1. POLICY Steering Committee approved / Effective Date: 9/19/11 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. A link to the most current list of expedited categories can be found on the RSPP web site. Federal regulations permit an IRB to review research through an expedited review procedure only when those research activities: (1) present no more than minimal risk to human subjects; and (2) involve only procedures listed in one or more of the specific categories listed in the Federal Register, Volume 63, No. 216, pages 60362-67, which may change from time to time. A link to the most current categories can be found on the RSPP web site. 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. Authority of the IRB ChairExpedited 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 Page 1 of 9
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. 1.1.1.1. The SeniorAn 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 submission or modification to previously approved research). A research proposal activity may be disapproved only after review by the full 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 belowrcas: The designated reviewer will be an Aurora IRB committee member with two or more years of experience serving on an Aurora IRB;, and meets and one or more of the following criteria: o Has Ccertification 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.; The individual must be designated in writing by the Senior an IRB Chair in a memo to kept by the RSPP staff Manager to be approved to conduct review using the expedited procedure. 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. Page 2 of 9
At times, individuals with specific expertise ( consultant ) may be asked to provide a recommendation as to the minimal risk nature of the study. These individual 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. 1.1.1.3. Changes to research prior to issuance of the approval letterthat are proposed after the IRB has approved the research with Conditionsal of Approval The IRB (either the convened board or an expedited reviewer) may require changes or specific clarifications in the reviewed submission documents recommend or clarificationthat are. These changes are conditions of approval, and are required to secure IRB approval of the study. 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 issuance of final approval. No other changes may be to the study prior to issuance of the approval letter. Such changes must be made via the modification process outlined in SOP 403. (these changes would not be considered )Any that were not specifically recommended by the IRB and addressed in the meeting minutes requires thetoafter research has been approved with conditions by the IRB, additional changes are sometimes proposed by the investigator or recommended by designated reviewers before all conditions have been satisfied and the protocol documents have been finalized. The process for handling such changes is the same as for any change that is proposed during the period for which IRB approval has already been given. 1.3.2. Protocol Submission/protocol/consent corrections that are only administrative in nature (e.g., correction of typographical and spelling errors in the protocol) would do not need additional IRB review because the Aurora IRB does not consider such corrections to be changes to the research. Changes to the research that are minor may be reviewed by the IRB Chair or designee, and documented using Form RR 401-C. All members of the IRB will be advised of any such minor Page 3 of 9
changes that are approved under an expedited review procedure in accordance with section 1.8. Changes to the research that are more than minor would require further review by the convened IRB at a convened meeting. 1.2. Review of Newly Submitted Research Via Expedited Review Research studies to be reviewed 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, the Senioran IRB Chair or individual reviewer designated to conduct expedited review will determine whether the research study qualifies for an expedited review procedure. At times, individuals with specific expertise may be asked to provide a recommendation. If the study qualifies for expedited review, the Senior IRB Chair or individual designated to conduct expedited reviewer will document his/her final determination that the research meets applicable approval criteria and falls into one or more categories allowing expedited review. Such determinations will be documented through completion of the checklist for Review Using the Expedited Procedure (RR 401-A) and the Reviewer Checklist (Form RR 402-A). 1.3.1.4. Changes to Previously Approved Research ( Modifications )Categories Of Revisions To An Approved Protocol Revisions to an approved protocol and associated documents can be categorized as Minor or Major revisions. 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 revisions changes to previously approved research are isare defined as changes that do not involve an increase in risk that is more than minimal, do not change the risk/potential benefit relationship of the studyaffect 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 Page 4 of 9
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 nonsensitive 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 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. 1.3.1.1. 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 revisions are revisions changes that are do not qualify as not minor revisions. 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). 1.3.2. 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. 1.4. Additional Items That Pose No More Than Minimal Risk That May be Reviewed by the IRB Chair or Designee 1.4.1. Conditional approval pending specific revisions requested by the IRB: Revisions to consent documents and other documentation or clarifications submitted as a result Page 5 of 9
of full IRB review and as a condition to final approval may be reviewed by the RSPP Manager (or other IRB member designated by the IRB) provided that such revisions or clarifications require only simple concurrence by the Investigator. Final approval will be issued provided that the revisions, documentation, or clarifications do not indicate or result in a change to the study or change the risk/benefit ratio. 1.4.2. Review of minor revisions to research previously approved by a fully convened IRB during the period for which approval is authorized. Some examples might be: Minor revisions in approved research or informed consent documents. Examples of minor changes include: 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 provided it remains within the expedited category limitations,; adding nonsensitive 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; 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 whether the risk to the study participant is increased or changed based on the definition of minimal risk. Any revision that entails more than a minimal risk to the subjects must be reviewed by the full IRB at a convened meeting. Examples of a major revision include a change of the study drug or the addition of a research arm to the study. For changes to research involving 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. Recruitment Materials: Advertisements submitted with the initial protocol are reviewed by the fully convened IRB. When appropriate, the IRB Chair, or designated reviewer, may approve new or revised recruitment materials, advertisements or scripts. (See Policy RR 406)., RRecruitment materials that are submitted after a study is approved may receive expedited approval when Page 6 of 9
such advertisements are easily compared to the information contained in the approved consent document. Any revision that entails more than a minimal risk to the subjects or could affect the regulatory criteria for approval must be reviewed by the convened IRB. Examples of a major revision include a change of the study drug or the addition of a research arm to the study. 1.4.3. The SeniorAn IRB Chair, at his/her discretion, may ask another IRB member (e.g. the original Primary Reviewer, or a drug/device specialist) to also review the protocol modificationrevision. Upon completion of their review, the designated reviewer will be asked to provide a recommendation to the Senior IRB Chair as to whether the modification is a minor revision. If the designee s recommendation is that the changes are a minor revision, and the Senior IRB Chair concurs with the designee s recommendation, the Senior IRB Chair will consider whether the research meets the regulatory criteria for approval, and if so, can issue approvale of the modification. If the designee indicatesd that the revision is not a minor modification, the modification will be placed on a future IRB meeting agendareviewed by the convened IRB. 1.4.4. Translations: Translations of IRB approved consent documents will also be submitted for IRB approval and may be reviewed in an expedited manner. There are two options available to obtain approval of translated consent forms: Option #1: The IRB-approved consent form is translated by the Sponsor or site and submitted to the IRB. The IRB will have the Aurora Interpreter/Translation Services department review the translated document for accuracy. The Aurora Interpreter/Translation Services department will provide the RSPP office with documentation that the translated document is substantially similar to the English version. Option #2: The IRB will accept the consent translated by a certified translator when the consent is accompanied by appropriate documentation. 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 full Boardconvened 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. Cautions Page 7 of 9
1.6.1. Requirements related to informed consent apply regardless of whether the expedited review procedure or the fully-convened IRB review procedure is utilized. 1.6.2. Expedited review is not appropriate for the initial review of a Humanitarian Use Device (HUD) opened for the first time within any an Aurora Facility, or studies using an investigational device. 1.7.1.6. Notification of the IRB When the expedited review procedure is used for any research activity (i.e. new submissions, modification, continuing review), all IRB members shall be informed of thosesuch actions taken by the IRB at a subsequent meeting by documentation onvia the IRB meeting agenda. 1.8.1.7.ation The agenda will include documentation of any studies (initial review) or research 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. 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) Page 8 of 9
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 9 of 9