Form 43 Adult & CPC FB SCRWksht

NCI ADULT CIRB- Choose 1

REVIEWER WORKSHEET
COOPERATIVE GROUP RESPONSE TO CIRB REVIEW
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 1 hour 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:

1.

This Cooperative Group response is in reference to (check one):
CIRB Stipulations from Initial Review
CIRB Stipulations from Amendment/Revision/Update Review
CIRB Stipulations from Continuing Review

2.

I have reviewed the following documents (check all that apply):
Cooperative Group Response Letter/Memo
Revised Protocol Version
Revised Cooperative Group Informed Consent Document(s)
Revised NCI Adult CIRB Application for Treatment Studies or NCI
Adult/Pediatric CIRB Application for Ancillary Studies
Summary of CIRB Application Revisions

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Other (specify):
3.

Has the Cooperative Group and/or Study Chair adequately addressed the
CIRB stipulations and/or recommendations from the prior CIRB review?
Yes
No

4.

Did the Cooperative Group response include additional changes aside from
the CIRB stipulations and/or recommendations?
Yes (if yes, check all that apply below)
No (if no, skip to Question 6)

5.

Do the additional changes alter the risk/benefit ratio to the participants?
Yes
No

6.

Please provide your comments and/or concerns (if any) regarding the
Cooperative Group response and revised documentation.

7.

Please provide your recommendation for CIRB action on the Cooperative
Group response and revised documentation.

8.

Questions for the Study Team
Questions included below will be sent to the Study Team in advance of the CIRB
meeting. Whenever possible, CIRB Operations Office staff will forward responses
received prior to the meeting to the primary reviewers and post those responses
in ePanel. In order to ensure questions are sent to the Study Chair, questions
should be posted here in ePanel at least 36 hours prior to the CIRB meeting.

9.

Topics for CIRB Discussion
List below any topics requiring discussion among the CIRB members prior to a
final assessment of the study (e.g. whether inclusion of individuals with impaired
decision-making is appropriate).

10.

Proposed Stipulations
Changes or additional information that the CIRB requires before the study can be
approved should be listed below. The changes or requested information must
pertain to the regulatory criteria for approval or have a direct impact on the
protection of study participants.

11.

Recommendations

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List recommended changes below. Recommended changes do not relate to the
regulatory criteria for approval nor do they relate to protection of study
participants. The Study Chair may opt to address the recommendations, or may
disregard them.

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