 | Baruch A. Brody - Medical - 1998 - 412 pages
...short form written consent document stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject's...subjects with a written statement regarding the research. §46. 7 18 Applications and Proposals Lacking Definite Plans for Involvement of Human Subjects Certain... | |
 | Nancy M. P. King, Gail Henderson, Jane Stein - Medical - 1999 - 300 pages
...requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either: breach of confidentiality. Each subject will be asked...statement regarding the research. (Approved by the Off1ce of Management and Budget under Control Number 9999-0020). APPENDIX C CIOMS Epidemiological Research... | |
 | Administrative law - 2000 - 784 pages
...representative. When this method is used, there shall be a witness to the oral presentation. Also, the ERB shall approve a written summary of what is to be said...the research. (Approved by the Office of Management anc Budget under control number 9999-0020) {16.118 Applications and proposals lacking definite plans... | |
 | Administrative law - 2001 - 608 pages
...for the investigator to obtain a signed consent form for some or all subjects if it finds either: (l) That the only record linking the subject and the research...research. (Approved by the Office of Management and Budget under control number 9999-0020) (Authority: 5 USC 301; 20 USC 1221e-3, 3474; and 42 USC 300v-1(b))... | |
 | Daniel Farb, Bruce Gordon - Medical - 2005 - 337 pages
...short form written consent document stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject's...research. (Approved by the Office of Management and Budget under Control Number 9999-0020.) §46.118 Applications and proposals lacking definite plans... | |
 | Dorothea Magnus - Children - 2006 - 356 pages
...subject's wishes will govern; or (2) That the research presents no more than minimal risk of härm to subjects and involves no procedures for which written...research. (Approved by the Office of Management and Budget under control number 9999-0020) §46.1 18 Applications and proposals lacking definite plans... | |
 | Elizabeth A. Bankert, Robert J. Amdur - Institutional review boards (Medicine) - 2006 - 568 pages
...allows for a waiver of documentation of consent. Title §46. 117 Documentation of informed consent (c) An IRB may waive the requirement for the investigator...subjects with a written statement regarding the research. An example of research that fits under the waiver of documentation of consent would be an anonymous... | |
 | Administrative law - 2006 - 850 pages
...only record linking the subject and the research would be the consent document and the principal nsk would be potential harm resulting from a breach of...research. (Approved by the Office of Management and Budget under Control Number 0990-0260) [56 FR 28012, 28022. June 18, 1991, as amended at 70 FR 36328,... | |
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... a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form. (c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects... 
