IV.15

Review of Unanticipated Problems Involving Risks to Research Participants or Others

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Objective

Unanticipated problems involving risks to research participants or others refer to untoward events involving any aspect of a research study, and they may involve a variety of constituents that include participants, research staff, or others not directly involved in the research. Unanticipated problems must be promptly reported to the CPHS, appropriate institutional officials, and appropriate Department or Agency heads. This Procedure describes the process by which CPHS members review reports of unanticipated problems involving risks to research participants or others.

Policy/Procedure

I. The following requires reporting to the CPHS (via the iRIS system) within 10 working days of the principal investigator’s (PI) knowledge of the occurrence of death, unexpected and serious adverse events, related to the conduct of the research, and unanticipated problems involving risk to participants or others:

A. Any event (including on-site and off-site adverse events, injuries, side effects , deaths or other serious problems) that in the PI’s opinion was unanticipated, involved risk to participants or others and was related to the research procedures;

B. Any event that requires prompt reporting according to the protocol or the sponsor;

C. Any accidental or unintentional change to the CPHS-approved protocol that resulted in risks or has the potential to recur;

D. Any deviation from the CPHS-approved protocol taken without prior CPHS review to eliminate any immediate hazard to a research participant

E. Any publication in the literature, safety monitoring report, interim result, or other finding that indicates an unexpected change to the risks or potential benefits of the research;

F. Any complaint of a participant that indicates an unanticipated risk or which cannot be resolved by the research staff;

G. A breech in confidentiality that may involve risk to that individual or others;

H. Incarceration of a participant;

I. Any other event that, in the opinion of the PI, constitutes an unanticipated risk.

II. Reports that meet the criteria above shall be reviewed by a member of the CPHS.

A. The reports are provided to the CPHS member within 3 working days of receipt in the ORSC, via the iRIS system. All CPHS related documents are available in Documentum or iRIS should the reviewer require more information

B. The reviewer shall evaluate the report and determine one of the following outcomes:

1. No further action required

2. PI is to submit further report – requested information will be specified

3. Revisions to the informed consent form are necessary – requested revision will be specified and may involve re-consenting of participants already enrolled.

4. Revisions to the protocol are necessary – requested revision will be specified.

5. Suspension of the protocol upon notification to and agreement of the Executive Chairperson.

6. Termination of the protocol by the CPHS.

C. Depending on the severity of the event, the reviewer may ask that the report be presented at the next full committee meeting for discussion and further decision.

D. Depending on the severity, the CPHS may require the PI to notify subjects of unanticipated problems. This may be required to be in the form of a letter sent to all subjects and/or as part of a revised informed consent form to be signed by returning participants.

E. The CPHS may require more active monitoring of a research study, depending on the perceived risk of the research

F. All correspondence and decisions will be communicated/documented via iRIS and may in addition be transmitted verbally or in writing.

III. Events must also be reported to the appropriate authorities as HRP PP I.05.

Applicable Regulations and Guidelines

21CFR 56, 45CFR 46, ICH 6, AAHRPP Accreditation Standards

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