Presentation is loading. Please wait.

Presentation is loading. Please wait.

Expedited Review Procedure Expedited Review Procedure Initial Review of Research.

Similar presentations


Presentation on theme: "Expedited Review Procedure Expedited Review Procedure Initial Review of Research."— Presentation transcript:

1 Expedited Review Procedure Expedited Review Procedure Initial Review of Research

2 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 No Expedited Process is NOT allowed for initial review. The protocol must go before the full board for approval. Yes No 45 CFR ; DHHS, Categories of Research That May be Reviewed by the Institutional Review Board (IRB) through an Expedited Procedure, ht tp://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 1Chart 2Chart 3Chart 4Chart 5Chart 6

3 Q1: Does the study only involve minimal risks? Yes No Yes OR 45 CFR ; DHHS, Categories of Research That May be Reviewed by the Institutional Review Board (IRB) through an Expedited Procedure, ht tp://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm. 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 Expedited Process is NOT allowed for initial review under this category. Expedited Process is allowed for initial review. Fill out Protocol Submission Form Selecting Expedited as the Option. Expedited Process is allowed for initial review. Fill out Protocol Submission Form Selecting Expedited as the Option.

4 Q1: Does the study only involve minimal risks? Yes No Yes Chart 2: Expedited Process for Initial Review 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 Expedited Process is NOT allowed for initial review under this category. 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 Yes Expedited Process is NOT allowed for initial review under this category. No Expedited Process is allowed for initial review. Fill out Protocol Submission Form Selecting Expedited as the Option.

5 Q1: Does the study only involve minimal risks? Yes No 45 CFR ; DHHS, Categories of Research That May be Reviewed by the Institutional Review Board (IRB) through an Expedited Procedure, ht tp://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm. Chart 3: Expedited Process for Initial Review Q2: Does the project involve prospective collection of biological specimens? No Expedited Process is NOT allowed for initial review under this category. 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 Expedited Process is NOT allowed for initial review under this category. No Expedited Process is allowed for initial review. Fill out Protocol Submission Form Selecting Expedited as the Option.

6 Q1: Does the study only involve minimal risks? Yes No 45 CFR ; DHHS, Categories of Research That May be Reviewed by the Institutional Review Board (IRB) through an Expedited Procedure, ht tp://www.hhs.gov/ohrp/humansubjects/guidanc e/expedited98.htm. Chart 4: Expedited Process for Initial Review No Expedited Process is NOT allowed for initial review under this category. 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 No Yes 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

7 Q1: Does the study only involve minimal risks? Yes No 45 CFR ; DHHS, Categories of Research That May be Reviewed by the Institutional Review Board (IRB) through an Expedited Procedure, ht tp://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm. Chart 5: Expedited Process for Initial Review 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, records or specimens may be considered as not human research or exempt depending certain factors. Check out the decision 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

8 Q1: Does the study only involve minimal risks? Yes No 45 CFR ; DHHS, Categories of Research That May be Reviewed by the Institutional Review Board (IRB) through an Expedited Procedure, ht tp://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm. Chart 6: Expedited Process for Initial Review No Expedited Process is NOT allowed for initial review under this category. NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR (b)(2) and (b)(3). Check the exemption research decision tree. 45 CFR 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. Expedited Process is allowed for initial review. Fill out Protocol Submission Form Selecting Expedited as the Option.


Download ppt "Expedited Review Procedure Expedited Review Procedure Initial Review of Research."

Similar presentations


Ads by Google