| Administrative law - 1994 - 1062 pages
...given to the subject or the representative, in addition to a copy of the short form. (c) An ГОВ may waive the requirement for the investigator to...research. (Approved by the Office of Management and Budget ander control number 9999-0020) 5 60.1 18 Applications and proposals lacking definite plane... | |
| Administrative law - 1987 - 502 pages
...actually obtaining consent shall sign a copy of the summary. A copy of the summary §46.117 §46.121 shall be given to the subject or the representative,...required outside of the research context. In cases where the documentation requirement is waived, the IRB may require the investigator to provide subjects... | |
| Administrative law - 1994 - 1082 pages
...be given to the subject or the representative, in addition to a copy of the short form. (c) An ШВ may waive the requirement for the investigator to...which the documentation requirement is waived, the !RB may require the investigator to provide subjects with a written statement regarding the research.... | |
| Administrative law - 1995 - 1102 pages
...a signed consent form for some or all subjects If It finds either: (1) That the only record Unking the subject and the research would be the consent...written statement regardIng the research. 'Approved by tbe Office of Management and Budget under control number 9999-0020) •745.118 Applications and proposals... | |
| Administrative law - 1995 - 1088 pages
...the research would be the consent document and the principal risk would be potential harm resulting1 from a breach of confidentiality. Each subject will...research. (Approved by the Office of Management and Budget under control number 9999-0020) §219.118 Applications and proposals lacking definite plans... | |
| Administrative law - 1999 - 492 pages
...research, and the subject's wishes will govern; or (2) That the research presents no more than minima.! risk of harm to subjects and involves no procedures...research. (Approved by the Office of Management and Budget under control number 9999-0020) § 1230.118 Applications and proposals lacking definite plans... | |
| Administrative law - 2007 - 512 pages
...of confidentiality. Each subject will be asked whether the subject wants documentation linking the j subject with the research, and the subject's wishes...the documentation requirement is waived, the IRB may reWire the investigator to provide subjects with a written statement regarding the research. (Approved... | |
| Kenneth Getz - Bioethics - 2007 - 377 pages
...be potential harm resulting from a breach of confidentiality. Each subject will be asked whetherthe subject wants documentation linking the subject with...outside of the research context. In cases in which the documenta296 tion requirement is waived, the IRB may require the investigator to provide subjects with... | |
| |