Form 51 Reviewer Worksheet Recruitment materials

NCI CIRB
REVIEWER WORKSHEET
CIRB Review of Recruitment Materials
Attachment_B35_Rev_Wkst_Recruit_Matls

OMB# 0925-0753, Expiration Date: 07/31/2021

The purpose of the information collection is to conduct reviews of clinical trial studies. NCI guidelines mandate the participation of
institutions in the CIRB for Network group studies. You are being requested to complete this instrument so that we can conduct
activities involved with the operations of the NCI CIRB Initiative. Although your participation in Network group research and completion
of the forms is voluntary, if you wish to participate in the CIRB, you must complete all questions on the form. The information you
provide will be combined for all participants and reported as summaries. It will be kept private to the extent provided by law.
NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
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reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
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information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705
Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0753). Do not return the completed form to this address.

STUDY ID:
STUDY TITLE:
NAME OF CIRB REVIEWER:
DATE COMPLETED:

Reminder to reviewers: Recruitment materials should be reviewed for the following three components:
• accuracy of the information presented,
• to ensure that the material is not coercive, and
• to ensure that the material does not promise a certainty of cure or benefit beyond what is outlined in
the informed consent document and the protocol.
Remember that potential study participants will be given a consent document providing greater detail on the
study and its foreseeable risks and benefits.
1.

Indicate the documents reviewed (check all that apply):
Updated NCI CIRB Application for Treatment Studies
Summary of CIRB Application revisions
Recruitment Material. Indicate the material reviewed:
Pamphlets
Webpage
Video
Other:

2.

Is a distribution plan provided (see section 5 of the CIRB Application)?
Yes. If yes, briefly describe the plan:
No. If no, a distribution plan is required before the recruitment material can be approved.

July 2018

3.

Does the recruitment material include any exculpatory language?
Exculpatory language is “language through which the subject or the representative is made to waive or
appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the
sponsor, the institution or its agents from liability for negligence.” (45 CFR 46.116). Examples of
exculpatory language can be found in the 1996 OPRR Letter “Exculpatory Language in Informed
Consent Documents: Examples of Acceptable and Unacceptable Language” available at:
http://www.hhs.gov/ohrp/policy/exculp.html.
Yes. If yes, identify the language and provide suggested revisions:
No.

4.

Does the recruitment material state or imply a certainty of a favorable outcome or other benefits
beyond what is outlined in the informed consent document and protocol?
Yes. If yes, identify the language and provide suggested revisions:
No.

5.

Does the recruitment material include language that in any way appears to place undue
influence on the potential study participant to enroll in the study? (i.e. access to free drugs or
treatment, compensation, etc).
Yes. If yes, identify the language and provide suggested revisions:
No.

6.

Does the recruitment material suggest that the investigational article is safe, effective,
equivalent, or superior to other options?
Yes. If yes, identify the language and provide suggested revisions:
No.

7.
Does the recruitment material refer to an investigational drug, biologic or device as a “new
drug” or “new treatment” without explaining that the test article is investigational?
Yes. If yes, identify the language and provide suggested revisions:
No.
8.
Does the recruitment material emphasize any payment to be made to subjects or compensation
for participation in the study?
Note that NCI-Sponsored research generally does not provide compensation for participation in a study.
Nonetheless, if compensation is offered, it may be noted in recruitment materials but should not be
emphasized over other elements of the material.
Yes. If yes, identify the language and provide suggested revisions:
No.

9.
Does the recruitment material promise “free treatment” when the intent is only to say
participants will not be charged for taking part in the study?
Yes. If yes, identify the language and provide suggested revisions:
No.
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10.

Recommendation to the CIRB

If a distribution plan is provided (per question 2) and there are no changes required to language in the
recruitment materials (per questions 3 through 8) the recruitment material may be approved.
Approve
A distribution plan is provided and there are no required or suggested revisions.
Approve Pending Modifications
There are required changes to the recruitment materials (per questions 3 through 9).
Approve with Recommendations
The reviewer has identified potential improvements to the material but has determined that they
are not required.
Table
There is insufficient information available to make a determination regarding the recruitment
material, or substantive changes are required and warrants re-review by the convened CIRB.
Disapprove
The submitted material is inaccurate and does not meet the regulatory and CIRB SOP
requirements for approval.
11.

Comments

July 2018