Monday, June 13, 2005
This just in from the Teaching Hospitals and Academic Medical Centers Practice Group of the AHLA:
The Office for Human Research Protection (OHRP) has issued two press releases this morning. The first addresses reporting of adverse incidents:
(June 13, 2005) - Guidance on Reporting Incidents to OHRP
The Office for Human Research Protections (OHRP) has issued guidance on 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: (1) Applicability of incident reporting requirements; (2) information to be included in incident reports; (3) time frame for reporting incidents; (4) OHRP focus on corrective actions when reviewing incident reports; and (5) OHRP's response to incident reports. Access the guidance in HTML format or PDF format.
The second addresses review of protocols involving children:
(June 13, 2005) - Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 (407) Review Process
The Office for Human Research Protections (OHRP) has issued guidance on the HHS 45 CFR 46.407 review process required under subpart D of the HHS Protection of Human Subjects Regulations at 45 CFR part 46. In particular, OHRP offers guidance on the following topics: (1) IRB findings necessary to submit a protocol to OHRP for 407 consideration and/or review; (2) steps in the submission process; (3) OHRP's response to submissions; (4) the schedule and details for 407 panel review; and
(5) potential outcomes of the 407 review process. Access the guidance, which applies to HHS-conducted or -supported research, in HTML format or PDF format.