The minor differences in wording reflect that (1) Part 50 is an interlocking but separate part of FDA's bioresearch monitoring regulations (2) purely behavioral research is not regulated by FDA, and (3) HHS has promulgated its IRB and informed consent requirements together in one subpart which was published in the Januissue of the Federal Register. The substance of the informed consent requirements of the two regulations, with minor differences, therefore, is identical. Many comments suggested that FDA's informed consent requirements should be identical to the informed consent requirements adopted by HHS.įDA agrees that uniformity of requirements is desirable and that uniform requirements would be less confusing to investigators who frequently may conduct both research funded by HHS and research involving FDA-regulated products. The substantive comments received and FDA's conclusions about them are discussed below. Comments were received from clinical investigators, institutional review boards, trade associations, professional societies, drug companies, and private citizens. The comments received at the hearings and the hearing transcripts were made a part of the record of this regulation and are on file in the Dockets Management Branch (formerly the Hearing Clerk's office) along with the written comments received in response to the proposal. The hearings were held in Bethesda, MD, on September 18, 1979, San Francisco, CA, on October 2, 1979, and Houston, TX, on October 16, 1979. In addition, FDA held three open hearings to give the public an opportunity to comment on both the informed consent proposal and the IRB proposal that was reproposed in the same issue of the Federal Register (44 FR 47699). 539-583), required that informed consent be obtained before an investigational device is used on a human subject (6) FDA's Bioresearch Monitoring Program could be conducted more efficiently and effectively with uniform, agency-wide requirements for informed consent and (7) FDA regulations should take into account the recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) regarding institutional review boards (IRB's) and informed consent, published in the Federal Register of Novem(43 FR 56174).įDA allowed 90 days for comment on the proposal of Aug(44 FR 47713). FDA believed that a complete revision of its requirements relating to informed consent is needed because (1) current regulations had not been comprehensively reviewed in 12 years (2) actions by the Department of Health and Human Services (HHS) and the Congress suggested the need for, and desirability of, strengthening and clarifying informed consent requirements as they apply to research that involves human subjects and is intended for submission to FDA (3) wherever possible, informed consent requirements adopted by FDA should be identical to, or compatible with, HHS regulations (4) the General Accounting Office (GAO) has recommended changes in current FDA regulations (5) Congress, in enacting the Medical Device Amendments of 1976 (Pub. In the Federal Register of Aug(44 FR 47713), the Commissioner of Food and Drugs proposed regulations concerning standards of informed consent. Petricciani, Office of the Commissioner (HFB-4), Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20205, 30. The regulations clarify existing FDA requirements governing informed consent and provide protection of the rights and welfare of human subjects involved in research activities that fall within FDA's jurisdiction.įOR FURTHER INFORMATION CONTACT: John C. SUMMARY: The Food and Drug Administration (FDA) is issuing regulations to provide protection for human subjects of clinical investigations conducted pursuant to requirements for prior submission to FDA or conducted in support of applications for permission to conduct further research or to market regulated products.
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