Human Research Protection Program: Guidance

Expedited Review

An expedited review procedure consists of a review of a research protocol by the IRB chair or by one or more experienced IRB members designated by the chair in accordance with the requirements set forth in the federal Common Rule [45 CFR 46.110] and FDA regulations [21 CFR 56.110]. 

 

Expedited review procedures may be applied to both initial and continuing review of research and the review of certain minor changes in protocols. Research that involves more than minimal risk may not be reviewed using an expedited process.

 

UW-Madison IRBs do not use expedited review procedures for the initial review of research involving prisoners.

Expedited Initial and Continuing Review

OHRP and the FDA have published parallel guidance describing when expedited initial and continuing review of research is appropriate and a list of categories of research that may be reviewed through and expedited procedure.  See, OHRP’s guidance, Expedited IRB Review - Categories, and the parallel provisions in FDA Guidance:

 

Applicability of Expedited Review (as set forth by OHRP and the FDA):

 

1. Research activities that (a) present no more than minimal risk to human subjects, and (b) 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.

 

NOTE: Federal rules define minimal risk as a risk of harm to the subject from participation in the research that is no greater than the risk encountered in normal day to day activities or during routine physical or psychological examinations.

 

2. The categories in this list apply regardless of the age of subjects, 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 confidentiality are no greater than minimal. 

 

4. The expedited review procedure may not be used for classified research involving human subjects.

 

5. 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.

 

6. Categories one (1) through seven (7) pertain to both initial and continuing IRB review (See, 45 CFR 46.110 and 21 CFR 56.110).

 

Categories of research that may be reviewed through an expedited procedure (set forth in OHRP’s Expedited IRB Review — Categories and the parallel provisions in FDA Guidance):

 

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 (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/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:

 

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.

 

*NOTE: 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)] See, also, 21 CFR 50.3(o).

 

3. Prospective collection of biological specimens for research purposes by noninvasive means.

      Examples:

 

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. 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 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;
9. mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
10. 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. (NOTE: 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:

 

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.

 

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 DHHS 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:

 

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.

 

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.

 

Source: 63 FR 60364-60367, November 9, 1998.

Expedited Review of Minor Change of Protocol

Expedited review procedures can also be used to review minor changes in previously approved research during the period (of one year or less) for which approval is authorized. UW-Madison defines “minor change” as a change that does not adversely affect the risk/benefit ratio of the study or make it less favorable for research subjects.

 

Examples of “minor changes” include:

1. Administrative (non-medical) changes
2. Minor changes to consent form, HIPAA form, surveys, questionnaires, brochures or recruitment materials
3. Submission of new consent form, HIPAA form, surveys, questionnaires, brochures or recruitment materials that are easily compared to previously approved forms or materials
4. Editorial changes for purposes of clarification
5. Minor study design changes that do not negatively affect the risk/benefit ratio
6. Addition of study personnel or study sites

 

For health sciences protocols, see Expedited Review of Minor Changes Guidance for further information.