Form 6L Determination of Unanticipated Problem (UP) and/or Serio

N CI CIRB

REVIEWER WORKSHEET

Determination of Unanticipated Problem and/or Serious or Continuing Noncompliance

OMB#: 0925 – 0625

Expiry Date: 01/31/2014

Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of your participation in the National Cancer Institute (NCI) Central Institutional Review Board (CIRB) Initiative is protected by The Privacy Act of 1974, as amended. The purpose of the information collection is to conduct reviews of clinical trial studies. Although your participation in NCI-sponsored research and completion of the forms is voluntary, if you wish to participate in the CIRB, you must complete all questions on the form. The information you provide will be combined for all participants and reported as summaries. It will be kept private to the extent provided by law.

NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN

Public reporting burden for this collection of information is estimated to average 10 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 (0925-0625). 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

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.

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. Reviewer Analysis – 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. 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. Reviewer Analysis – 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. Is this incident, experience, or outcome continuing noncompliance?

Yes, Explain and go to question 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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