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Institutional Review Boards
UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
Other Policies
UChart Forms & Guidance
HSRO Forms & Documents
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Ancillary Committee Information
eProst User Guide
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Western IRB (WIRB)
About the HSRO


Basic Folder Information

8.2 Expedited Studies


8.2 Expedited Reviews

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

March 31, 2006

Revised: August 17, 2011

 



8.2(a) General Principles of Expedited Reviews

8.2(a) General Principles of Expedited Reviews

Approval of new or continuing studies may be made on an expedited basis by the IRB chair or designee of the IRB Chair. It is the responsibility of the IRB Chair to ensure that the designee has the required expertise and knowledge of IRB policies and procedures.  Criteria for approval by expedited review are the same as those of the convened IRB (c.f. Policy 7.3) and the expedited review should be as meaningful and significant as that of the convened IRB (c.f. Sections 9 & Section 10).

A study may be forwarded by the HSRO for expedited review and approval if it is considered that the study involves no more than minimal risk to human subjects and if it fits under one or more of the nine categories qualifying a study for expedited review in accordance with federal regulations 45 CFR 46.110 and 21 CFR 56.110.

[NOTE – "Minimal risk" is defined by the OHRP and FDA 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 the daily life or during performance of routine physical or psychological examinations or tests."]

The expedited review category will not be used if identification of 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 are implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.  The expedited review category shall also not apply to studies involving the use of investigational drugs, devices, or biologics for which an IND/IDE is required.

If the study qualifies for expedited review, the IRB chair or designee may approve the study, seek additional information from the principal investigator, require modifications to the study to gain approval or defer the study to the convened IRB.  If the IRB chair or designee determines that the study does not qualify for expedited review, the IRB chair designee shall refer the study to the convened IRB.  The IRB Chair or designee conducting an expedited review may not disapprove a study but rather must forward the study for review by the convened IRB if he/she believes disapproval is warranted.

A report of all studies approved under expedited criteria shall be forwarded to each IRB for its review on a monthly basis. If the convened IRB expresses concerns about an expedited study which, in its estimation, should not have been expedited, the study will be prepared by the convened IRB at a subsequent meeting.



8.2(b) Categories of Studies Qualifying for Expedited Review

8.2(b) Categories of Studies Qualifying for Expedited Review

Studies may qualify for expedited review only if they fit within one or more of the following categories:

EXPEDITED CATEGORY 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; OR

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

[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.]

EXPEDITED CATEGORY 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 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.

EXPEDITED CATEGORY 3.  Prospective collection of biological specimens or other biological information for research purposes by noninvasive means. Examples include but are not limited to:

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.

k)  Vaginal swabs that do not go beyond the cervical os

l)   Rectal swabs that do not go beyond the rectum

m) Nasal swabs that do not go beyond the nares

EXPEDITED CATEGORY 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 subjects or an invasion of the subjects’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

EXPEDITED 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).

NOTE: This category includes research involving materials that were previously collected (retrospective/existing) for either non-research or research purposes, provided that any materials collected for research were not collected for the currently proposed project.

NOTE: This category permits research on materials collected prospectively but only if such materials are collected solely for non-research purposes.

EXPEDITED CATEGORY 6.  Collection of data from voice, video, digital, or image recordings made for research purposes.

EXPEDITED CATEGORY 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.

The following two expedited review categories (8 & 9) pertain to continuing reviews but not to initial reviews

EXPEDITED CATEGORY 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.

[NOTE – For a multi-center study, an expedited review procedure may be used by the UM IRB whenever any of the above conditions are satisfied at the University of Miami site.]

 EXPEDITED CATEGORY 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.



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