Opinion: exploring the ethics of human testing
Washington University law professor Rebecca Dresser wrote an article published in the journal Science, talking about some changes she’d like to see made. She spoke with St. Louis Public Radio's Véronique LaCapra.
DRESSER: People should be free to make informed choices about whether they want to be in research. They shouldn’t be forced to be in research. They shouldn’t be put in research without their knowledge. And they shouldn’t be in research that they don’t really understand, where, for example, they don’t understand the risks that they’re being exposed to.
So I suggest that there be a requirement that researchers do some kind of an evaluation about how well subjects have understood the very basic, important information about a study, not every little thing, but things like how long will this thing be, what are the potential harms that could come to me, what might I get out of this, if anything. In many studies, there is no what we call direct benefit to subjects. In other studies there’s a potential direct benefit, but it’s uncertain, and subjects need to understand that.
What were some of the other issues you raised in your paper?
DRESSER: Some subjects are injured in research, no matter how careful researchers are. We have a system in the U.S. that does not require the sponsors of research or research institutions to pay for the care and other costs that subjects might encounter if subjects are injured in research.
Other countries that are involved in research do require compensation to injured subjects, and so I argue that we should become part of that group. That it’s only fair that subjects, who are in a way like police officers and firefighters and soldiers, they’re engaged in an activity to help society. And when they’re injured on the job, we should contribute to take care of them. It’s as simple as that really.
The third recommendation I make is to incorporate more requirements for studies to be evaluated for merit. If a proposal for human research is going to the National Institutes of Health, then that proposal will be rigorously evaluated for quality. If a proposal goes to some non-profits, it will receive rigorous peer-review. However in other places, it may not be carefully reviewed.
You’re talking about a study that a company might fund itself on one of its own products?
DRESSER: Right. Companies obviously have financial interests, and sometimes will do studies producing data, where the methods or the quality of the study is questionable. Research Review Committees are supposed to look at the merit of proposals to study humans. However, these committees are small, have limited expertise; they do not know the science involved in every proposal. So what I’m saying is, since human studies expose people to risk, we need to make sure those studies are worthwhile. Otherwise, they are not going to contribute to the knowledge base that we need to advance science and medicine.
Web extras: more from our conversation with Rebecca Dresser
How does the current law protect people who participate as subjects in clinical trials or other scientific research?
DRESSER: The Common Rule is very careful about the information subjects ought to know about a study. So there are a number of requirements about what we call consent forms but, more broadly, the discussion and document that subjects receive when they’re thinking about being in a trial. So you have to talk about things like, what are you expecting the subject to do? What are the risks? What are the potential benefits? And by the time you spell out all the requirements, these forms and the discussion can get very long, and there have been a number of empirical studies showing a fair number of subjects don’t understand very well this information.
You mentioned that when people participate in a study, they’re doing it essentially for the benefit of people in the future. But do you think most people know that when they participate in a study, or are they doing it because they think it will benefit them, or maybe even for the money, because people do receive compensation for participating in studies?
DRESSER: Some people do benefit by being in research. For example, if you’re in a situation where, say there are three different drugs and nobody knows which is best. If someone is in a study they’ll be assigned to receive one of those drugs. And it might be the drug that turns out to be best. So they will benefit.
Some people get benefits from extra visits or exams that are part of research. The point is for them to understand this is not like receiving medical treatment from your doctor where there has already been research showing it’s likely to be safe and effective. This is more uncertain.
And there are studies showing that a certain proportion of people don’t understand that. They think that by being in a trial, they’re definitely going to get what’s best for them. And so that’s definitely a concern.
Some people do participate in early phase studies involving what we call “normal volunteers” or “healthy subjects,” or some of them call themselves “professional guinea pigs.” And they do it for the money. Some people actually earn part of their living doing this. And there are definitely concerns about the power of the incentive.
- Here's that bit of extra information on our story image, a story from NPR on Da Vinci's Vitruvian Man