IRB Policy Updates, “Purpose and Scope”, “Administrative Hold, Suspension or Termination of IRB Approval” and “Board Meetings and Administrative Policies”
Tuesday, December 29, 2009 (110 reads)
The following IRB policies have been revised to add minor administrative clarifications.
- IRB Policy, “Purpose and Scope”: page 2 of this policy has been revised to clarify that anyone who plans to engage in an activity that qualifies as “research involving human subjects” requires Institutional Review Board (IRB) review and approval prior to commencement of the research.
- IRB Policy, “Administrative Hold, Suspension, or Termination of IRB Approval”: pages 1 and 2 of this policy have been revised to clarify that the investigator may be asked to submit a report of any adverse events and/or outcome events to the IRB if the IRB suspends or terminates an IRB approved research protocol.
- IRB Policy, “Board Meetings and Administrative Policies”:
- page 9 of this policy has been revised to clarify that when a request for waiver of consent for Emergency Research is made, the research activities must be conducted in accordance with FDA regulation 21 CFR 50 and will be carried out under an FDA investigational new drug application (IND) or an FDA investigational device exemption (IDE)
- Page 11 was revised to add the word “not” to the header of the following section, “Requirements for Emergency Research Subject to not FDA regulation.”
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