Attachment C2 South Carolina IRB notice

OFFICE OF RESEARCH COMPLIANCE

October 2, 2006

Dr. Robert McKeown
Arnold School of Public Health
Epidemiology & Biostatistics
University of South Carolina
HESC 202A
Columbia, SC 29208
Re: CONTINUATION of: Longitudinal Study of Attention Deficit Hyperactivity
USCeRA #: HSA3546
CR#: 9/28/2006
Dear Dr. McKeown:
The University of South Carolina Institutional Review Board (USC IRB) for the use of human subjects in research
reviewed and approved this project for another year in accordance with the federal Common Rule, 45 CFR 46, and
any other governing regulations by Full IRB Review on 9/28/2006.
Approval is for a one-year period from 9/28/2006 to 9/27/2007.
University of South Carolina Assurance number: FWA 00000404 / IRB Registration number: 00000240
PLEASE NOTE THE FOLLOWING APPROVAL CONDITIONS
• The research must be conducted according to the proposal/protocol that was approved by the IRB.
• Changes in the research procedures or the consent document must be approved by the IRB prior to
implementation.
• If applicable, each subject should receive a copy of the consent document stamped with the current USC IRB
approval dates shown above.
• It is the responsibility of the principal investigator to report promptly to the IRB:
o Unexpected risks to subjects
o Adverse events effecting the rights or welfare of any human subject participating in the project
• Research records, including signed consent documents, must be retained for at least three (3) years after the
termination of the last IRB approval.
• An update on the study is required each year on or before the end date referenced above. A final report is also
due upon completion or early termination of the study, reports are to be made on the “Continuing Review Report”
form.
If you have questions concerning the approval process, please contact me at [email protected] or
(803) 777-4456.

Sincerely,

Thomas A. Coggins (am)
Thomas A. Coggins
Director

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