IRB Review Levels
IRB Review Levels
At UNH there are three levels of Institutional Review Board review:
To qualify for Exempt level review, the research study must fall into any of six (6) categories delineated in the federal regulations. Exempt DOES NOT mean the study is exempt from IRB review. The categories represent studies that present minimal risk to subjects. Risk is minimized through anonymity of responses or through the use of non-invasive paradigms that will not harm subjects.
Exempt level reviews are conducted by one IRB member. Common examples of Exempt level research at UNH are:
- Anonymous surveys,
- Interviews of adults about non-sensitive topics,
- Educational tests, and
- Observation of public behavior.
Special guidelines apply to children included in research classified as Exempt. Please contact the Research Integrity Services (RIS) staff for more information.
For reviews of certain Exempt level studies (involving no greater than minimal risk) in the departments of Psychology and Sociology, contact the respective Department Chair.
To qualify for Expedited level review, research must fall into any of nine (9) regulated categories. Expedited categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects.
Expedited level reviews are conducted by two IRB members. Common examples of research that may be reviewed at the Expedited level at UNH are:
- Studies including blood samples taken from healthy volunteers,
- Studies involving moderate exercise by healthy volunteers,
- Collection of data via recordings (such as those taken in the investigation of speech defects),
- Studies of existing data or pathological specimens that include identifying information,
- Linguistic and ethnographic studies, or
- Studies involving focus groups.
Proposed research studies involving human subjects that do not qualify for Exempt or Expedited level review must be reviewed by the IRB at a convened meeting (Full Board level review). Studies requiring Full Board review present more than minimal risk to subjects, and/or involve vulnerable populations, such as children, prisoners, institutionalized individuals, or persons with diminished capacity to consent (e.g., Alzheimer patients).
Full Board studies are reviewed on a first come, first served basis by the IRB at scheduled meetings. Common examples of research reviewed at the Full Board level at UNH are studies that include:
- Maximal exercise (VO2 Max) by healthy volunteers,
- Institutionalized persons (e.g., prisoners, patients in long term care facilities)
- Persons who lack capacity to consent (e.g., persons with severe mental disabilities or developmental delays), or
- Sensitive topics (e.g., criminal behavior, sexuality).