Problems in Securing Informed Consent of Subjects in Experimental Trials of Unapproved Drugs and Devices: Hearing Before the Subcommittee on Regulation, Business Opportunities, and Technology of the Committee on Small Business, House of Representatives, One Hundred Third Congress, Second Session, Washington, DC, May 23, 1994, Volume 4Distributed to some depository libraries in microfiche. |
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ALLER Ambu approved Belmont Report benefit BPRS factor scores Caplan cardiac arrest Chairman WYDEN clinical investigation clinical research clinical trials COMBEST Committee comparison periods conducted consent form deferred consent device doctors effect Emergency Medicine emergency room ethical experimental FDA's Food and Drug Francis Scott Key head injury HHS regulations human subjects research incompetent individual Institutional Review Board IRB review IRB's issues Johns Hopkins Katz Medical Center minimal risk monitored OPRR participation patients PENDERGAST physician placebo potential problems procedures prodromal prospective informed consent Protection from Research protection of human proxy consent psychotic relapse questions regulatory research involving research protocol Research Risks research study research subjects resuscitation research Rhode Island Hospital rights and welfare schizophrenia situation standard subcommittee Subcommittee on Regulation symptoms test article testimony therapeutic therapy tion tirilazad treatment Tuskegee Syphilis Study UCLA study Upjohn waiver of informed within-patients
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Page 231 - ... a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; 2.
Page 231 - ... (2) A description of any reasonably foreseeable risks or discomforts to the subject. (3) A description of any benefits to the subject or to others which may reasonably be expected from the research. (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food...
Page 232 - ... (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled...
Page 47 - 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 226 - I ) prospective and 2) continuing review of proposed research by a group of individuals with no formal involvement in the research. Ideally, it is a local review, by individuals who are in the best position to know the resources of the institution, the capabilities and reputations of the investigators and staff, and the prevailing values and ethics of the community and likely subject population.
Page 228 - When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Page 244 - Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law.
Page 234 - The Secretary may require that specific research activities or classes of research activities conducted or funded by the Department, but not otherwise covered by these regulations, comply with some or all of these regulations. (e) The Secretary may also waive applicability of these regulations to specific research activities or classes of research activities, otherwise covered by these regulations. Notices of these actions will be published in the FEDERAL REGISTER as they occur.
Page 252 - These formulations are (1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to each person according to merit.
Page 228 - ... specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas.