COTTAGE HEALTH SYSTEM POLICY
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IRB Education, Compliance and Audit Activities
Through education, audits, and compliance procedures, the CHS IRB aims to ensure the ethical and safe practices of local human subject research under its purview.
To comply with guidelines set forth by the Department of Health and Human Services (DHHS) Office for the Protection of Research Participants (OHRP), Cottage Health System and the CHS IRB has established educational training and oversight mechanisms (appropriate to the nature and volume of its research) to ensure that research investigators, IRB members and staff, and other appropriate personnel maintain continuing knowledge of, and comply with, relevant ethical principles, relevant Federal Regulations, OHRP guidance, other applicable guidance, state and local laws, and institutional policies for the protection of human subjects. To further comply with OHRP guidances:
Investigator and Research Staff Education
In addition to regularly scheduled continuing reviews of all active studies, investigators must provide the IRB with all revisions and amendments, adverse events (from all sites), and any recruitment plans. All changes to the study must be approved by the IRB before being initiated. Failure to report changes or unanticipated problems to the IRB can result in an on-site audit and/or suspension of the study.
In order to monitor compliance as per OHRP recommendations, the CHS IRB requests copies of all monitor reports and external audits performed on trials under the IRB's purview. The CHS IRB requires copies of written documentation and reports resulting from site monitoring and auditing by the study sponsor. If no written report is obtained, the investigator is required to send a memo outlining the review and all of its findings. When sponsors highlight potential problems, a for-cause audit can be initiated by the IRB.
The IRB may ask the investigator to submit one or more signed consent documents and may witness the consent process in order to monitor compliance in this area.
III. Auditing of IRB-Approved Research
On-site audits of investigative sites are conducted periodically to ensure compliance with regulations and provide education as needed. During an on-site audit, the primary focus of review includes:
Questionnaires have been developed which may be sent to participants to determine voluntary participation, understanding of research treatments/procedures, and adequacy of the investigator's consenting process. Mailing of participant questionnaires is coordinated with study audits and investigators may decline their patients' participation.
Cottage Health System Institutional Review Board
Research Participant Questionnaire
The Cottage Health System Institutional Review Board (IRB) is a special committee that oversees the rights and safety of members of our community participating in research studies. The IRB has approved the study you are in and it is important for us to find out more about your enrollment process.
We are required by federal guidelines to keep research studies safe and ethical for you and others like you. To help us do this, we ask you to answer the following questions and return this survey as soon as possible to the Cottage Health System Office of Research in the enclosed, self-addressed envelope. Or FAX it to (805) 682-6584
We would like to thank you in advance for your time and wish you the best of luck in your study. This survey is completely anonymous: do not sign your name or put a return address on the envelope.
Please tell us in your own words what type of study you are enrolled in and why: