LOI3-RT-01-N- IRB Continuation Approval

Attachment 4 - LOI3-RT-01-N: IRB Continuation Protocol

NOTICE OF EXPEDITED CONTINUATION APPROVAL
To:

William Lyman
Pediatrics
Children's Research Center

From: Virginia Delaney-Black, M.D., M.P.H. or designee _______________________________________________
Chairperson, Medical/Pediatric Institutional Review Board (MP4)
Date: October 26, 2011
RE:

IRB #:

104610MP4F

Protocol Title:

RT-01-M GC/MS Methods to Determine Environmental Factors on Fetus and Newborn

Funding Source: Award: 015265-001
Protocol #:
Expiration Date:

1010008916
October 25, 2012

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

Continuation for the above-referenced protocol and items listed below (if applicable) were APPROVED following
Expedited Review by the Chairperson/designee of the Wayne State University Institutional Review Board (MP4) for the
period of 10/26/2011 through 10/25/2012. This approval does not replace any departmental or other approvals that may
be required.
• Waiver of consent to collect urine routinely collected for clinical purposes continued and approved (as described in
the amendment approved 1-10-11).
• Parental Permission/Research Informed Consent with HIPAA Authorization (dated 3-16-11).

° 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 IRB BEFORE implementation.
° Adverse Reactions/Unexpected Events (AR/UE) must be submitted on the appropriate form within the timeframe specified in the IRB
Administration Office Policy (http://www.irb.wayne.edu//policies-human-research.php).
NOTE:
1. Upon notification of an impending regulatory site visit, hold notification, and/or external audit the IRB Administration Office must be contacted
immediately.
2. Forms should be downloaded from the IRB website at each use.
*Based on the Expedited Review List, revised November 1998