IRB Guidelines - Levels of Review
At the University of Massachusetts Amherst all research involving human subjects conducted by those acting as an agent of UMASS Amherst, regardless of where the research is done or what category of review it falls into, must be submitted to the IRB for review if the research is funded. Unfunded research may be reviewed at the local level if an authorized Local Review Board (LRB) exists within your department/college.
To qualify for Expedited review, research must fall into any of seven (7) regulated categories. Expedited reviews are conducted by at least one experienced member of the IRB members. Common examples of Expedited research at UMASS include:
- Studies involving moderate exercise by healthy volunteers,
- Analyses of data collected via recordings (such as those taken in the investigation of speech defects),
- Linguistic and ethnographic studies, or Studies involving focus groups,
- Collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects.
For more information, see Expedited categories.
To qualify for Exempt level review, the research study must fall into any of six (6) categories delineated in the federal regulations listed below. Exempt DOES NOT mean the study is exempt from IRB review. The categories represent studies that present minimal risk to subjects. Risk is reduced through anonymity of responses, use of data from human subjects that is existing or publicly available, or through the use of non-invasive paradigms that will not harm subjects. NOTE: Exempt review may not be used for deception research, where prisoners are subjects or for some research using children as participants.
For more information, see Exempt categories.
Full Board Review
Proposed research involving human subjects that does not qualify for Exempt or Expedited review, must be reviewed by the IRB at a convened meeting (Full Board review level). Studies requiring Full Board review present more than minimal risk to subjects and/or involve vulnerable populations.
For more information, see the Full Board IRB meetings schedule.