IRB Guidelines: Exemptions

The basic premise of the human 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 University has adopted six categories of research as exempt from continuing Institutional 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 University 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.

Exempt Categories

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: (a) research on regular or special education instructional strategies, or (b) research on the effectiveness of or comparisons among instructional techniques, curricula, or classroom management methods.
   Educational research proposals are exempt providing all of the following conditions are met:
   
   1. All of the research is conducted in a commonly accepted educational setting (e.g., public school).
   2. The research involves normal educational practices (e.g., comparison of instructional techniques).
   3. The study procedures do not represent a significant deviation in time or effort requirements from those educational practices already existent at the study site.
   4. The study procedures involve no increase in the level of risk or discomfort associated with normal, routine educational practices.
   5. The study procedures do not involve sensitive subjects (e.g., sex education).
   6. Provisions are made to ensure the existence of a non-coercive environment for those students who choose not to participate.
   7. The school or other institution grants written approval for the research to be conducted.
      
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (a) information obtained is recorded in such a manner that human subjects can be identified, directly, or through identifiers linked to the subjects; and (b) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk for criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
   
   NOTE: Sensitive survey research is not exempt. A sensitive survey is one that deals with sensitive or highly personal aspects of the subject's behavior, life experiences or attitudes. Examples include chemical substance abuse, sexual activity or attitudes, sexual abuse, criminal behavior, sensitive demographic data, detailed health history, etc. The principal determination of sensitivity is whether or not the survey research presents a potential risk to the subject in terms of possible precipitation of a negative emotional reaction. An additional risk consideration is, of course, whether or not there is risk associated with a breach of confidentiality should one occur. With respect to potential psychological risk associated with a survey, the presence or absence of subject identifiers is not necessarily a consideration since the risk may be primarily associated with the sensitive nature of the survey as opposed to being dependent upon confidentiality. Subject identifiers do, however, become a factor when confidentiality is an issue.
   
   NOTE: When children are involved as subjects in research using survey or interview procedures, the research is not exempt.
   
   NOTE: When children are involved as subjects in research using observation techniques, the research is not exempt.
   
   NOTE: Observation research involving sensitive aspects of a subject's behavior is not exempt.
   
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph 2 of this section, if: (a) the human subjects are elected or appointed public officials or candidates for public office; or (b) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information is maintained throughout the research and thereafter.
   
4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects.
   
5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; and/or (d) possible changes in methods or levels of payment for benefits or services under those programs.
   
6. Taste and food quality evaluation and consumer acceptance studies: (a) if wholesome foods without additives are consumed; or (b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.