Procedure for Communication Among IRBs - IRB PRO118

Procedure for Communication Among IRBs - IRB PRO118

Abstract:
This procedure lists responsibilities of the investigator, ORIB and IRB for communication among IRBs.
Effective Date:
12/10/2014
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

 
 
HRPP Document:     PRO118
Effective Date:   3/30/07
Revision Date:  11/7/14
Subject:  Procedure for Communication Among IRBs


PROCEDURE

Investigator Responsibilities 

The Investigator:

  • 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;
  • 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.

OIRB Responsibilities

The Review Staff:

  • Reviews initial, continuing, and modification applications to the IRB to determine if the research is being conducted at other performance sites;
  • Makes preliminary determination if the other site(s) is “engaged in research” based on OHRP guidance;
  • Refers to the OIRB Director when requesting opinions from OHRP regarding “engagement in research”;
  • Determines if the other site that is engaged in research has an IRB with a Federalwide Assurance (FWA) and, if so, checks for documentation of 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;
    • 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 and must define the scope of studies subject to review by the IRB.

  • Forwards appropriate review agreement documents to OIRB Director and 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 file to ensure that before the initial approval form 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 on file 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 IPR at time of continuing review to insure that the investigator has noted that (s)he is collecting and maintaining IRB approvals from other sites.

The Review Staff:

  • Communicates the request to the OIRB Director or IRB Chair;
  • Requests copy of the relying institutions' Federal Wide Assurance for the file;
  • Creates the agreement to be sent to the relying site for review and signature;
  • Sends to the Institutional Official for signature;
  • Distributes the executed agreement to the PI;
  • Files agreement with the other site.

IRB Responsibilities

The 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.

Approved on December 10, 2014, by:

Ferdinand Urthaler, MD
IRB Chair

Jonathan Miller, MPPA, CIP
OIRB Director