For many years, the social, behavioral, and educational research (SBER) community has worked within a regulatory framework originally built to oversee biomedical research. While much of that framework certainly applies to SBER oversight, there are nuances, and outright differences, which make one size not fit all.
As many know, the Common Rule may be on the verge of being revised. The Notice of Proposed Rulemaking (NPRM), upon which any new rule would be based, offered some significant changes to the exempt and excluded categories. Additionally, changes are proposed to how minimal risk research will be defined. Since these changes, if encoded in a new rule, could fundamentally change how SBER research is reviewed and overseen, we felt now was the time to launch an SBER Network.
We propose building a network of SBER human research protection programs (HRPPs) across the US and internationally where these groups can discuss SBER-specific issues, serve as a resource, develop guidelines and standards for human subjects research oversight, and provide a collective voice in the larger human subjects research ethics community. We hope that this network will help members derive creative solutions in real time.
PRIM&R has agreed to help this effort by setting aside space for us to meet at the 2016 Advancing Ethical Research (AER16) Conference. If you’re interested in being a part of that gathering, please contact us directly at email@example.com. We hope you’ll join us in Anaheim for a discussion about the future of SBER and human subjects research.
Linda Petree, BA, CIP currently serves as Director of the University of New Mexico’s Human Research Protections Program in Albuquerque, NM and has been a CIP since 2005. She has also conducted and published research in the area of research ethics, specific to the return of incidental findings.
Cecilia Brooke Cholka, MA, CIP is a Senior IRB Analyst for the Office of the IRB at the University of New Mexico. She has 10 years SBER research experience and 3 years IRB administration experience.