31
Mar2015

By Avery Avrakotos, education and policy manager

Last year, I was fortunate to have an opportunity to attend Ethical Issues in Global Health Research (EIGHR): Blending Cultures, Building Capacities, and Bolstering Collaboration. The four-day program, offered by the Harvard T.H. Chan School of Public Health, examined the unique issues that face institutional review boards (IRBs) and researchers reviewing and conducting international research.

As education and policy manager at PRIM&R, I regularly prepare written updates on federal laws, regulations, and news stories related to human subjects protections for distribution to PRIM&R's members, the majority of whom are research protections professionals. This task requires me to understand the ethical and regulatory aspects of human subjects protections. Given the nature of change and evolution in our field, I continually seek to expand my understanding, so when I heard about the EIGHR program, I was excited at the prospect of attending and gaining better insight into the complexities of global research.

Through a mix of small group discussions, interactive presentations, and cases studies, EIGHR provided me with an understanding of issues that should be considered in the context of global research. For instance, this year, I spent time exploring some of the challenging ethical and regulatory questions that came to the fore in the wake 2014 West African Ebola outbreak. As many who followed the outbreak know, the absence of approved treatments and vaccines exacerbated the epidemic, and researchers and regulators alike rushed to develop new options. This has been a complicated endeavor, however, because research, and especially research being conducted across borders in the midst of a public health crisis, requires careful ethical deliberation. The question of the appropriate design of studies aimed at evaluating the safety and efficacy of various investigational Ebola treatments became, and continues to be, a particularly contentious one. The knowledge I gained through my participation in EIGHR provided me with a solid framework for understanding the issues and questions that emerged during this debate.

The program also helped to strengthen my contributions as an IRB member at the Harvard T.H. Chan School of Public Health, where I regularly review protocols for research being conducted outside of the United States. Program discussions about how best to protect vulnerable populations through culture-specific approaches to consent, and presentations that highlighted resources for locating and identifying applicable laws, rules, and guidelines, have provided me with the knowledge and skills necessary to identify and address ethical concerns in a more efficient manner.

I also appreciated the program's emphasis on the importance of developing and fostering a strong relationship with local research partners. From reviewing consent documents, to assessing risk, to determining appropriate remuneration for subjects, numerous presenters emphasized that local partners can be an invaluable resource for understanding local context and adjusting research protocols to reflect it. Program director and associate dean for regulatory affairs and research compliance at the Harvard T.H. Chan School of Public Health Delia Y. Wolf, MD, JD, MSCI, highlighted the value of knowing your local counterparts, establishing direct communication with local ethics review committees, conducting site visits (when possible), and harmonizing requirements amongst participating institutions as much as possible, in her presentation.

While all of the program content helped to shed light on the complexities of global research, the opportunity to apply what I learned was what I enjoyed most. Through a series of detailed case studies and a mock IRB review, I gained hands-on experience to address issues that can arise during the conduct of research in international settings. Having an experienced IRB chair help me navigate a complex research protocol was invaluable, as I gained a firsthand understanding of some of the questions that I should be asking and issues I should be exploring.

This year's EIGHR program will take place from June 22-25, 2015, in Boston, MA, and I encourage those seeking to gain practical tools for reviewing and conducting international research to enroll. Topics on the agenda for this year's program include ensuring equivalent protections, conducting health research in international settings, study monitoring and regulatory compliance, and much more.

This year's Ethical Issues in Global Health Research program is being sponsored by PRIM&R. A limited number of partial fellowships are available to PRIM&R members who register. To take advantage of this partial fellowship, register today.

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