49 CFR 11.109 - IRB review of research.
(b) An IRB shall require that information given to subjects as part of informed consent is in accordance with § 11.116. The IRB may require that information, in addition to that specifically mentioned in § 11.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
(c) An IRB shall require documentation of informed consent or may waive documentation in accordance with § 11.117.
(d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
(e) An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.
Title 49 published on 2015-10-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 49 CFR Part 11 after this date.