Because of the intensity of my institution’s human research program, I always have to strike a balance, upon returning from a PRIM&R Advancing Ethical Research conference, between wanting to immediately focus on incorporating what I’ve learned—policy revisions, procedural changes, and staff/member training ideas—and having to jump instead into the usual fray of trying to keep up with “normal” responsibilities. As with so many things in life, compromise and balance come into play.
Key take-home points from the 2016 Advancing Ethical Research Conference (AER16) were, for me, quite varied. I was profoundly affected by learning more about the investment that parents had made to hasten research developments for conditions that affected their children. I was also both buoyed by helpful information, and disappointed that there was not more concrete guidance available, for two areas in which our research program has significant investment: personalized medicine and single IRB reviews.
With respect to parental/family advocacy, I have a heightened awareness of the effect that foundations or private donations can have on research projects, and the conflicts that may be involved. This awareness, developed by keynote speaker Patricia Furlong, during her address “SUBJECTS” Matter: Burden of Participation for Children in Clinical Trials, and panel presenter Glenn O’Neill, on Panel IX: Can’t Buy Me Love, but Maybe a Clinical Trial Spot? How IRBs Wrestle with Participant Funding and Influence, has allowed me to more effectively assess such situations as they have since arisen. The knowledge gained from these presentations has helped us better navigate the ethical and legal issues of private funding by participants in real-life situations. In addition, we made it a priority to remind office staff and IRB members of the need to keep who bears the burden of research participation in sight—particularly when reviewing protocols that involve children or medically compromised individuals—and to ensure that accurate information about the number, type, location, and duration of study visits is conveyed during the consent process, to facilitate truly informed consent.
On the personalized medicine and single IRB fronts, we immediately implemented some of the novel suggestions from the conference, and reluctantly accepted that guidelines for these emergent and rapidly evolving components of so many research programs—including ours to a very significant degree—would not be standardized anytime soon. We were encouraged to realize that our efforts to prepare for roll-out of these programs were further along than those of many other institutions.
AER16 was inspiring. Our efforts to operationalize tips we gained from the conference will continue throughout the year, and will impact revisions we make to policies, procedures, and training programs. We are preparing our reaccreditation application, and it will reflect enhancements to our human research protection program, in part due to information obtained at this and other AER conferences.
Brenda L. Ruotolo, BA, CIP, is executive director of the Human Research Protection Office at Columbia University, and has been affiliated with Columbia since 2003. She has extensive experience with IRB review of both biomedical and social science/behavioral research. As executive director she is responsible for the functions of the seven IRBs and oversight of approximately 6000 active research studies. Ms. Ruotolo has been a member of PRIM&R for approximately 20 years. She presents at local and national conferences on a variety of topics related to the protection of human subjects.