These IRB Written Policies and Procedures, together with federal, state and local regulations, address the fundamental ethical principles and goals of human subject protection at the University of Miami and affiliated institutions. In conducting research within these policies, the University and affiliates affirm their commitment to the respect for persons, beneficence and justice in all investigations involving human participants (per the Belmont Report).
These UM IRB Written Policies and Procedures strictly apply federal, state and local regulations (e.g. 45 CFR 46 and 21 CFR 50, 56) to those studies that fall within the purview of those regulations. In considering the application of regulations and policies to other human studies that do not fall within this category, the University recognizes several principles including:
- participants in research at UM and affiliates shall be afforded protections at least as effective as those defined by federal, state and local regulations and in conformity with the principles of the Belmont Report
- as for laws, respect for policies requires that policies be respectable (Justice Lewis Brandeis); and common sense often makes for good law and policy (Justice William Douglas)
- research is ever changing. Policies and processes must account for such changes within an environment that facilitates and encourages the individual nature of each research program. While regulations provide essential guidance for policies and processes of human subject protection in research, the university must consider situations where regulations allow flexibility in policy and procedures which, in turn, may be advantageous to human subjects, investigators and the institution.
The University of Miami applauds the University of Michigan and its trendsetting Demonstration and Initiatives Program. Under this program, policies are being defined that provide ‘equivalent’ protections to human subjects while enhancing efficiency and facilitating human studies. Guided by regulations and the experiences of other institutions including the University of Michigan, and consistent with the principles of the Belmont Report and institutional standards, the University of Miami has implemented its Innovative Practices to Protect Participants in Research Program (the IP3R Program). Goals of this program are to facilitate applicable research, streamline processes, promote efficiency, reduce bureaucracy and minimize administrative burdens to investigators and reviewers while assuring that institutional human protection resources are allocated to areas where such resources are most needed.
In subsequent sections of these IRB Written Policies and Procedures, individual policies approved by the IRB Policy and Procedures Committee and implemented under the UM IP3R Program will be so identified to distinguish them from policies that are strictly defined by regulations.
NOTE -- Policies approved under the UM IP3R Program shall not pertain to studies or to training associated with studies that:
- are under federal jurisdiction pursuant to 45 CFR 46 because support for the study or for training purposes related to the study is derived from federal sources
- are under FDA jurisdiction pursuant to 21 CFR 50 because the study includes FDA regulated components (drugs, devices or biologics)
- are under state or local regulations that relate to the ethical standards of research involving human subjects
- are in receipt of NIH-issued Certificates of Confidentiality
- are under federally related obligations or contractual restrictions
- pose more than minimal risk to participants as determined by the IRB
Policies implemented under this IP3R Program are not meant to decrease the protection of human subjects. In fact, the University expects that such policies will result in better protection of research participants by allocating IRB resources with emphasis on the review and oversight of studies pursuant to their risk. Policies approved under the IP3R Program should also encourage compliance as investigators understand that the institution is working to reduce bureaucracy, streamline processes and strengthen the bonds between those who conduct research and those who are responsible for its oversight.
The achievements of the UM IP3R Program must result from a partnership among IRB panels, HSRO staff and investigators. For this reason, all involved in human subject research at UM and affiliated institutions are encouraged to submit suggestions for policies or policy revisions to the HSRO or to Chairs or members of the IRB.