Search Images Maps Play YouTube News Gmail Drive More »
Sign in
Books Books
" ... 1 . a 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... "
Code of Federal Regulations: Containing a Codification of Documents of ... - Page 268
1999
Full view - About this book

Validation Compliance Annual: 1995

International Validation Forum - Science - 1995 - 1200 pages
...changed circumstances. 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information...confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the...
Limited preview - About this book

Human Radiation and Other Scientific Experiments: The Federal Government's ...

United States, United States. Congress. Senate. Committee on Governmental Affairs - Government publications - 1995 - 176 pages
...also explicitly set forth in CFR 46.116(a). The basic elements of consent include the following: (1) A statement that the study involves research,...confidentiality of records identifying the subject will be maintained. (6) For research involving more than minimal risk, an explanation as to whether any...
Full view - About this book

Research Ethics: Cases and Materials

Robin Levin Penslar - Medical - 1995 - 278 pages
...description of the procedures to be followed, and identification of any procedures which are experimental; z. a description of any reasonably foreseeable risks...confidentiality of records identifying the subject will be maintained; 6. for research involving more than minimal risk, an explanation as to whether any compensation...
Limited preview - About this book

Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1996
...sponsor, the institution or its agents from liability for negligence. (a) Baste elements of in formed consent. Except as provided in paragraph (c) or (d)...confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any...
Full view - About this book

The Code of Federal Regulations of the United States of America

Administrative law - 1996
...52817, Dec. 21, 1990] 50.25 Elements of informed consent. (а) Basic elements of informed consent. In seeking informed consent, the following information...confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the...
Full view - About this book

Idea to Product: The Process

Nancy J. Alexander, Anne C. Wentz - Medical - 1996 - 200 pages
...procedures that are experimental. 3. A description of any benefits to the subject or to others that may reasonably be expected from the research. 4. A...confidentiality of records identifying the subject will be maintained. 6. For research involving more than minimal risk, an explanation as to whether any compensation...
Limited preview - About this book

Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1997
...reasonable manner. (Approved by the Office of Management and Budget under control number 9999-0020) S 16.116 General requirements for Informed consent. Except...advantageous to the subject; (5) A statement describing trie extent, if any, to which confidentiality of records identifying the subject will be maintained;...
Full view - About this book

Medical Ethics

Robert M. Veatch - Medical - 1997 - 461 pages
...subparts, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective...confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk, an explanation as to whether any...
Limited preview - About this book

Oversight of NIH and FDA: Bioethics and the Adequacy of Informed Consent ...

U. S. Government Staff, United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources - Bioethics - 1997 - 228 pages
...risks or discomforts to the subject 3) A description of any benefits to the subject or to others that may reasonably be expected from the research. 4) A...confidentiality of records identifying the subject will be maintained. 6) For research involving more than minimal risk, an explanation as to whether any compensation...
Full view - About this book

Oversight of NIH and FDA: Bioethics and the Adequacy of Informed Consent ...

U. S. Government Staff, United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources - Bioethics - 1997 - 228 pages
...risks or discomforts to the subject. 3) A description of any benefits to the subject or to others that may reasonably be expected from the research. 4) A...confidentiality of records identifying the subject will be maintained. 6) For research involving more than minimal risk, an explanation as to whether any compensation...
Full view - About this book




  1. My library
  2. Help
  3. Advanced Book Search
  4. Download EPUB
  5. Download PDF