Ten years ago, Rebecca Dresser, MS, JD, faced a life-changing and, quite possibly, life-saving decision. As a bioethicist and IRB member, she was informed of a diagnosis of cancer and offered a difficult choice: She could enter a new clinical trial for treatment, or follow a specific regimen recommended by oncologists on a tumor board.
As Dresser describes it in her new book Silent Partners: Human Subjects and Research Ethics, the board recommended a regimen that included a new chemo drug that had just been approved for her type of cancer. Considering also that qualifying for the trial might delay treatment, a “terrified” Dresser reluctantly turned down the opportunity to be a research subject.
She had mixed feelings about it, knowing that other research subjects had participated in trials to prove the effectiveness of the new drug she would now be taking. The treatment worked and she survived, but this existential moment of weighing clinical trial participation versus personalized treatment spurred an interest and empathy for research subjects faced with similar decisions. The result was her book. IRB Advisor recently interviewed Dresser, a law professor at Washington University in St. Louis, and the questions and answers are summarized as follows.
IRB Advisor: You made a choice as an IRB member who was a potential research subject. What were some of the factors that went into your decision?
Dresser: I had the opportunity to be in a treatment trial, but I was also offered a regimen the tumor board recommended. It included a new chemo drug that had just been approved for my kind of cancer. That was in the regimen the tumor board recommended for me. I didn’t like the idea that I wouldn’t have at least a chance to get that [drug] in the trials and I asked whether that would delay my treatment if I went to the trial. If you go into a trial, you have to be screened and half the time you don’t even qualify. Even if you do, you have to be randomized [into one of the research arms]. I was really in a lot of pain and discomfort and I wanted to go into treatment. The idea that it would delay my treatment wasn’t very appealing, so those were the main two reasons I said no. Even though I realized I might be wrong. It might turn out that the trial was just as effective and maybe with fewer side effects, but I just felt that here was this recommendation a bunch of experts had come up with for me as an individual.
IRB Advisor: How did this experience inspire your book, Silent Partners?
Dresser: It got me interested in what other subjects think about their research experiences. I started reading a lot of literature, everything from journalist interviews with subjects and sometimes research subjects writing about their own experiences. There are a lot of empirical studies of what subjects think, so I read a lot of that. I also read fiction that was written from the subject’s point of view, and that’s how I put the book together.
IRB Advisor: IRBs sometimes have a member of the community on a board, but is it uncommon for IRBs to include someone who has been a subject in a clinical trial?
Dresser: It happens, and other people on an IRB might have been in clinical studies, but there is no intentional effort to do that. I recommend in the book appointing more research-experienced subjects to IRBs, even just to add it to the potential qualifications for somebody. Has the researcher ever been a subject? That’s a bonus point. There is an issue of having one or two people [with this background], but you have to worry about representativeness. You don’t want to get people who had a totally wonderful or a totally awful experience and nothing in between.
And even then, what happened to a research subject is not necessarily what happens to all subjects, but it is better than nothing. I know one IRB that has something called “volunteers for health,” which is a bunch of people who have been in studies and they are willing to think about other studies. If you can find some people who have been in different types of studies, you could have an advisory board. Then, if an IRB gets a cancer study or something that is raising a lot of issues, they can ask for advice from people who have been in similar studies. In the education that IRBs often offer the research community, they can have some sessions where they bring in some past research subjects and have them talk about what happened to them and offer their views on things.
IRB Advisor: Has this been a kind of blind spot in the research review process?
Dresser: In my reading, I found various remarks suggesting that this would be a good idea, but nobody really has picked up on it and run with it. In the book, I discuss the tradition of self-experimentation, where researchers used to try things on themselves first. Part of the reason they did that was that it was a way to educate themselves and it helped them design their regular studies. This still goes on to some extent, so I advocate that we would bring that back — not that you are experimenting on yourself, but that you are volunteering for other studies people are doing as a way to educate yourself about the things that might matter to subjects. Usually, if you are working at a research institution there are all sorts of trials going on. Finding out more about what subjects think could be helpful in recruitment of [future] subjects. I think it has a kind of professional research aspect to it.
IRB Advisor: What kind of perspectives do research subjects bring to the discussion?
Dresser: In my research, one of the things I’ve found was that subjects really care about how they are treated. You might think of it as trivial, but are they treated with courtesy? Are their appointments on time? Do they have to wait around, and what’s the waiting room like? Is the staff rude, condescending, or disorganized?
They see all of that as part of respect for the research subjects. I don’t know if that is something IRBs would be directly involved in, but certainly it would be something to talk about in the education of researchers. I really think for most subjects, their study appointments are an inconvenience. You have to take time off from work, get a babysitter, and take time out of your day, so the minimum number of study visits necessary to get the data is a real consideration. If you have more than necessary, that is really a burden on subjects, and they talk about that.
IRB Advisor: You mention that you sent in a comment when the Common Rule was being finalized, but there is no requirement to include subjects in the manner you describe.
Dresser: It doesn’t necessarily have to be in regulations. The person who is an unaffiliated member of the IRB [could be a research subject]. IRBs could easily start thinking about this on their own. There is nothing in the regulations that suggest this would be inappropriate. When I talk to people about this issue, even people who are on IRBs or are researchers, I usually get a few comments from the audience from people who have been subjects. They thought they got some benefits from that [that they could share]. Things like the disclosure and consent process. One woman said the informed consent warned of possible flu-like symptoms. She said, “that’s not going to happen to me,” but it did and she had to take time off work that she was not prepared to take. Even someone who is very familiar with research may not get a sense from the consent process that an adverse outcome is a real possibility. There are ways to make consent language [more clear] and more meaningful and also learn about potential burdens and benefits of study participation that researchers may not be tuned in to.