Would You Sign Up to be a Human Subject?
Recently, Dr. Isis realized that the number of people volunteering to serve as human subjects in her research projects is way, way up. She reports that in previous projects, it took her three years to recruit 100 participants, with about 20 interested (but not necessarily eligible) people responding to each call. Earlier this month, however, she put out a call for subjects and received--within six days--300 responses. Why, she wonders, are so many people suddenly so interested in participating in her research? Was it better advertising, a local culture of research voluntarism, or is it that the financial incentives to participate are especially attractive during a deep recession?
It seems possible to me, though, that is just an exacerbation of the situation that obtained previously - which is that poorer people have always been attracted to participation in clinical research trials either as a means of making money, or as a means of obtaining at least some sort of health care, even though clinical studies are most definitely not about providing health care to the participants. That may be the other motivator for Isis's applicants. Many people don't really understand that clinical trials are not really places to receive health care.
If you are wealthy, or even reasonable well-off, you have access to the best already-tested and approved health care and treatments on offer. Or you can figure out how to work the system and get yourself into Phase III clinical trials if your medical situation is such that there are no good tested options available out there. What you most likely aren't doing is saying to yourself, "Hey! I could make fifty bucks if I sign up for this Phase I clinical trial, AND I'll be helping out science, AND maybe I'll finally get my blood pressure checked by a real doctor, too!"
Melody Walker reports on research led by Cynthia Cryder, assistant professor of Marketing at WUSTL's Olin Business School, that suggests "volunteers have a very different view of clinical trial compensation. High-paying research studies raise a red flag for human guinea pigs and signal high levels of risk." At the same time, Walker writes, "Research institutions view payments to volunteers as compensation for time and expenses; not as compensation for potential risks related to participating in the experiments." Walker quotes a study co-author, George Loewenstein from Carnegie Mellon University, on the repercussions of the study:
"Most organizations that do research prohibit participation payments that substantially exceed compensation for time and expenses. The fear is that people will be overly tempted by high payments to take excessive risks. Our research challenges this common practice. It suggests that people assume that studies that don't pay much aren't risky."
The study concludes that there is a "mismatch" between current research guidelines for setting compensation levels and the assumptions participants make about the levels of pay and risk. Loewenstein explains:
"Contrary to the assumption that high payments are excessively tempting, our research suggests that they alert subjects to potential risk and make them more vigilant about protecting themselves. An added bonus of high payments is that it is ethically sensible for people to be adequately compensated when they do, in fact, incur risks."
And there are risks. That's why universities insist researchers' projects be approved by institutional review boards. For a full (and frankly sordid) history of human experimentation over the past two centuries, and the resulting establishment of review boards and ethics panels, check out "The Evolution of Informed Consent" by viraginity--it's a carefully researched post that's packed with interesting information.
Despite the protections afforded to human subjects by institutional review boards, researchers still manage to find themselves in sticky ethical situations. For some eye-opening reporting on more recent studies gone awry, read Jeanne Lenzer and Shannon Brownlee's HuffPo piece "Major Gaps in Oversight of Human Medical Research." Jeffrey Willett provides four more discouraging examples from the too-recent past.
As you can see, there are definitely risks involved in participating in these studies, even at some of the most august research institutions in the United States. Is it fair, then, that most of the burden of participating in these studies to advance medical research and practice falls, as Zuska suggests, on the poor?
I want to return to Zuska a moment to highlight an idea she floated at the end of her post:
Thought experiment: Sometimes I have imagined a society where everyone is eligible for, and required to, participate in clinical research, akin to jury duty, or maybe like military service in Israel. Only when you were called up, you'd be assigned to a research study that was a good "match" - if you are healthy, you go into a Phase I or II; if you have a medical problem, you go into some relevant Phase III. Spread the risks and responsibilities out across the society regardless of social glass, gender, race. Of course its unworkable, but what would be the pros and cons of such a system? What things would need to change radically to make it work? Would drug development research need to move largely out of the hands of private industry or could it stay pretty much as it is?
Note I am not advocating for such a system, just floating it as a thought experiment to examine how we do things now and how we might do them differently.
What are your thoughts? Should we all share the responsibility of advancing medical knowledge? Why or why not?
Leslie Madsen-Brooks develops learning experiences for K-12, university, and museum clients. She blogs at The Clutter Museum, Museum Blogging, and The Multicultural Toybox and is the founder of Eager Mondays, a consultancy providing unconventional professional development.