Science & Research
Protection of Human Research Subjects; Clinical Investigations Which May Be Reviewed Through Expedited Review Procedure Set forth in FDA Regulations
January 27, 1981
AGENCY: Food and Drug Administration.
SUMMARY: This notice contains a list of research activities which institutional review boards may review through the expedited review procedures set forth in FDA regulations for the protection of human research subjects.
FOR FURTHER INFORMATION CONTACT: John C. Petricciani, Office of the Commissioner (HFB-4), Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20205, 301-496-9320.
SUPPLEMENTARY INFORMATION: Elsewhere in this issue of the Federal Register, the Food and Drug Administration (FDA) is publishing final regulations establishing standards for institutional review boards (IRBs) for clinical investigations relating to the protection of human subjects in research. Section 56.110 (21 CFR 56.110) of the final IRB regulations provides that the agency will publish in the Federal Register a list of categories of research activities, involving no more than minimal risk, that may be reviewed by an IRB through expedited review procedures. This notice is published in accordance with § 56.110.
The agency concludes that research activities with human subjects involving no more than minimal risk and involving one or more of the following categories (carried out through standard methods), may be reviewed by an IRB through the expedited review procedure authorized in § 56.110.
(1) Collection of hair and nail clippings in a non-disfiguring manner; of deciduous teeth; and of permanent teeth if patient care indicates a need for extraction.
(2) Collection of excreta and external secretions including sweat and uncannulated saliva; of placenta at delivery; and of amniotic fluid at the time of rupture of the membrane before or during labor.
(3) Recording of data from subjects who are 18 years of age of older using noninvasive procedures routinely employed in clinical practice. This category includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy. It also includes such procedures as weighting, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. This category does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays or microwaves).
(4) Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects who are 18 years of age or older and who are in good health and not pregnant.
(5) Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth, and the process is accomplished in accordance with accepted prophylactic techniques.
(6) Voice recordings made for research purposes such as investigations of speech defects.
(7) Moderate exercise by healthy volunteers.
(8) The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
(9) Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
This list will be amended as appropriate and a current list will be published periodically to the Federal Register.
Dated: January 19, 1981.
Jere E. Goyan,
Commissioner of Food and Drugs.
[FR Doc. 81-2690 Filed 1-21-81; 3:59 pm]
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