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 |
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Page 60
... the Nuremberg Code , among a number , is that studies in experimental animals need to be done before substances are given to humans for the first time . Informed consent is another one . But in terms of our requirements for animal 60.
... the Nuremberg Code , among a number , is that studies in experimental animals need to be done before substances are given to humans for the first time . Informed consent is another one . But in terms of our requirements for animal 60.
Page 176
... consent . 46.117 Documentation of informed consent . 46.118 Applications and proposals lacking definite plans for involvement of human subjects . 46.119 Research undertaken without the intention of involving human subjects . 46.120 ...
... consent . 46.117 Documentation of informed consent . 46.118 Applications and proposals lacking definite plans for involvement of human subjects . 46.119 Research undertaken without the intention of involving human subjects . 46.120 ...
Page 177
... consent of each participant or subject . § 46.102 Definitions . ( a ) Secretary ' ' means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom authority has ...
... consent of each participant or subject . § 46.102 Definitions . ( a ) Secretary ' ' means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom authority has ...
Page 179
... consent is in accordance with 46.116 . The IRB may require that information , in addition to that specifically mentioned in § 46.116 , be given to the subjects when in the IRB's judgment the information would meaningfully add to the ...
... consent is in accordance with 46.116 . The IRB may require that information , in addition to that specifically mentioned in § 46.116 , be given to the subjects when in the IRB's judgment the information would meaningfully add to the ...
Page 180
... consent will be sought from each prospective subject or the subject's legally authorized representative , in accordance with , and to the extent required by § 46.116 . 45 CFR 45 ( 5 ) Informed consent will be appropriately documented ...
... consent will be sought from each prospective subject or the subject's legally authorized representative , in accordance with , and to the extent required by § 46.116 . 45 CFR 45 ( 5 ) Informed consent will be appropriately documented ...
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Common terms and phrases
amended amphetamine appropriate approval Attorney bill California Chairman chemical structure chemists clandestine laboratories Committee compounds conducted CONGRESS THE LIBRARY controlled substance analogs Controlled Substances Act Cosmetic Act criminal Department of Health designer drug manufacture designer drug problem drug abuse Drug Enforcement Drug Enforcement Administration drug or substance effect emergency scheduling exemption Federal Food fentanyl analogs fetus Florida Food and Drug GRINSPOON HAWKS Health and Human heroin HUGHES human consumption Human Services human subjects illegal illicit drug individuals informed consent Institutional Review Board intended for human intent to distribute investigational law enforcement legislation legitimate research LIBRARY OF CONGRESS LUNGREN MCCOLLUM MDMA meperidine MPPP MPTP NIDA paragraph Parkinson's disease potential procedures produce programs public health regulations research involving Secretary of Health Senator CHILES specific statement studies subpart substance in Schedules substantially similar synthetic Thank therapeutic tion Tocus toxicity trolled substance
Popular passages
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...