DEPARTMENT: Quality Management / POLICY DESCRIPTION: Use of Non- Local, Cooperative and Multi-Institutional IRBs
PAGE: 1 of 3 / REPLACES POLICY DATED: January 1, 2003
APPROVED: April 8, 2003 / RETIRED:
EFFECTIVE DATE: April 14, 2003 / REFERENCE NUMBER: QM.IRB.006
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: All Company-affiliated facilities engaged in human subject research must be affiliated with one of the following:
1.  its own (institutional) IRB, or
2.  an external IRB, which could be:
a.  a non-local IRB;
b.  a multi-institutional IRB; or
c.  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) 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. A sample IRB Agreement is attached to this policy and model IRB Agreements can be found at the Quality Management site on the Company’s intranet at:
http://atlas.medcity.net/servlet/dcs/storage/DCSstore/public/Gallery/MyJobFocus/QualityManagement/QualityStandards/HumanSubjectResearch/. A sample BAA is attached to this policy and can be found at the HIPAA site on the Company’s intranet at: http://atlas.medcity.net/servlet/dcs/storage/DCSstore/public/Gallery/hcame/CompanyInformation/HIPAAInitiative/4-Privacy/07-BusinessAssociateAgreementInformation/BusinessAssociateAgreement.pdf
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.
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.
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 facilities party to the IRB Agreement. This IRB carries out the IRB responsibilities for all 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, QM.IRB.001
IRB Protocol Review - Initial and Continuing Review Policy, QM.IRB.002
Informed Consent IRB Review Policy, QM.IRB.003
Development of Local Standard Operating Procedures Policy, QM.IRB.004
Adverse Event Review Policy, QM.IRB.005
Recruitment of Vulnerable Subject Populations Policy, QM.IRB.007

4/2003

SAMPLE Institutional Review Board (IRB) Authorization Agreement

Name of the Institution or Organization Providing IRB Review (i.e., “IRB”):

______

IRB Registration #:______Federalwide Assurance (FWA) #, if any: ______

Name of Institution Relying on the Designated IRB:

______

OHRP Federalwide Assurance #: ______

The Officials signing below agree that ____(name of the institution)___ (the “Institution”) may rely on the IRB for review and continuing oversight of its human subject research as described below: (check one)

(___) This Agreement applies to all human subject research covered by the Institution’s FWA.

(___) This Agreement is limited to the following specific protocols(s):

Name of Research Project: ______

Name of Principal Investigator: ______

Sponsor or Funding Agency: ______Award Number, if any:______

(___) Other (describe):

The IRB agrees that the review and the continuing oversight performed by the IRB will meet the human subjects protection requirements as set forth in the JCAHO standards, the DHHS and FDA regulations and any applicable State or local requirements.

Duties of the IRB:

All studies submitted will be evaluated in accordance with the IRB’s policies and procedures and/or rules and regulations. A copy of the IRB’s policies and procedures and/or rules and regulations will be forwarded to the Institution. The IRB policies and procedures must include, but are not limited to, the following important elements in the protection of human subjects:

  1. The role and responsibilities of the IRB as defined by Federal and appropriate State regulations.
  1. Review and approval of proposed human subject research protocol and consent.
  1. Receipt of and analysis of the adverse event reports.

5

Sample for an Institution to utilize an IRB outside its facility

Attachment A to QM.IRB.006

  1. Periodic reviews of the consent process, the study progress, and renewals of approval at defined intervals.
  1. Board composition complying with the FDA and DHHS requirements to include the expertise and experience to adequately review each specific human subject research protocol.
  1. A mechanism to adequately review and include in each protocol review process the dynamics of the Institution’s community and local laws. Language confirming the IRB’s responsibility for the oversight of research to include knowledge of the local community from which subjects are drawn. IRB meeting documentation must clearly state how community attitudes were obtained and that they were considered with each review, initial and continuing.
  1. The IRB retains 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, and be defined in policy and this Agreement.

The IRB shall perform all reporting obligations under applicable laws and regulations pertaining to the performance of clinical research studies on human subjects. The IRB agrees to promptly advise the Institution in writing of any termination and/or suspension of any human subject research studies authorized at the Institution, and the reasons for the termination and/or suspension.

The IRB shall promptly inform the Institution of any contact by the FDA or other persons regarding one of the Institution’s studies and shall promptly notify the Institution in the event that the FDA or other Government Agency issues the IRB any “Notice of Inspectional Observations”, “Warning Letters” or other communications citing improper or inadequate research practices with respect to any activity of the IRB or the Principal Investigators. As used in this Agreement, “promptly” shall mean within three (3) business days of such an event.

The IRB shall perform record keeping and maintenance of necessary documents related to the Institution’s studies in conformity with all applicable federal and state laws and regulations. The IRB must perform this record keeping in a manner acceptable for submission or review by the FDA and other regulatory bodies.

Relevant minutes of the IRB meetings will be made available to the Institution upon request (The Institution may define its own expectations).

The IRB will supply the Institution’s governing body with a report on each applicable study at least annually and more frequently depending on the volume of studies or risk determinations of individual studies. Determinations of the timing of individual studies will be agreed upon at the time of the initial study approval between the IRB and the Institution.

Duties of the Institution:

The Institution shall ensure that all Principal Investigators are credentialed and privileged to perform procedures contemplated by the study. The Institution shall ensure that the Principal Investigators for each study submitted to the IRB are members of the Institution’s medical staff and are members in good standing. The Institution shall be responsible for ensuring compliance with the IRB’s determinations.

The Institution agrees to promptly inform the IRB in writing of any termination and/or suspension of any of its studies authorized by the IRB and the reasons for the terminations and/or suspension. The Institution shall promptly advise the IRB of the termination, suspension or modification of any clinical privileges for members of its medical staff that are participating in human subject research authorized by the IRB.

The Institution shall promptly inform the IRB if the FDA or other government agency issues the Institution any “Notice of Inspectional Observations” or “Warning Letters” or other communications citing improper or inadequate research practices by the Institution, or its Principal Investigators.

The Institution agrees to maintain a copy of the legally effective informed consent of each patient participating in the human subject research study approved by the IRB in the patient’s medical record.

The Institution remains responsible for ensuring compliance with the IRB determinations and with the terms of its OHRP-approved Assurance, when applicable. This document must be kept on file at both the institution and provided to the OHRP upon request.

The IRB or its authorized representatives, including the FDA to the extent permitted by law, shall be permitted to conduct the following tasks: (1) examine and inspect the Institution’s facilities used for the performance of the research, including storage and use of any investigational products; (2) observe the conduct of research; (3) inspect and copy all documents relating to the research, including patient medical and informed consent documents, Investigational Product logs, required licenses, certificates and accreditations; and (4) interview all necessary personnel involved in patient care for the study.

Indemnification:

The IRB and the Institution shall each indemnify and save harmless the other against all actions, claims and demands whatsoever, including costs, expenses and attorney’s fees resulting from or claimed to have resulted from any negligent acts or omissions or acts of willful misconduct by the indemnifying party or its employees or independent contractors engaged in the work under this Agreement at the time of the event or occurrence upon which such actions, claims or demands are based.

Insurance:

The parties each agree to secure, maintain and enforce during the term of this Agreement, their own liability insurance or policies at their own expense with minimum limits that are consistent with the community standard. Each party shall ensure that their employees or independent contractors are also insured to those limits. Upon written request, each party further agrees to provide the other with a certificate(s) of insurance, stating that the above coverage is in force and will continue in force throughout the term of this Agreement. Each party shall provide ten (10) days prior to written notice of expiration or cancellation of such insurance coverage to the other party.

Choice of Law:

The laws of the State of ______shall govern this Agreement.

Assignment:

Neither party may assign this Agreement without the written consent of the other party, such consent to be granted in the sole discretion of the non-assigning party.

Waiver:

Waiver by either party of a breach or violation of any provision of this Agreement will not constitute or be construed as a waiver of any subsequent breach or violation to that provision or any other provision of this Agreement.

Notices:

Any notice given under this Agreement shall be mailed to the party to be notified at the address set forth herein, by registered or certified mail, with postage prepaid, and shall be deemed given when made:

IRB Name and address:

Institution Name and address:

Term:

The term of this Agreement shall be for ___ years beginning on ______, 20__, provided that either party may terminate this Agreement at any time without cause upon 90 days written notice to the other party.

Payment:

To be determined between the IRB and the individual Institution.

IN WITNESS WHEREOF, the parties have executed this Investigation Review Board Authorization Agreement as of the date written below.

IRB:

Signature of Signatory Official:______Date:______

Print Full Name:______Title:______

INSTITUTION:

Signature of Signatory Official:______Date:______

Print Full Name: ______Title: ______