5.1.5 Review for Determination of Exempt Status
5.1.6 Expedited Review
5.1.7 Full Board Review
5.1.5 Review for Determination of Exempt Status
Federal guidelines identify those research activities that are exempt and therefore do not require full IRB review. If your proposed research falls under one of the exempt categories below, submit your protocol to the IRB Chair for determination of exempt status. (See Section 5.3.1 for information on submission requirements and review process.)
The following information on exempt categories is from 45CFR46.101(b).
Unless otherwise required by federal department or agency heads, research activities in which the only involvement of human subjects (excluding prisoners, fetuses, pregnant women or human in vitro fertilization) will be in one or more of the following categories are exempt:
- Research conducted in established or commonly accepted educational settings, involving normal education 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
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior UNLESS both of the following conditions hold:
- information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
- 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
Note: This exemption DOES NOT apply to minors, except for research involving public behavior when the investigators 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 paragraph 2 above, if:
- the human subjects are elected or appointed public officials or candidates for public office; or
- Federal statute(s) require(s) without exception that the confidentially 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 a 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 federal department or agency heads, and which are designed to study, evaluate or otherwise examine:
- public benefit or service programs
- procedures for obtaining benefits or services under these programs
- possible changes in or alternatives to these programs or procedures
- possible changes in methods or levels of payment for benefits or services under these programs
- Taste and food quality evaluation and consumer acceptance studies if:
- wholesome foods without additives are consumed, or
- a food is consumed that contains a food ingredient at or below the level and for a use found to be safe by the FDA or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
If you have any questions regarding the exempt categories defined above, please contact the IRB Chair for assistance.
5.1.6 Expedited Review
Federal guidelines identify those research activities eligible for expedited IRB review. If your proposed research meets the applicability requirements described below and falls under one of the expedited review categories identified below, submit your protocol to the IRB for expedited review. (See Section 5.3.2 for information on submission requirements and review process.)
The following information on expedited review categories is from the Federal Register (63 FR 60364-60367, November 9, 1998).
- Research activities that 1) present no more than minimal risk to human subjects and 2) involve only procedures listed in one or more of the following categories may be reviewed by the IRB through expedited review. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
- The categories listed herein apply regardless of the subject’s age, except as noted.
- The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of privacy and breach of confidentiality are no greater than minimal.
- The expedited review procedure may not be used for classified research involving human subjects.
Research Categories for Expedited Review
- Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
- Research on drugs for which an investigational new drug application (21CFR312) is not required. Note: Research on marketed drugs that significantly increases risk or decreases the acceptability of risks associated with the use of the product is not eligible for expedited review.
- Research on medical devices for which 1) an investigational device exemption (21CFR812) 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.
- Prospective collection of biological specimens for research purpose by noninvasive means. Examples include:
- hair and nail clippings in a nondisfiguring manner;
- deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
- permanent teeth if routine patient care indicates a need for extraction;
- excretia and external secretions (including sweat);
- uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum base or was or by applying a dilute citric solution to the tongue;
- placenta removed at delivery;
- amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
- supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic techniques;
- mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washing;
- sputum collected after saline mist nebulization.
- Collection of data through noninvasive procedures (not nvolving 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:
- 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 subject's privacy;
- weighing or testing sensory acuity;
- magnetic resonance imaging;
- electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography;
- moderate exercise, muscular strength testing, body composition assessment and flexibility testing where appropriate given the age, weight and health of the individual.
- Research involving materials (data, documents, records or specimens) that have been collected solely for nonresearch purposes (such as medical treatment or diagnosis). Note: Some research in this category may be exempt from the DHHS regulations for the protection of human subjects (See Section 5.2.1, #4). This listing refers only to research that is not exempt.
- 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, identify, 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 DHHS regulations for the protection of human subjects (See Section 5.2.1, #2 and #3). This listing refers only to research that is not exempt.
5.1.7 Full Board Review
If your project involves human subjects and does not qualify for exempt status or expedited review, full board review is required. If funding support is requested from the federal government and human subject research is involved, full board review is required. All expedited reviews that are not approved will be subject to full board for final determination. In addition, the IRB can request a full board review of any protocol that has been approved through the expedited review process. (See Section 5.3.3 for information on submission requirements and review process.)