Giving Subjects a Voice in Research Ethics and Oversight

“Research partners”—that’s what scientists and doctors call people who serve as study subjects.  Government officials and ethicists use the same term, depicting subjects as equal to the professionals who conduct and oversee health research.  But there’s a problem with the egalitarian language.  It simply isn’t accurate.

Subjects don’t have the power that truly equal partners would have.  Although people are free to say yes or no to study participation, they have little say over anything else in research.  People with first-hand knowledge of what it is like to be a study participant are rarely appointed to advisory groups that make rules and recommendations for research.  They are rarely consulted when the ethics of proposed human studies are considered.

Experienced subjects have a special understanding of what study participation involves.  I know because I had my own research encounter.  Before this happened, I had spent years teaching and writing about research ethics.  I was a longstanding IRB member and had served on expert committees considering how different kinds of research should be done.  But this background wasn’t much help when research questions became personal.

My real education began when I was diagnosed with advanced cancer.  I was told that treatments were available, but my survival odds weren’t good.  After discussing my case, a team of doctors recommended six weeks of chemotherapy with four different drugs, then five weeks of combined radiation and chemotherapy.  One drug they recommended had just been approved by the FDA for my kind of cancer.

My other option was to join a clinical trial seeking subjects with cancers like mine.  I knew how important trials were, so I was open to the possibility.  Then I learned that the trial didn’t offer the newly approved drug I would get if I chose what the doctors had recommended.  If I enrolled in the trial, I would instead be randomly assigned to receive one of two treatment regimens that included fewer chemotherapy drugs.  My treatment could also be delayed if I signed up for the study.

It seemed like a bad deal to me.  Desperate and frightened, I wasn’t willing to make the sacrifice the trial seemed to require.  So I said no to study participation.

Researchers who listen to patients and subjects hear stories like mine.  They hear why people don’t enroll in trials, and why many drop out before studies are complete.  They hear how seriously ill patients struggle, and often fail, to make sense of consent forms in the midst of personal crisis.  They hear about subjects’ hopes, expectations, and disappointments in research.

Researchers need information like this to design trials that give patients decent options.  They need it to make studies more humane and less confusing to subjects.  If researchers paid more attention to subjects, they could conduct studies that are both more ethical and more likely to attract volunteers.  There is a severe shortage of people willing to sign up for studies and one reason for this is the failure to take seriously subjects’ views of research participation.   

In a new book, Silent Partners: Human Subjects and Research Ethics, I describe in detail the contributions that experienced subjects can make to research ethics and policy.  I also describe how to include subjects in research decision making.  I argue that people with first-hand experience as participants should be members of and advisers to IRBs and other ethics and oversight groups.  Experienced participants should also be part of community engagement and patient-centered research efforts.

Giving experienced subjects a voice in research activities like these would be a meaningful way to respect what they do.  Subjects should be real—not just symbolic—research partners.

Since 1983, Rebecca Dresser has taught medical and law students about legal and ethical issues in end-of-life care, biomedical research, genetics, assisted reproduction, and related topics.  She has been a member of the Washington University in St. Louis faculty since 1998.  Before coming to Washington University, she taught at Baylor College of Medicine and Case Western Reserve University.  Dresser was Chair of the Hastings Center Fellows Council from 2014-16 and has for many years been an “At Law” columnist for the Hastings Center Report.  Her 2016 book, Silent Partners: Human Subjects and Research Ethics, calls for including experienced study subjects in research ethics deliberations.  She is also the author of When Science Offers Salvation: Patient Advocacy and Research Ethics (Oxford University Press, 2001) and editor of Malignant: Medical Ethicists Confront Cancer (Oxford University Press, 2012).  Dresser has written commissioned papers for the National Academy of Sciences and National Bioethics Advisory Commission.  From 2002-2009, she was a member of the President’s Council on Bioethics and from 2011-2015, she was a member of the National Institutes of Health Recombinant DNA Advisory Committee.

Hear more from Professor Dresser; listen to her interviews done as part of PRIM&R’s People & Perspectives project: The Heart of Medicine and Malignant.