Designer Drugs: Hearing Before the Subcommittee on Crime of the Committee on the Judiciary, House of Representatives, Ninety-ninth Congress, First Session, on H.R. 2014, H.R. 2977, H.R. 3936, and S. 1437, May 1, 1986
U.S. Government Printing Office, 1986 - Designer drugs - 199 pages
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Page 39 - I would be pleased to respond to any questions you or members of the committee may have.
Page 178 - Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Page 178 - Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (ie, the identity of the subject is or may readily be ascertained by the investigator or...
Page 33 - No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) is effective with respect to such drug.
Page 178 - ... for determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review...
Page 177 - Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available, or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Page 179 - Except when an expedited review procedure is used (see § 46. 1 10), review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.
Page 185 - The purpose of the activity is to meet the health needs of the mother and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or (2) the risk to the fetus is minimal.
Page 178 - A statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the research is subject to federal regulation.
Page 188 - The risk represents a minor increase over minimal risk; (b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; 45 CFR Subtitle A (10-1-93 Edition) (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects...