IRB: Frequently Asked Questions
What must be reviewed by the IRB?
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) data through interaction with the individual, or (b) identifiable private information.
Examples of work that must be reviewed by the IRB:
- 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.
Examples of work not considered research and does not require IRB review:
- Interviews by journalists conducted solely for the purpose of writing an article in a newspaper, magazine, or other media outlet are not considered research
What levels of review are conducted by the IRB?
The IRB may conclude that research falls in one of three categories.
Exempt Research includes the following:
Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation. Note: According to 45 CFR 46.401, if the subjects are children, this exemption applies only to research involving educational tests or observations of public behavior when the investigator(s) do not participate in the activities being observed
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 #2 (above) of this section if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
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 as manner that subjects cannot be identified, directly or through identifiers linked to the 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 approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Expedited reviews are conducted on the following types of research:
Some clinical studies of drugs and medical devices.
Some studies involving collection of blood samples.
Prospective collection of biological specimens for research purposes by noninvasive means.
Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
Collection of data from voice, video, digital, or image recordings made for research purposes.
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) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
Continuing review of some research previously approved by the IRB
Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
Full reviews are conducted by the IRB on all other types of research.
Who determines the appropriate level of review for a given project?
The researcher may request exempt, expedited, or full review, but the IRB makes the final determination.
Who needs training in the proper conduct of research involving human subjects?
Everyone, including students, who plans to engage in research involving human subjects will need training.
What training do I need in order to conduct research with human subjects?
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.
Do I have to request approval for each project in a research methods course?
Students do not have to submit individual IRB applications if they are enrolled in these courses and if the research is not intended for publication. However, course instructors must submit an blanket IRB Application of all projects in the course.
What do I have to do in order to get a proposal reviewed by the IRB?
Be sure the Office of Research and Sponsored Programs has evidence that you have undergone formal training in protection of human subjects.
Fill out the appropriate IRB Application.
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).
Include:
Questionnaires, surveys, tests, or other materials that will be administered to subjects.
Advertisements, letters, or flyers that will be used, if any.
Written permission from other institutions or agencies involved in the research (e.g., school board, hospital, agency, prison)
Submit all forms and materials to the Office of Research and Sponsored Programs (RSP), Suite 1A RSP Building. You may also submit electronically to IRB@tnstate.edu
How much time is required for IRB review?
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 at anytime, and review can normally be completed in 21 business days or less.
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 the no than the 10th day of every month to be reviewed at the IRB meeting for that month. All applications submitted after the 10th of every month will be reviewed at the monthly meeting of the IRB for the following month.
How long is a research project approval good for?
Research projects are approved for one year, but never longer. If your project will go beyond the approval expiration date, you must file an Amendment form with the IRB.
What if my research project was approved by the IRB and I want to change it?
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, an Amendment Form with the IRB
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.