1. OHRE Update: What’s new with the IRBs? Daniel Nelson Director, Office of Human Research Ethics Associate Professor of Social Medicine and Pediatrics University of North Carolina- Chapel Hill

2. Office of Human Research Ethics l Responsible for ethical and regulatory oversight of research at UNC-Chapel Hill that involves human subjects l OHRE administers, supports, guides and oversees the work of the campus Institutional Review Boards (IRBs) and all related activities

3. Decentralized IRB Structure at UNC-Chapel Hill (1968-2003) Institutional Official Dean AVC- Research Admin Staff 2.0 FTE IRB AA Admin Staff 0.25 FTE IRB SON Admin Staff 1.0 FTE IRB SOD Admin Staff 1.25 FTE IRB SOPH Admin Staff 7.5 FTE IRB SOM Federal Government

4. Problems with Decentralized Structure l Inefficiency  5 of everything! l 5 sets of operating procedures l 5 websites and databases l 5 application forms l 5 documentation standards l 5 channels for communication and policy l Variability l Inconsistency in applying common regulations l Little sharing of best practices l Staffing and budgetary support l Workload, experience, expertise, compliance l Fragmented reporting lines l School-based operations l University-based obligations

5. Reorganized Structure at UNC-Chapel Hill (2003-present) OFFICE OF HUMAN RESEARCH ETHICS Biomedical IRBs (N=4) Chairs: S Bernard, JC Garbutt, R Humphry, JH Patterson Academic Affairs IRB (N=1) Chairs: B Goldman, L.Rosenfeld Public Health/Dental/ Nursing IRBs (N=3) Chairs: A Biddle, S West, D Zajac, M Lynn Advisory Committee

6. “Nice org chart... So what have you been doing for the past year?”

7. Total IRB Actions at UNC-Chapel Hill 1999-2003 4,079 4,728 4,850 5,307 6,202

8. What have we been doing for the past year? l Ongoing oversight of 4000 active research studies l OHRE created! l Centralized reporting lines l New positions established and filled l Existing positions standardized and consolidated l Advisory Committee l Integrated Budget Model for FY’05 l Working Groups on Common Practices l Standard Operating Procedures (SOPs) l IRB application form l Consent form templates l Website l Database l Training policy and modules l Public outreach and education l Accreditation

9. What is coming for the research community? l SOPs l Better guidance for IRBs and research teams l  Investigators Manual l Common Application and Consent Forms l Less confusion, greater consistency, interchangeable across IRBs l  Electronic submissions!? l Common Website l One stop shopping, enhanced guidance l Common Database l Better management of workflow and protocol info l Links to other campus data l  Access by research teams and dept managers l Required Education l Upgraded training for research teams and IRBs (CITI) l Linked to application process l Public Outreach and Education l Brochure for research volunteers l Accreditation l Ongoing self-assessment (QA/QI) l De facto requirement l Demonstration of institutional commitment to highest standards