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To:
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National Institutes of Health
National Institute of
Environmental Health Sciences
P. O. Box 12233
Research Triangle Park, NC 27709
http://sharepoint.niehs.nih.gov/ohrc/default.aspx
July 03, 2013
NIEHS IRB Chair, through the Office of Human Research Compliance
Chief, Epidemiology Branch and PI, the GuLF STUDY
Expedited Amendment to Protocol # 11-E-NO7 titled “The Gulf Long-term Follow-up Study“
An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more
experienced reviewers designated by the chairperson from members of the IRB in accordance with the requirements set forth in 45 CFR
46.110. Additional information on determining the appropriate level of review for a submission can be found at
http://ohsr.od.nih.gov/irb/Attachments/Chapter7.htm.
Note: If an NIH investigator is added to the protocol, attach a signed/cleared Personal Financial Holding Clearance form along with an email from the new investigator stating they are aware they are being added to the protocol.
Expedited Amendment Summary and Justification:
We request expedited review and approval of introduction scripts for the previously approved Supplemental
Mental Health Questionnaire that will be administered to ~4,600 participants at the end of their follow-up
telephone interview. The scripts inform the participant that they are eligible to complete the additional survey,
will be invited to complete subsequent interviews, and that they will receive a $10.00 for their additional time
upon completion of these questions. A thank you letter and the gift card will be mailed to the participants within 2
weeks of completing the interview.
Associated Files:
SAMHSA_Mental_Health_Telephone_Scripts_V1.0_07022013
GuLF_STUDY_SAMHSA_Telephone_Thank_You_Letter_V1.0_07022013
Principal Investigator, NIEHS
I authorize the above changes to my study and have included updated edited and clean versions of all
revised documents as attachments for submission via my NIH e-mail account to the NIEHS Office of
Human Research Compliance.
For Approving Official Use Only:
The attached expedited amendment request is a minor change in the research that does not increase risks to subjects
or reduce potential benefits and falls within the OHRP Categories of Research that May be Reviewed by the IRB
through an expedited review procedure. Approval is hereby granted.
N. Almodovar
Protocol Specialist
Office of Protocol Services
7/15/13
Date
Z
Amendment
Letter
Page 1 of 1
Protocol eSign History
Protocol Number: 11-E-N076
Date/Time
07/02/2013 6:33 PM
Review: Amendment 07/02/2013
User
Dale Sandler
07/02/2013 6:33 PM Dale Sandler
07/02/2013 6:33 PM Dale Sandler
07/02/2013 6:34 PM
Dale Sandler
07/02/2013 6:34 PM Dale Sandler
07/03/2013 2:00 PM Frederick Miller
Type
Action
Electronic signature
eSignature Verified Principal
access
Investigator
Electronic signature
eSignature Verified Accountable
access
Investigator
Electronic signature
eSignature Verified Branch
access
Chief
Electronic signature
eSignature Verified Accountable
access
Investigator
Electronic signature
eSignature Verified Branch
access
Chief
Electronic signature
eSignature Verified Clinical
access
Director
Electronic signature
07/08/2013 12:49 PM David Resnik
(26)
access
eSignature Verified IRB Chair
| File Type | application/pdf |
| File Modified | 2014-01-27 |
| File Created | 2013-07-15 |