...individual can reasonably expect that no observation or recording is taking place, and informa tion which has been provided for specific purposes by an...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...

...in Figure 7.1. In subsection 46.102 (i), the CFR suggests the following definition for minimal risk: Minimal risk means that the probability and magnitude...routine physical or psychological examinations or tests. Given that the study's risk classification determines its approval, this definition is a paramount...

...minimal risk on children is permissible. Minimal risk is defined in the federal regulations as meaning that "the probability and magnitude of harm or discomfort...routine physical or psychological examinations or tests."10 This definition leaves a number of issues open to interpretation. For example, different...

...the course of research that does not offer the prospect of direct benefit. Minimal risk is defined as "the probability and magnitude of harm or discomfort...routine physical or psychological examinations or tests."1'5'5"'1021'" The National Commission initially stipulated that this standard should be indexed...

...expedited review as long or longer than a full-board review, from the viewpoint of the researcher. probability and magnitude of harm or discomfort anticipated...physical or psychological examinations or tests." (Title 45 CFR Part 46, 2001, 102 (i)). In 1998, guidelines defining these procedures and to whom they...

...The second of these problems needs further discussion. According to 45CFR 46.1021, minimal risk means "the probability and magnitude of harm or discomfort...life or during the performance of routine physical and psychological examinations or tests." The description provides an inclusive disjunction that compares...

...two ambiguities. The term is defined as 'the probability and magnitude of physical or psychological harm or discomfort anticipated in the research are...routine physical or psychological examinations or tests'.52 While this definition details the breadth of what risks should be assessed, it lacks a subject...

...if the research involves no more than minimal risk to subjects, where minimal risk is defined such that "the probability and magnitude of harm or discomfort...routine physical or psychological examinations or tests" (§ 46.102(i)). The probability of harm or discomfort is likely to be remarkably small in most forms...

...additional pertinent information after participation.269 The regulations define "minimal risk" to о mean that "the probability and magnitude of harm or discomfort...routine physical or psychological examinations or tests."270 Drawing from the seminal work of the National о Commission for the Protection of Human...

...changes to a previously approved research project. Minimal risk for the Common Rule is defined as: The probability and magnitude of harm or discomfort...routine physical or psychological examinations or tests.10 Under expedited procedures that bypass the full IRB process, the IRB chair or one or more...