...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...

...a potential breach of confidentiality. Similarly, documentation can be waived when a study involves no more than minimal risk of harm to subjects and...normally required outside of the research context (45 CFR 46.117(c)). With the prospect of commercial gain and the use of exculpatory language, some...

...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...

...subject and the research would be the consent document and the principal risk would be potential härm resulting from a breach of confidentiality. Each subject...the research presents no more than minimal risk of härm to subjects and involves no procedures for which written consent is normally required outside...

...subject, or the subject's legally authorized representative, sign a written consent form if it finds that the research presents no more than minimal risk...which written consent is normally required outside the research context; or (2) The IRB may, for some or all subjects, find that the requirements in Sec....

...46.117c) indicate that IRBs can waive requirements for signed consent forms when the research poses only minimal risk of harm to subjects and involves no procedures...normally required outside of the research context, but local IRBs are responsible for interpreting these regulations. An IRB is most likely to require...

...wants documentation linking the subject with the research, and the subject's wishes will govern. 2. The research presents "no more than minimal risk"...outside of the research context. In cases in which the consent documentation requirement is waived, the IRB may require the investigator to provide subjects...

...subject, or the subject's legally authorized representative, sign a written consent form if it finds that the research presents no more than minimal risk...which written consent is normally required outside the research context; or (2) The IRB may, for some or all, find that the requirements in Sec. 50.24...

...form written consent document stating that the elements of informed consent required by Sec. 219.116 have been presented orally to the subject or the subject's...which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research....

...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...