Form 36 Ped AR FB Reviewer Worksheet

NCI Pediatric CIRB
REVIEWER WORKSHEET
Amendment to Cooperative Group Protocol

OMB #0925-xxxx Expiration Date: xx/xx/xxxxx
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 2 hours 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.

I have reviewed the following documents (check all that apply):
NCI Pediatric CIRB Application for Treatment Studies or NCI Adult/Pediatric
CIRB Application for Ancillary Studies
Summary of CIRB Application Revisions
Summary of Changes related to the Amendment
Study Protocol
Cooperative Group Model Informed Consent Document(s)
Other (specify):

2.

The amendment includes the following changes (check all that apply):
Increase or decrease in accrual (impacts statistical design)
Addition or deletion of a treatment group/arm
Addition or deletion of a study drug
Change in treatment period/treatment design
Changes in the informed consent document(s)
Editorial and/or administrative changes
Other:

Adapted from ePanel© 08/19/16

3.

Please provide a brief summary of the current approved protocol. (Note to
reviewer: Not applicable for amendments containing solely editorial and/or
administrative changes)

4.

Please provide the rationale for the amendment. (Note to reviewer: Not
applicable for amendments containing solely editorial and/or administrative
changes)

5.

Do the changes in the amendment alter the risk/benefit ratio to the
participants?
If Yes, explain whether the benefits continue to outweigh the risks.:
No
If Uncertain, please explain:

6.

Do any of the changes in this amendment include significant new findings
that might relate to the participant’s willingness to continue participation in
the research?
If Yes, describe what plans are included to notify/re-consent participants
and indicate whether the plans are sufficient.:
If No, please explain:

7.

Please provide your comments and/or concerns regarding the amendment.

8.

Please provide your recommendation for CIRB action on the amendment.

Pediatric Risk Assessment
9.

45 CFR 46.404: Research no involving greater than minimal risk
Minimal Risk
Explanation based on study documentation:
Adequate provisions are made for soliciting the assent of the children and
the permission of their parents or guardians, as set forth in 46.408.
Explanation based on the study documentation:

Permission required from

Adapted from ePanel© 08/19/16

One Parent
Both Parents

10.

45 CFR 46.405: Research involving greater than minimal risk but presenting
the prospect of direct benefit to the individual subjects
Greater than minimal risk
Explanation based on study documentation:
Prospect for direct subject benefit
Explanation based on study documentation:
The risk is justified by the anticipated benefit to the subjects
Explanation based on study documentation:
The relation of the anticipated benefit to the risk is at least as favorable to
the subjects as that presented by available alternative approaches
Explanation based on study documentation:
Adequate provisions are made for soliciting the assent of the children and
permission of their parents or guardians, as set forth in 46.408.
Explanation based on study documentation:

Permission required from
One Parent
Both Parents
11.

45 CFR 46.406: Research involving greater than minimal risk and no
prospect of direct benefit to individual subjects, but likely to yield
generalizable knowledge about the subject's disorder or condition
Greater than minimal risk
Explanation based on study documentation:
The risk represents a minor increase over minimal risk
Explanation based on study documentation:
The intervention or procedure presents experiences to subjects that are
reasonably commensurate with those inherent in their actual or expected
medical, dental, psychological, social, or educational situations
Explanation based on study documentation:
The intervention or procedure is likely to yield generalizable knowledge
about the subjects' disorder or condition which is of vital importance for
the understanding or amelioration of the subjects' disorder or condition
Explanation based on study documentation:
Adequate provisions are made for soliciting assent of the children and
permission of their parents or guardians, as set forth in 46.408. Both

Adapted from ePanel© 08/19/16

parents will provide permission.
Explanation based on study documentation:
12.

45 CFR 46.407: Research not otherwise approvable which presents an
opportunity to understand, prevent, or alleviate a serious problem affecting the
health or welfare of children

The IRB does not believe meets the requirements of 46.404,
46.405, 46.406
Explanation based on study documentation:
The IRB finds that the research presents a reasonable opportunity to
further the understanding, prevention, or alleviation of a serious problem
affecting the health or welfare of children
Explanation based on study documentation:
13.

45 CFR 46.408: Requirements for assent by children

Assent requirement waived
Capability of some or all of the children is so limited that they cannot
reasonably be consulted
OR
Procedure involved in the research holds out a prospect of direct benefit
that is important to the health or well-being of the children AND the
intervention is available only in the context of the research
OR
Assent may be waived in accord with 45 CFR 46.116
Explanation based on study documentation:
Assent required
Age where assent is expected. Standard age ranges will be determined
and provided as options.
14.

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.

15.

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).

Adapted from ePanel© 08/19/16

16.

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.

17.

Recommendations
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.

Adapted from ePanel© 08/19/16