...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...

...act or under sections 351 and 354-360F of the Public Health Service Act (42 USC 262 and 263b-263n). (i) Minimal risk means that the probability and magnitude...routine physical or psychological examinations or tests. (m) Legally authorized representative means an individual or judicial or other body authorized under...

...or under sections 351 and 354-360F of the Public Health Service Act (42 USC 262 and 263b-263n). (1) Minimal risk means that the probability and magnitude...routine physical or psychological examinations or tests. (m) Legally authorized representative means an individual or judicial or other body authorized under...

...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...

...research are not greater in and of themselves than those ordinarily encountered in daily §1c.102 §1c.!03 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...

...Data through intervention or Interaction with the individual, or (2) Identifiable private information. Intervention includes both physical procedures by...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...

...within the constraints set forth by the IBB and by other institutional and Federal requirements. (1) Minimal risk means that the probability and magnitude...examinations or tests. (j) Certification means the officiai notification by the institution to the supporting: department or agency, in accordance with...

...Intervention includes both physical procedures by which data are gathered (for example, venlpuncture) and manipulations of the subject or the subject's...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...

...approved research. In terms of the American regulations, research involves no more than minimal risk when the probability and magnitude of harm or discomfort...routine physical or psychological examinations or tests. (US Federal Policy, 1991: Section 102(i)) Adoption of expedited review (in these terms) could gready...

...public behavior when the investigator! s) do not participate in the activities being observed. tions of the subject or the subject's environment that are...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...