Form 26 Pediatric CIRB Reviewer Findings - Initial Review of Coo

Attachment 6B:

NCI Pediatric CIRB
REVIEWER FINDINGS
INITIAL REVIEW OF 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 4 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
INITIAL REVIEW OF 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
Study Protocol
Cooperative Group Model Informed Consent Document(s)
Information Sheets
Investigator’s Brochure
Study instruments to be completed by participants
Recruitment materials
Other (specify)

2. Does this protocol have scientific value?
Is the study worthwhile?
3. Does the protocol have scientific validity?
•
•
•
•

Are the background assumptions that lead to the hypothesis valid?
Is literature/background described to justify the trial?
Is the hypothesis or research question clearly stated?
Is the study design appropriate to prove the hypothesis?
(Consider sensitive and specific measures of difference, statistical testing,
sample size)

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4. Does the study have a valid scientific design and yet pose an inappropriate risk for
subjects?
•

•

Is there substantial evidence that one of the arms is inferior to another or to
standard/conventional
care or will deprive a subject of his/her right to receive a life-prolonging
treatment?
Is it possible that one arm will expose a subject to a serious risk of harm?

5. Are risks to subjects minimized?
•
•
•

•

Does the research design minimize risks to subjects?
Do the procedures expose subjects to unnecessary risks?
Are procedures already being performed on the subjects for diagnostic or
treatment purposes
being used whenever appropriate?
Can alternative procedures be used that would expose the subjects to fewer
risks?

6. Are the risks to subjects reasonable in relation to anticipated benefits, if any, to
subjects and the importance
of the knowledge that may reasonably be expected to result? *
•
•

What is the perceived level of risk/discomfort/inconvenience to the subject?
Is there the prospect of direct benefit to the subjects?

* (Consider only those risks and benefits that may result from research as opposed to those that would
result from alternative therapies not involved in the research.)

7. Is the selection of subjects equitable?
•
•
•
•

Who is to be enrolled?
How will subjects be identified and recruited?
Are these subjects appropriate for the protocol?
What is the rationale for the inclusion/exclusion of specific populations?

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8. Are additional safeguards in place for subjects likely to be vulnerable to coercion or
undue influence?
•

Are appropriate protections in place for vulnerable subjects (e.g., pregnant
women, fetuses, socially- or economically -disadvantaged, decisionally impaired,
extremely ill/desperate)?

9. Will informed consent be obtained from research subjects or their legally
authorized representatives?
•
•
•

Does the informed consent document include the eight required elements?
Is the consent document understandable to subjects/legal guardian?
Is the CIRB requested to waive or alter any informed consent requirement?

10. Is there adequate provision for monitoring the data collected to ensure the safety
of subjects?
•

What research oversight process will be used to enhance subject safety? (e.g.,
data safety monitoring boards)

11. Are there adequate provisions to protect the privacy of subjects and to maintain
the confidentiality of data?
•
•

Will personally-identifiable research data be protected to the extent possible
from access or use?
Are any special privacy and confidentiality issues properly addressed, e.g., use
of genetic information?

12. Additional Remarks

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PEDIATRIC RISK ASSESSMENT

13. 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
14. 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:

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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
15. 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:

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16. 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:

17. 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.

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