Share Research Results With Participants, Ethicist Says

This transcript has been edited for clarity. 

Hi. I'm Art Caplan. I'm at the Division of Medical Ethics at NYU Grossman School of Medicine in New York City. 

An interesting issue has come to the surface, driven by some changes in the ethics of how we do clinical trials and how we view people who are in clinical trials. When I first got into medical ethics, probably back in the 18th century — well, maybe not that long ago, but let's say in the late 1970s — regulations and ethical principles were put into place for recruiting people into studies and referring people to studies in whatever area, such as oncology, neurologic disease, or dermatologic disease. 

Basically, we treated people as subjects, meaning passive people who were coming into studies, presuming they didn't understand much and presuming they were highly vulnerable to being mistreated by researchers. The rules that were in place had been put there because of terrible abuses like the Tuskegee Study, where African American men in Alabama were denied proven treatment and lied to about it in order to study the impact of end-stage syphilis. 

Many other immoral studies were done, such as those from Brooklyn's Jewish Chronic Disease Hospital to see whether cancer could be transmitted, done on nonconsenting older people with dementia. There were studies done by the CIA where people were given psychedelic drugs without knowing that they were study subjects. Puerto Rico was the site of the first birth control studies, where the women involved didn't really understand or give consent to the risks — and some of them were given placebo. 

Protectionism was the ethos of research ethics. What you did was you tried to make sure that people consented, and you had groups like research ethics committees, or institutional review boards, review the studies to make sure that they were truthful and science was sound, and to lay out the fact that subjects needed to know their rights.

Coming up to current times, we've changed our moral thinking. Now we don't talk about subjects. We talk about partners or participants. People are recruited into studies more as, I'll say, if not equals then at least people who are part of the family doing research. Are we worried as much about protecting them? Not as much. 

Many people today who want to get into research may ask you about research opportunities for their migraines, cancers, or whatever it might be. They may come and say, "I want to get access to the latest work because I'm optimistic that cutting-edge research might help me." They're not worried about somebody denying them something. They're worried about missing out as much as they are anything else. 

If you're trying to recruit people into studies (which is a problem still because many people are still somewhat distrustful when they hear about research), it's still important to decide how you treat the participants — notice the language — once the study is done. 

I've written recently, and some others agree, that we really owe it to the participants to get back to them with the findings of studies. It isn't enough just to recruit somebody into a trial, do the study, decide whether you've got a publishable paper, and you're done because the study's over and you said goodbye to the participants. You need to find the mechanism, be it the study directors or the institutions sponsoring these studies, to give them the results of what happened. 

Partners who are working with us, as that's what today's subjects in research are, deserve to know the outcomes. Now, there are two ways we could do that. We could just post a website and say, go look because everything, whether it worked, didn't work, or worked for a subgroup, is there. 

We could say you have a bigger obligation. You've got to reach out to the study subjects, send them an email or a text, and say, there is a website and you could go there and see what the results were. We're going to post the information on that website in understandable language — not just put up a technical paper for the medical journal, but we'll have a one-page explanation of what we think we found or didn't find. 

I think being more aggressive about getting back to participants is a good idea. It does make them feel more like partners. You may build more trust in terms of getting more people to sign on to research and get involved with clinical trials because they're more trusting, knowing that we try hard to tell them the results, to tell them what went on, and to get back to them when we've got some findings. 

However, I also have to concede that I'm not sure how many participants actually want all this information or would use it if we did a better job reaching out to them and saying, here's a website, or we could mail you the findings, or however you want to do it. I think some study is needed there to determine what people want. 

I think, ethically, we have an obligation to give them what they want — and I'll concede I'm not always quite certain that an aggressive posture, which is the one I'm pushing to get back out to them post-studies, is what the participants/subjects/partners expect or would be pleased to have once they're done. 

It's an area where we need to take a look, and I hope it's one that we do take a look at. I feel if we treat the participants properly and we tell them we're going to give them the option at least to get back to them, they'll feel better and word will spread that it's a good environment to try to sign up more for clinical trials because people's dignity and desire to know what happened is going to be honored. 

I'm Art Caplan. I'm at the Division of Medical Ethics at NYU Grossman School of Medicine. Thanks for watching.