These “Written Policies and Procedures for the Protection of Human Subjects in Research” encompass the policies, procedures and operational guidelines for the University of Miami's Institutional Review Boards (IRB) and the Human Subjects Research Office (HSRO) (NOTE – In this document, the term “the IRB” is used to refer to all University IRB’s). In writing and/or revising this document, a goal is to make it an easily comprehensible reference manual for IRB members, for investigators and their staffs, for HSRO staff and for all others who hold an interest in, or who must implement and maintain a commitment to protecting the rights and welfare of human subjects while carrying out responsibilities in human subjects research. For this reason, the restating of federal regulations is minimized. Rather, such regulations that underlie these policies and procedures are usually only referenced within the narrative. Instead, these Policies and Procedures are written and organized to teach and to provide reference to the requirements and best practices in meeting the high ethical standards of the University of Miami and in carrying out federal, state and local regulations.
The importance of written policies and procedures for the proper functioning of Institutional Review Boards and the Human Subjects Research Office cannot be overemphasized. For one thing, written policies and procedures are required by federal regulations (Code of Federal Regulations: Title 45, Part 46.103 (b)(4) and Title 21, Part 56.108(a)). [NOTE – Further such references to federal codes will be made in a shortened manner such as 45 CFR 46.103]. Equally important is that written policies and procedures are essential to:
a. Establish consistency in decisions and decision-making
b. Promote predictability to investigators and others on the process that the IRB and HSRO will follow
c. Reduce errors by providing a framework for careful conduct
d. Give clarity to authorities and responsibilities
e. Facilitate the training of, and serve as a reference manual for IRB members, investigators, HSRO staff and others
f. Ensure that human studies research and IRB matters are managed appropriately and equitably
These Policies and Procedures are a “living document” that will be reviewed, revised and supplemented at regular intervals and as needed. This will ensure that they account for advances in methodologies, new concepts of organization, shifts in community ethical standards and changes in regulations. No matter the changes, the goal of these Policies and Procedures shall remain the assurance that human subjects in all research studies of the University of Miami and affiliated institutions receive ethical treatment in concert with the principals of the Belmont Report (i.e. respect for persons, beneficence and justice) federal regulations and the ethical standards of the University and its community of scholars.
Although much effort was expended to make these policies and procedures as complete as possible, it should be expected that matters will be forthcoming for IRB decisions that are not explicitly covered in this document just as this is likely to occur at other institutions. In this circumstance, reference shall be made to existing policies and procedures, and decisions of the IRB and the University shall be guided by federal regulations and the University's ethical standards for the protection of human subjects. A goal shall be to learn from these situations and thereby to improve these policies and procedures to account for such research-related matters in the future. In fact, aren't increasing knowledge and making improvements for societal benefit essential goals of quality research?
Comments and suggestions on the organization and contents of this document and on the effectiveness of the University's human subjects protection program are welcome. These may be addressed to IRB members or to the Human Subjects Research Office (HSRO).
Dushyantha Jayaweera, M.D.
Associate Vice Provost for Human Subjects Research