Form 55 Reviewer Worksheet CPC UP FB

NCI Cancer Prevention and Control CIRB
REVIEWER WORKSHEET
Determination of Unanticipated Problem and/or Serious or Continuing
Noncompliance

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 15 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:
NAME OF CIRB REVIEWER:
DATE COMPLETED:
1.

Briefly describe the incident, experience, or outcome reported to the CIRB.
Note: Incidents, experiences or outcomes described on this worksheet can
be an unanticipated problem, serious or continuing non compliance, both
or neither.

2. I have reviewed the following documents (check all that apply).
Memorandum from the Study Chair describing the potential unanticipated
problem and/or serious or continuing noncompliance
Adverse event report
Participant/Family letter(s)
Doctor letter(s)
Protocol
Model Version of the Informed Consent Document

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Other (specify)
Section 1: Unanticipated Problem Determination
Background: OHRP and FDA regulations require reporting of unanticipated
problems involving risks to subjects or others (45 CFR 46. 103(b)(5) and 21 CFR
56.108(b)(1)). OHRP Guidance defines an unanticipated problem as being
(A) unexpected,
(B) related or possibly related to participation in the research, and
(C) placing participants or others at a greater risk of harm.
3.

Reviewer Analysis (A) “unexpected” – Is the incident, experience, or
outcome unexpected (in terms of nature, severity, or frequency) given (a)
the research procedures that are described in protocol-related documents,
such as the IRB-approved research protocol and informed consent
document; and (b) the characteristics of the subject population being
studied?
NOTE: Findings from planned interim analysis are not considered
“unexpected”.
Yes, it is unexpected. -- Provide an explanation.
No, it is not unexpected. -- Provide an explanation.
4.

Reviewer Analysis (B) “related or possibly related to participation in the
research” – Is the incident, experience, or outcome related or possibly
related to participation in the research (possibly related means there is a
reasonable possibility that the incident, experience, or outcome may have
been caused by the procedures involved in the research)?
Yes, it is related or possibly related. Provide an explanation.
No, it is not related or possibly related. Provide an explanation.

5.

Reviewer Analysis (C) “places subjects or others at greater risk of harm” –
Does the incident, experience, or outcome suggest that the research places
participants or others at a greater risk of harm (including physical,
psychological, economic, or social harm) than was previously known or
recognized?
Yes, there is greater risk of harm. Provide an explanation.
No, there is not a greater risk of harm. Provide an explanation.

6.

Reviewer Determination Regarding Unanticipated Problem
If you have answered Yes to all parts of question one (A, B, or C), the
incident, experience, or outcome is an unanticipated problem.

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If you have answered No to any part of question one (A, B, or C), the
incident, experience, or outcome is not considered an unanticipated
problem.
Reviewer Recommendation regarding Unanticipated Problem
Determination:
Yes, it is an Unanticipated Problem because it meets all three criteria
above.
No, it is not an unanticipated Problem because it does not meet all three
of the criteria above
7.

Additional Considerations - Regardless of whether or not the event
constitutes an unanticipated problem, please consider the following:
Are appropriate steps being taken to notify participants or others affected
by the incident, experience, or outcome of any information that would
impact participants’ willingness to continue in the research?
Yes, describe what steps are being taken.
Not Applicable
No

8.

If No, should participants be notified of this incident, experience or
outcome?
Yes, describe what steps are being taken.
No

Section 2: Serious or Continuing Noncompliance Determination
Background: OHRP and FDA regulations require reporting of serious or
continuing noncompliance (45 CFR 46. 103(b)(5) and 21 CFR 56.108(b)(2)).
9.

The CIRB SOPs define “noncompliance” as a failure to meet the
requirements of Federal regulations pertaining to human subjects
protection and/or the requirements and decisions of the CIRB. Is the
incident, experience, or outcome evidence of noncompliance?
Yes, Explain and complete questions 10 and 11.
No, Explain and go to question 12.

10.

The CIRB SOPs define “serious” noncompliance as noncompliance that
adversely affects the rights and welfare of study participants or results in
any untoward medical occurrence that meets the criteria of “serious” or
significantly impacts the integrity of study data.
Serious is defined as side effects that may require hospitalization or may
be irreversible, long-term, life-threatening, or fatal. The CIRB may also
consider as serious those events which, based on appropriate medical
judgment, may jeopardize the patient or subject and am require medical or

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surgical intervention to prevent one of the outcomes above..
Is the incident, experience, or outcome evidence of serious
noncompliance?
Yes, Explain and complete questions 10 and 11.
No, Explain and go to question 12.
11.

The CIRB SOPs define “continuing” noncompliance as a systematic and
habitual disregard of the requirements of Federal regulations pertaining to
human subjects protection and/or of the requirements or decisions of the
CIRB. Continuing noncompliance is an indication of a pattern that, if
unaddressed, could jeopardize the rights and welfare of research
participants or the integrity of the study data due to noncompliance with
the protocol, Federal regulations, and/or the requirements of the CIRB. Is
this incident, experience, or outcome continuing noncompliance?
Yes, Explain and go to querstion 12.
No, Explain and go to question 12.

12.

Additional Considerations
Regardless of whether or not the event constitutes serious or continuing
noncompliance, please consider:

Are appropriate steps being taken to notify participants or others affected
by the incident, experience, or outcome of any information that would
impact participants’ willingness to continue in the research?
Yes, describe what steps are being taken.
Not Applicable
No, Explain and go to question 12.
13.

If No, should participants be notified of this incident, experience, or
outcome?
Yes, describe what steps should be taken.
No

FINAL NOTE: Per the regulations, the CIRB reports determination of
unanticipated problems and/or serious or continuing noncompliance to OHRP and
FDA.

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