Tenet looks forward to partnering with our medical staff in searching for new and better ways to care for our patients. Clinical research uses human volunteers to answer specific health questions by testing various new treatment methods within the clinical research protocol. Facilities and practices that participate in these studies help make a difference in how medicine is practiced.
- Access to new drugs, treatments or devices before they are widely available
- Chance to make a valuable contribution to medical research
- Possibility of improvement in their medical condition
- Access to physicians who are on the leading edge of medical science
Tenet has established policies and procedures for research including having a coordinator to ensure all sites are compliant with the regulatory agencies for research. Institutional Review Boards (IRB) must approve all human subject research studies and in order to comply with OHRP regulations.
Your facility research coordinator will help vet protocols to ensure the proposed research meets our quality standards, clinical research billing compliance, and mission statement.
- The Tenet Home Office shall serve as a resource and subject matter expert for Tenet Entities preforming or proposing to preform clinical research.
- The Tenet Research Director in conjunction with the Chief Medical Officer, Principal Investigator, and IRB or record will exercise oversight of clinical research studies.
- Clinical research oversight includes the authority to end a study prior to completion or inhibit a study from starting by notifying the Tenet Entity Chief Executive Officer, Compliance Officer, and Clinical Research Staff of the suspension or termination without regard to any previously granted approval.
- In the event a clinical research study is suspended or terminated the Tenet Entity CEO shall notify all required individuals or groups including but not limited to:
- Tenet Entity Institutional Review Board (IRB)
- Medical Executive Committee (MEC)
- Governmental Entities to which the Tenet Entity is required by law to notify
- Any person who is required to receive notice pursuant to contract terms related to the study
- The Tenet Research Director shall propose policies with respect to clinical research activities in order to promote an environment and culture of patient and employee safety consistent with the most current ethical, clinical and compliance standards.
- Tenet Entities shall maintain information for research studies conducted involving medical intervention within Tenet’s designated Patient Data Reporting (PDR) and Clinical Conductor (CC) databases.
- The Tenet Research Director shall direct and ensure clinical research, incidental to research, and prospective registry studies with medical interventions are captured within the Clinical Trail Management System (Clinical Conductor).
- Proposed arrangements for clinical research or prospective registry studies with medical interventions require approval from the Tenet Research Director and through the eCATS approval process prior to execution.
- Each clinical research or prospective registry study shall be processed and reviewed as a separate arrangement and package within eCATS.
- Studies cannot commence until the eCATS package is executed with all required documents and approvals.
- Each Tenet Entity must identify, and engage by written agreement, at least one Institutional Review Board (IRB) to review clinical research studies to be conducted.
- Copies of the IRB’s written procedures covering the services provided must be maintained at the Tenet Entity for all IRB’s designated on the entity’s Federal wide Assurance (FWA).
- Internal IRB’s must be registered with the Office of Human Research Protections (OHRP) and listed on the Tenet Entity’s FWA.
- Each Tenet Entity must submit and maintain a Federal wide Assurance (FWA) thru OHRP to designate the Institutional Review Board (IRB) currently reviewing the greatest number of research studies for the Tenet Entity.
- Changes to the IRB ratio must be amended by Tenet Entity on their FWA.
- The Tenet Entity must maintain a current FWA submitting renewal requests prior to expiration.
- Legal name changes must be filed as a new FWA within 90 days of any change with the Human Protections Administrator (HPA).