not to take these ethics review boards out of the institution and create a different kind of ethics review model.

It's an interesting debate and one that, I'm sure, we have not heard or seen the end of quite yet.

Why even suggest taking the ethics review board outside of the institution?

Well, there are a few reasons. First, there is a claim that it would create a kind of "arms-length" board that can fulfill the need for ethics review for research without, presumably, the worry over potential conflicts of interest, special treatment of certain researchers or bias against others. Of course, this is a pretty difficult claim to make. The world of research and research ethics is much smaller than you'd think. The act of situating an ethics review board outside of an institution doesn't necessarily take away the worry that board members might be faced with a potential conflict of interest.

Second, ethics review boards that are not situated directly within an institution might well be better able to coordinate ethics review for multi-centre research projects. Without a clear institutional affiliation, such a Board may be able to approve a project that could be carried out at a number of institutions right away, instead of what happens now. Currently, researchers must apply to every local review board within institutions where the research may be conducted (as well as any institution with which they are affiliated). For many researchers involved in multi-centre projects, this can be burdensome and frustrating. Case in point: Recently, for my own low-risk research, I had to apply to 17 separate Ontario Research Ethics Boards. Each had different local norms and requirements for recruitment and consent, thus requiring me to "reinvent the wheel" with almost every application. Some Research Ethics Boards did not allow an expedited review (typical for already-approved low risk research) even when the project had clearly been previously approved by 15 other Boards. With outsourcing, some institutions might agree to regional reviews or something of the like — where a "regional" external ethics review Board could approve a study once for a number of local institutions.

Third, getting faculty members, students and clinicians to serve as Board members is a notoriously difficult task. It's not like some committee work at Universities that involves simply attending an occasional meeting with no "homework". Compared to most committee work (required by most higher educational institutions as part of the service requirements for tenure-track faculty), it's a great deal more work and effort. However, it's clearly not a priority for many institutions who don't recognize or promote the importance of these kinds of processes nor are those involved in the work rewarded or supported as well as they should be. Old news.

Outsourcing that work to an external Board would eliminate, to some degree, the need to recruit busy professors and clinicians from within the institution. However it would likely involve increased costs. Currently, many ethics review board Chairs and members essentially "work for free". They might perhaps be provided with a course release or a merit increment in pay for their ethics review work. Outsourcing ethics review responsibilities would mean direct costs for institutions, who would have to pay for external Board members and their work.

Which leads us to the clear downsides of a move to outsource research ethics review. But, really, shouldn't we just be glad to offload this work?

Well, the model of local review works — at the very least, it helps ethics review boards with their primary mandate of protecting participants. A local board, situated within an institution or community, has special knowledge of that community, the populations, etc. That "insider" knowledge not only helps to maintain the protection of potential participants from within the community but also it helps researchers. At the end of the day, knowledge of community-held local norms and offering advice on such communities can help researchers to gain appropriate access into certain institutions and participants.

Local norms help protect institutions with "special" populations or considerations. Here's how. A pediatric hospital or a community mental health centre may have very different local norms for ethics review than a large academic acute care hospital. In turn, a small arts college may have much different norms than those of a large University with emphases on biomedical research programs. These kinds of local norms are, for the most part, based on local interpretations of the federal guidelines for the ethical conduct of research. These kinds of variations in, for example, approaches to recruitment or requirements for a consent form, are vitally important in helping to protect participants, especially those "special" populations that may be more vulnerable.

Additionally, the issues of responsibility and liability are unclear when a Board that is external to the institution approves a study. Detailed agreements would need to be in place and would require ongoing revision, almost on a case-by-case basis for large centres with highly varied research being carried out. Again, the issue of the competing priorities of academic research centres comes up. It would require a great deal of dedicated vigilance to work with an external body to ensure that local standards for the ethical conduct of research are being upheld. If the support for research ethics work isn't in place now, how will support for that dedicated vigilance and ongoing coordination, required with an external board, ever become a reality?

This isn't an easy question to answer. It also isn't one that will be answered by a "one size fits all" kind of solution. Clearly, the model of local review has particular attributes that are situated in important values and principles for how the Canadian community feels that research participants should be protected. Whether those values and principles can be upheld by taking the REB completely out of the institution remains to be seen.

Here's an older, but still very interesting article on this issue, which also puts forth some suggestions for alternative models:
Debate Over Institutional Review Boards Continues as Alternative Options Emerge

Finally, Some Good News in Research Ethics

Call it effect of the "Back to School" time of year, filled with hope for new beginnings, but I am compelled to write a blog entry about something positive in research ethics. I have found the last few months replete with discouraging stories about deception and bad behaviour in the conduct of research. I was more than ready for something inspiring when I happened upon the website for this UK-based program.

R4D (Research for Development) is a web "portal" for the funded research of the DFID (The Department for International Development) in the UK. The DFID, as part of its mandate, funds research in the developing world and R4D is the mechanism by which the rest of the world can learn about the research that is underway.

Here's a bit about DFID from their website:

The UK government believes it is in all our interests to help poor people build a better life for themselves. So in 1997 it created a separate government department - the Department for International Development (DFID) - to meet the many challenges of tackling world poverty. It is DFID’s job to make sure every pound of British aid works its hardest to help the world’s poor.

We work in 150 countries and have 2,600 staff, half of whom work abroad. We have headquarters in London and East Kilbride, near Glasgow, and 64 offices overseas.

The R4D website is essentially a repository of information about the kinds of research the DFID funds. It has case studies, a database of information from previous studies, information about the 6 research priorities for DFID (Growth, Sustainable Agriculture, Climate Change, Health, Governance in Challenging Environments, Future Challenges and Opportunities) and published papers from DFID-funded projects.

One such project is the Young Lives project. Young Lives is a long-term international project documenting the changing nature of child poverty in four developing countries: Ethiopia, Peru, India and Vietnam. Following 12 000 children, the investigators on this project are aiming to facilitate the implementation of more relevant policies to aid the world's poor, especially children and youth. It's a very worthwhile project and the methods are outlined in incredible detail on the website.

But something else drew me to this project, aside from the obviously meritorious objectives. On their website, they have a section called "Research Ethics". Here they address the kinds of research ethics issues they have faced in their project and articulate their approaches to these issues, e.g. informed consent, anonymity and compensation. They also include a guidelines paper on the use of photography in research on children. They even provide a link to a working paper by a Young Lives Co-Investigator, Virginia Morrow on The Ethics of Social Research with Children and Families in Young Lives: Practical Experiences

Why is this so positive? Well, it demonstrates that the investigators on the project don't consider research ethics to be merely a bureaucratic or administrative process to be completed before research can begin or to fulfill the requirements of funding agencies or federal guidelines. Rather, it shows that they consider research ethics to be an important, dynamic and consistent part of conducting research. And while I'm a little hesitant to use the buzzword "transparent" to describe their approach, the fact that anyone can visit their website to read their consent forms or learn more about photography of children in their project, is laudable. It's clear that novice researchers, graduate students and research assistants on this project are getting valuable and relevant education on how to conduct research with integrity. And to see this approach taken on a project involving such a vulnerable population — poor children — is more than encouraging.

It's clear that, at least in the eyes of these researchers, research ethics is more than simply an application or stamp of approval. It's an integral part of a project, from beginning to end. And while that isn't necessarily a newsflash to most of us, to see research ethics presented as an intrinsic part of the research process is very good news.

CIA Physicians and Research on Torture

As reported by The Guardian:

Doctors and psychologists the CIA employed to monitor its "enhanced interrogation" of terror suspects came close to, and may even have committed, unlawful human experimentation, a medical ethics watchdog has alleged.

Physicians for Human Rights (PHR), a not-for-profit group that has investigated the role of medical personnel in alleged incidents of torture at Guantánamo, Abu Ghraib, Bagram and other US detention sites, accuses doctors of being far more involved than hitherto understood.

PHR says health professionals participated at every stage in the development, implementation and legal justification of what it calls the CIA's secret "torture programme...."

It's important to note that (at least as reported by the Guardian) what's at issue, here, is not the simple presence of physicians and psychologists at interrogation sessions; it's the notion that they were there doing research. According to the PHR's press release...

The [CIA Inspector General's] report details how the CIA relied on medical expertise to rationalize and carry out abusive and unlawful interrogations. It also refers to aggregate collection of data on detainees' reaction to interrogation methods. PHR is concerned that this data collection and analysis may amount to human experimentation and calls for more investigation on this point....

Now, on one hand, the fact that detainees were used as research subjects without their consent might be thought of as the worst of their problems. I suspect that when you're being waterboarded, the fact that the guy in the white coat standing in the corner didn't ask your permission to take notes isn't your foremost worry. But think of it this way: if there's anything worse than being tortured, it might just be being tortured with the additional knowledge that your torturers are using you as a way of learning how to torture others more effectively.

Interestingly, notwithstanding the focus on consent in the Guardian and in the PHR's press release, the PHR's full report barely mentions consent as an issue, or research more generally for that matter. This raises the question of whether the research ethics angle, here, is considered an important one by PHR, or whether research ethics rules are being used (rightly or wrongly) as a tool to achieve other objectives.
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p.s., back in May, Nancy posted this related item: Research on torture: Should we put limits on what topics researchers can study?