Exempt vs. Expedited vs. Full Board

Exempt

Federal guidelines identify those research activities that are exempt and therefore do not require full IRB review. The following information on exempt categories is from 45CFR46.104(d).

Unless otherwise required by federal department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt. Note that these exemptions may not apply to research that includes prisoners and children as human subjects.

1. Research, conducted in established or commonly accepted educational settings, that specifically involves normal education 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.
2. 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:
   1. information obtained is recorded by the investigator in such a manner that the identity human subjects cannot be readily ascertained, directly or through identifiers linked to the subjects;
   2. 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;
   3. The information obtained is recorded by the investigator in such a manner that the identity of human subjects can be readily ascertained, directly or through identifiers linked to the subjects, and the IRB conducts a limited review to determine that there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of data.
      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.
3. 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:
   1. information obtained is recorded by the investigator in such a manner that the identity human subjects cannot be readily ascertained, directly or through identifiers linked to the subjects;
   2. 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;
   3. The information obtained is recorded by the investigator in such a manner that the identity of human subjects can be readily ascertained, directly or through identifiers linked to the subjects, and the IRB conducts a limited review to determine that there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of data.
      Note: 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 unlikely to be 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 he or she will be unaware of or misled regarding the nature or purposes of the research.
4. Secondary research involving the use of non-identifiable information or biospecimens, or secondary research involving the use of identifiable private information or identifiable biospecimens if at least one of the following criteria is met:
   1. The identifiable private information or identifiable biospecimens are publicly available.
   2. 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.
   3. The investigator’s secondary use of identifiable private information is regulated under HIPPA as “healthcare operations,” “research,” or “public health.”
   4. The secondary research is conducted by or on behalf of a federal department or agency, using data collected or generated by the government for nonresearch purposes, and the information is subject to federal privacy standards and other requirements specified in the exemption.
5. Research and demonstration projects that are conducted or supported by a federal department or agency, or otherwise subject to the approval or department or agency heads, and that are designed to study, evaluate, improve, or otherwise examine:
   1. public benefit or service programs
   2. procedures for obtaining benefits or services under these programs
   3. possible changes in or alternatives to these programs or procedures
   4. possible changes in methods or levels of payment for benefits or services under these programs
      Note: 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.
6. Taste and food quality evaluation and consumer acceptance studies if:
   1. wholesome foods without additives are consumed, or
   2. 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.
7. Storage or maintenance for potential secondary research of identifiable private information or identifiable biospecimens, provided that the IRB conducts a limited review and determines that broad consent from human subjects has been properly obtained and documented for the storage, maintenance, and secondary research use of their identifiable materials.
8. Secondary research involving the use of identifiable private information or identifiable biospecimens for which broad consent was obtained and documented, provided that the IRB conducts a limited review and determines that the research to be conducted is within the scope of this broad consent and that the investigator does not include returning individual research results to subjects as part of the study plan.

If you have any questions regarding the exempt categories defined above, please contact the IRB Chair for assistance.

Expedited

The following information on expedited review categories is from the Federal Register (63 FR 60364-60367, November 9, 1998).

Applicability

1. 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.
2. The categories listed herein apply regardless of the subject’s age, except as noted.
3. 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.
4. The expedited review procedure may not be used for classified research involving human subjects.

Research Categories for Expedited Review

1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
   1. 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.
   2. 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.
2. Prospective collection of biological specimens for research purpose by noninvasive means. Examples include:
   1. hair and nail clippings in a nondisfiguring manner;
   2. deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
   3. permanent teeth if routine patient care indicates a need for extraction;
   4. excretia and external secretions (including sweat);
   5. 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;
   6. placenta removed at delivery;
   7. amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
   8. supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic techniques;
   9. mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washing;
   10. sputum collected after saline mist nebulization.
3. 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:
   1. 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;
   2. weighing or testing sensory acuity;
   3. magnetic resonance imaging;
   4. electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography;
   5. moderate exercise, muscular strength testing, body composition assessment and flexibility testing where appropriate given the age, weight and health of the individual.
4. 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 DIRB Section 5.2.1, #4). This listing refers only to research that is not exempt.
5. Collection of data from voice, video, digital or image recordings made for research purposes.
6. 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 DIRB Section 5.2.1, #2 and #3). This listing refers only to research that is not exempt.

Full Board

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.