Projects need to be submitted to the IRB for review when research involving human interaction is about a person or group, and includes a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102.d).
For a detailed breakdown of whether your research may require IRB review or at what review category it should be submitted, please see the OHRP Human Subjects Regulations Decision Charts. Please note that individual institution’s IRB’s may interpret regulations differently and it is important to check with your institution’s IRB for the appropriate interpretation for your institution. Also, all Exempt studies MUST be submitted to the RU IRB for review. For further information, please contact the IRB Office at 540-831-5290 or firstname.lastname@example.org.
Classroom Exercises (does not include INDEPENDENT STUDIES OR OTHER INDIVIDUALIZED RESEARCH ACTIVITIES)
Classroom exercises are those activities that are designed to provide classroom instruction concerning research methodology and that involve human interaction, but that are not intended to generate data for publication beyond presentation at the Radford University Undergraduate/Graduate Student Engagement Forum and the Masters of Social Work Poster Presentation.
However, please note the following limitations/exclusions from Classroom Exercises:
- No minors or vulnerable populations,
- No more than minimal risk activities,
- No intervention with the subjects,
- No deception of the subjects,
- No audio or video recordings
- Not for independent or directed studies, dissertations, theses, honors theses, or any other individualized learning experience.
Please contact the IRB Office PROMPTLY if you have any questions about your proposed project.
It is the instructor's responsibility to ensure that the criteria are met appropriately. Please read and review the entire Classroom Exercise Guidelines [PDF] and, if desired, the optional Classroom Exercise Agreement [PDF] may be used between student and instructor to ensure that the criteria are appropriately discussed and understood.
Review Method: Those human subjects activities meeting the criteria of Classroom Exercises are not submitted to the IRB for review.
Exempt research must be of minimal risk. According to 45 CFR 46.102(i), minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Review Method: Exempt research submissions are not reviewed at convened meetings. They are reviewed individually as they are received.
Listed below are the six categories of human subjects research that the federal government considers to be exempt:
1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
a. research on regular and special education instructional strategies, or
b. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
c. the research is not FDA regulated
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 of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
c. the research involves surveys of children, interviews of children, or observation of public behavior of children where the investigators participate in the activities being observed.
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 #2 of this section, if:
a. the human subjects are elected or appointed public officials or candidates for public office; or
b. federal statutes require without exception that the confidentiality of the personally identifiable information will be 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; 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, (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.
Protocols determined to be minimal risk, but not falling into any exempt category, may be considered for Expedited review.
Review Method: Expedited research submissions are not reviewed at convened meetings. They are reviewed individually as they are received via the Expedited review process, as allowed by federal law.
Research must meet all of the following criteria in order to be reviewed by the IRB through an Expedited review procedure (45 CFR 46 §110):
1. Be of minimal risk to the subjects
2. Must not involve prisoners or mentally impaired persons
3. Must be in one or more of the following categories:
A. Clinical studies of : (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.) (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
B. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or (b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection may not occur more frequently than 2 times per week.
C. Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
D. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subjects privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
E. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
F. Collection of data from voice, video, digital, or image recordings made for research purposes.
G. 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)(2) and (b)(3). This listing refers only to research that is not exempt.)
Full Board Review
All protocols determined by the IRB Administrator, Reviewer, or Board to be more than minimal risk (e.g., failing to meet the requirements of Exempt or Expedited Review) are required by federal and state regulation to be reviewed and approved by a fully convened IRB.
If your protocol is greater than minimal risk, you will be notified by the IRB Office with any required changes/corrections to the protocol prior to distributing the protocol documents to the committee.
Full board review protocols must be submitted 3 weeks in advance of the IRB meeting for all faculty submissions, and two weeks in advance for all graduate student protocols.
Review Method: Full Board submissions are reviewed at convened meetings of the IRB. The PI and/or research team is usually encouraged and invited to present and defend their research and to be available for any questions that the Board may have.