13.1 Communication among IRBs in Multi-Site Research

Section revised: 3/13/13††

The IRB is responsible for the review of all STANFORD research that involves human research participants, whether the research is conducted at Stanford University, a STANFORD affiliate institution or another site outside STANFORD.

When Stanford is conducting research at an external site (e.g., nursing home, school) and is not the coordinating site or lead investigator, and that site is engaged in research, the IRB requires contact information for the coordinating/lead site, whether the site has an IRB, and if so, confirmation of the IRBís permission to conduct the research.

STANFORDís IRB relies on the IRBs of other sites and also agrees to have other sites rely on Stanfordís IRB on occasion.Presently, the Stanford IRB relies on the National Cancer Instituteís IRBs (CIRB).Stanford University FWAs include the Adult and Pediatric CIRBs as the IRB of Record for eligible Oncology Group protocols.

If Stanford agrees to serve as the IRB of Record for an external site, that site obtains an FWA through OHRP which subsequently cites Stanfordís IRB registration number.OHRP notifies Stanford of this addition.An IRB Authorization Agreement is signed by the institutional officials of Stanford and the external site, authorizing Stanford to serve as IRB of Record for that site.

STANFORD Serving as Participating Institution

When STANFORD is a participating institution (sending data or tissue samples out of STANFORD) the PD must submit data in a timely manner to the coordinating institution, report unanticipated problems (UPs) and other reportable events in a timely manner to the coordinating institution and the Stanford University IRB, and ensure that the PDís study team has the current approved version of the protocol and consent form.

The IRB Role in the Central IRB (CIRB) Initiative

STANFORD ensures that the Human Research Protection Program has resources sufficient to protect the rights and welfare of research participants for the research activities that STANFORD conducts or oversees.(AAHRPP Standard I-2)

The CIRB Initiative is sponsored by the National Cancer Institute in consultation with the Department of Health and Human Services Office for Human Research Protections (OHRP).The Stanford University IRB functions as a liaison between the CIRB and the investigators, and as a resource to investigators when needed.

Stanford is participating in the pilot independent CIRB model. The IRB completes the Annual Institutional Worksheet which apprises the CIRBs of local context, includes required informed consent template language, applicable local and State regulations, and Stanford policies.Investigators submit an Annual Investigator Worksheet for each investigator, and a Study-specific Worksheet for each study in which they wish to enroll participants directly to the CIRB. The CIRB is responsible for continuing review, review of subsequent modifications, non-compliance, and unanticipated problems. CIRB copies the IRB on notices when studies are initiated or closed.Investigators copy the Stanford IRB on reports of local non-compliance, and unanticipated problems, and report these directly to CIRB on forms designed for this purpose.

VA protocols are not involved in this initiative.

13.2††† Information Management in Multi-Site Research

Section revised: 3/13/13††

The IRB has and follows policies and procedures for managing multisite research by defining the responsibilities of participating sites that are relevant to the protection of research participants, such as reporting of unanticipated problems or interim results.(AAHRPP Element II.2.H)

STANFORD Serving as Coordinating Institution

When STANFORD is serving as the coordinating institution, the PD must describe the plans for communicating information relevant to the protection of participants among the participating sites and institutions as part of the Protocol Application, including communications of adverse outcomes, UPs, protocol modifications, and interim results.

When completing the Protocol Application, PDs must indicate if STANFORD is serving as the coordinating institution.The PD must list all other sites involved with the proposed research, the contact person at each site and contact information, such as phone number and email address.The PD must indicate if each participating site has an IRB and if that IRB has reviewed and approved the research.

When STANFORD is the coordinating institution receiving data or tissue samples from other sites the PD must submit the following documentation for each of the other participating sites along with the Protocol Application to the IRB before receiving any data or tissue samples from a site:

       IRB approval letter from each participating site that includes the type of review, the other institutionís FWA information, and

       When appropriate, the consent forms from all participating sites.

The Stanford University IRB will keep this information on file for all internal and external reviews.

By submitting the protocol application form, the PD documents his/her acceptance of the responsibility of ensuring that all participating sites have obtained IRB approval prior to initiation of the research at that site.The participating sites must have written procedures that define the scope of studies subject to review by their IRB.The Stanford University IRB staff will review and confirm that each protocol application for a STANFORD coordinating site project includes the appropriate documentation from all participating institutions.

If a participating site does not have an IRB, that site may request that the Stanford University IRB serve as the IRB of Record.A written agreement must be reached between the participating site and the Stanford University IRB which clearly outlines the review and approval procedures.This written agreement must be reviewed, approved and signed by the Institutional Official.(STANFORD generally reserves this option for studies that involve a Small Business Innovation Research (SBIR) grant).

For a prospective clinical trial, the consent forms used at all sites must indicate that data or samples are being sent to STANFORD.Data or tissue samples, even though they are anonymous, may not be received from an outside institution whose consent form prohibits data or tissue from going outside the institution.

There must be documentation of regular communication (e.g., teleconferences) with the participating sites to update and inform all participating sites about progress of the study.

Reporting to the IRBs in Multi-Site Research

As the lead investigator at the coordinating institution, the PD is responsible for receiving data and reports from the outside sites in a timely manner and distributing them to the Stanford University IRB as required - see Chapter 3.10.Stanford IRBs give the same considerations to such reports in multi-site research as they do to internal reports.

Identifying Material Changes in Multi-Site Protocols

The PD must report any material changes in the protocol that take place at any of the participating research sites.The IRB may require independent verification to ensure that no material changes have occurred in multi-site research or cooperative study protocols since the previous IRB review.

Additional Requirements

VA Multi-Site Research: Refer to VHA Handbooks 1200.05 and 1200.01) for local approvals required.

Other Federal Agencies: Additional requirements might apply, (such as a formal agreement to specify the roles and responsibilities of each party), depending on the source of support/funding (e.g., Department of Defense, Department of the Navy). See Other Federal Agencies - Additional Requirements [GUI-42].