...and by other Institutional and federal requirements. 32 CM Ch. I (7.1.93 Edition) (1) Minimal rltk means that the probability and magnitude of harm or...requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved...

...and for the purposes expressed in this policy. (h) IRB approval means the determination of the ШВ that the research has been reviewed and may be conducted...encountered in daily life or during the performance of rou§1230.103 tine physical or psychological examinations or tests. (J) Certification means the official...

...the following circumstances pertain: the research involves no more than minimal risk to the subjects; ("Minimal risk" means that the probability and magnitude...routine physical or psychological examinations or tests (45 CFR 46.102(i)).) g] the waiver, or alteration, of consent will not adversely affect the rights...

...anticipated in the research are not greater in and of themselves than those ordinarily encountered In dally life or during the performance of routine physical...requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved...

...additional pertinent information after participation. "Minimal risk" in both FDA and DHHS regulations means that, "the probability and magnitude of harm...physical or psychological examinations or tests." This definition is a key factor in the DHHS regulations. Whether to permit the waiver of informed consent...

...some or all consent elements if the research exposes subjects to no more than "minimal risk," meaning "that the probability and magnitude of harm or discomfort...routine physical or psychological examinations or tests."11 IRB's vary greatly in their interpretation of the risks of daily life. There are three provisions...

..."the research Involves no more than mtnUmal risk to subjects." Minimal risk is defined as follows: The probability and magnitude of harm or discomfort...physical or psychological examinations or tests.* Minimal risk is meant to serve as a threshold standard of risk that Is based upon the normal risks...

...exposes subjects to no more than "minimal risk," meaning "that the probability and magnitudes of harm of discomfort anticipated in the research are not greater...physical or psychological examinations or tests." Overall, IRBs are required to review research involving humans according to the following criteria:...

...262 and 263b-263n). (1) Minimal risk means that the probability and magnitude of harm or diecomfort anticipated in the research are not greater in and...routine physical or psychological examinations or tests. (m) Legally authorized representative means an individual or judicial or other body authorized under...

...event of an investigation conducted by a team of individuals, is the responsible leader of that team. (i) Minimal risk means that the probability and magnitude...physical or psychological examinations or tests. (j) Sponsor means a person or other entity that initiates a clinical investigation, but that does not actually...