Institutional Review Boards
CARE is responsible for ethical and regulatory oversight of research in the Tenet Healthcare, Florida Region that involves human subjects, regardless of funding source. CARE administers, supports, and guides the work of the Institutional Review Boards (IRB) and all related activities. Any research involving human subjects proposed by Tenet employed physicians, staff or affiliated students must be reviewed and approved by an IRB before research may begin, and before related grants may be funded. CARE and the IRB are critical components of the coordinated Human Research Protection Program, which serves to protect the rights and welfare of human subjects. All components of this program must work together to ensure institutional compliance with ethical principles and regulatory requirements.
It is the policy of CARE that all research involving human subjects should be conducted under equivalent levels of protections as those afforded by the federal regulations that govern this area, regardless of source of funding. This includes the requirement that all research must be reviewed and approved or determined exempt by an institutional review board (IRB) prior to the involvement of human subjects, with attention to informed consent and other protections.
Charter Statement for the Institutional Review Boards
(1) There shall exist committees at CARE which shall serve as IRBs in accordance with 45 CFR 46, 21 CFR 50 and 56, and other federal regulations. New IRBs shall be created or existing IRBs abolished from time to time as necessary to provide expert and timely review and oversight of the human research protection program within the Tenet Healthcare, Florida Region. Each IRB shall be registered as a separate and distinct IRB with the federal Office for Human Research Protections (OHRP).
(2) The IRBs shall be guided by and act in a manner consistent with the ethical principles contained in the “Belmont Report.” The IRBs shall also be guided by relevant published ethical and professional standards of the various disciplines and professions represented among the investigators who conduct research with human participants.
(3) The IRBs shall receive all protocols in which the use of human subjects in research is proposed, regardless of the source of funding for such protocols. Each IRB shall review and have the authority to approve, require modifications to secure approval or, disapprove research conducted by the CARE; to suspend or terminate approval of research not being conducted in accordance with the IRB’s requirements or that had been associated with unexpected harm to participants; and to observe or have a third party observe the consent process and the conduct of the research. Each IRB shall exercise these authorities as it deems appropriate, consistent with the various federal regulations and CARE policies that govern its work. No research with human subjects shall take place at any Tenet Healthcare, Florida Region facility without the prior approval of an IRB.
(4) The judgments of the IRBs shall be final. There shall be no appeal of substantive decisions of the IRBs to any other authority. Appeal on procedural matters may be heard by the CARE Institutional Official who shall have the authority to require an IRB to reconsider a protocol if there is reason to believe the IRB did not follow its established procedures or acted in violation of federal regulations or CARE policy.
(5) It is CARE policy that no Tenet protocol is subject to ongoing review and approval by more than one IRB. Any IRB may enter into agreements with any other IRB within CARE to allow protocols to be reviewed by the IRB with greatest expertise in the subject matter of the protocol or with the greatest facility to oversee the resulting research.
(6) With the approval of the CARE Institutional Official for Human Subjects, any IRB may enter into agreements with other institutions to serve as the IRB of record for some or all of the human subject protocols originating within such other institutions. With the approval of the CARE Institutional Official for Human Subjects, any IRB may enter into agreements with other institutions to allow an IRB at another institution to serve as the IRB of record for a project conducted collaboratively between the CARE and the other institution, so long as the other institution has a valid federal wide assurance of compliance and the other IRB is registered with OHRP.
(7) The IRBs shall provide standard procedures for investigators to follow and standard forms for investigators to use in applying for approval of protocols to any of the IRBs and shall adopt and publish Standard Operating Procedures, consistent with applicable federal regulations and Tenet policies, to govern their activities.
Mission Statement for the Human Research Protection Program
CARE is committed to expanding and disseminating knowledge for the benefit of the people of Tenet Healthcare, Florida Region and the world. An important part of that commitment to knowledge is research of the highest quality on all aspects of the health and behavior of people, and such research is only possible through the participation of humans as research subjects. Human subjects are partners and participants in research and a precious resource to the Tenet Healthcare. At CARE, human subjects research is a privilege, not a right. Consistent with that philosophy, it is the mission of the CARE Human Research Protection Program to provide that:
The rights and welfare of human subjects are paramount in the research process;
The highest standards of ethical conduct are employed in all human subjects research;
Research investigators are properly trained in the ethical and regulatory aspects of research with human subjects.
Research investigators deal honestly and fairly with human subjects, informing them fully of procedures to be followed, and the risks and benefits of participating in research; and
Research using human subjects at CARE conforms to all applicable local, state and federal laws and regulations and the officially adopted policies of the Tenet Healthcare.