NOTE: THIS GUIDANCE DOCUMENT HAS BEEN ARCHIVED BECAUSE IT HAS BEEN REPLACED BY GUIDANCE ON CONTINUING REVIEW AT http://archive.hhs.gov/ohrp/humansubjects/guidance/contrev2002.htm .
Number 97-02 Human Subject Protections
February 20, 1997
Subject: Expedited Review of Certain Research
This letter conveys to Institutional Officials and Institutional Review Board (IRB) Chairs a clarification of policy from the Office for Protection from Research Risks (OPRR) and the Food and Drug Administration (FDA).
The clarification comes in response to inquiries from several IRBs that review research protocols which are closed to accrual of new subjects but remain open for long-term follow-up of enrolled subjects who have completed all protocol-related interventions.
Please feel free to contact OPRR with any questions on the enclosed.
|Gary B. Ellis, Ph.D.||J. Thomas Puglisi, Ph.D.|
|Office for Protection from Research Risks||Division of Human Subject Protections|
February 19, 1997
Subject: Research That May Undergo Expedited Review
The purpose of this letter is to assist Institutional Officials and Institutional Review Board (IRB) Chairs in identifying research for which "expedited review" is appropriate, for both FDA- and HHS-regulated research.
In specific, we are writing to clarify that the IRB may use expedited review procedures for continuing review of research activities where 1) the protocol is permanently closed to the enrollment of new subjects; 2) all subjects have completed all protocol-related interventions; and 3) the protocol remains active only for long-term follow-up of subjects.
Expedited review procedures are described in 45 CFR 46.110 and 21 CFR 56.110. The IRB Chair, or one or more experienced reviewers designated by the Chair from among the members of the IRB, reviews the research and may either approve it or refer it to the IRB for full discussion.
Attached is a list of research activities for which expedited procedures may be used for initial review.
|Gary B. Ellis, Ph.D.||Stuart L. Nightingale, M.D.|
|Director||Associate Commissioner for Health Affairs|
|Office for Protection from Research Risks||Office of Health Affairs|
|Food and Drug Administration|
Research activities which may be reviewed through expedited review procedures
Research activities involving no more than minimal risk and in which the only involvement of human subjects will be in one or more of the following categories (carried out through standard methods) may be reviewed by the Institutional Review Board through the expedited review procedure authorized in 45 CFR 46.110 and 21 CFR 56.110.
(1) Collection of: hair and nail clippings, in a nondisfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction.
(2) Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
(3) Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice. This 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 weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, 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 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) [Pertains to 45 CFR 46.110, but not to 21 CFR 56.110] Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.
(10) [Category 9 under 21 CFR 56.110] Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
Sources: 46 Federal Register 8392 (January 26, 1981) and 46 Federal Register 8980 (January 27, 1981).