Study Risk Levels

Overview

Exempt Review means the research falls under the 8 categories of human subjects research that are exempt from the other provisions of the regulations. The regulations found in 45 CFR 46.101 have determined that the following eight categories of research are eligible for exemption status, [45 CFR 46.101(b)]: This review type does NOT mean that IRB Approval is not required.

Additional HIPAA Requirements That Indirectly Impact The Review Of Exemption Status: The Privacy Rule is a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996. [45 CFR 160 and 164]. If an IRB has been given the responsibility to consider HIPAA in research issues and if the research potentially falls under the purview of HIPAA, an IRB will be applying not only the 45 CFR 46 exemption categories but also determining if HIPAA applies. HIPAA applicability requirements vary compared to the DHHS exemption requirements. A research project that is exempt from the human research subject IRB requirements may not be exempt from HIPAA provisions. A project that is not exempt from IRB might be exempt from HIPAA. See the DHHS OHRP Guidance on Research Involving Coded Private Information or Biological Specimens, and the NIH and guidance entitled Institutional Review Boards and HIPAA Privacy Rule.

Under current federal regulations, any study approved under Exempt procedures does not have an expiration date of its IRB approval. There are times when you are required to follow-up with the IRB with your project, please see the Post Approval Section at bottom of linked webpage.

When Review of Exemption Status is Not Appropriate: According to the DHHS regulations 45 CFR 46, research involving the following are not appropriate for exemption: 1) Prisoner; 2) Surveying or interviewing of children; 3) Observations of public behavior of children when the investigator(s) participates in the activities being observed.

Exempt Review Categories

Exempt Category 1
    
Research in Established or Commonly Accepted Educational Settings:

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.

Exempt Category 2
    
Educational Tests, Surveys, Interviews, Observations of Public Behavior:

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 be readily ascertained, directly or indirectly through identifiers linked to the subjects; OR
2. Any disclosure of 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 be readily ascertained, directly or indirectly through identifiers linked to the subjects, AND an

IRB conducts limited IRB review. (See “WORKSHEET: Limited IRB Review and Broad Consent (HRP-319).”)
 
If the research involves children and is conducted, funded, or subject to regulation by DHHS, Dept. of Defense (DOD), Dept. of Education (ED), Environmental Protection Agency (EPA), or Veterans Administration (VA), the procedures are limited to (1) the observation of public behavior when the investigator(s) do not participate in the activities being observed or (2) the use of educational tests and 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 indirectly through identifiers linked to the subjects; OR
2. Any disclosure of 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 achievement, or reputation.
    

Exempt Category 3
    
Benign Behavioral Interventions in Conjunction with the Collection of Information From Adult Subjects

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. 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 indirectly, through identifiers linked to the subjects; OR
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 be readily ascertained, directly or indirectly through identifiers linked to the subjects, AND an IRB conducts limited IRB review. (See “WORKSHEET: Limited IRB Review and Broad Consent (HRP-319).”)

3 (iii). 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.
 
NOTE: 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.

Exempt Category 4
    
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; OR
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; OR

The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164 (HIPAA), subparts A and E, 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); (NOTE:  Because the Rutgers IRB also serves as the HIPAA Privacy Board for research, submissions under this category must be reviewed by an IRB member.)OR

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, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

Exempt Category 5
    
Research and Demonstration Projects that Are Conducted or Supported by a Federal Department or Agency
Research and demonstration projects which are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are 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.
 
(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal website 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.

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.

Exempt Category 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 Dept. of Agriculture.
 
Note that for FDA-regulated research exemption (6) is an exemption from IRB review in 21 CFR §56, but unlike DHHS regulations is not an exemption from FDA requirements for consent in 21 CFR §50. If an organization’s policy is to grant exemptions to FDA-regulated research in category (6), then additional criteria for such exemptions would be that consent will be obtained in accordance with 21 CFR §50.20 and §50.25, and the consent will be either be documented in writing in accordance with 21 CFR§50.27 or waived in accordance with 21 CFR §56.109(c)(1)

Exempt Category 7
Storage or Maintenance for Secondary Use for Which Broad Consent is Required
Storage or maintenance of identifiable private information or identifiable bio-specimens for potential secondary research use if an IRB conducts limited IRB review. (See “WORKSHEET: Limited IRB Review and Broad Consent (HRP-319).”)

Exempt Category 8     
Secondary Research for Which Broad Consent is Required

Research involving the use of identifiable private information or identifiable bio-specimens for secondary research use. (See “WORKSHEET: Limited IRB Review and Broad Consent (HRP-319).”)
 

Expedited review means that the review can be completed by a qualified IRB reviewer rather than at a convened IRB meeting.
 
Federal Regulations establish nine categories that IRBs may use to invoke the expedited review process. Institutions may adopt some or all of the categories when determining if a research activity can be appropriately reviewed by an expedited review process. Categories 1 through 7 pertain to both the initial and to the continuing IRB review. Categories 8 and 9 pertain only to continuing review. The 9 categories are listed below.
 
The Federal Regulations establish two main criteria for an expedited review. They are:

The research may not involve more than "minimal risk". "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." ([45 CFR 46.102(i)] and [21 CFR Part 56.102(i)])

The entire research project must be consistent with one or more of the following federally defined categories (quoted from the OHRP, the IRB oversight agency, guidance document on Expedited Reviews.)

Some institutions/IRBs have additional requirements. Check with your IRB office for more information about how expedited review is handled by your IRB.

Expedited Review Categories

Expedited Category 1

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 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.)

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.

Expedited Category 2

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 from other adults and children [2], 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.

Expedited Category 3 

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.

Expedited Category 4

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 subject's 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.

Expedited Category 5

Research involving data, documents, records, or specimens that: 1) Have been collected. or 2) Will be collected solely for non-research purposes (such as for medical treatment or diagnosis).

Note: Some research in this category may be exempt from the DHHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.

Expedited Category 6

Collection of data from voice, video, digital, or image recordings made for research purposes.

Expedited Category 7

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.)

Expedited Category 8

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.

Expedited Category 9
Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (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.

Fully-Convened Board Review

Full committee review or review by the convened IRB is the standard type of review described in the Federal regulations. It must be used for the initial review of all studies that are not eligible for expedited review or exemption, and research involving prisoners.