Form 28 Pediatric CIRB Reviewer Findings Cooperative Group Respo

Attachment 6D:
NCI Pediatric CIRB
REVIEWER FINDINGS
COOPERATIVE GROUP RESPONSE TO CIRB REVIEW

OMB#: 0925 – xxxx Expiry Date: xx/xx/xxxx
STATEMENT OF CONFIDENTIALITY
Collection of this information is authorized under 42 USC 285a. While your participation is
completely voluntary, to participate in the NCI CIRB, completion of this form is required. Data
collected as part of the NCI CIRB review is private and protected by law. Under the provisions of
Section 301d of the Public Health Service Act, no information that could permit identification of a
participating individual may be released. All such information will be kept private under the
Privacy Act and will be presented only in statistical or summary form.
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.

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NCI Pediatric CIRB
REVIEWER FINDINGS
COOPERATIVE GROUP RESPONSE TO CIRB REVIEW
DOCUMENT NAME:
DOCUMENT DESCRIPTION:
Name of 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 Study Protocol
Revised Cooperative Group 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):

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

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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. 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

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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
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:

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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
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

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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:
When we looked at this the first time we required assent for children ages
14 and up.
Assent required
Age where assent is expected. Standard age ranges will be determined and
provided as options.

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