To establish reporting guidelines for research and data requests with varying degrees of involvement with a Cottage Health System (CHS) facility.
The CHS Institutional Review Board (IRB) has established specific reporting guidelines for research, depending upon the extent to which a CHS facility is engaged in the research. These guidelines include recommendations for off-site studies and research approved by, or in conjunction with, other IRBs. The guidelines are designed to:
- Protect research patients’ rights and safety in the event they are admitted to a Cottage Health System facility;
- Protect patients under requirements set forth by the Health Insurance Portability and Privacy (HIPAA) Act;
- Provide operational coordination of services rendered;
- Assess possible indemnification and reimbursement requirements.
This policy currently reflects:
- Office of Human Research Protections (OHRP) Guidance on Engagement of Institutions in Human Subjects Research, October16, 2008.
Engagement of an institution in research: In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research. In applying this guidance, it is important to note that at least one institution must be determined to be engaged in any non-exempt human subjects research project that is conducted or supported by HHS (45 CFR 46.101(a)).
I. Local Studies in Which All or Part of the Study is Taking Place at a CHS Facility (including Laboratory / Diagnostic Services)
It is the responsibility of the CHS Office of Research to coordinate the use of hospital facilities and to determine costs and staffing needs required for the intervention. In addition, the CHS Office of Research negotiates fees for services and billing, and may be required to negotiate a Clinical Trial Agreement with the study sponsor on behalf of Cottage Health System. By-passing the CHS Office of Research / IRB risks jeopardizing the institution by potentially neglecting to fulfill certain regulatory requirements.
Therefore, regardless of whether or not the CHS IRB or another IRB is used, the investigator must contact the CHS Office of Research as soon as possible in order to initiate the set up of the various operational requirements and/or to begin negotiation of the Clinical Trial Agreement. The investigator shall not circumvent the CHS Office of Research’s responsibilities related to study start-up by coordinating procedures directly with hospital staff or specific departments.
A. Studies Being Conducted Under the Purview of the CHS IRB
The investigator must submit an Office of Research IRB Application as outlined in IRB policy 8012.06, IRB Review of Research.
B. Studies Being Conducted Under the Purview of an Outside/Central IRB
If another IRB is used, and the research is being conducted such that an Authorization Agreement is needed in order to waive oversight to the outside/central IRB (eg the investigator is receiving federal funds to conduct the study), the CHS IRB shall execute an Authorization Agreement with the outside IRB, granting them responsibility over the conduct of the study.
Prior to the Initiation of the Study:
The investigator 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 the outside/central IRB.
- A copy of the approved consent form.
- A copy of the protocol.
- A Waiver of Authorization for Prescreening Application, if applicable.
CHS IRB will provide the following services:
- An expedited review of the submitted documents.
- Assignment of an IRB number by the Research Administrator (after completing the operational requirements).
- An IRB letter acknowledging: Waiver of CHS IRB oversight; approval of the Waiver of Authorization for Prescreening request (if applicable); the need for participants to sign an Authorization for Use or Disclosure of Health Information to allow the release of their PHI; and instructions to send a copy of the signed Authorization document to the Health Information Management department.
- A copy of the study-specific CHS Authorization for Use or Disclosure of Health Information addendum that should be signed by the patient prior to any health information being released by a CHS facility.
- Patient identification cards for study participants (see Office of Research policy 8010.10).
At the Completion of the Study:
- The investigator will provide the CHS IRB with a copy of the outside/central IRB’s letter acknowledging the closure of the study.
- The CHS IRB will retain the IRB file for the study for 6 years after notification of study closure.
Occasionally, an investigator may conduct studies within his/her own office environment, but will contract the services of Cottage Health System. These interventions include, but are not limited to:
- Outpatient laboratory
- X-rays, mammograms, ultrasound
- EKG, EEG
- Body scans (MRI, CT)
- Gastrointestinal procedures (EGD, colonoscopy, etc.)
For studies taking place off site, using only the services of a CHS facility, the same steps apply as per Section I B above.
II. Data Collected from Cottage Health System Patients for Research Being Conducted by Off-Site Researchers
In order to oversee and coordinate requests for data, the institution has established the Data Use Committee (DUC). The DUC meets regularly to review both internal and external requests for data via review of the Pre-Assessment Tool (PAT). When reviewing external requests, consideration will be given regarding the investigator’s eligibility for access to patient information. The PAT is routed through CHS Executive Administration for final allowance of data requests.
If the Investigator wishes to have direct access to patient records, the ISD Security Administrator will be required to authorize access. If authorization is denied, access cannot be granted. If possible, it is preferable for a CHS employee to aggregate the necessary data and de-identify it prior to the investigator’s receipt. If the investigator requires a Limited Data Set, as defined by the HIPAA Privacy Rule, the investigator will be required to enter into a Data Use Agreement with the institution, prior to disclosure of the data. The IRB may also approve a Request for Waiver of Authorization, in order to allow the release of identifiable patient information (Please refer to policy 8012.11).
A. Data Requests for Research Studies without IRB Approval
If no other IRB has approved the research for which the investigator is seeking CHS patient data, the investigator is required to complete a CHS IRB application. The Research Compliance Office will determine what type of IRB application is appropriate for the proposed research.
B. Data Requests for Research Studies with Approval by an Outside IRB
Occasionally, patient data is requested from outside investigators who may or may not be on the medical staff of our institution. Moreover, the data may or may not be affiliated with patients in their care. Such situations usually require the data to be collected on behalf of the investigator by a CHS employee. This scenario is different from section I B of this policy in that there are no operational considerations involved.
When the research has received approval from an outside (non-CHS) IRB, submission requirements for CHS IRB review include:
- A completed Pre-Assessment Tool detailing the data request;
- A copy of the application submitted to the off-site IRB, including the informed consent document or waiver request document;
- A copy of the off-site IRB’s approval letter;
- A copy of the study protocol.
If authorization is granted by CHS Administration, the CHS IRB will approve the request for data and relinquish oversight to the outside IRB. When the study has been completed, the investigator shall provide a copy of the outside/central IRB’s letter acknowledging the closure of the study. The CHS will maintain the study files for 6 years.
C. Non-Research Data Requests
Not all requests for data qualify as human subjects’ research. If the request for data is granted, but the request does not constitute research, the IRB will provide the requestor with an exemption letter allowing the release (use or disclosure) of CHS patient data without further reporting requirements to the IRB.
III. Research Participants Admitted to a Cottage Health System Facility While Enrolled in Off-Site Research
Occasionally, a patient who is enrolled in an off-site research study will be admitted to a Cottage Health System facility. Examples include patients enrolled in research in other cities who are hospitalized due to health problems, motor vehicle accidents, etc. There are also occasions when an oncology patient requires study-specific treatment while visiting Santa Barbara.
In such situations, no CHS IRB or Office of Research purview is required, as the treatment will not be on-going and is not a pre-determined part of the research plan.
Once it has been established that an admitted patient is enrolled on a research study, such information should be documented in the patient’s medical record. It is recommended that the treating physician procure information regarding the study as soon as possible, to avoid contraindicated care or risk to the patient. If possible, a copy of the consent form should be faxed or emailed to the unit and placed in the patient’s medical record.
If any medical record information from the patient’s hospitalization is to be collected by the study investigator or sponsor, the patient shall sign an Authorization for Use and Disclosure of Health Information form, available in the Health Information Management Department.
COTTAGE HEALTH SYSTEM POLICY
|ORIGINAL POLICY EFFECTIVE DATE:
||1/05; 9/05, 7/07, 8/08, 1/11, 7/11, 7/12