by Suzanne M. Rivera, Ph.D.
For legitimate reasons, the human research enterprise frequently is regarded with suspicion. Despite numerous rules in place to protect research participants’ rights and welfare, there is a perception that research is inherently exploitative and dangerous.
Consequently, most people don’t participate in research. This is not only a fairness problem (few people undergo risk and inconvenience so many can benefit from the knowledge derived), but also a scientific problem, in that the results of studies based on a relatively homogeneous few may not be representative and applicable to the whole population. Larger numbers of participants would improve statistical significance, allowing us to answer important questions faster and more definitively. And more heterogeneous subject populations would give us information about variations within and between groups (by age, gender, socio-economic status, ethnicity, etc.).
Put simply, it would be better for everyone if we had a culture that promoted research participation, whether active (like enrolling in a clinical trial) or passive (like allowing one’s data or specimens to be used for future studies), as an honorable duty. (Of course, this presumes the research is done responsibly and in a manner consistent with ethical and scientific standards, and the law.)Two events last week got me thinking more seriously about the idea that participation in research ought to be thought of more like a responsibility of citizenship (like voting) and less like a danger from which people need protection.
The first was a symposium at Case Western Reserve University on the occasion of the awarding of an ethics prize to environmentalist David Suzuki. He spoke about the need for a paradigm shift in the discourse about conservation versus growth, such that we would start approaching decisions with an eye toward effects on future generations, rather than measuring outcomes based on current-year balance sheets or four-year election cycles.
The second was President Obama’s acceptance speech at the Democratic National Convention. In it, he also promoted long-term thinking, offering a definition of citizenship that asks us to consider not only our responsibilities today but, “the idea that this country only works when we accept certain obligations to one another, and to future generations.”
As I listened to both Suzuki and Obama, I thought about the significant changes in behavior affecting public health that were made possible during my lifetime through deliberate culture change. Over the last forty years, public attitudes and norms about smoking, seatbelts, domestic violence, and littering have changed radically. As a result of new scientific knowledge, new laws, and campaigns to persuade the public that we’d all be better off if we would do or see things differently, we’ve actually changed what we do and how we think about it.
A debate is underway in policy circles about whether and how we should change the current regulations that govern research in the U.S. Some advocate changing the rules to increase protections related to use of existing data and specimens, even when personal identifiers have been removed. Others want to see the rules streamlined, with limits in place only for the riskiest kinds of studies.
Practically speaking, the fact that there is not a consensus probably means we will see only modest tinkering around the edges of rules that were promulgated more than 30 years ago. This is unfortunate because the current rules have not kept pace with technology or public attitudes.
But even more than a change in rules, what we need is a true paradigm shift from research protectionism to research promotion. This would require a public awareness campaign about the benefits of research and the safeguards in place to protect participants’ rights and welfare.
The best course for future generations would be for research participation to be viewed as a valued and honorable expression of shared responsibility for improving human health and welfare.
Great post, Sue. I’m reminded of this old story: https://en.wikipedia.org/wiki/The_Little_Red_Hen
I do believe I had the Little Golden Book version of this story as a child– must have made an impression.
Great post. I’m completely sympathetic to the idea of research participation as a civic duty. But I expect that you (and others who have proposed ethical and even legal duties to participate in research) have a long row to hoe. A social contract justification for increased research participation (via an ethical or legal duty) places a lot of weight on fair distribution of the fruits of knowledge production on the other end — a promise I’m not sure our society today can deliver. (Moreover, as you suggest, research is often viewed in a knee-jerk way as dangerous and/or exploitative — more so if research is described as an “experiment,” less so if it’s described as a “study,” which itself should tell us something about how thoughtful these responses are. Nevertheless, under these lamentable circumstances, we can expect significant resistance to anything like a duty to participate in research.)
A *presumably* more paletable proposal would be for regulators to simply to get out of the way of individuals and groups who, on their own initiative, are either called to the kind of civic (or more directed) duty that you envision or motivated to participate by the many benefits that research participation can offer, almost none of which regulators “count” in research risk-benefit analysis. Rather than (or in addition to) implicitly promising equal access to the fruits of innovation (a goal towards which we should continue to work, as an independent matter), why not explicitly promise research participants, through the informed consent contract, whatever it is that researchers are willing to offer and that makes participation by their target population worth the while of that population? For some, that will be nothing more than the warm glow utility they derive from knowing that they’ve done a mitzvah. For others, it will be pocket cash. For still others, the satisfaction of curiosity or novelty-seeking. Or access to cutting edge diagnostics. (Again, none that IRB count none of these as “benefits” when they decide whether a study’s risks are reasonable in relation to its benefits, such that prospective participants may be even invited to participate.) Such private ordering in research risks and benefits wouldn’t result in the entire population participating in research, as would an enforced civic duty of participation. But it’s a start.
Your point about the fruits of a given study not necessarily accruing to the participants is well taken. I was thinking in more general terms about results benefitting everyone in the sense that the medical profession as a whole becomes more knowledgeable, more expert, better able to serve. You’ll note I stopped short of suggesting research participation should be compulsory. I’m imagining an ethos here– not a draft. Just as some people sell their plasma for case, lots more give it voluntarily– whether for the “warm glow” or because of a more abstract idea that contributing to the system makes the whole system better for everyone (including oneself, should the need ever arise).
I think Michelle above is on the right track. If willing research participation is too low, I don’t think it’s because people don’t have enough of a sense of civic duty. I think it’s because research participation simply doesn’t have enough rewards. When there is monetary compensation, it’s low. And while it’s true that there is some social benefit, the benefit added by a single individual in a single study is so low that, even if that social benefit were entirely internalized, participation probably wouldn’t be worth it for a significant segment of the population.
Although I am a proponent of regulatory change to stop “protecting” subjects from higher compensation due to fears about undue inducement, what I am advocating has more to do with a sense of shared responsibility. I already used the blood donation example below, so here’s another, albeit imprecise one: littering. I remember as a child people thinking it was totally okay to throw trash out of a moving car, or to leave soda cans on the curb. Cultural changes over the past 40 years have made littering socially unacceptable and have made recycling a venerated lifestyle choice. Imagine if being in a study or allowing one’s data/specimens to be used for science were something to brag about.
What great timing for this post, as this evening Alan Wertheimer is kicking off our health law and policy workshop, Alan Wetheimer will be discussing whether consent is necessary for ethical research and whether some form of conscription might in some circumstances be appropriate. https://www.law.harvard.edu/programs/petrie-flom/workshop/index.html
Very interesting line of thinking. I’d add that we have to stop being so respectful of the Common Rule and the regulatory system that has grown up around it. Even in the formal rules, but especially in the “customary law” that has proliferated in the many regulatory interstices, research is too often treated as an evil to be prevented, and researchers as cads to be treated with suspicion.
Agree. I respect the historical forces that led to the Common Rule, but it’s time to dust it off. Or, as Greg Koski says, “take off the training wheels.” Remuneration for participation is only one aspect that deserves reconsideration, in my view.
Your idea makes a lot of sense, Sue. I like it. The big condition is whether the research is truly ethically done: there are both bureaucratic and democratic dimensions to establishing a trustworthy culture of research beyond passing institutional reviews that aren’t corrupt. I say this as an outsider to research ethics, too –the kind of person and the kind of views that would need to be convinced to feel comfortable with the civic duty.
But in the abstract, what you say certainly seems right. Objectivity -or the aspiration toward it- certainly is essential for a just society, and it is in the interests of the common good that it be supported. For the sake of objectivity and its civic benefits, citizens ought to contribute to a world where objectivity takes root and is approached.
Suzanne. Interesting post and follow-up conversation. About the time the original rules came out (1974) there was talk about a national lottery tied in somehow to the draft. Of course, it never did or will go anywhere.
Your proposal, however, is more towards creating a culture in which participation is looked upon favorably. Call me naive (in reality I am more in the jaded category), but I don’t think any change of regulation will have an impact. I assert that regulatory change is irrelevant in terms of this discussion. Examples…
— The use of compensation is not forbidden anywhere. The idea that it is not a “benefit” is accepted lore. (I agree but there are better places to talk about it.) The amount should be due and not undue; it should not be such that it would require that a person in that population accept the risk. To pay at the upper reaches of the due spectrum requires a burden of proof that falls on the investigator plus the IRB’s trust that the investigator is essentially good.
— There is no prohibition against mentioning altruism, or future generations on consent forms or in discussion yet I rarely hear it mentioned. Investigators rarely mention it to me until I raise it to them. Why not?
What is more critical is changing the culture in institutions in which both IRBs and researchers are supported.
Suzanne mentions littering and seat-belts, helmets, smoking and domestic violence. These were all public health campaigns. Extolling a common good takes a budget (getting good PR), some creative people (creating a program), some good data (smoking data was pretty impressive), and results (happy, thriving faces).
There is a public benefit to a culture of proud participation but it is not being held back by (admittedly old) regulations.
Erica
@Erica, the rule that neither compensation nor altruism counts as a benefit for IRB risk-benefit purposes is a bit more than just “lore.” From OPPR’s IRB Guidebook, chap III, section A:
“Direct payments or other forms of remuneration offered to potential subjects as an incentive or reward for participation should not be considered a ‘benefit’ to be gained from research. . . . Although participation in research may be a personally rewarding activity or a humanitarian contribution, these subjective benefits should not enter into the IRB’s analysis of benefits and risks.”
See also OHRP/NIH info sheet 20; FDA guidance 1998.
As for whether altering the regs would make any difference in terms of the amount and quality of research participation, that of course depends on what alterations we’re talking about. I agree that the vast majority of proposed tweaks are just that: tweaks of a fundamentally broken system that would have little significant effect. On the other hand, eliminating the regulatory requirement that IRBs find that a study’s risks are “reasonable in relation to” its benefits before the study may commence would at least prevent research from being delayed, altered, foregone or blocked for reasons having to do with one IRB’s idiosyncratic view of what risk-benefit reasonableness entails. That, in turn, would allow more offers of participation (and more kinds of offers of participation) to reach prospective participants. There are, of course, various objections to amending the regulations in this way, but I don’t think that “irrelevancy” with respect to participation is likely to be among them.