COTTAGE HEALTH SYSTEM POLICY

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SUBJECT:

IRB Approval of Research Conducted Outside of Cottage Health System

Offsite Study Research

 

DEPT: IRB POLICY #: 8012.16

 

GOAL:  

To establish guidelines for investigators wishing to use the Cottage Health System IRB for studies being conducted outside of the institution.

 

POLICY:  

It is the official policy of the Cottage Health System Institutional Review Board to maintain the discretion to review local studies conducted elsewhere.

 

PROCEDURE :

In addition to reviewing applications for research studies conducted at Cottage Health System facilities, the Cottage Health System Institutional Review Board may, on request, review applications for local biomedical or health-related studies conducted elsewhere.  This provision allows investigators to have local IRB oversight by using the CHS IRB when conducting outpatient or laboratory research outside the hospital setting.

 

IRB jurisdiction over off-site studies covers research for institutions without an institutional IRB only.  Any research conducted at another hospital or research site which possesses its own IRB requires either the approval of the IRB at that institution or official written documentation waiving its oversight to the CHS IRB.

 

Investigators who have selected the Cottage Health System IRB as the IRB of choice must comply with all of the policies, procedures, and requirements of the CHS IRB regardless of where the study takes place.

  1. All principal investigators must sign the Cottage Health System Investigator’s Agreement (see IRB policy 8012.01).In addition, as stated in the Investigator's Agreement, all principal investigators are responsible for ensuring regulatory compliance by co-investigators or sub-investigators participating in the research and all members of their research staff.
  2. Principal investigators will receive a packet of regulatory guidelines in conjunction with the Investigator's Agreement.  It is their responsibility to read and understand the regulations and to make sure that all individuals involved in the research (investigators and staff) be provided with and familiar with the material as well.
  3. Investigators need not be members of the CHS Medical Staff and are not required to be physicians in order to apply for CHS IRB approval.  However, they must provide the IRB with sufficient information to justify their competency in the research and show sufficient experience and expertise in their field.  As such, the IRB routinely reviews an investigator's curriculum vitae (CV) as part of the IRB application.  However, the IRB may ask for additional information, if necessary, to satisfy this determination, such as:
    • FDA Form 1572 (if applicable)
    • A copy of the medical license (if applicable)
    • Research references (if necessary)

Occasionally, the principal investigator may be located in Santa Barbara, but have co-investigators or sub-investigators in other communities or even other states.  All of the required information listed in section C 3 above must be submitted for each co-investigator/sub-investigator.  The CHS IRB reserves the right to deny approval of any co-investigator or sub-investigator who is not deemed eligible to conduct the study independently at his/her location.  Therefore, the IRB expects local principal investigators to provide the IRB with a potential/interested co-investigator's information prior to providing that co-investigator with any suggestion that he/she has been added as a co-investigator.  Potential co-investigators should not be led to believe that they are automatically enrolled as researchers, once they have communicated their interest in doing so with the principal investigator.

 

Currently, the CHS IRB does not have limitations regarding the location of the off-site research and may agree to review research being conducted outside of the Santa Barbara metropolitan area.  Each study will be evaluated on a case-by-case basis to determine the feasibility of CHS IRB purview.  Proposed research studies being conducted by investigators with limited experience or those involving high risks to participants are less likely to be accepted by the CHS IRB.

 

he investigator is responsible for compliance with Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) regulations.  Despite efforts made by the IRB to screen investigators and potential studies, researchers who do not conduct their studies in an ethical manner, or who do not place the safety of their participants above the research being conducted, are liable for their own actions.  The IRB may audit sites at any time and report discrepancies to the FDA.  In addition, the IRB may suspend or terminate a study in order to protect the rights and safety of its participants (see IRB policy 8012.18).

 

Depending upon the study, off-site investigators may be provided with patient identification cards.  Study coordinators will instruct patients to display the card whenever they are admitted to a hospital or when receiving medical care.

 

Sponsored research conducted off-site is subject to IRB fees in accordance with IRB policy (see policy 8012.03).

4/11

 

 

COTTAGE HEALTH SYSTEM POLICY

RECOMMENDED BY: Leilani Price DATE: 7/03

ORIGINAL POLICY EFFECTIVE DATE: 11/03

APPROVED BY: .. DATE: ..

DATE REVISED: 1/08 DATE REVIEWED: 4/06, 1/08, 4/11