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GOAL:
To establish a collaborative policy for treatment studies being conducted by the Cancer Center of Santa Barbara via its affiliation with the TORI Research Network..
POLICY:
The CHS IRB has established specific reporting guidelines for the TORI Research Network, which is comprised of off-site adult oncology treatment studies approved by an independent IRB, Western IRB (WIRB). These guidelines are designed to protect the rights and safety of research patients in the event they are admitted to, or need the services of, a Cottage Health System facility.
DEFINITIONS:
TORI – Translational Oncology Research International
PROCEDURE:
Due to the unique collaborative efforts surrounding TORI research, the CHS IRB has established a separate policy specific to these trials. In addition, CHS IRB has signed an IRB Authorization Agreement with Western IRB, thus indicating in writing the waiver of CHS IRB’s purview.
The Cancer Center of Santa Barbara (CCSB) is affiliated as a satellite site for the TORI research network. As such, CCSB enrolls local patients into trials being conducted by TORI. These patients may come to a CHS facility for diagnostic services. A representative from the CCSB Research Department will meet with the SBCH Research Administrator as the point person for each new TORI study, so that she can act as the institutional intermediary and assist in the set-up of the study.
In order to protect the safety of local individuals enrolled in treatment-based research studies which are not under the oversight of the CHS IRB, procedures have been established to identify these persons should they require either treatment or unplanned investigational intervention at a CHS facility while they are enrolled in the research (see policy 8012.15).
The procedures are designed to protect participants by alerting the physicians and hospital staff of a patient’s research participation and to make sure that no procedures are conducted that may cause deleterious effects to the patient as a result of his/her participation in a clinical trial. They are also designed to fulfill regulations set forth by the HIPAA Privacy and Security Rules regarding the use and disclosure of Protected Health Information (PHI).
At the Initiation of the Study:
CCSB shall discuss the study protocol and participant’s use of a CHS facility, equipment, or services with the Research Administrator and provide the CHS Office of Research with the following information:
- A copy of the IRB approval letter from Western IRB.
- A copy of the approved consent form.
- A copy of the protocol.
- A Waiver of Authorization for Prescreening Application.
CHS IRB will provide the following services:
- An expedited review of the submitted documents.
- A letter acknowledging waiver of IRB oversight, approval of the Waiver of Authorization for Prescreening request, and the need for participants to sign an Authorization for Use or Disclosure of Health Information (attached) to allow the release of their PHI.
- Patient identification cards for study participants (see Office of Research policy #8010.10).
In the Event a Patient Needs to be Admitted:
- A memo will be sent to the CHS IRB stating that a patient needs to receive study treatment at a Cottage Health System facility.
- The Office of Research will coordinate the use of CHS facilities, such as Pharmacy.
- The CHS IRB will respond with a letter acknowledging and approving treatment of said patient on protocol. This letter will be sent to the sponsor by the CCSB study coordinator.
- The 1572 Form will be amended by CCSB to add Santa Barbara Cottage Hospital (or other CHS facility).
- The patient is then clear to receive protocol treatment at the Cottage facility.
At the Completion of the Study:
- CCSB will provide the CHS IRB with a copy of Western IRB’s letter acknowledging the closure of the study.
- CHS IRB will retain the study documentation for 6 years after notification of study closure.
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Cottage Health System
Informed Consent Addendum
Authorization for Use or Disclosure of Health Information for Research Purposes
Completion of this document authorizes the disclosure and/or use of individually identifiable health information, as set forth below, consistent with California and Federal law concerning the privacy of such information.
A. ABOUT THE HEALTH INFORMATION:
I request and authorize the release and disclosure of any/all medical information collected at a Cottage Health System facility in association with the research study listed below, which I am currently enrolled in. This includes the release of results of laboratory and/or diagnostic procedures*, and specimens and/or tissue samples.
* These interventions/diagnostic procedures include, but are not limited to: X-rays, mammograms, ultrasounds, EKG, ECG, body scans (MRI, CAT), and gastrointestinal procedures (EGD, colonoscopy,etc.).
I understand that this information will only be used, as necessary, as part of my consented enrollment in the research study described in the attached informed consent form.
B. TO WHOM INFORMATION SHOULD BE GIVEN:
I authorize that my Protected Health Information collected at a Cottage Health System facility be made available to employees and or designees of the Cancer Center of Santa Barbara who are coordinating the study, authorized representatives of the study sponsor, the designated Institutional Review Board, authorized officials of Cottage Health System, and other officials as needed in the task of study monitoring and/or auditing purposes.
This authorization is valid for ____ years from the date this form is signed. If you wish to revoke your authorization, you may do so at any time, but it must be in writing.
C. PATIENT INFORMATION:
Patient Name: ___________________________________________________
Date of Birth: ________________
Research Protocol number: _________________________________________
IRB number: ____________________________
My signature below attests to this authorization:
______________________________________________ DATE: ________________
Signature of authorizing individual
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COTTAGE HEALTH SYSTEM POLICY
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| RECOMMENDED BY: |
Leilani Price |
DATE: |
8/05 |
| ORIGINAL POLICY EFFECTIVE DATE: |
9/05
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| APPROVED BY: |
5/30/02 |
DATE: |
.. |
| DATE REVISED: |
11/05 , 5/11
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DATE REVIEWED: |
4/06, 1/08, 1/09
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