IRB Advisor asked Holly Fernandez Lynch, JD, MBioethics, executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School, Cambridge, MA, to discuss her role in joining the Secretary’s Advisory Committee on Human Research Protections (SACHRP). Before joining the Petrie-Flom Center, Lynch was a senior policy and research analyst for the Presidential Commission for the Study of Bioethical Issues’ report on the Guatemala STD inoculation study.
IRB Advisor: Would you please tell us a little about your work in human subjects research?
Lynch: In the role of executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, I serve as the co-lead of the Law and Ethics Initiative of the Football Players Health Study at Harvard University. It’s an innovative research program established to improve the health and well-being of professional football players.
I’m also involved with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst, where I co-lead a project focused on improving recruitment to clinical trials, and I serve on the Ethics Working Group of the Multi-Regional Clinical Trials Center at Harvard.
Previously, I was a non-scientific member of the IRB at The Fenway Institute in Boston, MA, a research center with a heavy focus on HIV/AIDS and LGBTQ [lesbian, gay, bisexual, transgender, and queer] studies.
Previously, I was a practicing attorney in the biotechnology and pharmaceuticals practice group of Hogan and Hartson — now Hogan Lovells — in Washington, DC, where my practice involved regulatory issues in drug development. I served as a bioethicist in the human subjects protection branch at the division of AIDS at the National Institutes of Health, where I worked closely with medical officers and statisticians on trial design, protocol review, informed consent, satisfaction of applicable regulatory requirements, and various issues that arose after trial launch. These involved expertise in ethical issues involving standards of care and prevention in the developing world, including research involving children, pregnant women, and the cognitively impaired, compensation for the research-related injury, biospecimen collection and storage, and the like.
IRB Advisor: What do you see as the most important aspects of SACRHP’s role and work, and what are some goals you’d like to accomplish with SACHRP in the next few years?
Lynch: I think SACHRP offers the benefit of bringing multiple diverse perspectives together, from industry and academia, lawyers and investigators, patients and research reviewers. Some of us are engaged with actually doing research every day — clinical and social/behavioral; some of us review research for our day jobs, and some of us are further removed. But all of the perspectives are an important addition to the perspectives of the regulators. I think SACHRP has the capacity to push the envelope and encourage thinking that ventures outside traditional boundaries, developing possible solutions that will improve research oversight and participant protections, even within the four corners of existing regulations — which, of course, leave a lot of open space for flexibility.
Since I’ve only been to one SACHRP meeting so far, it would be premature and presumptuous for me to suggest that I’m ready to suggest an agenda for SACHRP. But certainly, I do have areas of interest that I am hoping we pick up at some point during my term. For example, I am very interested in clarifying the concepts of undue influence and coercion, improving informed consent beyond nibbling around the edges, and calling attention to the problem of research exceptionalism, i.e., acting as though research is always something special even when it shares many characteristics in common with other activities that may be riskier but are substantially less regulated.