IRB Approval Letter

Population Assessment of Tobacco and Health (PATH) Study (NIDA)

Attachment 15
PATH Study
IRB Approval Memo
June 26, 2014

AMENDMENT REVIEW FORM
(TO ADD OR CHANGE PREVIOUSLY APPROVED RESEARCH)
All changes or new activities for previously approved studies require submission, review, and approval of
an Amendment Review Form. Please complete and submit this form to [email protected] and attach all necessary
materials to be reviewed. Once the request has been reviewed, you will be contacted. If this change or new activity
requires a full Board review, those meetings occur on the second Tuesday of every month. To check the date of
meetings, please see the meeting schedule under IRB in WesInfo. Thank you for your cooperation.
1. Today’s Date:

03 / 06 / 2014

Date of Original Approval:

07 / 19 / 2012

Project Name:

Population Assessment of Tobacco and Health (PATH)

Westat Project Number:

8954.00.00

Agency Grant or Contract Number:

HHSN271201100027C, Ref # NO1DA-11-5568

Project Director:

Scott Crosse/Lucy (for Dave Maklan)

Unit Ops Number/Study Area:

1121.56

Area IRB Representative:

Katie Gasque

Ext. 2128

Ext. 3694

2. Indicate the type of addition or change being requested to a previously approved study.
(SELECT ALL THAT APPLY.)
Name(s) of investigators
Review of final instrument such as interview
questions or data collection sites for a
Project number
previously approved study
Introduction of a new IRB or request for
Mode of administration of instruments in your
Westat to serve as the IRB
study (e.g., from mail or telephone to web or
Study design, survey questionnaire, or
Internet access)
procedure(s)
Data access rights
Informed consent process, consent form(s),
Any other change in protocol that affects
parent permission(s), or assent form(s)
treatment of human subjects:
Recruitment materials or strategies
(PLEASE SPECIFY)
Incentives
Survey instruments
Number or type of populations studied

AMENDMENT REVIEW FORM
January 2010 version

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Amendment Review Form

Submit materials by email: [email protected]

3. Please provide a brief summary of your change or addition to previously approved research.
This request is for IRB review and approval for the Population Assessment of Tobacco and Health
(PATH) Study to conduct the Wave 2 (first follow-up) collection of data and biospecimens,
scheduled to begin in the fall of 2014. Some PATH Study materials and procedures have been
revised and are now being resubmitted to the IRB for approval before the Wave 2 collections start.

4. How does each change or addition affect the risks to participants in your study? (SELECT ONLY ONE.)
a.
No change
b.

N/A – no risks

c.

Decreases the risk (SPECIFY):

d.

Increases the risk (SPECIFY):

e.

Adds a new risk (SPECIFY):

FOR HARD-COPY SUBMISSION, PLEASE SIGN HERE:
A signature is not required when you return this form electronically; however, please fill in the date of
completion.
The information provided in this request form is complete and correct.
Project Director/
Principal Investigator:

Date: 03 / 06/ 2014

Please attach:
 One document that clearly identifies (through track changes, highlights, or italics) the revision in the
previously approved submission.
 Another document labeled “corrected version.”
If you have any questions, feel free to contact Sharon Zack, the IRB Administrator, at x8828.
IRB Administration Use Only
Expedited review and approval for the modification(s) on this form:

3/12/14
IRB Chair / Associate Chair / Designee
IRB Office Only
APPROVED – NEXT CONTINUING REVIEW DATE: 3 / 01/ 2015
CONDITIONAL APPROVAL (PLEASE SEE ATTACHED LETTER)
DID NOT QUALIFY FOR EXPEDITED REVIEW
AMENDMENT REVIEW FORM
January 2010 version

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