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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. (8) A statement that participation is voluntary, that... "
Code of Federal Regulations: Containing a Codification of Documents of ... - Page 254
1996
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The Code of Federal Regulations of the United States of America

Administrative law - 1990 - 460 pages
...subject's participation, a description of the proce§50.20 Food and Drug Administration, HHS dures to be followed, and identification of any procedures...that the subject may discontinue participation at ajny time without penalty or loss of benefits to which the subject is otherwise entitled. (b) Additional...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1998 - 692 pages
...participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time...informed consent. When appropriate, one or more of the following1 elements of information shall also be provided to each subject: (1) A statement that the...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1994 - 1112 pages
...participate will involve no penalty or loss of benefits tc which the subject is otherwise entitled and the subject may discontinue participation at any time...elements of informed consent. When appropriate, one 01 more of the following elements of Information shall also be provided tc each subject: (1) A statement...
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The Code of Federal Regulations of the United States of America

Administrative law - 2006 - 626 pages
...participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time...benefits to which the subject is otherwise entitled. Cb) Additional elements of informed consent. When appropriate, one or more of the following elements...
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Recombinant DNA Research, Volume 9

DNA - 1986 - 588 pages
...participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time...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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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1981 - 412 pages
...this section shall be submitted to the IRB within 5 working days after the use of the test article. § 50.25 Elements of informed consent. (a) Basic elements...that the subject may discontinue participation at any timewithout penalty or loss of benefits to which the subject is otherwise entitled. (b) Additional...
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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
...participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time...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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Health and the Law: A Primer for Health Professionals

Tom Christoffel - Law - 1985 - 472 pages
...participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time...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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Clinical Trials: Design, Conduct, and Analysis

Curtis L. Meinert, Susan Tonascia - Clinical trials - 1986 - 502 pages
...participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time...benefits to which the subject is otherwise entitled • When appropriate, one or more of the following elements of information shall also be provided to...
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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 - 304 pages
...WILL INVOLVE NO PENALTY OR LOSS OF BENEFITS TO WHICH THE SUBJECT IS OTHERWISE PAGE 7 ENTITLED, AND THE SUBJECT MAY DISCONTINUE PARTICIPATION AT ANY TIME...LOSS OF BENEFITS TO WHICH THE SUBJECT IS OTHERWISE ENTITLEDMR CHAIRMAN, THESE ELEMENTS OF INFORMED CONSENT WERE DISTILLED FROM HUNDREDS OF HOURS OF DELIBERATION...
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