Levels of ReviewInstitutional Review Board

This checklist is a guide to assist researchers in determining if research involving human subjects qualifies for Expedited review as specified by 45 CFR 46.111(OHRP) and 21 CFR 56.110 (FDA).

In order for research activities to be reviewed through the Expedited process, the activities must not present more than minimal risk and involve only procedures listed in one or more of the categories found below.

• Minimal risk generally means that the probability and magnitude of physical or psychological harm anticipated in research is not greater than those experienced in daily life, or in routine medical, dental, or psychological examinations.
• If your research procedures satisfy one or more of the Expedited categories, the “Request for Review of Expedited Research” should be completed/submitted as part of the Initial Application process (through InfoEd).
• If your research procedures do not satisfy the criteria for one or more of the expedited categories and/or your procedures involve more than minimum risk to the participants, the protocol should be submitted for Full Board Review as part of the Initial Application process (through InfoEd).

Clinical studies of drugs and medical devices only when conditions below are met

1. Research on drugs for which an investigational new drug (IND) 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.
2. 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 or 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

1. From healthy, non‐pregnant 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
2. 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.

Prospective collection of biological specimens for research purposes by noninvasive means

Examples include:

1. Hair and nail clippings in a non‐disfiguring 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. Excreta and external secretions (including sweat).
5. 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.
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 sub‐gingival 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.
9. Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings.
10. Sputum collected after saline mist nebulization.

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 a 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.

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: Some research in this category may be exempt from HHS regulations for the protection of human subjects. 45 CFR 46.111 (b)(4). This listing refers only to research that is not exempt.

Continuing review of research previously approved by the convened IRB as follows:

1. Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research‐related interventions; and (iii) 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

• UTMB Research Services‐IRB Office
• Office of Human Research Protection (OHRP) Code of Federal Regulations (45 CFR 46)

Effective January 21, 2019

This checklist is a guide to assist researchers in determining if research involving human subjects qualified for Exempt review as specific by the Office of Human Research Protection (OHRP) pursuant to 45 CFR 46.104 (d)(1-8).

If your research procedures satisfy one or more of the Exempt categories the research is considered exempt from annual IRB review and exempt from the informed consent requirements that apply to other types of research. However, some of the categories outlined below will require prospective participant agreement. Additionally, the “Request for Exemption” should be completed/submitted as part of the Initial Application process through InfoEd. Even when research is exempt from further requirements of federal regulations, basic ethical standards still apply.

• Except in the case of chart reviews or database research, potential subjects must be provided enough information to be able to choose whether or not to participate. The information would typically include the voluntariness of their participation, the purpose of the research, the nature of the subject’s involvement, time commitments, and contact information for the investigator.
• Research data must be handled and stored securely, in compliance with university policy
• Access to research data must be limited to study team members and other authorized personnel
• All members of the research team must be current on human subjects training and must have a current conflict of interest disclosure

Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are all of the following:

1. not likely to adversely impact students’ opportunity to learn required educational content
2. not likely to adversely impact 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 institutional techniques, curricula, or classroom management methods.

Guidance: There must not be any impact of subject’s opportunity to learn or any negative impact if the research involves an evaluation of the instructors. If the research involves significant time and attention away from the delivery of regular curriculum or withholding of standard educational content, this exemption would not apply. Also, there must be protection against negative impact on employment if instructors are being evaluated. Research involving randomization to a unproven educational technique, or research conducted by supervisors involved in employment decisions may not be approvable under this exemption.

Notes regarding vulnerable populations:

• Pregnant women may be included in this type of research.
• Research that targets a prisoner population is not eligible for this exemption.
• Research involving children is eligible for this exemption.

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. The information obtained 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;
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; or
3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

Guidance: This category involves interactions (verbal and written responses) and data collection only. The data collection can include audio or video recordings. Research involving “interventions” would not be approvable under this category. Interventions include manipulation of the environment or physical procedures to collection information, such as a cheek swab.

Research involving benign* behavioral interventions and collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subjects prospectively agrees to the interventions and information collection**, and at least one of the following criteria are met:

1. the information 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;
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 the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).

* For the purpose of this provision, 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. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

** 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.

Notes regarding vulnerable populations:

• Pregnant women may be included in this type of research.
• Research that targets a prisoner population is not eligible for this exemption.
• Research involving children is not eligible for this exemption.
• Research involving decisionally impaired persons is not eligible for this exemption.

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:

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 research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under HIPAA, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b);
4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities.

Guidance: Data or specimens under this exemption may be both retrospective and prospective. It is important to note the Exemption Category 4 only applies to the re-use of data and specimens that were or will be collected for non-research purposes or from research studies other than the proposed research study. The research materials typically will be publicly available materials, medical records or existing repositories of clinical specimens. No contact between investigator and subject is allowed. If an investigator wants to collect information/specimens directly from research subjects, then another approval path would be required.

Notes regarding vulnerable populations:

• Data/specimens from pregnant women may be included in this exemption.
• Data/specimens from a prisoner population is not eligible for this exemption.
• Data/specimens from children may be included in this exemption.
• Data/specimens from persons with decisional impairment may be included in this exemption.

Research and demonstration projects that are all of the following:

• conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects)
• designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.
• Published (prior to commencing the research involving human subjects) on a publicly accessible Federal website or in such other manner as the department or agency head may determine

Taste and food quality evaluation and consumer acceptance studies, if at least one of the following is true:

1. wholesome foods without additives are consumed.
2. 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.

Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review.

Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:

1. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with the requirements for informed consent;
2. Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §46.117;
3. An IRB conducts a limited IRB review and makes the determination required by §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and

The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.