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" ... available if injury occurs and, if so, what they consist of, or where further information may be obtained; (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects... "
Code of Federal Regulations: Containing a Codification of Documents of ... - Page 129
1996
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Problems in Securing Informed Consent of Subjects in Experimental ..., Volume 4

United States. Congress. House. Committee on Small Business. Subcommittee on Regulation, Business Opportunities, and Technology - Law - 1994 - 290 pages
...research subjectst rights, and whom to contact in the event of a research-related injury to the subject. 8) A statement that participation is voluntary, refusal...benefits to which the subject is otherwise entitled. However, HHS regulations for Protection of Human Subjects provide an avenue, in certain narrow circumstances,...
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Problems in Securing Informed Consent of Subjects in Experimental ..., Volume 4

United States. Congress. House. Committee on Small Business. Subcommittee on Regulation, Business Opportunities, and Technology - Law - 1994 - 280 pages
...subjects' rights, and whom to contact in the event of a research-related injury to the subject. 8l A statement that participation is voluntary, refusal...benefits to which the subject is otherwise entitled. However, HHS regulations for Protection of Human Subjects provide an avenue, in certain narrow circumstances,...
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Cold War Era Human Subject Experimentation: Hearing Before the Legislation ...

United States. Congress. House. Committee on Government Operations. Legislation and National Security Subcommittee - Medical - 1994 - 236 pages
...research subjects' rights, and whom to contact in the event of a researchrelated injury to the subject • A statement that participation is voluntary, refusal...benefits to which the subject is otherwise entitled " 4 The regulations define minimal nsk as meaning "that the probability and magnitude of harm or discomfort...
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Problems in Securing Informed Consent of Subjects in Experimental ..., Volume 4

United States. Congress. House. Committee on Small Business. Subcommittee on Regulation, Business Opportunities, and Technology - Law - 1994 - 280 pages
...research subjects' rights, and whom to contact in the event of a research-related injury to the subject. 8) A statement that participation is voluntary, refusal...time without penalty or loss of benefits to which Ihe subject is otherwise entitled. However, HHS regulations for Protection of Human Subjects provide...
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Problems in Securing Informed Consent of Subjects in Experimental ..., Volume 4

United States. Congress. House. Committee on Small Business. Subcommittee on Regulation, Business Opportunities, and Technology - Law - 1994 - 296 pages
...research subjects' rights, and whom to conua in (be event of a research-related injury Ui Ihc subject 8) A statement that participation is voluntary, refusal...participation at any time without penalty or loss of benefits lo which (he subject is otherwise entitled. However, HHS regulations for Protection of Human Subjects...
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Research Ethics: Cases and Materials

Robin Levin Penslar - Business & Economics - 1995 - 346 pages
...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...loss of benefits to which the subject is otherwise entitled.7 In addition, where appropriate, further information must be provided: i. a statement that...
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The Code of Federal Regulations of the United States of America

Administrative law - 1995 - 436 pages
...whether any medical treatments are available if injury occurs and, if so, what they consist of, от where further information may be obtained; (7) An...following elements of information shall also be provided W each subject: (1) A statement that the particulai treatment or procedure may involve risks to the...
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Human Radiation and Other Scientific Experiments: The Federal Government's ...

United States. Congress. Senate. Committee on Governmental Affairs - Medical - 1995 - 188 pages
...research subjects' rights, and whom to contact in the event of a research-related injury to the subject. (8) A statement that participation is voluntary, refusal...benefits to which the subject is otherwise entitled. There is, of course, no guarantee that every research project involving human beings is submitted for...
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The Search for an AIDS Vaccine: Ethical Issues in the Development and ...

Christine Grady - Medical - 1995 - 220 pages
...committees (including the IRB which approved the protocol) and the data and safety monitoring board (DSMB). (8) a statement that participation is voluntary, refusal...benefits to which the subject is otherwise entitled Affirmation that each subject's participation is voluntary and refusal is not subject to penalty is...
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Human Radiation and Other Scientific Experiments: The Federal Government's ...

United States. Congress. Senate. Committee on Governmental Affairs - Medical - 1995 - 206 pages
...subject. (8) A statement that participation is voluntary, refusal to participate will involve no penaltv. or loss of benefits to which the subject is otherwise...benefits to which the subject is otherwise entitled. There is, of course, no guarantee that every research project involving human beings is submitted for...
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