1) Exempt Status
Protocols that may be exempt from review by the IRB.
Note: Exempt status does not apply to research involving prisoners, fetuses, pregnant women, or human in vitro fertilization.
The following types of research are normally approved as exempt from IRB review. Research projects eligible for exemption include the following:
- Research to be conducted in established or commonly accepted educationally normal
educational practices, such as
- research on regular or special educational instructional strategies, or
- research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research which will involve the use of educational tests (cognitive, diagnostic, aptitude, achievement), if information taken from these sources is to be recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Surveys and Interviews
- Research that will involve survey or interview procedures, except where the subjects could be identified directly or through identifiers linked to the subjects. NO EXEMPTION can be given if the subject’s responses, if known outside the research, could place them at risk of civil or criminal liability, damage their financial standing or employability, or the research deals with sensitive areas such as illegal conduct, drug or alcohol use, or sexual behavior, or if the research can be anticipated to be distressful to adult subjects. In addition, NO EXEMPTION can be given for research with children, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
- Research that will involve survey or interview of elected or appointed public officials or candidates for public office.
- Research that will involve the observation (including observation by participant) of public behavior. NO EXCEPTION can be given if the subject’s responses, if known outside the research, could place them at risk of civil or criminal liability, damage their financial standing or employability, or the research deals with sensitive areas such as illegal conduct, drug or alcohol use or sexual behavior, or if the research can be anticipated to be distressful to adult subjects. In addition, NO EXCEPTION can be given if the research involves children as subjects.
- 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: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) 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 the Food Safety and Inspection Service of the of the U.S. Department of Agriculture.
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2) Expedited Reviews
Most protocols that involve no more than minimal risk and do not involve vulnerable populations of research participants (other than minors) and are not otherwise exempt from full IRB review (see below), may receive expedited review. This type of review necessitates that a subset of the full IRB, delegated this authority by the Chair, independently evaluates the protocol, and when all reviewers concur, the protocol is approved. When one or more of these IRB members cannot agree with approval of a protocol, the protocol is then referred to the full IRB for consideration at a convened meeting.
The IRB Chair, the relevant College or Site Representative, a Community Professional Representative, and one additional member of the IRB will review each Expedited review proposal. IRB staff transmits substantively complete protocols to reviewers within 24 hours of their receipt. Estimated response time for Expedited proposals is five-seven working days after receipt of a substantively complete protocol.
Research that involves no more than minimal risk and falls within one or more of the following categories (as outlined in 45 CFR 46.110 and listed below) can receive expedited review under most circumstances:
- Research conducted in commonly accepted educational settings involving normal educational practices, use of educational tests, survey procedures, interview procedures or observation of public behavior provided that the information obtained is recorded in such a manner that the participants cannot be identified and that any disclosure of the participants' responses outside the research could not reasonably place the participants at risk of criminal or civil liability nor be damaging to the participants' financial standing, employability, or reputation.
- Research and demonstration protocols that are designed to study, evaluate, or examine: public benefit or service programs; procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or, possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies.
- Use of educational tests, surveys and interviews in which the participants are elected or appointed public officials or candidates for public office or when Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Collection of hair and nail clippings, deciduous teeth, or permanent teeth that need extraction.
- Collection of excreta, sweat, or un-cannulated saliva.
- Collection and recording of data from participants 19 years or older using non-invasive procedures routinely employed in clinical practice (i.e., weighing, testing of sensory acuity, thermography, electrocardiography, electroencephalography).
- Collection of blood samples by venipuncture in amounts not exceeding 450 ml in an 8 week period and no more often than two times per week from participants 19 years or older and who are in good health and not pregnant.
- Collection of supra and sub-gingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and is accomplished in accordance with accepted prophylactic techniques.
- Voice recordings made for research purposes such as investigations of speech defects.
- Moderate exercise by healthy participants.
- Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development where the Principal Investigator does not manipulate participants' behavior and the research will not involve stress to participants.
- Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
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3) Full Reviews
Protocols require review by the full IRB at a convened meeting unless they meet the criteria for Expedited review or Exemption. This means protocols that involve more than minimal risk to research participants or vulnerable populations of research participants (other than minors when the protocol qualifies for expedited review) are reviewed by the IRB at a convened meeting. IRB meetings are held monthly at a time and place that is subject to change from semester to semester. See Schedule of Meetings for current information. Protocols that necessitate review at a convened meeting must be received by the IRB Chair office two weeks prior to the meeting date. Protocols that are substantively complete are sent to IRB members within 24 hours of their receipt. Estimated response time for Full Review proposals is four to six weeks after receipt of a substantively complete protocol.
Principal Investigators and Co-Principal Investigators may attend the IRB meeting to provide information to the members, but they may not be present during the final discussions and vote. IRB members may not participate in the review and approval process of their own protocols.
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4) Other Reviews
Other protocols where there is no immediate involvement of human participants, such as training grants or where the research protocol is not complete or the research instruments are yet to be developed, generally fall into a special category ("Indefinite Plans") that are reviewed solely by the IRB Chair. Upon completion of review a letter advising to proceed with the funding request will be sent to the Principal Investigator. A copy of this letter is sent to the Office of Research and Grants. When funded a detailed protocol describing the research (including the informed consent process and research instruments) must be reviewed and approved by the IRB. Allow four to six weeks for this process.