II.07

Information Required to be Submitted to the CPHS for Continuing Review of Research

Objective

The Committee for the Protection of Human Subjects (CPHS) conducts continuing reviews of research at intervals appropriate to the degree of risk, but not less than once per year. This procedure describes the information to be provided to the CPHS in order to determine whether the proposed research continues to fulfill the criteria for approval.

Policy/Procedure

For a continuing review, the PI must complete the Continuing Review Submission form via the iRIS system.

I. For those requiring full review, the following information must be submitted or available in iRIS.

A. An updated, current full protocol, if not currently on file with the Office of Research Support Committees (ORSC).

B. A protocol summary containing relevant information to determine whether the proposed research continues to fulfill the criteria for approval.

C. Status report on the progress of the research that includes the following.

1. Number of participants accrued

2. Summary of adverse events and any unanticipated problems involving risks to participants or others since the last IRB review

a) The CPHS may rely on a current statement from the data and safety monitoring board or sponsor indicating that it has reviewed study-wide adverse events, in lieu of requiring that this information be submitted directly to the CPHS

b) Local, on-site adverse events must still be received and reviewed individually

3. Number of subjects withdrawn and a summary of the applicable reasons since the last CPHS review

4. Any complaints about the research since the last CPHS review

5. Any relevant recent literature since the last CPHS review

a) The CPHS may rely on a current statement from the data safety monitoring board (DSMB) indicating that it has reviewed any recent literature that may be relevant to the research, in lieu of requiring that this information be submitted directly to the CPHS.

6. Any interim findings since the last CPHS review

a) The CPHS may rely on a current statement from the DSMB indicating that it has reviewed interim findings, in lieu of requiring that this information be submitted directly to the CPHS.

7. Summary of amendments or modifications since the last review

8. Any relevant multi-center trial reports

9. Any other relevant information, especially information about risks associated with the research

10. A copy of the approved consent is either submitted or available in iRIS.

11. A summary of participant benefits

12. A current risk-benefit assessment based on study results

13. A summary of the progress of the research since the last CPHS review

14. A new HIPAA Authorization form (if not incorporated into the informed consent document)

Applicable Regulations and Guidelines

21CFR 50 (http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr50_04.html )

21CFR 56(http://www.access.gpo.gov/nara/cfr/waisidx_04/21cfr56_04.html )

38CFR 16 (http://www.access.gpo.gov/nara/cfr/waisidx_04/38cfr16_04.html )

45CFR 46 http://www.access.gpo.gov/nara/cfr/waisidx_04/45cfr46_04.html )

ICH E6 (http://www.ich.org/MediaServer.jser?@_ID=482&@_MODE=GLB )

AAHRPP Evaluation Instrument For Site Visitors (http://www.aahrpp.org/Documents/D000043.PDF )

OHRP Guidance on Continuing Review (http://www.hhs.gov/ohrp/humansubjects/guidance/contrev2002.htm#REGULATORY%20REQUIREMENTS

FDA Information Sheets: Continuing Review After Study Approval (http://www.fda.gov/oc/ohrt/irbs/review.html )

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Updated 10/2007, Report broken links