Procedure - Completes the FOR200 Human Subjects Protocol (HSP) at the time of initial review, convened or expedited, indicating that the research will be conducted at multiple performance sites, and provides a thorough and clear description of the type of activities to be conducted at each site or the reviewing IRB forms if relying on an external IRB;
- Provides protocol materials and sufficient local context information from any relying sites that needs to be considered during IRB review;
- Provides a description of reporting requirements for other performance sites (e.g., revisions/amendments, serious adverse events);
- Provides information regarding whether the performance site(s) have an IRB;
- Submits copies of the IRB approval(s) from other site, if applicable and when available;
- Indicates that (s)he is the investigator for a coordinating center for a multi-center study, and includes in the HSP a description of the following:
- How human subjects approvals will be obtained or supplied by other sites prior to initiation of the project at the site;
- How the human subjects approvals (both initial and continuing) will be maintained;
- The mechanisms/agreements that describe reporting requirements for amendments/revisions, serious adverse event reporting, etc.
- Indicates in the IPR, at time of continuing review, that (s)he is collecting and maintaining continuing IRB approval for all sites.
Reviewing Staff:
- Reviews applications to the IRB to determine if the research is being conducted at other sites.
- Makes preliminary determination if the other site(s) is “engaged in research” based on OHRP guidance.
- Refers to Institutional Official when requesting opinions from OHRP regarding “engagement in research”.
- Determines if the other site engaged in research has an IRB with a Federalwide Assurance (FWA) and documents IRB approval.
- Communicates and determines with the local PI, performance site PI, and IRB, the best review arrangement for the other site engaged in research if other institution does not have a FWA. This may include:
- Joint review, if not NIH funded or governed by the Common Rule
- Reliance upon the review of another qualified IRB or similar arrangement aimed at avoiding duplication of efforts.
Note: These types of review arrangements must be in writing, define the roles of the reviewing and relying organization, and must define the scope of studies subject to review by the IRB. The preference of UAB will be to utilize the provisions of the SMART IRB agreement, whenever possible. - Forwards appropriate review agreement documents to UAB Institutional Official for signature, as required.
- Ensures when a UAB investigator serves as the PI of a coordinating center that the HSP addresses how initial and continuing IRB approvals are collected and maintained from other sites.
- Inspects protocol records to ensure that before initial approval is issued, all collaborating sites have provided current IRB approval of the protocol. If approvals have not been collected from all collaborating sites, only approval for those sites in which IRB approval is documented will be issued. Approvals for additional sites will be issued as local IRB approval is received by the OIRB through the revision/amendment process (see PRO148 Procedure for Review of Modifications to Previously Approved Research by the Convened IRB).
- Reviews the Investigator’s Progress Report (FOR225) at time of continuing review to insure the investigator has noted that (s)he is collecting and maintaining IRB approvals from other sites.
- Maintains documentation of agreements with other sites in the electronic system.
- Provides copies of agreements with other sites to the site and to the PI.
IRB:
- Reviews and approves reliance agreements if satisfied that human subjects protections afforded under the agreement will be appropriate and adequate.
- Reviews amendment submissions concerning addition of other sites using the convened or expedited IRB procedures, as appropriate.
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