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Who Must Apply for IRB Review

Exemptions from Full IRB Review

Federal regulations have declared certain categories of human subjects research exempt from full IRB review. Generally speaking, exempted categories involve standard research activities that represent little or no risk to their human subjects. Research is generally not considered exempt from full IRB review if it employs deception, offers undue or inordinate financial incentives as inducements to imprudent risk-taking, exposes volunteers to hazardous materials, investigates new drugs or pharmaceutical products, or involves vulnerable populations such as prisoners, pregnant women, persons not capable of providing proper informed consent and (in some cases) minors. In all cases, exemptions are granted only to research in which data are recorded anonymously that is, information must be recorded in such a way that subjects cannot be identified either directly or through "linked identifiers" such as code numbers.

It is the prerogative of the Institutional Review Board, rather than the researcher, to determine whether a research project is exempted from full IRB review. Your Request for Ethical Review of Research on Human Subjects application will be promptly assigned on a rotating basis to a single IRB member for verification of exemption status. The application is not required to come before the full IRB if an exemption is granted. In some cases, the assigned IRB member may request additional information from the Principal Investigator for purposes of clarification. If the Board member does not verify the claim, the proposal will be scheduled for full IRB review.

Studies that are exempted from full IRB review are not required to provide written informed consent forms. However, the principle of respect for persons requires all researchers to provide prospective subjects with sufficient information to make an informed decision about their participation. The Institutional Review Board accordingly requires all research projects, including those exempted from full review, to include certain elements of informed consent. Specifically, all researchers must inform prospective participants in advance of the identities of the principal investigators, the names of sponsoring agencies (if any), and the purpose of the study. In addition, researchers must also provide prospective volunteers with assurances that their participation is voluntary and that the information they provide will remain anonymous. This information should be provided during oral introductions to telephone surveys and in-person interviews. The introductory statement to self-administered questionnaires should read as follows:

Title of Your Study

This study is being conducted by ___________ (Name of investigator), a(n) faculty member/student/administrator in the ___________ (Name of department or school) at Saint Xavier University. It is sponsored by ___________ (if applicable). The purpose of the study is to ___________. Your participation in this study is strictly voluntary; there are no penalties if you choose not to participate.

If you decide to participate, the information you provide will remain completely anonymous.

Special Instructions to Researchers Employing Questionnaires, Surveys and Interviews

While most research surveys do not require full IRB review, they still must be reported to the Institutional Review Board via a Request for Ethical Review of Research on Human Subjects application. Researchers who have developed a final version of their research instrument must include a copy of the instrument with their application. Researchers who are in the process of developing a survey instrument may still apply for exemption; however, they must submit the instrument to the IRB when it becomes available. In the special case of research employing open ended interviewing (such as ethnographies, anthropological/sociological field studies, comparative psychological case studies or focus groups), the researcher must inform the IRB of the topics of investigation and provide a list of research questions.