IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review: Exempt, Expedited, and Full. Show
Exempt ReviewStudies that receive an exemption determination from IRB are exempt from the specific regulations and requirements in Title 45, Part 46 of the Code of Federal Regulations. Please note, however, that they are still considered human subject research. If the proposed research involves no greater than minimal risk to participants and involves any of the following, it may qualify for exempt status in accordance with the revised Common Rule (effective January 21, 2019):
Expedited ReviewStudies that involve no more than minimal risk but which do not meet any of the above criteria for exempt status may be eligible for Expedited Review. According to the CFR, “minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” If the proposed research presents no more than minimal risk, does not involve any vulnerable populations (i.e., children, prisoners, individuals with impaired decision-making capacity, and/or economically or educationally disadvantaged persons), and involves any of the following, it may qualify for Expedited Review.
Full ReviewIf the proposed research does not qualify for Exempt or Expedited Review as defined above, it will be subject to a Full Review. In addition, if the proposed research involves any of the following, it will be subject to Full Review.
Protocols requiring Full Review are vetted by the entire IRB and discussed at a convened meeting. Please see our Timing of the IRB Process web page for submission deadlines and meeting dates for Full Review protocols. If you have questions about what type of review may be appropriate, contact the Chair of IRB at prior to submitting a proposal. IRB, however, makes all final determinations of what level of review is required. Which of the following studies would it not be appropriate to provide subjects with information about missing elements of consent?In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent: Your answer : A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.
Which of the following is considered a requirement of informed consent?Valid informed consent for research must include three major elements: (1) disclosure of information, (2) competency of the patient (or surrogate) to make a decision, and (3) voluntary nature of the decision. US federal regulations require a full, detailed explanation of the study and its potential risks.
Is disclosure of a subject's involvement in a specific research study?If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which of the following would be most helpful: Obtain a waiver of documentation of informed consent.
Which of the following is an example of exculpatory language?Examples of Exculpatory Language:
I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
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