The type of review an application receives depends on the risks posed to potential subjects by participating in the research. RISK is defined by Office of Human Research Protections (OHRP) as “the probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant.”
There are three categories of IRB reviews: exempt, expedited, and full board review. Only the Chair and the Expeditor may determine the category assigned to individual projects. Exempt review does not imply that the research does not need to be submitted to the IRB. It is exempt from review by the full board review.
Exempt review - Does not require review by the full board. The review period can take up to two weeks.
Expedited review – Minimal risk to human subjects. The review period can take up to two weeks.
Full Board Review - Proposed research involving human subjects that does not qualify for exempt or expedited review, must be reviewed by the IRB at a convened meeting (Full IRB Committee). The review period can take up to four weeks.
For additional information link to the specific categories. Reference to the OHRP regulations are included.
Following submission, the application is reviewed by the IRB Chair/Expediter based
on the IRB guidelines. The Chair/Expediter then determines whether the IRB application
is complete and appropriate for review. Proposals must be submitted using the most
current forms. Incomplete or poorly prepared proposals will be returned unreviewed.
Exempt Research 45 CFR 46.110.
Although called "exempt," this type of research does require IRB review. The exempt process is much less rigorous than an expedited or full board review. Reviews are completed by the IRB Chair or one reviewer designated by the Chair. To qualify, research must fall into seven (7) federally-defined exempt categories. These categories present the lowest amount of risk to potential subjects because they involve either collection of anonymous or publicly-available data, or conduct of the least potentially-harmful research experiments. Some examples of exempt research are:
- anonymous surveys or interviews
- passive observation of public behavior without collection of identifiers
- retrospective chart reviews
The following are the federally defined exempt categories:
- Normal Educational Practices
Research conducted in established or commonly accepted educational settings, involving normal educational practices such as:
- research on instructional strategies
- research on the effectiveness of or the comparison among instructional techniques,
curricula, or classroom management methods.
This does not include questionnaires distributed in an educational setting which do not relate to the points above.
- Educational Testing
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) if information taken from these sources is recorded in such a manner that participants cannot be identified, directly or through identifiers linked to the participants.
- Survey/Interview Procedures
Research involving survey or interview procedures with legally competent non-institutionalized adults, except where either of the following conditions exist:
- the participant's responses, if they become known outside the research, could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant's reputation, financial standing or employability or
- the research deals with sensitive aspects of the participant's own behavior, such as illegal drug conduct, drug use, sexual behavior, or the use of alcohol.
All research involving survey or interview procedures is exempt, without exception,
when the respondents are elected or appointed public officials or candidates for public
Surveys and interviews conducted with children do not qualify for exempt status.
Research involving observation (including observation by participants) of public behavior except where any of the following conditions exist:
- the observations recorded about the individual, if they become known outside the research, could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant's reputation, financial standing, or employability or
- the research deals with sensitive aspects of the participant's own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol.
- the research deals with the observation of the public behavior of children where the investigator participates in the activities being observed.
- Use of Existing Records
Research involving the collecting or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded in such a manner that participants cannot be identified, directly or indirectly, through identifiers linked to the participants.
- Evaluation of Federal Research and Programs
Research and demonstration projects which are conducted by or subject to the approval of the Department of Health and Human Services, and which are designed to study, evaluate, or otherwise examine:
- programs under the Social Security Act or other public benefit or service program,
- procedures for obtaining benefits or services under those programs,
- possible changes in or alternatives to those programs procedures, or
- possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and Food Quality Evaluation and Consumer Acceptance Studies if
- wholesome foods without additives are consumed, or
- food ingredients are at or below the safe level as designated by the Food and Drug Administration or the Food Safety and Inspection Service.
Expedited Research 45 CFR 46.110.
An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in
To qualify for an expedited review, research must fall into nine (9) federally-defined expedited categories. These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects. Some examples of expedited research are:
- studies involving collection of hair, saliva or dental plaque samples,
- studies of blood samples from healthy volunteers,
- analyses of voice recordings
- studies of existing pathological specimens with patient identifiers.
Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study. When a reviewer cannot approve the research under expedited review, the study is referred to the full Committee for review.
- 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 the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
- 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 in this list apply regardless of the age of subjects, 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 confidentiality are no greater than minimal.
- The expedited review procedure may not be used for classified research involving human subjects.
- IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review utilized by the IRB (i.e., expedited or full committee review).
- Categories one (1) through nine (9) pertain to both initial and continuing IRB review.
The following are the federally defined expedited categories:
- 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. 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.
- 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 children2, 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
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) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (g) 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 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 subjects 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.
- Research involving materials (data, documents, records, or specimens) that have been
collected, or will be collected solely for nonresearch purposes (such as medical treatment
or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations
for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
- Collection of data from voice, video, digital, or image recordings made for research
- 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.)
- Continuing review of research previously approved by the convened IRB as follows:
- 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
- where no subjects have been enrolled and no additional risks have been identified; or
- where the remaining research activities are limited to data analysis.
- 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.
Full Committee Research
Proposed human subject research which does not fall into either the exempt or expedited review categories must be submitted for full committee review. These studies have been determined to be more than minimal risk. Federal regulation define “minimal risk” as: “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.” This is the most rigorous level of review and, accordingly, is reserved for research projects that present more than minimal risks to subjects.
Categories that require full board review include:
- More than minimal risk
- Biomedical protocols (medical research/clinical trials/experimental therapies)
- Research with vulnerable populations. Vulnerable populations are those research participants who are likely to be vulnerable to coercion or undue influence or lack decision-making capacity, including children, prisoners, pregnant women, neonates, mentally disabled persons, or economically or educationally disadvantaged persons, and those who may be vulnerable because of a physical condition, severe illness or pain, psychological or emotional condition, status relationship with a member of the research team, cultural or political factors or other circumstances
- Projects that involve deception of subjects
- Projects that plan to use procedures that are personally intrusive, stressful or potentially traumatic(stress can be physical, psychological, social, financial, or legal)
(a) Federal Regulations regarding "Children" (both 45 CFR 46 and 21 CFR 50) state, "'Children' are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." Thus, who qualifies as a "child" depends on local laws.
(b) Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. The goal of the assent process is to involve children in discussions and decisions about research participation.
(c) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research.
(d) Parent means a child's biological or adoptive parent. Because children cannot legally provide consent for research on their own behalf, permission by at least one parent or legal guardian is required prior to enrollment of a minor in a research study.
(e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.
For additional information on research with children refer to 45 CFR 46.404 and 21 CFR 50.51
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- IRB Overview
- Review Process
- Categories of Review
- Consent Overview
- Informed Consent
- Minor Assent & Parental Permission
- Tips on Obtaining Consent
- International Research
- Guidelines for Internet Research