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The Review Process
The IRB and the investigator are partners in the research endeavor. Protection of subjects is the responsibility of all.
3.1 - Assessment of Risk
3.2 - Full IRB Review
3.3 - Expedited Review
3.4 - Exempt Research
3.5 - IRB Decisions
3.1 Assessment of Risk
Federal regulations allow the IRB to categorize research studies according to the risks associated with the research and to provide different levels of review based on an assessment of risk. See the Definitions of "risk" and "minimal risk" in the References section of the IRB website.
See also: 2.4 Research Risks and 3.3 Expedited Review.
3.2 Full IRB Review
Research that exposes subjects to risks that are greater than the kind of risks normally experienced in daily life or in routine medical, dental, or psychological examinations must be reviewed by the full IRB at a properly convened meeting. At such a meeting, the IRB will review the protocol and consent documents for compliance with federal regulations. The IRB will also assess whether the study's purpose and procedures are ethically appropriate. The UConn-Storrs IRB meets once per month. Investigators must complete a Protocol Application (IRB-1) and submit it to the IRB for review at least 10 days before the scheduled meeting. Investigators should consult the IRB website for submission deadlines and meeting dates. Investigators will be notified of the IRB decision in writing approximately one to two weeks after the IRB meeting.
Protocols that were originally approved by the full IRB must also be submitted to the IRB for continuing review. Protocols requiring continuing review by the full IRB must be submitted 8 weeks before the lapse date.
3.3 Expedited Review
Federal regulations allow for expedited (i.e., administrative) review of some research if it involves no more than minimal risk and it falls within one of the specific expedited research categories. "Minimal risk" research is generally considered to be activity that has the same risk level as activities experienced in daily life or routine medical, dental or psychological examinations [45 CFR§46.102(i)], but the IRB has the discretion to require full IRB review of any study where risks are not clearly minimal. 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 subject's financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented. Some research involving children may qualify for expedited review.
See also: Definition: "minimal risk," 2.4 Research Risks and 3.1 Assessment of Risk.
PLEASE NOTE THAT "EXPEDITED" DOES NOT MEAN "FASTER" REVIEW. IT ONLY REFERS TO THE FEDERAL CATERGORIES OF RESEARCH THAT DO NOT REQUIRE FULL BOARD REVIEW.
The expedited research categories generally involve the following activity (45 CFR 46.110 and 21 CFR 56.110):
(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.
Research Categories
(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 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.
(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.
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1 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. The IRB Chair or the Chair's designee has the authority to decide whether or not the study qualifies for expedited review.
2 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.
Expeditable research is reviewed by either the IRB Chair or by an IRB member specially designated by the Chair to review it. Investigators must complete a Protocol Application (IRB-1) and submit it to the IRB. There is no submission deadline for studies that qualify for expedited review. At present, investigators are being contacted with the IRB reviewer's comments within four weeks after the protocol has been received. Protocols that were originally approved through expedited review may also receive expedited continuing review. Expeditable protocols should be submitted 4 weeks before the lapse date.
3.4 Exempt Research
Federal regulations allow six specific categories of human subjects research to be exempt from continuing IRB review. Although these six categories do involve research with human subjects, the research does not expose participating subjects to psychological, social or physical risks.
The purpose of the IRB review is 1) to approve the study procedures and consent processes as appropriate for research with human subjects and 2) to determine that an exemption for continuing IRB review is appropriate. Only the IRB may decide if the research is exempt from further review. Exempt research is reviewed by either the IRB Chair or by an IRB member specially designated by the Chair to review it. Investigators must complete a Request for Exemption (IRB-5) and submit it to the IRB for review. There is no submission deadline for studies that qualify for exemption. Investigators will be notified of the IRB decision in writing approximately one week after it was received by the IRB. If granted an exemption, the study does not need to be submitted to the IRB for continuing review.
The exempt research categories are (45 CFR 46.101b):
- 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.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
- information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
- 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.
- 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:
- the human subjects are elected or appointed public officials or candidates for public office; or
- Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- 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.
Note: Exemption 4 applies to retrospective studies of specimens and/or data that have already been collected. The materials must be "on the shelf" (or in the freezer) at the time the protocol is submitted to the IRB. Research that involves the ongoing collection of the specimens and/or data does not meet the criteria for Exemption 4.
- 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:
- Public benefit or service programs;
- procedures for obtaining benefits or services under those programs;
- possible changes in or alternatives to those programs or procedures;
- or possible changes in methods or levels of payment for benefits or services under those programs
- Taste and food quality evaluation and consumer acceptance studies,
- if wholesome foods without additives are consumed or
- 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.
NOTE:
- Research with children is NOT exempt unless it is strictly observational. Observational research is only exempt if the researcher does not interact with the child or manipulate the child's environment in any way.
- Audiotaping and video taping of interviews does NOT qualify for exemption.
3.5 IRB Decisions
There are three possible courses of action that the IRB may take.
Approved
Research that is approved outright requires no further revisions and may be initiated as soon as the investigator receives the IRB's decision. The IRB will approve and validate the consent form with an approval stamp. Subjects must be given only consent forms/information sheets with the IRB's validation stamp.
Modifications Required to Secure Approval
Often the IRB will require specific revisions to the protocol and/or consent form before the research will be approved. When the IRB asks for specific revisions, the investigator must submit the revised protocol to the IRB for the changes to be reviewed. The revised protocol will be reviewed either by the IRB Chair or the Chair's designee. The research will be approved outright as long as the protocol was revised in accordance with the IRB's requirements. The investigator must have received the IRB Approval letter before beginning the research; she/he may not submit the revisions and begin advertising or recruiting.
Tabled
Sometimes the IRB will require additional information about the research before the protocol can be approved. This usually happens because the protocol does not contain enough information to allow the IRB to fully review and understand the nature of the research. In these cases the IRB will ask the investigator to revise the protocol and submit it for re-review.
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