Emory University IRB

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Emory UniversityIRB

• Chairman James W. Keller, M.D.
• Director Tanya Sudia-Robinson, RN, Ph.D.

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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 trustNEJM 3461403, 2002
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Emory IRB

• Reviews about 1500 protocols/year
• Full Board about 40
• Expedited about 55
• Exempt 5

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Emory IRB

• Currently
• 4 Biomedical Committees
• 1 Social-Behavioral Committee
• SPH, College
• Near Future
• 2 Additional Biomedical Committees

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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.

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IRB Primer

• Human Subjects Protection
• Education Requirement
• CITI exam
• Access via emory.edu/IRB webpage

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eIRB
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eIRB

• 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 password

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Submission
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Start Process
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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

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Consent Sections

• Introduction/Purpose
• Procedures
• Risks
• Alternatives
• Benefits

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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

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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_at_emory.edu or 712-0727