1. Emory University IRB Chairman: James W. Keller, M.D. Director: Tanya Sudia-Robinson, RN, Ph.D.

2. No matter how much we improve our system of checks and balances, the primary responsibility for full and thoughtful disclosure, enrollment without coercion, monitoring of the conduct of a trial, reporting of adverse events and confidentiality must remain with the local primary investigator. The approach provides the essential basis for trust NEJM 346:1403, 2002

3. Emory IRB Reviews about 1500 protocols/year Full Board – about 40% Expedited – about 55% Exempt – 5%

4. Emory IRB Currently: 4 Biomedical Committees 1 Social-Behavioral Committee SPH, College Near Future: 2 Additional Biomedical Committees

5. IRB Chair and Vice-Chairs James W. Keller, M.D., Chairman James W. Keller, M.D., Chairman Biomedical I: Cliff Gunthel, M.D. Biomedical I: Cliff Gunthel, M.D. Biomedical II: Larry Tune, M.D. Biomedical II: Larry Tune, M.D. Biomedical III: Dayle Geroski, Ph.D. Biomedical III: Dayle Geroski, Ph.D. Biomedical IV: Susan Ray, M.D. Biomedical IV: Susan Ray, M.D. Committee V/SHB: Co-Vice Chairs: Committee V/SHB: Co-Vice Chairs: –Colleen DiIorio, Ph.D. (SPH) –Alan Abramowitz, Ph.D. (College) New Committees: New Committees: Biomedical VI: Ann Haight, M.D. Biomedical VI: Ann Haight, M.D. Biomedical VII: Amy Langston, M.D. Biomedical VII: Amy Langston, M.D.

6. IRB Primer Human Subjects Protection Education Requirement: CITI exam Access via emory.edu/IRB webpage

7. eIRB

8. eIRB Your Account: Enter: Emory email user ID (net ID) Pass Word – at first log in: * 1 st initial of your first name * Last 4 digits of SSN * Last 4 digits of SSN * 1 st initial of your last name (i.e., j3581k) At initial log-in, you will be instructed to change password

9. Submission

10. Start Process

11. Submission Needs 1. Protocol 2. Lay summary 3. Consent(s) – core/banking/assent/etc 4. HIPAA 5. Revocation Letter 6. Clinical Investigator Brochure 7. Amendments 8. Grant 9. Advertisements

12. Consent Sections Introduction/Purpose Introduction/Purpose Procedures Procedures Risks Risks Alternatives Alternatives Benefits Benefits

13. Consent Sections Confidentiality – short without HIPAA Confidentiality – short without HIPAA Compensation – injury and $ for time, etc Compensation – injury and $ for time, etc Costs – what is paid for Costs – what is paid for Voluntary Participation/Withdrawal Voluntary Participation/Withdrawal Contact Persons Contact Persons New Findings New Findings Entitlement to Copy Entitlement to Copy

14. IRB Contact Information www.emory.edu/IRB www.emory.edu/IRB www.emory.edu/IRB IRB Office IRB Office 404-712-0720 404-712-0720 Briarcliff Campus at 1256 Briarcliff Rd Briarcliff Campus at 1256 Briarcliff Rd Suite 307 North Suite 307 North Chairman: James W. Keller, M.D. Chairman: James W. Keller, M.D. Director: Tanya Sudia-Robinson, RN, Ph.D. Director: Tanya Sudia-Robinson, RN, Ph.D. eResearch at Emory: eIRB & eIACUC: Christine Gomez eResearch at Emory: eIRB & eIACUC: Christine Gomez eIRB Class Registration: Tammie Starks eIRB Class Registration: Tammie Starks tstarks@emory.edu or 712-0727 tstarks@emory.edu or 712-0727 tstarks@emory.edu