To establish written guidelines regarding Cottage Health System Institutional Review Board's functions in response to complaints or concerns received from research participants pertaining to the patient's research involvement.
The Cottage Health System Institutional Review Board will investigate, and endeavor to resolve, complaints/concerns received from research participants and assist the Patient Advocate in providing a response in a timely, reasonable and consistent manner.
Every research consent document provides contact information for the Cottage Health System IRB (CHS IRB). Specifically, research subjects are informed in writing that they may contact the IRB for questions or concerns regarding their rights as research participants. In addition, each research participant receives and signs a copy of the State of California Experimental Subject's Bill of Rights (a document that outlines the rights of research participants).
The IRB’s Role in Handling Research Participant Complaints and Grievances
Concerns about any protocol involving human research participants should be directed to the IRB Administrator. The IRB should be notified of any concerns or complaints received by any Cottage Health System representative such as Nursing, Quality Improvement, Risk Management, Corporate Compliance, or through the Compliance Hot Line. Persons raising such concerns are encouraged to express them in writing.
When contacted regarding a research participant grievance, the IRB shall document the following:
- Name of the patient
- The name of the person reporting the complaint
- The date the incident occurred
- Date incident was reported to the IRB
The IRB will investigate the complaint and determine whether or not the complaint involved risks to the patient's health or safety. The summary of this investigation will be documented.
The IRB will work in tandem with the Patient Advocate to identify/provide a resolution for the specific identified complaint/concern. All efforts will be made to effectively and expeditiously resolve the patient's complaint, preferably within 72 hours. The Patient Advocate assures that all complaints/concerns receive priority and every effort will be made to respond to the patient, in writing or by phone, within seven (7) days. If the complaint/concern has not been resolved, or if the investigation is not or will not be completed within 7 days, the Patient Advocate will inform the patient that the hospital is still working to resolve the complaint.
On-Site Research Studies
The Quality Support Services Department shall be notified by the IRB and shall follow its procedures in documenting and/or handling the complaint.
The IRB Administrator or designated member will contact the study coordinator and/or investigator to gather additional information on the patient and to inform them of the complaint. It should be noted whether the participant remains enrolled in the study or has withdrawn.
Complaints regarding research will be reviewed by the IRB Administrator and the IRB Chair, and reported to the IRB and the Quality Support Services Department. Additionally, grievances may be subject to reporting to pertinent government agencies and/or the study sponsor.
The IRB shall send written notification of the Full Board's determinations and required actions regarding the complaint to the principal investigator, any relevant CHS Department Heads (if their department is involved), the Corporate Compliance Officer, and the Institutional Official.
Off-Site Research Studies
If the patient is enrolled in a research study which is NOT taking place in a CHS facility (i.e. it is an off-site study), the IRB will only notify CHS departments (which may or may not include Quality Support Services Department, Risk Management, etc.) if appropriate and deemed necessary due to CHS departmental involvement.
As per above, the IRB Chair or designated member will contact the investigator to inform them of the complaint and to gather additional information on the patient. It should be noted whether the participant remains enrolled in the study or has withdrawn.
Complaints regarding research will be reviewed by the IRB Administrator and the IRB Chair and reported to the IRB. If necessary, grievances may be reported to pertinent government agencies and/or the study sponsor.
The IRB will send written notification of the Full Board's determinations and required actions regarding the complaint to the principal investigator and the Institutional Official.
Research Approved by Another IRB
If the patient's complaint arises in a CHS facility, the IRB shall also contact the Quality Support Services Department and the Compliance Department.
The Quality Support Services Department shall follow its procedures in documenting and/or handling
Medical Care Compensation
Currently, research institutions are not mandated to provide free medical care or compensation to research participants for research-related (induced) injuries. As stated in the informed consent document, Cottage Health System does not have any program to provide compensation for persons who may experience injury while participating in research projects
Relevant Institutional Policies
The IRB will refer to Administrative Policies #2.07, Patient Event Reporting and Management and #2.16, Patient Complaints and/or Concern Follow-up and follow the procedures outlined therein, as applicable.
The IRB will refer to IRB Policy 8012.18, IRB Action Plan for Investigator Non-Compliance, if the grievance was related to investigator non-compliance. A Non-Compliance Report will be completed and the appropriate intervention will take place as outlined in the policy.
If desired, the patient or patient's representative may access the case review subcommittee of the CHS Bioethics Committee to resolve ongoing ethical issues concerning patient care. The IRB may report such patient grievances to the Bioethics Committee on behalf of the patient, or patients may report their grievances to the Committee directly. The review procedure will take place as outlined in Patient Care Policy #12.13, Access to the Case Review Subcommittee of the Bioethics Resource Committee by Patient, Patient Representative, Hospital Employee and/or Medical Staff.
COTTAGE HEALTH SYSTEM POLICY
|ORIGINAL POLICY EFFECTIVE DATE: