Emory University IRB - PowerPoint PPT Presentation

1 / 14
About This Presentation
Title:

Emory University IRB

Description:

James W. Keller, M.D., Chairman. Biomedical I: Cliff Gunthel, M.D. ... Chairman: James W. Keller, M.D. Director: Tanya Sudia-Robinson, RN, Ph.D. ... – PowerPoint PPT presentation

Number of Views:36
Avg rating:3.0/5.0
Slides: 15
Provided by: medi233
Category:
Tags: irb | emory | james | tanya | university

less

Transcript and Presenter's Notes

Title: Emory University IRB


1
Emory UniversityIRB
  • 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 trustNEJM 3461403, 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
  • 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.

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
  • 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

9
Submission
10
Start Process
11
Submission Needs
  • Protocol
  • Lay summary
  • Consent(s) core/banking/assent/etc
  • HIPAA
  • Revocation Letter
  • Clinical Investigator Brochure
  • Amendments
  • Grant
  • Advertisements

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

13
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

14
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
Write a Comment
User Comments (0)
About PowerShow.com