| 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... | |
| 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... | |
| 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... | |
| 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... | |
| 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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