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OHRP Guidance – Reporting Incidents to OHRP

Office for Human Research Protections (OHRP)

Department of Health and Human Services (HHS)

Guidance on Reporting Incidents to OHRP

Date: May 27, 2005

Scope:
This document provides guidance about procedures institutions may use to file incident reports with OHRP. Incident reports include reports of unanticipated problems involving risks to subjects or others; serious or continuing noncompliance with Department of Health and Human Services (HHS) regulations at 45 CFR part 46 or the requirements or determinations of the institutional review board (IRB); and suspension or termination of IRB approval. In particular, OHRP offers guidance on the following topics:
I. Applicability of incident reporting requirements;

II. Information to be included in incident reports;

III. Time frame for reporting incidents;

IV. OHRP focus on corrective actions when reviewing incident reports;

V. OHRP's response to incident reports; and

VI. Additional guidance.
Target Audience:
IRBs, institutional officials, and institutions that may be responsible for review, oversight, or conduct of human subjects research covered by an OHRP-approved assurance.
Regulatory Background:
HHS regulations at 45 CFR 46.103(a) and (b)(5) require that institutions have written procedures to ensure that the following incidents related to research conducted under an OHRP- approved assurance are promptly reported to OHRP:
a. Any unanticipated problems involving risks to subjects or others;

b. Any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and

c. Any suspension or termination of IRB approval.

Guidance:

I. Applicability of incident reporting requirements

In general, these reporting requirements apply to all nonexempt human subjects research that is:
(a) conducted or supported by HHS;

(b) conducted or supported by any non-HHS federal department or agency that has adopted the Common Rule and is covered by a Federalwide Assurance (FWA) determined to be appropriate for such research; or

(c) covered by an FWA, regardless of funding source.
Federal departments or agencies other than HHS that have adopted the Common Rule may determine that the FWA is not appropriate for certain research that they conduct or support. OHRP notes that these incident reporting requirements are not applicable to such research. In such cases, the institution should contact the non-HHS department or agency that supports the research about reporting requirements. See decision chart below.
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