Exemptions

The basic premise of the human and animal subjects review process is that all studies are subject to continuous review. However, some studies may require only an initial review and are EXEMPT from ongoing review. No study is totally exempt from review. The Institute has adopted six categories of research as exempt from continuing Institute Review Board for the Protection of Human Subjects (IRB) review based upon Department of Health and Human Services (DHHS) regulations published in the Code of Federal Regulations, 45 CFR 46, March 8, 1983 and amended in the Federal Register on June 18, 1991. In order to establish an individual research project as exempt, an investigator must complete an IRB application. On the IRB application the investigator should indicate the number of the category under which an exemption is claimed. Final determination as to whether a project is exempt rests with the IRB.

If a research project is certified as exempt by the IRB, the investigator need not resubmit the project for continuing IRB review as long as there are no modifications in the exempted procedures. In other words, the use of the term "exempt" refers to the requirement for continuing IRB review but not to the general requirements for informed consent and protection of subjects. Thus, even if a project is determined to be exempt, the investigator still must inform potential subjects of the proposed procedures and their rights as subjects.

In accordance with DHHS regulations for the Protection of Human Subjects (45 CFR 46, as amended), the following categories of exemption have been adopted by Indiana Institute of Pennsylvania. The exempt categories do not, however, apply to research involving deception of subjects (i.e., where the researcher deceives the subject with regard to the purpose of the research and/or the results of the subject's actions in the study), sensitive behavioral research, or to research involving pregnant women, prisoners, mentally disabled people, and other subject populations determined to be vulnerable.