The Use of Human Biological Materials in the Development of Biomedical Products: Hearing Before the Subcommittee on Investigations and Oversight of the Committee on Science and Technology, House of Representatives, Ninety-ninth Congress, First Session, October 29, 1985
United States. Congress. House. Committee on Science and Technology. Subcommittee on Investigations and Oversight
U.S. Government Printing Office, 1986 - Biomedical engineering - 278 pages
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academic activity addition applications appropriate approved basic become believe benefits biological materials biomedical biotechnology blood Board body cells Chairman changes concerned conducted consider continue Department determine direct disease doctor ethical example fact Federal funding gift give given going Government grant Health human subjects important individual industry informed consent institution interest involved issues knowledge LEVINE LIBRARY OF CONGRESS materials means MOORE obtained opportunity organ PACKARD participation particular patient person physician possible potential practice presented probably problem procedures profit programs proposed protection question reasonably regulations REIMERS relationship removed representative respect risk scientific scientists Secretary situation specific statement subpart Thank things tion tissue understand unique VOLKMER
Page 171 - ... 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...
Page 170 - Suspension or termination of IRB approval of research. An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.
Page 170 - Risks to subjects are reasonable In relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
Page 172 - A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable...
Page 171 - No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
Page 186 - This is a question of justice, in the sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally.
Page 169 - IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. (e) An IRB shall...
Page 176 - The risks to the subject are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept these risks...
Page 174 - Viable" as it pertains to the fetus means being able, after either spontaneous or induced delivery, to survive )given the benefit of available medical therapy) to the point of independently maintaining heart beat and respiration. The Secretary may from time to time, taking into account medical advances, publish in the Federal Registei guidelines to assist in determining whether a fetus is viable for purposes of this subpart.