Last Modified: 18 Apr 2011 Overview The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review. All categories of research review involve the same steps; however, not all research proposals will demand the same level of ethical oversight and scrutiny. The type of review a project receives depends upon the (1) risks to potential subjects and (2) involvement of 'vulnerable populations'. Federal regulations define only 'minimal risk' (46.102(i): 'that the probability and magnitude of harm or discomfort anticipated in the research are no greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.' This definition of minimal risk serves as the benchmark to determine whether proposed studies are eligible for an abbreviated or require the full review. There are three levels of review: exempt, expedited, and full. Once approved, a proposal may be amended, but subsequent review is required. Continuing review is also required during the course of the research. Research Review Types and Time Required by the FSRG IRB 1. Exempt review, where only the chairman reviews the research protocol and any accompanying documents, takes place when there are essentially no ethical considerations. • This type of review will be conducted within 24-36 hours. 2. Expedited review, involving the chairman and one or two other members, is carried out when there is no more than minimal risk to research subjects. • This type of review will be conducted within 48 hours. 3. Full review is required for all research proposals involving more than minimal risk or serious ethical questions (as relating to 'special groups' in the example above). • This type of review will be conducted within 7 days. 4. Continuing review takes place at least yearly, after the initial approval. • The type and frequency of continuing review afforded the PI is determined at the time of initial research approval. Generally, the same guidelines apply to continuing reviews as do initial reviews with respect to risk, populations involved, PI notification, and fillings. Form Use and Submission Requirements Initial Human Subjects Study Application Packet: • Study Protocol (HS-01) • Informed Consent (HS-02) • Informed Assent (HS-03) • Initial Human Subjects Study Application (HS-04) [Submit with cover letter.] • Authorisation Waiver to Access, Use and Disclose PHI (HS-06) • Research Team Roster (UNI-01) • Conflict of Interest Disclosure Statement (UNI-02) [Submit with cover letter.] • Any other documents, such as advertisements. Initial Animal Subjects Study Application Packet: • Study Protocol (AS-01) • Initial Animal Subjects Study Application (AS-02) [Submit with cover letter.] • Research Team Roster (UNI-01) • Conflict of Interest Disclosure Statement (UNI-02) [Submit with cover letter.] • Any other documents, such as drug information. Study Modification Packet: • Any affected documents or forms, with highlighted and clean copies. • Study Modification (UNI-04) [Submit with cover letter.] • Modification Log (UNI-05) • Serious Adverse Event Log (UNI-06) Continuing Review Application Packet: • Continuing Review (UNI-03) [Submit with cover letter.] • Modification Log (UNI-05) • Serious Adverse Event Log (UNI-06) Study Closure Packet: • Study Closure (UNI-07) [Submit with cover letter.] • Modification Log (UNI-05) • Serious Adverse Event Log (UNI-06) Serious Adverse Event (SAE) Packet: • Serious Adverse Event (HS-05) [Submit with cover letter.] • Modification Log (UNI-05) • Serious Adverse Event Log (UNI-06) |
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