Hibest Assefa

I have over 20 years of experience in human subject’s research (HSR) with expertise as a regulatory compliance manager and IRB specialist. In addition, I advise on design and human subject interaction for research and programming, because clarity on what is "not research, NR" or "not human subject research, NHSR" per the regulations will determine level of risk and therefor minimize IRB delays. At the project level, I work closely with PIs to support compliance training and monitoring of HSR. At an institutional level, I build and sustain systems for human research protection to foster a culture of compliance. I am a team player, and my leadership approach is to gently and calmly mentor colleagues on the importance of compliance regulatorily and in consideration of the individuals in the research. Because things happen, even with the best of intentions, a PI needs the support of a specialist to guide them through IRB reporting and resolution of unanticipated events.