Institutional Review Board Manual
Research that Requires Approval
Research projects with human subjects may be exempt from Institutional Review Board (IRB) review only if they pose minimal risk to subjects. 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.
The following three categories of human subject research are exempt from IRB review:
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
- Information obtained is recorded in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects; and
- 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.
Note: The exemption for research involving survey or interview procedures or observation of public behavior does not apply to research with children.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if:
A. These sources are publicly available; or
B. The information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Note: The exemptions listed in items 1 and 2 above do not apply to research involving prisoners, fetuses, pregnant women, or human in vitro fertilization.
The concept of “identifiers” referred to in items 1 and 2 above is often confusing to researchers. Assigning codes to a subject and keeping the code in a secure place does not constitute de-identified data that exempts a project from IRB review. When it is possible to identify a subject, directly or indirectly through identifiers linked to the subject, the study must be reviewed by the IRB.
- Program Evaluation: The SCDMH IRB will exempt from IRB review data collection activities that are:
- Minimal risk: and
- For the sole purpose of evaluating the effectiveness of a service delivery program.
Program evaluation differs from research in a number of ways. For example, program evaluation is not intended to add to a body of common knowledge; it may be an evaluation component of a service grant whose effectiveness is already documented; it has no control group; and/or it may be a quality improvement activity reviewing data collected as a routine part of the treatment or assessment. If there is doubt about whether data collection is program evaluation or research, it should be submitted to the IRB.
Note: Categories 1 and 2 are a condensation of §46.101,b,1-6 of the Code of Federal Regulations, Title 45, Part 46. They are offered in abbreviated wording for the purpose of demonstrating the types of projects that may be considered for exempt review. The full text of federal regulations for exempt projects may be found at: