Why do ethical review in a low risk project?
by Azure Grant and Gary Wolf
For nearly a decade, Quantified Self has been helping people learn about themselves using their own data. Mostly our help involves maintaining the QS Forum, writing about new tools and methods on the QS Website, and encouraging people to talk about their work at one of our meetings. Only occasionally, when it seems really needed, do we do more. For instance, a few years ago we created a QS Access App that allows you to easily view your HealthKit data in a table, so you can explore it using any spreadsheet software.
As the tools for self-tracking have improved, and access to research publications and medical grade instrumentation has spread, QS participants are taking on more and more sophisticated projects. Some of these can be difficult to carry out alone. So lately we’ve been trying something new: group supported self-tracking. Our idea is that by working with a group of participants with diverse skills, self-trackers may be able to find the help they need close at hand.
At our QS17 conference, we gathered about twenty people who had questions about their cholesterol and cardiovascular health to discuss what we might learn by high-frequency (>1/day) lipid tracking. We call our group Blood Testers. (More background on the project is here.) But now that we are working in a group, we face an issue we’ve since spent many hours discussing with collaborators in public health and clinical research: How do we ethically conduct participatory research?
Normally, the ethics of a Quantified Self project are handled entirely by the people who do them. We often hear about ethical dimensions of QS projects in show&tell talks: Is the project too risky? Is it worth the commitment of time and money? Will other people be hurt? It’s obvious how much care people take with these decisions.
How does this care translate into the participatory research in Blood Testers? A framing principle of the project was that group members should only do as much as they wished; there would be no pressure to continue, and each participant would have complete control over their data. Each group member determines their manner and amount of participation. However, there are still group dynamics that concern us, a kind of momentum and collective responsibility that’s different from purely individual research projects.
That’s interesting.
We decided to pay close attention to the ethical dimensions of our project. Not only is it necessary to have an explicit process (even when using low-risk, FDA approved tools), but we felt it would be useful to develop a set of best practices should we someday venture further into experimental territory. Maybe you could compare it to doing the first camping trip of your life in your own backyard. It’s safe, but it leaves you more prepared for a real trip into the woods.
Fortunately one of the members of our Blood Testers group is bioethicist Dr. Camille Nebeker, who has deep experience with the philosophy and practice of ethical review in biomedical research. Dr. Nebeker has made the ethics of participatory research a focus of her scholarship, and she’s been helping us make use of mainstream scientific frameworks to strengthen our own practical efforts. Dr. Nebeker also hopes that the help can flow the other way, from QS projects into mainstream science, which is increasingly looking at self-collected data as a source of new discoveries.
“We are moving into an era where people will have more access to data, and we need to set a standard,” she says.
What does traditional ethical review look like, and how might it change?
The fundamental purpose of the ethical framework used in academic research is to ensure respect for participants and to give people the information needed to decide whether or not to volunteer. In the process, it’s important to make study results valid, useful and accessible. Along with respect and agency, the principles of ethical research include communicating about the risks — physical, psychological, economic, legal and social — and also about the benefits, which can be individual or altruistic. These principles have held up well for the past 50 years and we can learn a lot from them.
The process of informed consent typically involves describing risks and benefits to participants in writing. Because this is a bureaucratic process, participants may not always be in a timely and focused place to reflect seriously on the material they review. Blood Testers is exploring a different idea: convene participants with a bioethics expert for discussion, with advance preparation to make sure known risks are covered, and careful note-taking to allow later review.
Though we are doing this for ourselves rather than relying on an institutional process, our topics are similar to those considered in conventional reviews. Dr. Nebeker has provided material outlining the traditional regulatory framework for informed consent, including how these norms may apply to what we’re doing. Afterward, participants determine their own level of involvement, with the option to make adjustments as they see fit. Finally, participants will receive questionnaires throughout the project to provide further feedback.
Here are some of the risks and benefits we’ve exposed in our conversations so far:
§ Physical risks are fairly minor. Some pain and bruising can occur after frequent testing. Infection risk is negligible. Participants are trained in techniques to minimize discomfort and keep testing materials sterile.
§ Psychological risks included that participants might leave the project with uncertainty about the status of lipid levels in human health, and that this could cause some anxiety. Having high cholesterol alone may not be as risky as once thought. After discussion, we agreed that this risk might also be seen as a benefit: just as validating a new device familiarizes us with the uncertainty of a measure, learning the state of the field of lipid research familiarizes us with the current debates therein. We come from the perspective that informing ourselves is the best option — even when uncovering uncertainty can provoke anxiety.
§ Social risks. All participants stand a risk to reputation if collected data is not adequately rigorous. Project leaders in particular stand reputation risk if ethical concerns are not adequately conveyed, if the test system is not as effective as in preliminary trials, and if training in its use is not well understood. Finally, others may fear that participants and researchers being the same individuals will lead to a conflict of interest. To mitigate these risks, we have attempted to design the project in such a way that each participant is engaged individually and as a group in device validation and design of a personal experiment based on the scientific literature. All participants were self-selected to participate, motivated by want of personal insight into their physiology, which we feel is a strong motivator for learning background information and performing accurate (as possible) tests. Finally, as all of us are representing the Quantified Self movement, we are invested in providing a transparent, and as rigorous-as-possible example of participatory research.
§ Benefits. Sharing the method of small group, participatory research is our top benefit. This includes testing this platform for engaging self-consent, developing the use of MOOC-style project meetings, and thorough validation of testing materials. Within the project, we hope that participants will benefit from gaining new knowledge about current lipid research, learning how our lipids vary with time and behavioral change, and learning to communicate this new knowledge productively with one’s physician.
It’s inspiring to be exploring the ethics of everyday science with knowledgeable peers, and the novelty of the process has become one of the articulated benefits. What are your thoughts on bioethics in participatory research? How do you think this process might be improved? We’ve started a discussion called “Ethics of Participatory Research” on the QS Forum.
