Form 40 Ped Expedited Reviewer Worksheet

NCI PEDIATRIC CIRB
REVIEWER WORKSHEET
Expedited Amendment Review

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 30 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-xxxx*). Do not return the completed form to this address.

STUDY ID:
STUDY TITLE:
PROTOCOL VERSION DATE:
AMENDMENT NUMBER / UPDATE DATE:
CIRB EXPIRATION DATE:
NAME OF CIRB REVIEWER:
ROLE:

Chair

Vice Chair

Designated Reviewer

DATE COMPLETED:
REVIEWER CONFLICT OF INTEREST:
By checking this box, the reviewer confirms there are no conflicts of interest relative to this
study per the Conflict of Interest Policy for CIRB Members.
1.

Prior Pediatric CIRB Determinations:
Pediatric Risk Determination: Choose 1
Assent Requirement: Choose 1
Parental Permission Requirement: Choose 1

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Note: Modifications to the Pediatric Risk Determination, Assent Requirement, or Parental
Permission Requirement must be reviewed by the convened CIRB.
2.

Indicate the documents reviewed (check all that apply):
NCI Adult/Pediatric CIRB Application for Treatment Studies or NCI Adult/Pediatric CIRB
Application for Ancillary Studies (not applicable for studies permanently closed to
accrual)
Summary of CIRB Application revisions (not applicable for studies permanently closed to
accrual)
Summary of changes related to the amendment (Change Memo)
Study Protocol(s) (clean and tracked, when available)
Consent Form(s)
Other, please specify

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3.

Describe the changes included in the amendment as well as the rationale for the
changes:

4.

Only amendments that include minor changes may be approved by expedited review;
any changes that are not minor must be reviewed by the convened CIRB. The CIRB
SOPs define minor changes as those that do not negatively impact the risk/benefit ratio.
4a.

Do the changes in the amendment negatively impact the risk/benefit ratio?
Yes (If Yes, stop here. The amendment will be reviewed at the next convened CIRB
meeting and may be assigned to another reviewer.)
No

4b.

Describe why the changes are considered minor:
They are considered minor because:
The changes are editorial or administrative and do not affect the scientific intent
of the study, study design, patient risk, or protection of human subjects.
The changes are in response to a CTEP Request for Rapid Amendment and may
be expedited per the Memo from OHRP to Dr. Abrams, dated September 29,
2008.
Other, please describe:

5.

Does the current consent form(s) accurately reflect information included in the protocol?
Yes
No (If No, please indicate what information needs to be added:

6.

)

Are the following requirements for approval of research satisfied? (check the boxes to
verify that the requirements for approval of research are satisfied)
Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and
which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already
being performed on the subjects for diagnostic or treatment purposes;
Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the
knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider
only those risks and benefits that may result from the research (as distinguished from risks and benefits of
therapies subjects would receive even if not participating in the research). The IRB should not consider possible
long-range effects of applying knowledge gained in the research (for example, the possible effects of the research
on public policy) as among those research risks that fall within the purview of its responsibility;
Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the
research and the setting in which the research will be conducted and should be particularly cognizant of the
special problems of research involving vulnerable populations, such as children, prisoners, pregnant women,
mentally disabled persons, or economically or educationally disadvantaged persons;
Informed consent will be sought from each prospective subject or the subject's legally authorized representative,
in accordance with, and to the extent required by §46.116;
Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117;
When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the
safety of subjects;
When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the
confidentiality of data;

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When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children,
prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons,
additional safeguards have been included in the study to protect the rights and welfare of these subjects.

7.

Does the current consent form(s) include the following required and additional
elements? (check the boxes to verify the information is present)
A statement that the study involves research, an explanation of the purposes of the research and the expected
duration of the subject's participation, a description of the procedures to be followed, and identification of any
procedures which are experimental;
A description of any reasonably foreseeable risks or discomforts to the subject;
A description of any benefits to the subject or to others which may reasonably be expected from the research;
A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to
the subject;
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be
maintained;
For research involving more than minimal risk, an explanation as to whether any compensation and an
explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or
where further information may be obtained;
An explanation of whom to contact for answers to pertinent questions about the research and research subjects'
rights, and whom to contact in the event of a research-related injury to the subject; and
A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which
the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss
of benefits to which the subject is otherwise entitled.
A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if
the subject is or may become pregnant) which are currently unforeseeable;
Anticipated circumstances under which the subject's participation may be terminated by the investigator without
regard to the subject's consent;
Any additional costs to the subject that may result from participation in the research;
The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of
participation by the subject;
A statement that significant new findings developed during the course of the research which may relate to the
subject's willingness to continue participation will be provided to the subject;
The approximate number of subjects involved in the study; and
The following statement for trials activated after 03/12/12: “A description of this clinical trial will be available on
http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify
you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
( Not applicable)

8.

Are there any significant new findings that might relate to the participant’s willingness to
continue taking part in the study?
Yes (If Yes, describe what plans are included to notify or re-consent participants and
indicate whether the plans are sufficient:
)
No

9.

In your judgment, do the benefits of this study continue to outweigh the risks?
Yes
No (If No, stop here. The amendment will be reviewed at the next convened CIRB
meeting.)

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10.

Determinations:
a.

Pediatric Risk, Assent, and Parental Permission Determinations
Note: Modifications to the Pediatric Risk Determination, Assent Requirement, or
Parental Permission Requirement must be reviewed by the convened CIRB.

b.

i.

Pediatric Risk Determination: Choose 1
Confirm prior risk determination.
Change the risk determination. If changing the risk determination, select the
desired risk categorization above and provide a rationale for the change:

ii.

Assent Requirement: Choose 1
Confirm prior assent requirement.
Change the assent requirement. If changing the assent requirement, select
the desired age above and provide a rationale for the change:

iii.

Parental Permission Requirement: Choose 1
Confirm prior parental permission requirement
Change the parental permission requirement. If changing the parental
permission requirement, select the requirement above and provide a rationale
for the changes:

Review Determination
Approve
Approve Pending Modifications (provide required modifications in Question 11)
Forward for review by convened CIRB (provide reason in Question 11)
Reviewer requests additional information before a determination can be made
(provide details on additional information required in Question 11)

11.

Comments:

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