expedited review procedure expedited review procedure initial review of research

Expedited Review

Procedure

Expedited Review

ProcedureInitial Review of ResearchInitial Review of Research

Q1: Does the study only involve minimal risks?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.

Q2: Does the study fit within the DHHS approved categories of research that may be reviewed by

expedited review?

Yes

NoExpedited Process is NOT allowed for initial review.

The protocol must go before the full board for

approval.

Yes

No

45 CFR 46.110; DHHS, Categories of Research That May be Reviewed by the Institutional Review Board (IRB) through an

Expedited Procedure, http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm.

Overview: Expedited Process for Initial Review

Category 1: Clinical studies of drugs and devices

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

Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture

Category 4: Collection of data through non-invasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice.

Category 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).

Category 6: Collection of data from voice, video, digital or image recordings make for research purposes.

Expedited Process is allowed for initial review.

Fill out a Protocol Submission Form, selecting Expedited review as option.

Chart 1

Chart 2

Chart 3

Chart 4

Chart 5

Chart 6

Q1: Does the study only involve minimal risks?

Yes

No

Yes

OR



Chart 1: Expedited Process for Initial Review

Q2: Does the project involve a clinical study of drugs for which an IND is required under 21 CFR Part 312?Note: Research on marketed drugs that significantly increases risks or decreases acceptability of risks associated with the use of the product is not eligible for expedited review.

Q3a: Does the project involve a clinical study of a medical device where an IDE is required under 21 CFR Part 812?

No

Yes, IND is required.

Q3b: Is the medical device cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling?

No

No

Expedited Process is NOT allowed for initial review

under this category.


Fill out Protocol Submission Form Selecting Expedited as the Option.




Yes

No

Yes

Yes


Q2: Does the project involve a collection of blood samples by finger prick, heel stick, ear stick, or venipuncture?

Q3a: Will the blood samples be taken from health, non pregnant adults who weighs at lease 110 lbs?

Yes

No

Will the blood taken exceed 550 ml in a 8 week period or collection occur more frequently than 2 times per week?

Yes

No



Q3b: Will the blood samples be taken from other adults, considering age, weight, and health of the subjects, the collection procedure, and the frequency with which it will be collected.

Will the blood taken exceed the 50 ml or 3 ml per kg (which ever is lesser) in an 8 week period or collection occur more frequently than 2 times per week?

No

No

Yes

YesYesYes



No




Yes

No

45 CFR 46.110; DHHS, Categories of Research That May be Reviewed by the Institutional Review

Board (IRB) through an Expedited Procedure, http://www.hhs.gov/ohrp/humansubjects/guidance/expedit

ed98.htm.


Q2: Does the project involve prospective collection of biological specimens?

No



Yes

Are the specimens be taken for research purposes?

Are they being acquired 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.

Yes

No

Yes



No




Yes

No

45 CFR 46.110; DHHS, Categories of Research That May be Reviewed by the Institutional Review Board

(IRB) through an Expedited Procedure,

http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm.


No



Expedited Process is allowed for initial review.Fill out a Request for Expedited Process Form.

Yes

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.

Yes

NoYes

Q3: Was the data collected as part of routinely employed in clinical practice, excluding procedures involving x-rays or microwaves?

Q4: Is a medical device employed?Note: Studies intended to evaluate the safety and effectiveness of the medical device are generally not eligible for expedited review, including studies of cleared medical devices for new indications.

Yes

Is the medical device cleared/approved for marketing?

Q2: Does the project involve collection of data through non-invasive means? Note: Non-invasive is not involving general anesthesia or sedation.

No

No


Yes

No




No

Expedited Process is NOT allowed for initial review under Categories 5 or 6.

Expedited Process is allowed for initial review.Fill out a Request for Expedited Process Form.

Q2: Does the project involve data, documents, records, or specimens that have been collected, or will be collected solely for nonresearch purposes, i.e. collected for medical treatment or diagnosis purposes? Cat. 5

Yes

Note: Some research projects of

existing data, documents, r

ecords

or specimens may be considered

as not human research or exempt

depending certain factors. Check

out the decisio

n trees for not

human research or exemptions.

Q3: Does the project involve collection of data from voice, video, digital or image recording made for research purposes? Cat. 6. Note: when considering the level of risks consider if the video or recording would record drug/alcohol information or other information that would affect legal risk or employability. Expedited review may not be used where identification of the subject and/or response would reasonably place them at risk for criminal or civil liability or be damaging to subject’s financial standing, employability, insurability, reputation or be stigmatizing. Be sure t indicate if this is a possibility what protections will be implemented so that the risks to invasion of privacy and breach of confidentiality are no greater than minimal.

No

Yes


Yes

No




No



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). Check the exemption research

decision tree.

This listing refers only to research that is not exempt.

No

Yes

Q3: Does the project employ survey, interview, oral history, focus group, program evaluation, human factor evaluation, or quality assurance methodologies?

Yes

Q2: Does the project involve research on individual or group characteristics or behavior?Examples: Research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior.



http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101

expedited review procedure expedited review procedure initial review of research

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