IRB Evaluation of Unanticipated Problems UPsInvolving Risk in Research: Reporting Forms and WPP

1. IRB Evaluation of Unanticipated Problems (UPs)Involving Risk in Research: Reporting Forms and WPP New reporting forms and WPP 1/08 Prompt reporting Non-prompt reporting

2. What is an unanticipated problem (UP) involving risk to subjects or others? A UP is an event or problem occurring during the research that: is not anticipated or foreseen, i.e. not described in the consent form. involves risk or harm to a research participant or others AND is probably or definitely related to, or caused by, the research. All 3 criteria must apply!

3. The background - Federal regulations at 45CFR46.103 require: �Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of (i) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements of the IRB and (ii) any suspension or termination of IRB approval.�

4. The background � Ethical imperative to keep IRB informed of UPs Prompt reports to the IRB of �unanticipated problems involving risk to subjects or others� facilitate objective assessment of 1) risk or harm and 2) further action needed to protect current and future participants.

5. AAHRPP (accreditation organization) requires a mechanism for PIs to initiate prompt reporting to the IRB. 2 reporting forms are now on the IRB Forms page at http://www.research.vcu.edu/forms/vcuirb.htm: 1) �Prompt reporting form for unanticipated problems involving risk or harm to subjects or others� 2) �Non-prompt reporting form� Recognizes that the PI may need, or want, to report other occurrences to the IRB that do not rise to the level of �unanticipated problems.� These reports are not required by the IRB.

6. Problems in research which meet the 3 criteria for a UP must be promptly reported to the IRB. Use the �VCU IRB Prompt Reporting Form for Unanticipated Problems� Find this form under IRB Forms on the website Indicate the type of Unanticipated Problem (UP) from the menu of options. Both �internal� and �external� settings must be reported if the event meets the UP definition Report the UP to the IRB within 5 business days of occurrence or notification of the problem (provide 20 copies of form and other documents)

7. Differences in the old and new form for the reporting of Unanticipated Problems: OLD FORM Title: VCU IRB Reporting Form for UPs Designate serious, non-serious, or sponsor-required reporting No menu options given NEW FORM Title: VCU IRB Prompt Reporting Form for UPs For reporting an occurrence that meets UP criteria only - (see Non-Prompt Reporting Form for non-UPs at Slide #9) Menu of events that may be considered UPs

8. Differences in old and new forms for the reporting of Unanticipated Problems: OLD FORM Give name of PI or authorized designee NEW FORM UP menu options include: - an adverse event meeting the definition of UP; - an increase in severity or frequency of an anticipated occurrence; - a protocol deviation or violation; - a breach of privacy or confidentiality; - an unresolvable subject complaint To be reviewed and signed by PI. If PI is unavailable, explain why and who has reviewed the UP.

9. Anticipated problems should not be ignored! It is the responsibility of the PI to monitor ALL PROBLEMS that involve risk to research participants or others, both unanticipated and anticipated. Maintain a log of anticipated problems, participant questions and complaints, as well as other issues that arise within the conduct of the research that do not rise to the level of unanticipated problems requiring prompt reporting to the IRB. Anticipated problems that increase in frequency or severity may become unanticipated problems that require prompt reporting.

10. What is the new Non-Prompt Reporting Form? Allows a mechanism for sponsor-required reports to be submitted to the IRB in individual or bundled form � these are only acknowledged, not reviewed Allows a PI to report an �Other� event to the IRB as an FYI or for IRB assessment An �Other� event is reviewed by expedited review or it may be referred for full board review �Non-prompt reporting� is not required by the IRB. Provide 4 copies of the form and supporting information

11. IRB PolicyWPP #VIII-7Required Reporting of Unanticipated Problems Involving Risk or Harm to Subjects or Others  This WPP describes routing for review and the IRB determination process of a potential unanticipated problem involving risk to subjects or others; located at: http://www.research.vcu.edu/irb/wpp/flash/wpp_guide.htm#VIII-7.htm

12. A summary of how the IRB handles the UP report: The UP report is reviewed by the IRB Chair and/or designee. If it appears to comprise an �unanticipated problem� according to the definition, it must be referred to the full board, even if not initially a full board study. If determined by the convened panel to be a UP, it must be reported to OHRP, FDA, and relevant sponsor(s). If the UP involves a Protocol Deviation or Violation, the Panel must consider an additional determination of serious or continuing noncompliance, which is also reportable. WIRB utilizes different reporting forms than VCU. The determination by WIRB of an �unanticipated problem involving risk to subjects or others,� or serious or continuing noncompliance, is reported to VCU. VCU coordinates with WIRB on the reporting of such determinations to regulatory agencies and sponsors.

13. Review: Use the PROMPT Reporting Form to report an occurrence that meets all 3 criteria of an unanticipated problem involving risk to subjects or others: occurring during the research and is not anticipated or foreseen, i.e. not described in the consent form. involving risk or harm to a research participant or others AND probably or definitely related to, or caused by, the research.