12
Dec2014

by Krystal Bradford, CIP, Research Compliance Specialist at Cincinnati Children’s Hospital Medical Center

PRIM&R is pleased to introduce Krystal Bradford, CIP, a member of the PRIM&R Blog Squad for the 2014 Advancing Ethical Research (AER) Conference. The PRIM&R Blog Squad is composed of PRIM&R members who will blog here, on Ampersand, about the conference to give our readers an inside peek of what's happening December 4-7 in Baltimore, MD.

The second day of the 2014 AER Conference began with a keynote address Anthony S. Fauci, MD, the director of the National Institute of Allergy and Infection Diseases. Dr. Fauci discussed his experience treating HIV/AIDS patients and spearheading some of the founding research done in this area. The activities that Dr. Fauci led, and the obstacles that he faced, have been nothing short of amazing. During the early days of the epidemic, he was attacked by activists and members of the media numerous times for the way he approached HIV/AIDS research. However, in the end, with the help of a few dedicated members of the activist community he was able to radically shift the prevailing approach to HIV/AIDS research, a change that helped to empower the communities affected by the disease. Dr. Fauci’s willingness to hear and accept viewpoints different from his own, a quality that ultimately helped to change the course of HIV/AIDS research, was remarkable and impressed me as I reflected on the impact this man has had on the lives of others, individuals who may have no idea who he is or the impact he has had on their lives.

Later in the day, I had the opportunity to attend a panel discussion titled “The Ethics of Community Engaged Research.” The panelists were all very informed and raised great points, but the standout for me was Loretta Jones, MA, who spoke in a very conversational manner and left me with a number of important takeaways. One of Loretta’s central messages was be a part of the community—take time to learn about the community that you want to involve in your research. A successful community research program ensures that neither the research nor the research team offends the community. Researchers must be sensitive to the unique needs of each community and be able to handle complex situations that arise without upsetting the community dynamic. One of the panelists summed up the task researchers face when he reminded the audience that researchers need to consider the Belmont principal of justice, not “just us.”

The final session that I attended on Saturday focused on IRB documentation and recordkeeping. The session, titled “Essential Documentation: IRB Membership, Recordkeeping, Meeting Minutes, and More” left me reflecting on a slide that highlighted IRB deficiencies noted by the Food and Drug Administration during inspections in FY2013. The deficiencies noted included: inadequate initial and/or continuing review; inadequate standard operating procedures; inadequate membership rosters; inadequate meeting minutes; issues with quorum; Subpart D issues, inadequate communication, and, specific to devices, lack of or incorrect significant risk/non-significant risk determination. While the regulations are clear in some areas on what needs to be included, they can be vague on how to include such information. Institutions should take advantage of the flexibility of the how and make a process that works for their needs, while also ensuring that they’ve included the what. As an IRB staff member, I can see where any number of the deficiencies above could easily occur. My advice? Remain mindful and pay attention to detail. These attributes will payoff in the end.

All in all, I enjoyed a busy, but excellent day. I am still reflecting on the powerful contributions of Dr. Fauci, the importance message of Ms. Jones, and how I can ensure that I help my institution meets all documentation requirements.

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