The Public Health Service Act (Title IV, Part G, Section 491[a]), as amended, required the Department of Health and Human Services (DHHS) to issue regulations for the protection of human subjects of research and to implement a program of instruction and guidance in ethical issues associated with such research. The PHS Act gave rise to the Office for Human Research Protections (OHRP) as an extension of the The Department of Health and Human Services within The National Institute of Health (NIH).
The Office for Human Research Protections (OHRP) was created as an administrative unit within the Department of Health and Human Services and was commissioned to define and implement DHHS Regulations for the Protection of Human Subjects.
On July 12, 1974, the National Research Act (Public Law 93348) was signed into law, thereby creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the Commission's mandates was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to recommend steps to improve the Regulations for the Protection of Human Subjects to ensure that such research is conducted in accordance with these ethical principles. Accordingly, the "Ethical Principles and Guidelines for the Protection of Human Subjects of Research", known as The Belmont Report, was issued by the Commission in 1979.
Three basic principles of ethics are particularly relevant to the protection of human subjects in biomedical and behavioral research. They are:
1. Respect for Persons: recognition of the personal dignity and autonomy of individuals and special protection of those persons with diminished autonomy
2. Beneficence: obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm
3. Justice: fairness in the distribution of research benefits and burdens.
The Belmont Report gave rise to what is now known as Title 45/Part 46 (45 CFR 46). Title 45 contains the Code of Federal Regulations (CFR) regarding the use of human subjects in research and is the law under which the IRB at Weber State University functions. Title 45/Part 46 (45 CFR 46) was revised June 18,1991 and can be accessed through the web at www.nih.gov.
Under section 46.103 of the OPRR code of Federal regulations, each institution engaged in research involving the use of human subjects is required to appoint members to a formal review board (IRB) who's function is to review all projects generated by members of that institution and assure that each follow the basic guidelines set forth by (45 CFR 46). Certain guidelines have been established by the OPRR, however, authority has been given to the States and individual institutions to establish stricter guidelines as deemed appropriate.
OPRR has the power to refuse Federal funding to any institution which does not have a functioning IRB committee. It also has the power to shut down all research at a given institution which does not adhere to the mandates set forth in the (45 CFR 46) Code of Federal Regulations.
Page Updated 23 Aug. 2005