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" An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary, refusal... "
The Code of Federal Regulations of the United States of America - Page 200
1992
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The Code of Federal Regulations of the United States of America

Administrative law - 2002 - 996 pages
...that participation ii voluntary, refusal to participate will involve no penalty or loss of benefits tc which the subject is otherwise entitled, and the subject...information shall also be provided to each subject: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1995 - 754 pages
...participate will involve no penalty or loss of benefits to which the subject is otherwise entitled. 294 and the subject may discontinue participation at any...information shall also be provided to each subject: (1) A statement that the particular treatment or procedure may Involve risks to the subject (or to...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1996 - 460 pages
...participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time...information shall also be provided to each subject: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to...
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Recombinant DNA Research, Volume 9

DNA - 1986 - 588 pages
...treatments are available if injury occurs and, if so, what they consist of, or where further information nay be obtained; "(7) An explanation of whom to contact...benefits to which the subject is otherwise entitled." Specific points regarding gene therapy that follow from or relate to these general requirements are:...
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Protecting Human Subjects: First Biennial Report on the Adequacy and ...

United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research - Government publications - 1981 - 286 pages
...subjects' rights, and whom to contact in the event of a researchrelated injury to the subject; and (h) a statement that participation is voluntary, refusal...benefits to which the subject is otherwise entitled. Additional information must be provided, when appropriate: (a) A statement that the particular treatment...
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Oversight of the Drug Development Program of the National Cancer Institute ...

United States. Congress. Senate. Committee on Labor and Human Resources. Subcommittee on Investigations and General Oversight - Cancer - 1982 - 320 pages
...rights, and whom to contact in the event of a researchrelated injury to the subject; and (8) A statenent that participation is voluntary, refusal to participate...and the subject may discontinue participation at any tine without penalty or loss of benefits to which the subject is otherwise entitled. A complete HHS/FDA...
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The Code of Federal Regulations of the United States of America

Administrative law - 1998 - 668 pages
...extent, if any, to which confidentiality of records identifying the subject will be maintained; (б) For research involving more than minimal risk, an...information shall also be provided to each subject: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to...
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Biomedical-ethical Issues: A Digest of Law and Policy Development

Frank Harron - Law - 1983 - 192 pages
...whom to contact in the event of a research-related injury to the subject; and 132 Informed Consent (8) A statement that participation is voluntary, refusal...information shall also be provided to each subject: (1) A statement that the particular treatment or procedure may involve risks to the subject (or to...
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Health and the Law: A Primer for Health Professionals

Tom Christoffel - Law - 1985 - 472 pages
...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...loss of benefits to which the subject is otherwise entitled.36 An IRB may "approve a consent procedure that does not include, or which alters, some or...
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The Use of Human Biological Materials in the Development of Biomedical ...

United States. Congress. House. Committee on Science and Technology. Subcommittee on Investigations and Oversight - Biomedical engineering - 1986 - 288 pages
...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...information shall also be provided to each subject: Page 10 (1) A statement that the particular treatment or procedure may involve risks to the subject...
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