COTTAGE HEALTH SYSTEM POLICY

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SUBJECT:

Non-Affiliated Investigator Agreement

Non-affiliated Investigator Agreement

 

DEPT: IRB POLICY #: 8012.01

 

 

GOAL:
To provide a written agreement of investigator responsibilities between Cottage Health System and the investigator.

 

POLICY:

Cottage Health System Institutional Review Board (CHS IRB) requires investigators conducting research, who are requesting the CHS IRB to provide oversight for their research, to sign the Investigator Agreement, whether or not the research will take place in a CHS facility.

 

PROCEDURE:

Investigator Agreements will be completed, signed, and kept on file by the CHS Institutional Review Board in the Office of Research, for all investigators who request the CHS IRB as their IRB of choice.

 

The document is a co-signed agreement between the investigator and the CHS IRB.

 

The signed agreement binds the investigator to compliance with:

  • State and federal laws and regulations regarding research
  • Institutional and Office of Research policies and procedures
  • IRB review and findings

As part of the IRB's minimal education requirements, the investigator will receive various regulatory documents, in addition to the Investigator Agreement.  Additional regulatory documents may be selected, to provide timely guidance, as needed.  The following items are currently provided:

  • The Belmont Report
  • The Code of Federal Regulations (45 CFR 46, 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 812)
  • CA Health and Safety Code sections 24170 - 24179.5 (The Protection of Human Subjects in Medical Experimentation Act),
  • California Assembly Bill 211 (AB 211)
  • California Senate Bill 541 (SB 541)

 

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COTTAGE HEALTH SYSTEM POLICY

RECOMMENDED BY: Leilani Price DATE: 5/30/02

ORIGINAL POLICY EFFECTIVE DATE: 9/02

APPROVED BY: .. DATE: 5/30/02

DATE REVISED: 1/05; 6/10
DATE REVIEWED: 4/06, 1/08