Attach_10_IRB

Attachment 10: Institutional Review Boards (IRB's) Certifications

Department of Health & Human Services

Public Health Service
National Institutes of Health
National Cancer Institute
Bethesda, Maryland 20892

iRIS Reference Number 319990

Amendment Letter: B
IRB Number: OH97CN041
Version Date: 03/23/2012

4/9/2012
TO:

Robert Hoover

FROM:

Chairperson, Special Studies Institutional Review Board, NCI

SUBJECT:

Action on Clinical Research Protocol Amendment

Your amendment to protocol, “Early Marker and Etiologic Studies in the PLCO Trial,” was reviewed by the
National Cancer Institute Special Studies Institutional Review Board (NCI-SSIRB) by expedited review.
The SSIRB has taken the following action:
X

Approved as written. Forwarded to the CC OPS for administrative processing.
Approved with stipulations pending re-review by SSIRB Chair. See review comments.
Deferred pending response to stipulations and re-review by a subcommittee of the Board.
See review comments.
Tabled pending response to stipulations and re-review by the full SSIRB. See review
comments.

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:

04 / 16 / 2012

Date of Original Approval:

03 / 28 / 2011

Project Name:

PLCO CDCC

Westat Project Number:

8906.00.00

Agency Grant or Contract Number:

HHSN261201100008C

Project Director:

Barbara O'Brien

Unit Ops Number/Study Area:

1121.74

Area IRB Representative:

Nancy Weinfield

Ext. 3965

Ext. 2480

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.
We plan to collect additional exposure data from PLCO participants that may affect cancer risk. We
plan to mail a Risk Factor Questionnaire (attached) to all active participants. Our focus is on
collecting additional information on medications that are particularly common among older adults
including those that have not been assessed in PLCO previously. We are also requesting consent
from participants to link to other health databases like Medicare and Medicaid.

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: 04 / 16/ 2012

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:

IRB Chair / Associate Chair / Designee
IRB Office Only
APPROVED – NEXT CONTINUING REVIEW DATE: 03 / 00/ 2013
CONDITIONAL APPROVAL (PLEASE SEE ATTACHED LETTER)
DID NOT QUALIFY FOR EXPEDITED REVIEW

AMENDMENT REVIEW FORM
January 2010 version

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