In the wake of the controversy over the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT), a team of bioethicists set out to answer two main questions raised by the controversy: (1) “what do people think about the risks and benefits of research on medical practices?,” and (2) “what do people think about different approaches to informing patients that this type of research is being conducted?” Their research, the Research on Medical Practices Ethics Study, examined the views of the general population regarding research on medical practices through a series of surveys and focus groups. The team also partnered with PRIM&R to survey human subjects protections professionals to learn about their views regarding research on medical practices.
In April, the results of the group’s survey of the general population were published in an articled titled “Attitudes Toward Risk and Informed Consent for Research on Medical Practices” in the Annals of Internal Medicine. To learn more about the group’s work and their findings thus far, I recently interviewed Mildred Cho, PhD, a member of the study team and a professor of pediatrics at Stanford University.
Avery Avrakotos (AA): What motivated the Research on Medical Practices project?
Mildred Cho (MC): One of the main things that motivated our project was the questions raised by the Office for Human Research Protections in response to SUPPORT. More generally, we wanted to examine the differences in attitudes between traditional clinical research and research on medical practices. There is so much more research occurring now—from quality improvement to comparative effectiveness research—that compares standard medical practices. We wanted to look at this area of research and consider the ethical questions raised for potential participants and challenges posed for institutional review board (IRB) members, as heard from IRB members that there was confusion in how to implement the current regulations within the context of research on medical practices.
AA: Your general population survey results showed that the majority of respondents support comparative effectiveness research in health systems, but they would like to be asked for permission even if the research only involves gathering anonymous information. Was that a surprise? What implications do you think that finding has for comparative effectiveness research?
MC: We weren’t surprised by people’s desire to know about and be asked for their permission to conduct research, even if it was retrospective or observational research. That finding was similar to findings by researchers examining other research contexts that don’t necessarily involve an intervention, such as biobank research. People want to know about research that’s going on; it doesn’t matter what kind of research, or if they have a choice, they would prefer to be asked for permission. What did surprise us was that people don’t really think about randomized research any differently than they do about observational research. Initially, we thought that people would say: “Okay, yeah, you’ve got to ask us permission if you’re going to look at my medical records for research,” but that people would feel stronger about the need for permission if they were going to be randomized, but they didn’t.
AA: Do you think that was a matter of education, of understanding the differences in randomized versus observational research?
MC: That’s what we thought, but we actually asked knowledge questions as part of our survey to try to get at that issue. People scored really highly on all the knowledge questions. They do understand that there is a difference. What we’re taking away from that, as well as from our findings from the interviews and focus groups that we did, is that people don’t necessarily think about risk in the same way that IRBs think about risk. Our survey of IRB members supported that theory; we found that IRB members feel differently about whether consent should be required for randomized research versus observational research.
AA: Do you have a sense of the different concept of risk between these groups? In the broader public, what are the things that they perceive as the risks involved with the research versus the IRB?
MC: What the general population, or patients, think of as a risk has to do in part with their relationships with their doctors. The federal regulations for the protection of human subjects focus a great deal on the physical risks of interventions. But, when people talked to us about why they felt the way they did about participating in research, they talked a lot about trust. In order for them to maintain their trust in their practitioner, they felt it was very important that they be notified and asked for their permission to participate in research, no matter what kind of research it was. When they talked about risk, they talked about risks to relationships, which is very different than how we think about risk from a regulatory standpoint. That was really eye opening.
AA: What is one takeaway from your work that you would like to share with human subjects protections professionals and IRB members?
MC: The general population doesn’t view risk the same way that IRB members are trained to see risk. In light of that, it may be beneficial for IRB members to keep an open mind about what potential participants might classify as a risk.
AA: Is there any aspect of your work that you wanted to touch on that we haven’t spoken about already?
MC: I don’t think this is new or surprising, but our findings did reinforce that the general population feels it is important for research to be able to go forward. Our work showed that the general population was willing to forgo written consent, or even verbal consent (even though they prefer to be asked for consent to participate in research on medical practices) if obtaining consent would mean that the research could not be done. This also means that we could be more creative in thinking about the situations in which consent is required. On a related note, one of the things we’ve been learning about in recent interviews is preferences around consent. For IRB members, there is a sense that written consent is somehow preferable to verbal consent. Yet, we’ve been hearing that some many people prefer verbal consent because it’s a better form of communication for them. People have different communication styles and that may drive their preferences more than anything.
AA: Are you continuing your work on this project? What’s next?
MC: We are still in the midst of working through all of our data, and we are also working on some follow-up projects. We are doing a five-armed randomized trial to look at the effects of different modalities on willingness to participate in research on medical practices, as well as attitudes towards notification and consent. We are also examining similar questions in the context of biobanking and use of electronic medical records.
Thank you for taking the time to speak with Ampersand, Dr. Cho. PRIM&R’s research ethics community looks forward to hearing more about your work as it progresses.
by Avery Avrakotos, MPH Candidate at the University of Michigan School of Public Health