Form 44 Ped FB SCRWksht

NCI Pediatric CIRB
REVIEWER WORKSHEET
STUDY CHAIR’S RESPONSE TO CIRB REVIEW
Attachment_B28_Ped_Response_Rev

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
Public reporting burden for this collection of information is estimated to average 60 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 (0925-0753). Do not return the
completed form to this address.

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

1.

The Study Chair’s 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):
Study Chair’s Response Letter/Memo
Revised Protocol Version
Revised Model 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
Other (specify):

July
2018from ePanel© 10/12/16, Updated 07/07/2017
Adapted

3.

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

4.

Did the Study Chair’s 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 Study
Chair’s response and revised documentation.

7.

Please provide your recommendation for CIRB action on the Study Chair’s
response and revised documentation.

8.

45 CFR 46.404: Research not 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 study documentation:

Permission required from:
One Parent
Both Parents
9.

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

July
2018from ePanel© 10/12/16, Updated 07/07/2017
Adapted

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
10.

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 parents will provide
permission.
Explanation based on study documentation:

11.

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

July 2018

Adapted from ePanel© 10/12/16, Updated 07/07/2017

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:
12.

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
Passent may be waived in accord with 45 CFR 46.116
Explanation based on study documentation:

Assent required for those above seven years old.
Assent required
Age where assent is expected. Standard age ranges will be determined and
provided as options.
13.

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.

14.

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 decisionmaking is appropriate).

15.

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.

July
2018
Adapted from ePanel© 10/12/16, Updated 07/07/2017

16.

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.

July
2018
Adapted from ePanel© 10/12/16, Updated 07/07/2017