The characteristic of minimal risk in a research study is most associated with:
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. What is meant by minimal risk in research?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.
What are the risks associated with research?Researchers are expected to take steps to minimize potential risks.. Physical risks. Physical risks include physical discomfort, pain, injury, illness or disease brought about by the methods and procedures of the research. ... . Psychological risks. ... . Social/Economic risks. ... . Loss of Confidentiality. ... . Legal risks.. What are examples of minimal risk in research?Examples of Minimal Risk are: Study poses no more risk than expected in daily life (e.g., blood draw, physical exam, routine psychological testing). Non-interventional studies (e.g., observational studies of behavior or nutrition). Survey/Questionnaire studies of a non-sensitive nature.
How can you minimize risk in research?These include:. Using procedures that are consistent with sound research design.. Not exposing subjects to unnecessary risk.. Using procedures already being performed on the subjects for diagnostic or treatment purposes.. Prescreening to identify and eliminate high-risk participants,. |