The Department of Health and Human Services federal regulations (45 CFR 46) define three types of IRB review. When submitting to the IRB, the VCU investigator makes the initial determination of what type of review a study may qualify for. Upon review of the research, the IRB makes the final determination.
The HHS and FDA regulations identify categories of research that are exempt from the regulations, although the ethical principles of study conduct still apply. Even though the research may be exempt, at VCU the determination of exemption must be made by the IRB. Exempt projects are different from expedited or full-board review in that they are not assigned an expiration date, do not have to undergo continuing review and are able to be modified in most cases without IRB approval.
To qualify for exemption, a research study must fall entirely within one or more of the six categories for exemption, and it cannot place subjects at greater than minimal risk. If the research involves prisoners, then it does not qualify for exemption from federal regulations and IRB review.
OHRP decision charts: Does my study qualify for exemption/which exempt category applies?
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 methods.
Notes about involving children:
Examples:
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:
Notes about involving children:
Examples:
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:
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. 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 they will be unaware of or misled regarding the nature or purposes of the research.
Notes about involving children:
Examples:
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:
Notes about involving children:
Examples:
Research and demonstration projects that are designed to study, evaluate, improve or otherwise examine public benefit or service programs, including:
In addition, projects that are:
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.
See OHRP guidance on types of programs that qualify for this exemption.
Notes about involving children:
Examples:
Taste and food quality evaluation and consumer acceptance studies, (1) if wholesome foods without additives are consumed or (2) if a food is consumed that contains a food ingredient at or below the level 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.
Notes about involving children:
At this time, VCU is NOT implementing exemption categories 7 and 8.
Expedited review means that the review can be done by a single qualified IRB member rather than at a convened IRB meeting. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study. When reviewers cannot approve the research under expedited review, the study is referred for full board review.
To qualify for expedited review, research must be no greater than minimal risk and involve only procedures described by specific categories identified in the federal regulations.
Clinical studies of drugs and medical devices only when condition (a) OR (b) is met.
(a) Research on drugs for which an investigational new drug application (21 CFR 312) is not required. (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 (1) an investigational device exemption application (21 CFR 812) is not required; or (2) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
Collection of blood samples by finger stick, heel stick, ear stick or venipuncture as follows:
(a) From healthy, non-pregnant adults who weigh at least 100 pounds. For these participants, the amounts drawn may not exceed 550 ml in an eight-week period and collection may not occur more frequently than two times per week; OR
(b) From other adults and children, considering the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an eight-week period, and collection may not occur more frequently than two times per week.
Prospective collection of biological specimens for research purposes by noninvasive means. Examples include:
Note: On Oct. 4, 2010, OHRP clarified that it agrees with the FDA’s position that the following procedures are considered noninvasive:
Collection of data through non-invasive 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 include:
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).
NOTE:
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 utilizing these procedures may qualify for exempt category 2.
Continuing review of research previously approved by the convened IRB as follows:
(1) Where (1) the research is permanently closed to the enrollment of new subjects; (2) all subjects have completed all research-related interventions and (3) the research remains active only for long-term follow-up of subjects; OR
(2) Where no subjects have been enrolled and no additional risks have been identified; OR
(3) Where the remaining research activities are limited to data analysis.
Note: Closure of enrollment only has to apply to the local site, not to all sites.
Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories 2 through 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 board review means that the research is reviewed at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. This type of review applies to studies that are greater than minimal risk, or minimal risk but do not qualify for exempt or expedited review.
Contact us
General questions
orsp@vcu.edu
(804) 828-0868
Questions related to IRB submissions
irbpanela@vcu.edu
Questions related to single IRB, reliance agreements and/or external IRBs
irbreliance@vcu.edu
For individual staff email addresses
See Contact us page for staff directory