What must be reviewed by the IRB?
Examples of work that must be reviewed by the IRB
Examples of work that is not considered research and does not require IRB review
What levels of review are conducted by the IRB?
Who determines the appropriate level of review for a given project?
Who needs training in the proper conduct of research involving human subjects?
What training do I need in order to conduct research with human subjects?
Do I have to request approval for each project in a research methods course?
What do I have to do in order to get a proposal reviewed by the IRB?
How much time is required for IRB review?
What if my research project was approved by the IRB and I want to change it?
What do I do when I have finished my research project?
Any research activities that involve human subjects.
Research means a systematic investigation—including research, development, testing, and evaluation—designed to develop or contribute to generalizable knowledge. Dissemination of findings to a scientific audience is a sufficient criterion for identifying generalizable knowledge. Dissemination includes, but is not limited to, honor's, master's, and doctoral theses; presentation at a scientific meeting or conference; submission to or publication in a scientific journal; and Internet postings.
Human subject means a living individual about whom an investigator obtains (a) information or biospecimens through interaction with the individual, or (b) identifiable private information.
Research on individual or group characteristics or behavior (including but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior)
Research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
Clinical studies of drugs and medical devices, studies involving collection of body fluids, collection of biological specimens for research purposes by noninvasive means.
Interviews by journalists conducted solely for the purpose of writing an article in a newspaper, magazine, or other media outlet are not considered research and do not require IRB review.
Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
The IRB may conclude that research falls in one of the following three categories:
Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management method.
Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met: (i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (ii) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by § ll.111(a)(7).
Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met: (A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (B) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or (C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by § ll.111(a)(7). (ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else. (iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: (i) The identifiable private information or identifiable biospecimens are publicly available; (ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; (iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of ‘‘health care operations’’ or ‘‘research’’ as those terms are defined at 45 CFR 164.501 or for ‘‘public health activities and purposes’’ as described under 45 CFR 164.512(b); or (iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including 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. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended. (i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects. (ii) [Reserved]
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 approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by § ll.111(a)(8).
Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met: (i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with § ll.116(a)(1) through (4), (a)(6), and (d); (ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §ll.117; (iii) An IRB conducts a limited IRB review and makes the determination required by § ll.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.
The researcher may request exempt, expedited, or full review, but the IRB makes the final determination.
Everyone, including students.
Faculty should complete the CITI Program Training.
Students conducting independent research or research for a thesis should complete the same on-line training as described for faculty above.
Students in a research methods class should be trained by one of three methods detailed in the IRB policy (also detailed on Form H).
No. If the research is not intended for publication, you may file for certification of all projects in the course by using Form H. If theses or other publications are written as a result of the research in the course, file Form A.
Be sure the Office of Research and Sponsored Programs has evidence that you have undergone formal training in protection of human subjects.
Fill out Form A and a research summary.
Fill out Form B (exempt) or Form C (expedited), depending on the type of research you propose.
Prepare an informed consent form (unless you have a valid reason for waiver of this requirement).
Submit all forms and materials to the Office of Research and Sponsored Programs (ORSP), 1102 Blair Hall.
Studies submitted for exempt or expedited review are not reviewed at the monthly meetings of the IRB, but are reviewed by individual members of the IRB on a continual basis. These studies can be submitted to ORSP at anytime, and review can normally be completed in approximately two weeks.
Studies requiring full committee review can only be reviewed at one of the regular monthly meetings of the IRB. These studies should be submitted to ORSP no less than two weeks prior to the next scheduled monthly meeting of the IRB.
Any proposed modifications to the research project’s protocol or informed consent forms must be approved by the IRB prior to implementation.
To request a modification review, file Form D with the Office of Research and Sponsored Programs.
For minor modifications that do not change the substance of the project, the level of risk to the subjects, or the level of review required, the review timeline will be fairly short. For more than minor modifications, the review process and timeline are the same as for a new application.
When a research project has been completed, submit Form G to the Office of Research and Sponsored Programs. This will allow the IRB to close the active file.