Form 51 Reviewer Worksheet Recruitment materials

REVIEWER WORKSHEET
CIRB Review of Recruitment Materials

OMB #0925-xxxx Expiration Date: xx/xx/xxxx

Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of your participation
in the NCI CIRB is protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or
withdrawing from the NCI CIRB at any time. Refusal to participate will not affect your benefits in any way. The information collected
will be kept private to the extent provided by law. Names and other identifiers will not appear in any report of the NCI CIRB.
Information provided will be combined for all participants and reported as summaries. You are being requested to complete this
instrument so that we can conduct activities involved with the operations of NCI CIRB Initiative.
NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
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-xxxx*). 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.
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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.

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.

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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.

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.
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Comments

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