1PURPOSE
1.1This document describes the process for conducting expedited review, includingthe criteria and process for determining eligibility for expedited review.
2POLICY
2.1Expedited reviewis an IRB review procedure through which certain kinds of research activities may be reviewed and approved without convening a meeting of the full IRB.
2.2The reviewer(s).An expedited review may be performed by the IRB Chair and/or by an experienced IRB member(s) designated by the IRB Chair, based on the member’s area of expertise. At any time, the expedited reviewer may request consultation, additional reviewers, or may refer the item to the full IRB.
2.3Authority.In reviewing the research, the reviewer may exercise all of the authority of the full IRB Committee except disapproval, suspension, or termination of the research.
2.4Criteria for approval.The expedited review process uses the same criteria for approval as reviews conducted by a full convened IRB. For example, the standard regulatory requirements for informed consent (or its waiver or alteration) apply whether the review is performed by the expedited process or by the full convened IRB.
2.4.1The criteria include a list of categories of procedures that are considered eligible for expedited review. However, the procedures must also meet all of the other criteria, including the “minimal risk” criterion. A procedure is not considered to be minimal risk simply because it is included in one of the categories. The specific circumstances of the proposed research must also be considered in assessing the minimal risk criterion.
2.5Report of reviews.When an expedited review is completed, the other members of the IRB are informed about the review through a regular Subcommittee Report provided to the members and attached to the IRB meeting minutes.
2.6Eligibility for expedited review.The research (or changes to the research) is eligible for expedited review if it meets criteria specified in federal regulations. These are described in the WORKSHEET Expedited Review Eligibility.Activities that do not meet these criteria must be reviewed by the full IRB at a convened meeting. Additional information:
2.6.1It is UW policy that expedited review is allowed for research involving prisoners but only when the research involves no interaction with prisoners. Reviewers are urged to consult with a prisoner advocate if they have any questions or concerns.
2.6.2It is UW policy that the use of deception in research does not automatically disqualify a project from expedited review.
2.6.3Expedited review (Category 8(c)) may be used for continuing review of research that is identified by the researcher as being “in data analysis only”, beginning at the time when the researcher first identifies the remaining activities as consisting solely of data analysis.
2.6.4Expedited review (Category 9) may be used for continuing review of research at any time after initial review and under the following conditions, as clarified by correspondence with OHRP (reference 7.9):
2.6.4.1The research is not conducted under an investigational new drug application or investigational device exemption; and
2.6.4.2Expedited review categories 2 through 8 do not apply; and
2.6.4.3The IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk (this could be during initial review or later); and
2.6.4.4The IRB chair or designee has made a determination that no additional risks have been identified.
2.6.5Per FDA guidance, expedited review may be used (but is not required) for continuing review of Humanitarian Device (HUD/HDE) activities, if deemed appropriate by the IRB and if the HUD is being used solely for clinical purposes.
2.7Minor change. The concept of “minor change” is crucial in determining the eligibility of Modifications for expedited review. See the definition provided below.
3DEFINITIONS
3.1Expedited review. An IRB review procedure through which certain kinds of research, and changes to research, may be reviewed and approved without convening a meeting of the full IRB.
3.2Minimal risk.Minimal risk is defined by federal regulation 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 daily life or during the performance of routine physical or psychological examinations or tests.
3.2.1Prisoners: Minimal risk is defined by federal regulation as the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of a healthy person.
3.2.2Research involving the Department of Defense (funding, subjects, facilities, resources).Per DOD regulations (reference 7.8), the phrase “ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” must not be interpreted to include the inherent risks certain categories of subjects face in their everyday life. For example, the risks imposed in research involving human subjects focused on a special population should not be evaluated against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat zone) or having a medical condition (e.g., frequent medical tests or constant pain).
3.3Minor change.Minor changes may be reviewed by the expedited process rather than a full IRB. Per UW policy (based on references 7.6 and 7.8), a minor change:
3.3.1Neither meaningfully increases risk, nor meaningfully decreases benefit, when considered in light of any changes proposed to mitigate risk and improve benefit;
3.3.2Does not meaningfully decrease scientific merit; and
3.3.3Does not adversely affect the assessment of the research with respect to the criteria for approval described in 45 CFR 46.111.
4RESPONSIBILITIES
4.1Experienced senior HSD staff are responsible for determining whether an item is eligible for expedited review. They consult with other senior staff and management, IRB chairs, and IRB members as needed, particularly with respect to assessments of risks and benefits.
4.2Experienced senior HSD staff who are also members of an IRB have the expertise and knowledge to perform most of the expedited reviews. However, some expedited reviews require other or additional expertise. Such reviews are typically performed by the IRB Chair and/or by IRB members with appropriate expertise.
5PROCEDURES
5.1Eligibility assessment.
5.1.1Eligibility for expedited review is assessed by HSD staff as part of the routine pre-review process for all materials requiring IRB review, regardless of whether the researcher has requested consideration for expedited review.
5.1.2The WORKSHEET: Expedited Review Eligibilityis used to determine eligibility for expedited review.Experienced senior HSD staff make the decision, drawing as needed upon the expertise of HSD management, the IRB Chair, or IRB members, particularly with respect to the “minimal risk” criterion.
5.1.2.1The UW does not apply any criteria for expedited eligibility that are not listed on the WORKSHEET: Expedited Review Eligibility. Examples of criteria that may have been applied in past years to always disqualify a study from expedited review are:
5.1.2.1.1Putting information in a subject’s medical record.
5.1.2.1.2Increasing the number of subjects in a study by more than a specific number or percentage.
5.1.2.1.3Increasing the payment to subjects by more than a specific amount or percentage.
5.1.2.2Uncertainty or disagreements about eligibility for expedited review are adjudicated by an Assistant Director of Operations.
5.1.2.3If necessary, another member of the HSD management team is also consulted. Concurrence is considered the final decision. If there is disagreement, the item will be reviewed by the full convened IRB.
5.1.3The expedited reviewer may identify changes to the research that would allow the research to qualify for expedited review. If the investigator cannot agree on the changes, the expedited reviewer obtains consultation. If agreement can still not be reached, the item will be reviewed by the full IRB.
5.1.4The CHECKLIST: Master is used to document whether the item is eligible for expedited review and, if so, under which category.
5.1.5The eligibility decision is communicated to the investigator in writing if the investigator requested consideration for expedited review and the research is determined to be not eligible. Otherwise, the investigator is informed of the nature of the review (expedited or full IRB) in the IRB approval letter or IRB review letter.
5.2The expedited review.The expedited reviewer evaluates the materials provided by the investigator and performs the review as described in the SOP IRB Review. The review applies the applicable criteria for approval (seeWORKSHEET: Criteria for IRB Approval) and results in appropriate action and determinations as decided by the reviewer (see SOP IRB Actions).
5.2.1If the reviewer and the investigator cannot agree on changes (if any) required to meet the criteria for approval, the item will be referred to the full IRB for review.
5.3Report to the IRB. A report of completed expedited reviews is provided to the IRB on a regular basis, as a Subcommittee Report. It is distributed with other meeting materials and is attached to the meeting minutes (SOP IRB Meeting Minutes).
5.4Guidance.This guidance provides examples of changes that would likely qualify as “minor changes”. The group that advises the federal Office of Human Research Protections (OHRP) has published a document with numerous examples of modifications it considers to be (1) eligible for expedited review, or (2) not eligible for expedited review. See reference 7.6 (below). Other examples of “minor changes” include:
5.4.1Adding a new procedure to a research study, when the procedure is on the expedited categories list and involves no more than minimal risk.
5.4.2Adding a new minimal risk procedure to a study, when that procedure is not on the expedited listis eligible for expedited review ONLY if the study is not currently approved under category 1-7.
5.4.3A minor change to research that is not on the expedited list but that does not involve the addition of a procedure. Examples include (but are not limited to):
5.4.3.1Change in consent form wording that does not increase risk or decrease benefit.
5.4.3.2Replaced old case report forms or data abstraction forms with essentially equivalent new forms.
5.4.3.3Changing the order of questions in a questionnaire.
5.4.3.4Adding the word “approximately” to the table of a lab test schedule for the study.
5.4.3.5A new media advertisement.
5.4.3.6A statistically small change to the number of subjects.For example, a change from 100 to 105 in a single site study, or in a multi-site study, a change from 20 to 30 subjects at one site in a study involving 1,000 subjects.Minor decreases in the number of subjects also qualify for expedited review.
5.4.3.7Extending an observational follow-up period (depending upon the nature of the procedures, if any, used to collect the observational data.)
6MATERIALS
6.1WORKSHEET: Expedited Review Eligibility
6.2TEMPLATE Subcommittee Report
7REFERENCES
7.145 CFR 46.110 and 21 CFR 56.110
7.2OHRP Guidance, “Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure”, November 9, 1998.
7.3FDA, “Categories of Research That May Be Reviewed By the Institutional Review Board (IRB) through an Expedited Review Procedure; Federal Register; November 9, 1998; volume 63, number 216, page 60353-60356.
7.4OHRP Guidance, “Expedited Review Procedure”, August 11, 2003.
7.5OHRP Guidance, “Clarification of “noninvasive” in expedited review category 3”.OHRP website, posting date not provided.
7.6SACHRP Advisory Committee, Recommendations to OHRP regarding definition of a minor change in research under 45 CFR 46 and 21 CFR 56; July 20, 2011.
7.7OHRP, “Memorandum to the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute Regarding IRB Review of Protocol and Informed Consent Changes”, 9/29/08.
7.8Department of Defense, Instruction 3216.02, “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research”; November 8, 2011, section 6b.
7.9OHRP email communication to UW; July 22, 2014; “Expedited Category 9”
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