1. POLICY Steering Committee approved / Effective Date: 9/9/15 An expedited review procedure consists of a review of research involving human subjects by an IRB Chair or by one or more experienced reviewers designated by the IRB Chair from among members of the IRB. An IRB may use the expedited review procedure to review either or both of the following: (1) Some or all of the research appearing on the list (Federal Register, Volume 63, No. 216, pages 60362-67, which may change from time to time) and found by the reviewer(s) to involve no more than minimal risk, (2) minor changes in previously approved research during the period (of 1 year or less) for which approval is authorized. Specific Policies Terms used in this policy, but not defined herein shall have the meanings set forth in the Glossary. Minimal risk (as it applies to the research procedure or the investigational article) 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. Minimal risk (as it applies to the risk of violating the subject s privacy rights) means that the investigator has provided (1) an adequate plan to protect the subject s identifiers from improper use or disclosure; (2) an adequate plan to destroy the identifiers at the earliest possible opportunity consistent with the conduct of research, unless there is a health or research justification for retaining the identifiers or retention is otherwise required by law; and (3) adequate written assurances that the PHI will not be reused or disclosed to any other person or entity except for those individuals or entities who are also conducting the research studies or are disclosed in the authorization, as required by law, or for authorized oversight of the research study. 1.1. Expedited Reviewers The following individuals may review research activity (new submissions or changes to previously approved research) by expedited means if: 1) the individuals meet the criteria established by this SOP; 2) the activity qualifies for expedited approval per the categories established in the federal regulations; and 3) the activity meets or does not alter the regulatory criteria for approval. 1.1.1. IRB Chair 1.1.1.1. An IRB Chair (or designated reviewer see below) may exercise all of the authorities of the IRB during the expedited review, except that he/she may not disapprove the research activity (new Page 1 of 5
submission or modification to previously approved research). A research activity may be disapproved only after review by the convened IRB. 1.1.2. By way of this SOP, the IRB Chair designates any of the following individuals as a reviewer for expedited actions if they meet the criteria noted below: an Aurora IRB member; and one or more of the following criteria: o Certification as an IRB professional (CIP) or manager (CIM); o Has, in the Chair s opinion, demonstrated extensive knowledge of the ethical principles, federal regulations and applicable laws governing human subject research. 1.2. Newly Submitted Research Research studies to be reviewed in an expedited manner will be those submitted in accordance with Policy FO 301. Based on the categories of research eligible for expedited review referenced in 45 CFR 46.110 and 21 CFR 56.110, and the definition of minimal risk, as outlined above, an IRB Chair or reviewer designated to conduct expedited review will determine whether the newly submitted research study qualifies for review and approval under the expedited review process. At times, individuals with specific expertise ( consultant ) may be asked to provide a recommendation as to the minimal risk nature of the study. These individuals may not provide expedited approval of the research study. If the study qualifies for expedited review, the IRB Chair or designated reviewer will document his/her final determination that the research meets applicable regulatory criteria for approval, and falls into one or more expedited review categories allowed for by the federal regulations. Expedited review determinations are documented in the Checklist for Review Using the Expedited Procedure (RR 401-A) and the Primary Reviewer Checklist (Form RR 402-A). The completed checklists are required to be included in the study file. An approval letter (RR 401-B) will be issued to the PI once IRB review using the expedited procedure has been finalized and all administrative submission requirements completed. 1.3. Changes to research prior to issuance of the approval letter The IRB (either the convened board or an expedited reviewer) may require changes or specific clarifications in the reviewed submission documents. These changes are conditions of approval, and are required to secure IRB approval of the study. Page 2 of 5
These conditions of approval are communicated to the PI/research team in writing following the meeting/expedited review. These changes do not require expedited review but must be confirmed (by an individual identified during the review) prior to issuance of final approval. No other changes may be made to the study prior to issuance of the approval letter. Such changes must be made via the modification process outlined in SOP 403. 1.3.2. Submission/protocol/consent corrections that are administrative in nature (e.g., correction of typographical and spelling errors) do not need additional IRB review because the Aurora IRB does not consider such corrections to be changes to the research. 1.4. Changes to Previously Approved Research ( Modifications ) Changes in approved research may not be initiated without prior IRB review and approval except where necessary to eliminate apparent immediate hazards to human subjects. Changes to eliminate apparent immediate hazards to human subjects will be reviewed as Unanticipated Problems per SOP 403. 1.4.1. Changes to previously approved research (Modifications) can be categorized as Minor or Major. 1.4.2. Minor changes to previously approved research are defined as changes that do not involve an increase in risk that is more than minimal, do not affect the regulatory criteria for approval, do not affect the rights and welfare of subjects, and in which all added procedures fall into categories (1) (7) of research that can be reviewed using the expedited procedure [45 CFR 46.110(a)]. 1.4.2.1. Examples of minor changes to already approved research include (not an exhaustive list): basic informational revisions (changes in telephone numbers or contact persons on the consent form, addition or deletion of associates or staff, a change in the number of research participants anticipated to be enrolled at the local site, or the deletion of questions in a questionnaire); changing the amount of blood that is drawn or the frequency of the blood draws provided it remains within the expedited category limitations; adding non-sensitive questions to a questionnaire; revising the format of the consent form or other minor changes to the consent form; adding a standardized test; in certain circumstances, decreasing the drug dosage or the frequency of drug administration; changing the recruitment plan; new or revised recruitment materials, advertisements or scripts; adding a standard quality of life questionnaire; extending the time period of the study to include follow-up with the research participants; in some circumstances, revising eligibility to include or exclude study participants; adding a research site; changing the principal investigator; or changing the consent form to include a newly identified side-effect or adverse event related to the study provided the new risk information has been reviewed by the full committee. The key determining factor is Page 3 of 5
whether the risk to the study participant is increased or changed based on the definition of minimal risk. 1.4.2.2. Translations: Non-English translations of IRB approved consent documents may be reviewed in an expedited manner. The translated document must be accompanied by a Certificate of Accuracy and the qualifications of the translator. Translation by a certified translator is recommended. 1.4.2.3. For changes to research to a study in which an already enrolled subject becomes a prisoner, but the focus of the study does not involve a prison population, expedited review of changes to the approved protocol may be appropriate. 1.4.3. Major changes to previously approved research are changes that do not qualify as minor. These changes are any that entail more than a minimal risk, affects the regulatory criteria for approval or affects the rights and welfare of subject. Such changes must be reviewed by the convened IRB (SOP 304). 1.4.3.1. Examples of a major revision include: change of the study drug or the addition of a research arm to the study. 1.5. Continuing Review of Research Previously Approved at Convened IRB Meeting Federal regulations allow the IRB to use the expedited review procedure to provide continuing review of research previously approved by the convened IRB. In order for the reviewer to approve the continuing review of research by expedited review, the reviewer must ensure that the research has met the applicability criteria set forth in 45 CFR 46.110(a) (categories (8) or (9)) and 45 CFR 46.110(b). [See also SOP 404] 1.6. Notification of the IRB When the expedited review procedure is used for any research activity (i.e. new submissions, modification, continuing review), IRB members shall be informed of such actions via the IRB meeting agenda. 1.7. ation The agenda will include documentation of any activities (e.g. new submissions, modification, continuing review) that were reviewed via expedited review. 2. SCOPE These policies and procedures apply to all materials submitted to the IRB that qualify for expedited review. Page 4 of 5
3. APPLICABLE REGULATIONS, GUIDELINES, AND STANDARDS Minimal Risk: 45 CFR 46.102 21 CFR 56.102 Expedited Review: 45 CFR 46.110 21 CFR 56.110 Federal Register Volume 63, No. 216, pp. 60364-67 FDA Information Sheets, 1998 OHRP Guidance on Written IRB Procedures (January 15, 2007) OHRP IRB Guidebook OHRP Guidance on Continuing Review (January 15, 2007) OHRP Guidance on the Use of Expedited Review Procedures (August 11, 2003)AAHRPP Element II.E.2. Conditional Approval: OHRP Guidance on IRB Approval of Research with Conditions (November 10, 2010) 4. REFERENCES TO OTHER APPLICABLE SOPs SOP 301 SOP 401 SOP 402 SOP 403 SOP 404 SOP 406 Page 5 of 5