Human Research Protection Program: Policy

Multisite Research Studies

 

Adopted By: All Campus IRB

Adoption Date: November 10, 2005

Revised: April 10, 2008

Revised: December 4, 2008

Purpose:  This document describes how the UW-Madison IRBs manage multisite research studies.

Policy

I.      When UW-Madison engages in federally funded or supported research involving multiple sites, the following applies:

A.  If a non-UW-Madison site has its own FWA and IRB of record, then both UW-Madison’s IRB and the other site’s IRB must review and approve or exempt the research, unless UW-Madison determines that to avoid duplication of effort only one IRB needs to review and approve the research, in which case an IRB Authorization Agreement (IAA) is required between the UW-Madison and the other site’s IRB. See, UW-Madison IRB Authorization Agreement Policy. 

B.  An institution that holds an FWA and that is either a) the primary awardee under a federal grant, contract, or cooperative agreement supporting research to which the FWA applies, or b) the coordinating center for federally-conducted or federally–supported research to which the FWA applies, is responsible for ensuring that all collaborating institutions engaged in such research operate under an appropriate OHRP-approved or other federally-approved assurance for the protection of human subjects.  

C.  Each non-UW-Madison site that routinely engages in federally funded or supported research activities must have its own federalwide assurance (FWA) and an IRB of record.

D.  If a non-UW-Madison site is the primary awardee for a federally funded or supported award providing support for non-exempt human subjects research, the institution is “engaged in human subjects research” and must obtain its own FWA and IRB of record.

E.  For those non-UW-Madison sites that do not routinely engage in federally funded or supported research, the non-UW-Madison site is generally not required to have an FWA and IRB of record.  In this case, each person involved in research activities at that site will be required to enter into an individual or institutional investigator agreement (IIA).  See, UW-Madison Individual/Institutional Investigator Agreement Template and Supplements.

 

For additional information on multisite research, see, OHRP Guidance on Extension of an FWA to Cover Collaborating Individual Investigators

II.     When UW-Madison engages in non-federally funded or supported research involving multiple sites:  

A.  For those non-UW-Madison sites that do not have an IRB, the investigator must obtain a letter of support for the conduct of the research at the site signed by an appropriate official from the site. 

B.  If a non-UW-Madison site does not have its own IRB, then each person involved in research activities at that site will be treated as a collaborating investigator and must receive the Collaborating Investigator Responsibilities Summary at the time they are listed on a UW-Madison protocol.  See, UW-Madison Collaborating Investigator Responsibilities Summary.

III.    All investigators and key personnel listed on a UW-Madison IRB protocol application for multisite research studies involving human subjects, regardless of source of funding, must complete human subjects training as specified in the UW-Madison HRPP Education and Training Policy.

IV.   A UW-Madison IRB may act as IRB of record for a non-UW-Madison research site or defer review of a protocol to another institution’s IRB.

A.  UW-Madison IRB may act as IRB of record for a non-UW-Madison research site if the following conditions are met:

 

1.  The UW-Madison IRB satisfies the OHRP guidelines for knowledge of the local research context [See, http://www.hhs.gov/ohrp/humansubjects/guidance/local.htm].

 

2.  A formal request is made by the non-UW-Madison research site.

 

3.  An IRB Authorization Agreement (IAA) is completed as required by the UW-Madison IRB Authorization Agreement Policy if the other site has its own FWA and IRB of record.

 

4.  For federally funded or supported multisite research studies, Individual or Institutional Investigator Agreements are completed as required by Section I of this policy, if the other site does not have its own FWA and IRB of record.

    

5.  For non-federally funded research, Collaborating Investigator Responsibilities Summaries are given to all collaborating investigators at a site without its own FWA as required by Section II of this policy.

 

6.  The investigator provides an acceptable plan for monitoring activities at and communications amongst other sites and assuring compliance with applicable human subjects regulations.

B.  A UW-Madison IRB may defer review of a protocol to another institution’s IRB if the following conditions are met:

 

1.  A formal request is made by the UW-Madison investigator. 

 

2.  An IRB Authorization Agreement (IAA) is completed as required by the UW-Madison IRB Authorization Agreement Policy. 

C.  Although, in most cases, a UW-Madison IRB will agree to act as IRB of record for a non-UW-Madison institution or defer review of a protocol to another institution’s IRB on a protocol-by-protocol basis only, a UW-Madison IRB may enter into a “blanket” IAA under which it may review all protocols or protocols of a particular kind from a non-UW-Madison institution.

V.    Centralized IRB Review by Commercial or Publicly Funded Sponsor

A.  Documenting Central IRB Review Agreements

 

1.  If UW-Madison, its IRB, and a central IRB agree (under 45 CFR 46.114 & 21 CFR 56.114) to participate in a centralized IRB review process, the parties will enter into an IRB Authorization Agreement (IAA). 

 

a.  The agreement must be signed by the UW-Madison Institutional Official and copies of the IAA will be on file at all institutions involved. 

 

b.  If the agreement apportions IRB review responsibilities between the central IRB and a UW-Madison IRB, the agreement should delineate the specific responsibilities of the central IRB and the UW-Madison IRB for the initial and continuing review of the study.

B.  Written Procedures for Central IRB Review of FDA Regulated Protocols

 

1.  When a UW-Madison IRB relies on review by a central IRB for FDA-regulated protocols, both IRBs must have written procedures in place to implement the centralized IRB review process (21 CFR 56.108, 56.114). The procedures must address the following, when applicable:

 

a.  How the UW-Madison IRB determines that the central IRB is qualified to review research conducted at the institution

 

b.  How the central IRB intends to communicate with relevant institutions, the UW-Madison’s IRBs and investigators regarding its review

 

c.  How the central IRB ensures that it provides meaningful consideration of relevant local factors for communities from which research subjects will be drawn.

 

d.  How the central IRB assesses the ability of a geographically remote site to participate in a study (e.g., whether the site has medical services appropriate to the complexity of the study).

 

e.  If the IAA apportions IRB review responsibilities between the UW-Madison IRB and the central IRB, both the UW-Madison IRB and the central IRB will have written procedures describing how it will implement its responsibilities under the agreement (21 CFR 56.108, 56.115(a)(6)).

Procedure

VI.   IRB Review of Multisite Research Studies

A.  If UW-Madison is the coordinating center of a multisite study, regardless of source of funding, in addition to the documentation generally required for IRB approval of research, the IRB will require documentation from the investigator of the following:

 

1.  A description regarding how the coordinating center will ensure for each site that any required IRB approval is in place before the initiation of research involving human subjects, l .

 

2.  A copy of individual or institutional investigator agreements, if required.

 

3.  A copy of the Collaborating Investigator Responsibilities Summary, if required.

 

4.  A copy of the letter of support from those sites without their own IRBs, if applicable

 

5.  A description of the reporting obligations of the sites:

 

a.  What events need to be reported e.g., unanticipated problems, adverse events, noncompliance or new research findings.

 

b.  When the reports must be made

 

c.  How to make the reports

 

d.  To whom reports should be made

 

6.  Verification that investigators and key personnel listed on each UW-Madison protocol application have completed human subjects training.

B.  If UW-Madison is a participating site rather than a coordinating center of multisite research, regardless of source of funding, in addition to the documentation generally required for IRB approval of research, the UW-Madison IRB will require:

 

1.  Language in the research protocol stating that IRB approval will be obtained from all research sites 

 

2.  The coordinating center to disseminate information regarding reportable events and to describe what will get reported, when, how and who makes reports and to whom reports should be made.

C.  If UW-Madison is a “reading center” or statistical analysis center for clinical trials, regardless of source of funding, the Health Sciences IRB or Health Sciences Minimal Risk IRB will get confirmation from the coordinating center of IRB approval from each site that will be sending material or data to be “read” or analyzed by UW-Madison and a copy of the consent/authorization form used to collect the data or material.

D.  If the Social and Behavioral Sciences IRB or Education Research IRB reviews a protocol involving analysis of data collected at another site, regardless of source of funding, the IRB will require a copy of the IRB approval from the institution where the data was collected.