LOI3-RT-01-N- IRB Approval

Attachment 3 - LOI3-RT-01-N: IRB Approval

NOTICE OF FULL BOARD APPROVAL
To:

William Lyman
Pediatrics
Children's Research Center

From: Virginia Delaney-Black, M.D., M.P.H. _______________________________________________
Chairperson, Medical/Pediatric Institutional Review Board (MP4)
Date:

December 01, 2010

RE:

HIC #:

104610MP4F

Protocol Title:
Sponsor:

RT-01-M GC/MS Methods to Determine Environmental Factors on Fetus and Newborn
° NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEV.
° MICHIGAN STATE UNIVERSITY

Protocol #:

1010008916

Expiration Date:

October 27, 2011

Risk Level / Category: Pediatric: 45 CFR 46.404 - Research not involving greater than minimal risk
Adult: Research not involving greater than minimal risk

The above-referenced protocol and items listed below (if applicable) were APPROVED following Full Board Review by the
Wayne State University Institutional Review Board (MP4) for the period of 12/01/2010 through 10/27/2011. This approval
does not replace any departmental or other approvals that may be required.
• Revised Protocol (received in the IRB office 12/01/2010) and revised Protocol Summary Form (revisions received in
the IRB office 12/01/2010)
• Revised HIPAA Summary Form and revised HIPAA Authorization Form with consent (revisions received in the IRB
office on 12/01/2010)
• Parental Permission/Research Informed Consent (submission/revision dated 11/30/2010)

° Federal regulations require that all research be reviewed at least annually. You may receive a "Continuation Renewal Reminder" approximately
two months prior to the expiration date; however, it is the Principal Investigator's responsibility to obtain review and continued approval before the
expiration date. Data collected during a period of lapsed approval is unapproved research and can never be reported or published as research
data.
° All changes or amendments to the above-referenced protocol require review and approval by the HIC BEFORE implementation.
° Adverse Reactions/Unexpected Events (AR/UE) must be submitted on the appropriate form within the timeframe specified in the HIC Policy
(http://www.hic.wayne.edu/hicpol.html).
NOTE:
1. Upon notification of an impending regulatory site visit, hold notification, and/or external audit the HIC office must be contacted immediately.
2. Forms should be downloaded from the HIC website at each use.