PRIM&R’s 2018 Advancing Ethical Research Conference (AER18) was a fantastic opportunity to connect with colleagues, hear renowned speakers address regulatory hot topics, and share ideas and best practices. Science and technology are expanding exponentially; as a result, our research community is becoming increasingly diverse and multi-center research is booming. While historically the regulations have remained relatively unchanged, in recent years the regulatory community has worked together to provide feedback on suggested major updates and new guidance which are greatly shifting the regulatory world. AER18 was a great resource for discussing this changing regulatory research climate.
I enjoyed the expanse of opportunities presented at the conference. There were open table conversations with representatives from the FDA, OHRP, etc. I went to some of them, not with questions, but simply to listen and absorb the discussions. There were opportunities to take full-day deep dives into new updates such as the Single IRB mandate, biobanking, the revised Common Rule and more. The short break-out sessions and keynote speakers covered a wide array of interesting materials, from celebrity impact on the public’s conception of science (e.g. Gweneth Paltrow & GOOP) to international research, to research with wearable technology (e.g. Fitbit and tracking devices).
One topic that was especially meaningful to me was a session on vulnerable populations. For example, there has been a push in recent years to include more pregnant women in research when there’s a favorable risk-benefit ratio so that more is known about the effects of drugs on pregnancy. The thinking in the regulatory community has shifted from a historical view that pregnant women should be protected from research, to the current view that pregnant women should be protected through research. Many pregnant women have to take medication during pregnancy and there is very limited data available for women and doctors to make educated decisions regarding safe use of medication during pregnancy. Some researchers shy away from including pregnant women because of the additional regulatory protections, but these really are minimal especially for observational type studies and the knowledge gained on safety and outcomes can be tremendously beneficial. As a regulatory professional at a pediatric institution and a mom, I was really encouraged by the shifting in views of including pregnant women in research as much as possible. Hopefully this shift will increase our understanding of the how medicine is metabolized in pregnant women and outcomes of medical interventions on the developing fetus to improve care in the future.
I went to AER18 expecting to learn new things, have ideas challenged, and make connections and I was not disappointed. I found myself asking many questions during the sessions and also volunteering best practice solutions from my years of experience in the field. I connected with members from outside institutions, forming stronger bonds and in one case even receiving a request to be a mentor from a very motivated individual who was newer in her career. Hearing from other IRB leaders, I also feel more confident that the interpretations we’ve made and the paths we’ve taken within my office are on track and soundly developed.
I always leave PRIM&R conferences feeling inspired, motivated, and excited to put into practice what I’ve learned. It’s an immersive experience. PRIM&R has been a great resource for me over the years, from when I was first developing an understanding of the complex regulatory field to my current role of deliberating fresh ideas and fine-tuning best practices for my institution. I am grateful to PRIM&R for hosting this annual conference and to all those I’ve met along the way for their knowledge and collaboration.
I look forward to upcoming conferences and continuing the discussion on advances in medicine and technology and how the Common Rule changes are affecting our role as regulatory professionals. I’m eager to see where research will go in the future and what new challenges may lie ahead. One thing is for certain, working in this field you never stop learning. We learn from each other, from regulatory and federal agencies, and from research subjects, who all provide us valuable insight from their experiences. It is important that we always remember lessons from the past in order to ensure a positive future and that we work to expand public trust and participation in research. Working together, the advances we can make seem limitless.
Heather Cathrall, MBE, CIP, is the Assistant Director of the Children's Hospital of Philadelphia Institutional Review Board. She has a Master's degree in Bioethics from the University of Pennsylvania and Bachelor's degrees in Cognitive Science and Psychology from the University of California, Berkeley. She has worked for the Children's Hospital of Philadelphia IRB for over 13 years and was a research coordinator prior to her IRB work.
Members of PRIM&R’s Blog Squad and other guest contributors are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.
PRIM&R’s next AER Conference (AER19) takes place November 18-20, 2019 in Boston, MA; you also have the option attend either the AER19 Preconference Programs or our biennial SBER Conference on November 17. Visit primr.org/boston19 to explore this year’s conference agendas and register!