Emory University IRB - PowerPoint by QOMAGZ6


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

Reviews about 1500 protocols/year

Full Board – about 40%

Expedited – about 55%

Exempt – 5%
Emory IRB

 4 Biomedical Committees
 1 Social-Behavioral Committee
     SPH, College

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

Human Subjects Protection
Education Requirement:

CITI exam
     Access via emory.edu/IRB webpage
Your Account:
Enter: Emory email user ID (net ID)

Pass Word – at first log in:
  * 1st initial of your first name
  * Last 4 digits of SSN
  * 1st initial of your last name
                (i.e., j3581k)

At initial log-in, you will be instructed to change
Start Process
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
Consent Sections

   Introduction/Purpose
   Procedures
   Risks
   Alternatives
   Benefits
Consent Sections

   Confidentiality – short without HIPAA
   Compensation – injury and $ for time, etc
   Costs – what is paid for
   Voluntary Participation/Withdrawal
   Contact Persons
   New Findings
   Entitlement to Copy
IRB Contact Information
   www.emory.edu/IRB
   IRB Office
           404-712-0720
           Briarcliff Campus at 1256 Briarcliff Rd
                                    Suite 307 North

   Chairman: James W. Keller, M.D.
   Director: Tanya Sudia-Robinson, RN, Ph.D.
   eResearch at Emory: eIRB & eIACUC: Christine Gomez
   eIRB Class Registration: Tammie Starks
                  tstarks@emory.edu or 712-0727

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