Form 32 Ped IR FB Reviewerworksheet

NCI Pediatric CIRB
REVIEWER WORKSHEET
Initial Review of Cooperative Group Protocol

OMB #0925-xxxx Expiration Date: xx/xx/xxxx
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 3 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.

Indicate the documents reviewed (check all that apply):
NCI Adult 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 the study have scientific value?
Point to consider:
• Is the study worthwhile?

3.

Does the study have scientific validity?
Points to consider:
Adapted from ePanel© 08/19/16

•
•
•
•

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)

4.

Does the study have a valid scientific design and yet pose an inappropriate risk for
subjects?
Points to consider:
• 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 lifeprolonging treatment?
• Is it possible that one arm will expose a subject to a serious risk of harm?

5.

Are risks to subjects minimized?
Points to consider:
• 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?*
Points to consider:
• What is the anticipated 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
may result from therapies not involved in the research.

7.

Is the selection of subjects equitable?
Points to consider:
• Who is to be enrolled?
• How will the subjects be identified and recruited?
• Are these subjects appropriate for the protocol?
• What is the rationale for the inclusion/exclusion of specific populations?

8.

Are additional safeguards in place for subjects likely to be vulnerable to coercion or
undue influence?
Point to consider:
• Are appropriate protections in place for vulnerable subjects (e.g., pregnant women,
fetuses, socially – or economically – disadvantaged, decisionally impaired, extremely
ill/desperate)?
Adapted from ePanel© 08/19/16

9.

Will informed consent be obtained from the 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?

Pediatric Risk Assessment
10.

Is there adequate provision for monitoring the data collected to ensure the safety of
participants?
Point to consider:
• What research oversight process will be used to enhance subject safety? (e.g., data
safety monitoring board)

11.

Are there adequate provisions to protect the privacy of participants and to maintain the
confidentiality of data?
Points to consider:
• Will personally-identifiable research data be protected to the extent possible from
unauthorized access or use?
• Are any special privacy and confidentiality issues properly addressed, e.g., use of
genetic information?

12.

Additional Remarks:

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

Adapted from ePanel© 08/19/16

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
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:

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
Adapted from ePanel© 08/19/16

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
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.
18.

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.

19.

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).

20.

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.

21.

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

Adapted from ePanel© 08/19/16