Form 30 Pediatric CIRB Reviewer Findings Amendment to Cooperativ

Attachment 6F:

NCI Pediatric CIRB
REVIEWER FINDINGS
AMENDMENT TO COOPERATIVE GROUP PROTOCOL

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 1.5 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.

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NCI Pediatric CIRB
REVIEWER FINDINGS
AMENDMENT TO COOPERATIVE GROUP PROTOCOL
DOCUMENT NAME:
DOCUMENT DESCRIPTION:
Name of 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 (specify)

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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?
Yes
No
6. In your judgment, do the benefits of this study continue to outweigh the risks?
Yes
If No, please explain
If Uncertain, 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 not involving greater than minimal risk

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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
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:

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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 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

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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:
Subjects are infants.
Assent required
Age where assent is expected. Standard age ranges will be determined and provided as
options.

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