Protecting Research Volunteers: It’s All Part of the Family

By Dr. Toby Schonfeld

2014 Conference

2014 Advancing Ethical Research Conference

You know that great feeling you get when you gather with friends or family members that you haven’t seen in a while? I’m talking about that “I’m part of something special” feeling, where you barely even have to finish a sentence before others are agreeing with you, or exclaiming “Me too!” or just seem to really understand your perspective. In short, these people “get” you.

That’s the feeling I get when I attend the annual meeting of Public Responsibility in Medicine and Research (PRIM&R), as my EPA colleague Dan Nelson and I did in early December. PRIM&R is a place where people who care deeply about human subject research protections gather to share best practices and to learn from experts in ethics and compliance about contemporary strategies for human subject protections. Officially, the organization provides “professionals responsible for ensuring research protections, and those involved in the design and implementation of research protocols, with education, practical tools, and cutting-edge strategies” (PRIM&R website accessed December 23, 2014: http://www.primr.org/about/).

This year’s Advancing Ethical Research conference was no exception. More than 2,700 professionals traveled to Baltimore to participate in 130-plus break-out sessions and several special events throughout the three-day meeting.

The keynote speakers were particularly engaging this year. John Wilbanks, the Chief Commons Officer at Sage Bionetworks, discussed innovative processes for informed consent in the mobile era. The Director of the National Institutes of Allergy and Infectious Diseases, Anthony Fauci, drew a vivid picture of the history of clinical trials in HIV/AIDS over the past three decades, and included important comparisons between this history and current research involving ebola. Finally, Susan Lederer from the University of Wisconsin-Madison gave insights into the life of Henry Beecher, well known as the “whistle-blower” of unethical research in the 1960s.

Attending meetings like PRIM&R enhances our work at the Agency in a number of ways. Since EPA is one of the 16 agencies that has signed onto the Department of Health and Human Services’ regulation to protect human subjects (known as the Common Rule), we share a “parent” regulation with many other research partners. Interacting with others who apply the regulation to a variety of kinds of research enables us to learn from them how they approach issues and share with them our approaches.

As part of the sharing process, Dan and I held a “meet the EPA” session, where staff from Institutional Review Boards across the country learned about EPA’s specific research protections. Now, they will understand our particular context when research proposals supported by EPA’s Science to Achieve Results (STAR) grant program come across their desks. Dan and I also participated in several other sessions as presenters, which enabled us to share our expertise with the rest of the human research protections community.

Through these and similar mechanisms , the Agency supports and advances important science while also ensuring that those of us who review projects for regulatory compliance are part of a community of practice that also cares deeply about the protection of the volunteers who so generously agree to be human subjects to further research. For Dan and me, they are all kind of like family.

About the Author: Dr. Toby Schonfeld is EPA’s Human Subjects Research Review Official and the Director of the Agency’s Program in Human Research Ethics and Oversight.

Editor's Note: The views expressed here are intended to explain EPA policy. They do not change anyone's rights or obligations. You may share this post. However, please do not change the title or the content, or remove EPA’s identity as the author. If you do make substantive changes, please do not attribute the edited title or content to EPA or the author.

EPA's official web site is www.epa.gov. Some links on this page may redirect users from the EPA website to specific content on a non-EPA, third-party site. In doing so, EPA is directing you only to the specific content referenced at the time of publication, not to any other content that may appear on the same webpage or elsewhere on the third-party site, or be added at a later date.

EPA is providing this link for informational purposes only. EPA cannot attest to the accuracy of non-EPA information provided by any third-party sites or any other linked site. EPA does not endorse any non-government websites, companies, internet applications or any policies or information expressed therein.

Good Science Starts with Good Ethics

Young woman looks at EPA's Facebook pageThe social media world was rocked recently when a paper published in a scientific journal revealed that Facebook had been manipulating users’ news feeds to determine whether the concept of “emotional contagion” was the same in virtual contexts as it was in person. You know how the whole office lights up when one person gets flowers? Researchers wanted to confirm the hypothesis that the same kind of emotional transfer can happen in a virtual context devoid of non-verbal cues. Turns out: it can.

The problem with this study isn’t the science—it’s the ethics of the research. Specifically, the complaint is that investigators never obtained informed consent from Facebook users to participate in this research study.

Why should that matter? Here’s the problem: without giving members the option to choose whether or not they wanted to participate in research, the investigators treated people simply as a means to an end—in this case, to verifying their hypothesis. And there’s no guarantee that the researchers’ ends were the same as mine.

We treat many things as a means to an end—we use planes, trains, and automobiles to get us from place to place, and we use food and water to nourish our bodies. But people are not like autos or apples: people have interests, desires, and preferences. I am the only one who truly knows what my values, goals, and priorities are, and therefore I’m the only one who can decide whether or not participation in research coincides with those goals.

Facebook points out that users agreed—via the fine print—to participate in this kind of work when they agreed to the terms of service. But that argument doesn’t work either. Nobody can agree to unspecified future research; after all, how would one be truly “informed” about research that the investigators haven’t even imagined yet? The best that can be expected is that individuals can agree to be contacted for future research—and that’s what should have happened here.

Some would argue that there are no real “risks” here—they were not injecting anyone with a drug, or asking them to exercise to the point of exhaustion, or even asking them potentially sensitive survey questions. And because there are no risks, they claim, they didn’t need to ask permission.

But think about how it makes you feel to know that your news feed—and therefore your emotions—may have been manipulated without your knowledge or consent. Do you feel hurt? Confused? Violated? That’s a natural consequence when investigators fail to abide by an important ethical foundation of human subjects research known as respect for persons. The investigators failed to recognize that their subjects were autonomous individuals capable of self-determination and therefore had a right to opt out of this study.

At EPA, we take the informed consent process seriously. Whether you’re approached to be part of a study in our Healthy Heart program, or to help investigators understand more about how the environment affects your child’s asthma, EPA scientists will first explain the research to you so that you can judge whether or not participation makes sense for you and your family.

Good ethics starts with good science. But as we learn from this example, good science needs good ethics, too.

About the Author: Dr.Toby Schonfeld is EPA’s Human Subjects Research Review Official and the Director of the Agency’s Program in Human Research Ethics and Oversight.

Editor's Note: The views expressed here are intended to explain EPA policy. They do not change anyone's rights or obligations. You may share this post. However, please do not change the title or the content, or remove EPA’s identity as the author. If you do make substantive changes, please do not attribute the edited title or content to EPA or the author.

EPA's official web site is www.epa.gov. Some links on this page may redirect users from the EPA website to specific content on a non-EPA, third-party site. In doing so, EPA is directing you only to the specific content referenced at the time of publication, not to any other content that may appear on the same webpage or elsewhere on the third-party site, or be added at a later date.

EPA is providing this link for informational purposes only. EPA cannot attest to the accuracy of non-EPA information provided by any third-party sites or any other linked site. EPA does not endorse any non-government websites, companies, internet applications or any policies or information expressed therein.