Exempt Review Guidelines

While the Department of Health and Human Subjects does not dictate who determines whether research is exempt, CU-IRB’s policy is to review Exempt research in the same manner as Expedited research; however, the research can still be classified as exempt. Exempt review can be conducted by the IRB chair, other IRB members designated by the chair, or a subcommittee of the IRB.

 

The criteria for Exempt status follow all applicable federal regulations including: 45 CFR 46.101(b)(1) through (6), 45 CFR 46.301(a), 45 CFR 46.306(a) and (b), 45 CFR 46.401(b) and 21 CRF 56.104.  The criteria apply to all research regardless of funding or funding source.

 

These regulations identify specific categories of Exempt research activities and also identify when there are exceptions.  For research under CU-IRB policy, if a specific research activity meets the exemption criteria for one applicable regulation but not another, the research activity will not be given the Exempt status but will be processed under procedures for Expedited from Full Review.

 

To be classified as Exempt, the following criteria must be met:

  1. Research projects for instructional purposes and/or class demonstration, provided that the data obtained is not for formal analysis or future publication.  This type of research only needs to be reviewed from the CU-IRB Chair.  See “Research Not Needing Approval” on the website.
  2. Research conducted in established or commonly accepted educational settings, involving normal education practices such as
    1. Research on regular and special educational instructional strategies or
    2. Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
  3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior UNLESS:
    1. The information taken from these sources is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects; or
    2. Any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation; or
    3. The research involves children, except for research involving observations of public behavior when the investigator(s) does not participate in the activities being observed.
  4. Research involving the collection or study of existing data from publicly available sources.  Any identification of data by subject must be avoided unless the subject studied is a public figure.

Criteria for Protection of Human Subjects in Exempt Research:

While the research may be deemed Exempt from Expedited and Full Board Review, the research is not exempt from protection of human subjects. The following criteria must be met:

  1. The investigator assures that all investigators are trained in ethical principles
  2. The investigator assures that human subjects will voluntarily consent to participate in the research when appropriate and will provide subjects with pertinent information.
  3. The investigator assures that human subjects will be selected equitably, so that that risks and benefits of the research are justly distributed.
  4. The investigator assures the IRB will be immediately informed of any complaints from participants regarding their risks and benefits; and
  5. The investigator assures that confidentiality and privacy of the subjects and research data will be maintained appropriated to ensure minimal risk to subjects.