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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; 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; 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; 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. II. Information to be included in incident reports To fulfill the regulatory requirements for reporting incidents, OHRP would consider it acceptable for an institution to comply with written procedures specifying that the following information be included in an incident report submitted to OHRP: A. For unanticipated problems involving risks to subjects or others:
B. For serious or continuing noncompliance:
C. For suspension or termination:
III. Time frame for reporting incidents The regulations at 45 CFR 46.103(a) and (b)(5) do not specify a time frame for reporting, except "promptly." For a more serious incident, this may mean reporting to OHRP within days. For a less serious incident, a few weeks may be sufficient. It may be appropriate to send an initial report, and indicate that a follow-up or final report will follow by the earlier of:
IV. OHRP focus on corrective actions when reviewing incident reports When reviewing a report of an unanticipated problem, OHRP assesses most closely the adequacy of the actions taken by the institution to address the problem. Likewise, when reviewing reports of non-compliance or suspension or termination of IRB approval, OHRP assesses most closely the adequacy of the corrective actions taken by the institution. In particular, OHRP assesses whether or not the corrective actions will help ensure that the incident will not happen again, either with the investigator or protocol in question, or with any other investigator or protocol. Therefore, OHRP recommends that, when appropriate, corrective actions be applied institution-wide. V. OHRP response to incident reports After receiving and evaluating an incident report from an institution, OHRP will respond in writing and state that the report was adequate or request additional information. For questions on reporting, please contact the Director of the Division of Compliance Oversight, 301-496-7005 or 866- 447-4777. VI. Additional guidance Please see OHRP guidance on continuing review regarding the distinction between suspension and expiration of IRB approval (http://www.dhhs.gov/ohrp/humansubjects/guidance/contrev2002.htm). |
Last revised: May 27, 2005