DEPARTMENT: Clinical Services Group - Research / POLICY DESCRIPTION: Use of Non- Local, Cooperative and Multi-Institutional IRBs
PAGE: 1 of 3 / REPLACES POLICY DATED: 1/1/03, 4/14/03, 6/30/05
EFFECTIVE DATE: March 1, 2008 / REFERENCE NUMBER:CSG.RES.006 (formerly QM.RES.006)
APPROVED BY: Ethics and Compliance Policy Committee
SCOPE: All Company-affiliated facilities engaged in human subject research with or without an Institutional Review Board (IRB).
PURPOSE: To provide guidance for facilities engaged in human subject research when utilizing a non-local, multi-institutional or cooperative IRB.
POLICY:
The definitions in the IRB Guidance Policy, CSG.RES.001, apply to this and all other Company and facility IRB and human subject research policies.
All Company-affiliated facilities engaged in human subject research must be affiliated with one of the following:
  1. its own (institutional) IRB, or
  2. at least one external IRB, which could be:
  3. a non-local IRB;
  4. a multi-institutional IRB; or
  5. a cooperative IRB.
An IRB that is external to the institution will be required to have an IRB Authorization Agreement (IRB Agreement) and a Business Associate Agreement (BAA) (unless one is not necessary under HIPAA) with the institution’s governing body outlining its role and responsibilities to protect the rights of human subjects engaged in research and to maintain compliance with all Federal regulations and any applicable State and local laws where they exist. IRBs with existing national or boilerplate agreements can be located on the company intranet.
The institution remains responsible for maintaining an institutional system to protect human subjects in all research in which the institution engages and for ensuring such research is conducted within the parameters of the IRB and federal, state and local laws regardless of the type of IRB utilized. The institution must implement monitoring of the consent process and patient outcomes, including adverse events.
All IRBs retain the responsibility for initial and continuing study review. Therefore, a clear process for timely and accurate exchange of information should be agreed upon between the institution, investigator, and the IRB must be defined in policy and the IRB Agreement. An external IRB will usually develop its own SOPs that may deviate from the facility’s own IRB. This is acceptable as long as 1) the policies meet or exceed federal, state and local laws and 2) any additional requirements the facility may desire are detailed in the written agreement with that IRB.
A facility may use more than one type of IRB.
PROCEDURE:
Non-Local IRB
Research may be reviewed by an IRB not located where the research is being performed – i.e., by a non-local IRB. In such situations, the non-local IRB assumes the responsibility for the oversight and continuing review, and the principal investigator (PI) and the facility are responsible for the conduct of the study.
With the use of outside non-local IRBs, a written IRB Agreement must be in place and must include the following:
  1. The role and responsibilities of the non-local IRB;
  2. An agreement that the entities will comply with relevant federal regulations;
  3. A written agreement between the performance site where the research is to be conducted and the non-local IRB or its institution;
  4. Language confirming the IRB’s responsibility for the oversight of the research; and
  5. The non-local IRB must copy the facility’s designee on all correspondence to the Investigator, specifically letters documenting initial review with dates of approval, continuing review with dates of approval, issues requiring corrective action plans and investigator non-compliance.
Non-local IRBs are held to the same requirements as an institutional IRB. Therefore, they must have adequate knowledge of the community attitudes, information on conditions surrounding the conduct of research and the continuing status of the research to assure compliance with relevant regulations.
Knowledge by the non-local IRB of the community from which subjects are drawn is very important. This assists in safeguarding the rights and welfare of the subjects and that the consent process is appropriate for the subject population of the local community. The IRB should also be sensitive to the local community attitudes and laws regarding research. The capabilities of a non-local IRB to fulfill this requirement must be carefully considered by the institution prior to entering into an IRB Agreement with of this type of an IRB. Non-local IRB meeting documentation should clearly state how community attitudes were obtained and that they were considered with each review, initial and continuing.
Cooperative Research
A single IRB may provide review for several participating institutions. The respective responsibilities of the IRB and institution should be agreed upon in writing by each party. The responsibilities may vary from institution to institution depending on the scope and capabilities of each entity.
Multi-Institutional IRB
Facilities may cooperate to form a multi-institutional IRB that serves a community, hospital system or county and oversees research in all HCA-ownedfacilities party to the IRB Agreement. This IRB carries out the IRB responsibilities for all HCA-owned institutions and eliminates the individual facilities from having to maintain their own IRBs. The multi-institutional IRB must follow all regulations and requirements that a single-institution IRB would have to follow.
Each institution that participates in a multi-institutional IRB must have a written IRB Agreement with the multi-institutional IRB.
Federally Supported Research and IRB Agreements
IRB Agreements that involve DHHS-supported studies may be subject to DHHS approval through OHRP. Copies of the agreements must be forwarded to all parties to ensure compliance with regulations.
REFERENCES:
FDA
Community attitudes, 21 CFR 56.107
Community setting and vulnerable subjects, 21 CFR 56.111(a)(b)
Cooperative research, 21 CFR 56.114
DHHS
IRB membership and community attitudes, 45 CFR 46.107 (a)
Cooperative research and institutions responsibilities, 45 CFR 46.114
FDA Guidance for Non-Local and Cooperative IRBs
VA-ORCA Best Practice Guidelines
NCQA Accreditation Standards

Policies

IRB Guidance Policy, CSG.RES.001
IRB Protocol Review - Initial and Continuing Review Policy, CSG.RES.002
Informed Consent IRB Review Policy, CSG.RES.003
Development of Local Standard Operating Procedures Policy, CSG.RES.004
Adverse Event Review Policy, CSG.RES.005
Recruitment of Vulnerable Subject Populations Policy, CSG.RES.007
Patient Privacy Program Requirements Policy, HIM.PRI.001

1/2008