1. a. Short term problems / considerations b. Long term mission View of human subjects protection system: SACHRP July 2008 Elizabeth Bankert

2. Problems 1. Relationship / communication / respect IRBs and researchers do not have a relationship based on mutual respect. IRBs are viewed by researchers as bureaucratic; overly focused on regulatory documentation; and do not provide useful review comments. Researchers are viewed by IRB administrators as not well versed in regulations and/or not concerned enough about human subjects. OHRP is viewed as compliance driven and IRBs are ‘fearful’ of contacting OHRP for advice. OHRP and the FDA do not appear to work together on important issues of human research protections. There has been no ‘proof’ that increased regulatory burden has improved human subjects research review system.

3. a. Minimal risk research review is burdensome to IRBs and researchers. Minimal risk review diverts valuable time and resources from Full Committee reviews and time to devote to ‘big picture’ issues. b.Multi-site review is redundant, inconsistent, and does not necessarily enhance overall review quality. Problems (continued) Review processes:

4. OHRP leadership and staff should shift ‘perceived’ focus away from regulatory documentation and from being compliance driven to: - Educate IRBs on review of minimal risk research; review should be efficient, effective, and focused on issues not on documentation. Exempt is OK. Expedited is OK ( though change of terminology may be useful). - Develop ‘best practice forms’, application, minutes, agenda. - Encourage trust between IRBs in multi-site research. “IRB networking“: retain local review but become aware of other IRB reviews. Consider:

5. The Office for Human Research Protections (OHRP) supports, strengthens and provides leadership to the nation’s system for protecting volunteers in research that is conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP provides clarification and guidance to research institutions, develops educational programs and materials, and promotes innovative approaches to enhancing human subject protections. From OHRP website – Fact Sheet: Long term mission

6. Mission (reinvented): OHRP’s priorities should shift (from compliance driven) to becoming a proactive, collective voice for IRBs and researchers in order to improve the system Encourage and organize national dialogs related to all human subjects research issues. Include FDA, federal funding agencies, IRBs, and researchers. Actively announce actions to promote building of trust in the research enterprise.

7. How ? Considerations : 1. SACHRP 2. OHRP leadership / staff shift focus 3. OHRP dialog with IRBs and researchers 4. OHRP dialog with FDA