Types of IRB review
Investigators who believe their study does not meet the federal definition of humans subjects research may request preliminary review using an abbreviated version of the full application form. The IRB will review the information provided to ascertain whether your study is human subjects research. If the IRB agrees that your study is not human subjects research, you will receive a formal letter with this determination for your records. If the IRB determines all or part of your study is research with human subjects, the investigator must complete the full application. An application for preliminary review may be emailed to the IRB coordinator at any time. The IRB typically responds with a determination within 2-3 business days.
Some research that involves human subjects is exempt from the regulations requiring IRB review. The IRB administrator will recommend and the IRB chair and vice-chair will determine whether research is exempt. The IRB must track exempt research projects and review them on an annual basis to make sure that they continue to meet the exemption criteria.
45 CFR 46.101(b). Exemption criteria
(1) Research conducted in established or commonly accepted educational settings, involving normal educational 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 methods.
(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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.
(3) 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 (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
(4) 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.
(5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
(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 U.S. Department of Agriculture.
The IRB will use an expedited review process for research that involves no more than minimal risk, and for which the human subjects' involvement falls into one of the categories listed below. The IRB administrator will recommend and the IRB chair and vice-chair will determine whether a new protocol is eligible for expedited review. The administrator will then seek one or more IRB members to conduct the review. If the reviewer or reviewers find that the protocol should be disapproved, the protocol must go to the full board for a vote.
Categories of research that may be reviewed by the Institutional Review Board (IRB) through an expedited review procedure1
(A) 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. 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.
(B) The categories in this list apply regardless of the age of subjects, except as noted.
(C) 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.
(D) The expedited review procedure may not be used for classified research involving human subjects.
(E) IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review—expedited or convened—utilized by the IRB.
(F) Categories one (1) through seven (7) pertain to both initial and continuing IRB review.
(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.) (b) 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.
(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 (b) 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.
(3) Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a) hair and nail clippings in a non-disfiguring 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 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; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
(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.
(5) 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.)
(6) Collection of data from voice, video, digital, or image recordings made for research purposes.
(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.)
(8) Continuing review of research previously approved by the convened IRB as follows: (a) 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 (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.
(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.
References: Expedited review
- 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 45 CFR 46.110. Source: 63 FR 60364-60367, November 9, 1998 .
- Children are defined in the HHS regulations as "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." 45 CFR 46.402(a). Source: 63 FR 60364-60367, November 9, 1998.
Full board review
A full board review is one in which the study must be discussed and approved by majority vote at a meeting of the board.
Each proposed research project must be submitted on the IRB application form and include:
- A description of the principal investigator's training about using human subjects in research from a recognized institution, such as the University of Minnesota or the Mayo Clinic. One of the online courses from the NIH or CDC can serve this purpose at a minimum.
- A description of the training about using human subjects in research received by anyone having access to identifiable data. (The IRB strongly recommends that any such people take an online course from the NIH or CDC. The Protecting Human Research Participants course from the NIH Office of Extramural Research, developed in July 2008 for academic researchers, meets this requirement. Researchers/practitioners register online for free at Protecting Human Research Participants.)
- A detailed description of the research design and procedures as they affect human subjects;
- A list of precautions taken to safeguard the subjects' welfare;
- A precise description of the research’s subject population;
- A description of the informed consent process and copies of all recruitment materials and consent forms to be used; and
- Methods to be used to protect data confidentiality and subject privacy.
The board will review proposals at regularly scheduled IRB meetings. The board will use the criteria outlined in this section to assign one of the following status types to the proposal:
- Approval pending stipulations
A majority vote determines the proposal's status. The vote must include the presence of a non-scientist member. A quorum must be present for the vote. The IRB must record the number voting for, against, and abstaining. It must also record all stipulations, recommendations, and comments (as defined below) or reasons for disapproval.
Investigators will receive written notification of the proposal’s status approximately one week after the meeting. The notice will include a detailed description of stipulations that must be met before the IRB will grant approval. "Approval" status can be granted only after receipt and approval of the investigator’s written response to the IRB. The IRB will then notify the PI that the study has received final approval. Researchers may not begin data collection until the IRB administrator and primary reviewer have reviewed and approved all stipulations and other requested materials.
In addition to formal stipulations, which must be met before starting data collection, the IRB may also make "suggestions" and "comments" in reviewing protocols, defined as follows:
Stipulations: Approval with conditions that are mandatory (must be met) before final IRB approval and the beginning of research. The IRB will state these in its letter to the principal investigator and in the minutes of the meeting where the proposal was reviewed.
Suggestions: These are recommendations to the researcher, but are not mandatory for IRB final approval. These too will be stated in the letter to the principal investigator and in the minutes of the meeting where the proposal was reviewed.
Comments: These may or may not be included in the letter (depending on importance) and will not be recorded in the minutes unless related to a stipulation or suggestion.
The IRB must review a research project until the PI notifies the IRB that the study is complete. Approval for a research project is valid for no more than one year. The federal regulations require IRBs to conduct continuing reviews of research at intervals appropriate to the degree of risk, but not less than once a year.
Research protocols that required full IRB review initially and that have not completed data collection require full IRB review for continuation. The review must take place at a convened meeting of the IRB and action on the project must be approved by a majority of the members present. The researcher must meet the IRB's stipulations, if any, before approval for continuation is granted.
The IRB focuses on research related to public health, which carries a lower level of risk to human subjects than clinical trials or drug and medical device studies. Therefore, an annual re-review is sufficient unless, in the IRB’s discretion, there are adverse events or other evidence to warrant more frequent or closer scrutiny. The IRB has the authority to observe or have a third party observe the consent process and the research. In full board reviews, the board will determine whether the risk is sufficient to require monitoring and what is needed to address the risk. The IRB will implement a monitoring plan when one is warranted.
Research protocols that initially required full IRB review, have completed collecting data, and are in the process of analyzing data may be reviewed using the expedited process. Research protocols that were reviewed initially using the expedited process may be re-reviewed using the expedited process as long as the degree of risk associated with the study has not increased.