...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...

...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...

...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...

...wants documentation linking the subject with the research, and the subject's wishes will govern; or (b) That the research presents no more than minimal risk...provide subjects with a written statement regarding research. (Approved by the Office of Management and Budget under Control Number 9999-0020.) 9.12 RESEARCH...

...wants documentation linking the subject with the research, and the subject's wishes will govern; or (b) That the research presents no more than minimal risk...normally required outside of the research context. ln cases in which the documentation requirement is waived, the lRB may require the investigator to...

...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))...

...requirement for the investigator to obtain a signed consent form for some or all subjects if it finds . . . that the research presents no more than minimal risk...normally required outside of the research context. Scientifically, a study design with complete blinding was preferred because it eliminated any possibility...

...representative"). 806. See 45 CFR § 46.117(c) (2) (stating that the IRB may waive the signedconsent requirement if "the research presents no more than minimal risk of...normally required outside of the research context"); see also id. § 46.116(d) (1) (stating that the IRB may approve experimentation even if all the elements...

..."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...required outside of the research context. In cases where the documentation requirement is waived, the IRB may require the investigator to provide subjects...

...because the limited regulatory detail provided is written in the context of clinical research (ie, "that the research presents no more than minimal risk...normally required outside of the research context" (40 CFR 117(c) (2)). As discussed in Chapter 4, the committee finds the concept of "minimal risk" to...