1. POLICY Steering Committee approved / Effective date: 9/11/15 Except when an expedited review procedure is appropriate or an exemption determination may be made, the IRB will review proposed research at a convened meeting at which quorum is present. The IRB will establish meeting dates as discussed in section 1.1 of this Policy. An IRB Chair may call an urgent review meeting at which the IRB will convene to address issues that the IRB Chair believes requires IRB consideration before the next scheduled meeting. Specific Policies Terms used in this policy but not defined herein shall have the meanings set forth in the Glossary. 1.1. Meeting Schedule 1.1.1. The Aurora IRB has established meeting dates for a given year. A meeting schedule for the year is determined in early fall of the previous year. The schedule is distributed to all IRB members once created. The schedule is also placed on the IRB Member Connection website. Investigators and research staff are provided the meeting schedule and a list of with corresponding protocol submission deadlines via the RSPP/IRB website. 1.1.2. It is sometimes necessary to change a previously scheduled meeting date. IRB members are notified by e-mail, and phone of such changes. A notice of meeting date change is also placed on the IRB web site. 1.1.3. At times it may be necessary to convene an urgent review IRB meeting to address issues that an IRB Chair believes requires IRB consideration before the next scheduled meeting. IRB members are requested to attend by e-mail, phone or fax and relevant materials are immediately sent. The urgent review meeting will be convened only if quorum is present, there is proper composition of the IRB, and voting members have had sufficient time to review the meeting materials. 1.2. Quorum 1.2.1. Quorum is defined as a majority (more than half) of members. The IRB members must align with the criteria established for proper IRB composition (SOP OR 201). The IRB cannot review research if a quorum is not present. 1.2.2. An alternate member may attend in the place of a regular member in order to meet the quorum requirements outlined above, provided that the alternate is provided all meeting materials in advance of the meeting with sufficient time to review. If the regular member and his/her alternate attend the same convened meeting, only one individual may vote and the minutes will reflect which member was able to vote. (See SOP OR 201) Page 1 of 9
1.2.3. If quorum is lost during an IRB meeting, the IRB will not conduct business requiring a vote until quorum is restored. 1.3. Primary Reviewers Prior to the meeting, an IRB Chair will designate a Primary Reviewer for each research proposal based on the expertise required of the protocol and the member s IRB experience. The RSPP Director or alternate will also review the members scheduled to be present at the meeting and whether any of the proposed Primary Reviewers have a Significant Interest in the research under review. When research involves the enrollment of subjects who are vulnerable, at least one member who is knowledgeable about or has experience working with such a population will be present at the meeting. The IRB is otherwise constituted with appropriate expertise. If the RSPP Director determines that appropriate membership will not be present at a particular IRB meeting, he/she will inform the IRB Chair who will defer the review of the affected study to a subsequent IRB meeting that will have appropriate expertise, or obtain an outside consultant to provide sufficient expertise to allow the IRB to review the protocol. The Primary (and Secondary, if assigned) Reviewer duties are described in SOP OR 202. 1.4. Meeting Materials Sent Prior to IRB Meetings IRB members or their alternates will be sent/provided via the IRB Member Connection website (see SOP 303) a meeting packet prior to the scheduled IRB meeting. The meeting packet will contain the meeting materials required for review of all actions to be considered by the convened IRB, and will be sent sufficiently in advance of the meeting to allow time for adequate review. The meeting packet will include: 1.4.1. Agenda: A meeting agenda will be prepared by the IRB Coordinator (or designee) and distributed to IRB members prior to each meeting. A copy of the agenda will be maintained on file with the meeting minutes. 1.4.2. Voting ballot: The voting ballot will include all actions upon which the IRB must vote. It also includes a reminder for members to declare, at the outset of the meeting, any Significant Interest that they may have with the research to be considered, and for them to absent themselves from the meeting room during discussion and voting on that particular protocol, except to provide information to the IRB. The IRB minutes will reflect the name of the individual and reason for such recusal that occurred during the meeting. Page 2 of 9
If the IRB Chair has a Significant Financial Interest or Significant Non-Financial Conflict of Interest, another IRB member will preside over the meeting during discussion and vote of the specific action. Any issues related to whether a Significant Financial Interest or Significant Non-Financial Interest exists with respect to the IRB Chair shall be resolved by the Institutional Official. 1.4.3. Study materials for initial review. (i) For each study to be initially reviewed by the convened IRB, all IRB members will receive, at a minimum, a copy of the following: Completed IRB Submission Form (FO 301-A) Proposed informed consent document(s) and/or script as appropriate The complete study protocol Recruitment materials (Advertising) intended to be seen or heard by potential subjects, including flyers, media advertisements, e-mail solicitations, recruitment letters, and clinical trial web sites, if applicable Sponsor s sample informed consent, if applicable Subject materials (questionnaires, surveys, diaries, etc.), if applicable Any documentation from FDA related to a study with an IND or IDE (e.g. IDE letter or conditional approval letter) Delegation of Authority log (ii) In addition to the items listed in 1.4.3.i, for each study he/she is assigned to review, a Primary Reviewer will receive the following: Most recent Investigator Brochure or device manual (if applicable) Any adverse event reports submitted by the study sponsor with the protocol Primary Reviewer Checklist (form RR 402-A), and if applicable, a copy of the Reviewer Drug/Device checklist and any other Page 3 of 9
pertinent checklists (for review of research involving vulnerable populations (e.g. pregnant women, prisoners, or children), Department of Defense, Justice, et al. research, or research requesting inclusion of decisionally incapacitated adults [SOP 702]) Primary Reviewer Presentation Guide Any relevant grant applications when the study is PHS funded and Aurora is the funding recipient ( awardee ) DHHS-approved sample consent document (when one exists). Complete DHHS-approved protocol (when one exists). 1.4.4. Study materials for review of modifications. (i) For each study undergoing modification review by the convened IRB, all IRB members will receive, at a minimum, the following: the completed modification form, including a summary of the changes to the study other modified documents (e.g. consent document, submission application, recruitment tools, etc.) as applicable. (ii) For each study undergoing review of modifications by the convened IRB, the Primary Reviewer will also receive, at a minimum, the following: the annotated version of the revised protocol or a summary of changes; other revised documents as necessary (e.g. consent document, Investigator Brochure or Device Manual, etc) Primary Reviewer checklist for convened IRB modifications. 1.4.5. Study Materials for Continuing Review. (i) For each study undergoing continuing review by the convened IRB, all IRB members will receive, at a minimum, the following: Completed Continuing Review Form (RR 404-A) Page 4 of 9
Any submitted materials to address questions on the Continuing Review Form Current consent document (when applicable). (ii) For each study undergoing continuing review by the convened IRB, Primary Reviewers, and Secondary Reviewers as assigned, will also review, at a minimum, the following: Complete protocol that includes any protocol modifications previously reviewed by the IRB. Continuing Review Checklist/Evaluation form 1.4.6. Any other materials to be discussed by the convened IRB may include forms: Unexpected Event Reporting Form Local (RR 403-A) and External (RR 403-B), Significant New Findings Form (RR 403-F), or Significant Violation Form (RR 403-G), and IRB member education materials. 1.4.7. Copies of UPIRSO Review Considerations and Noncompliance Review Considerations as necessary. 1.5. Minutes Minutes will be created to meet the applicable federal regulations and guidance documents. The Aurora IRB meeting minutes will document the following: Actions taken by the IRB. Separate deliberations for each action. Votes for each protocol as numbers for, against, or abstaining. Attendance at the meeting. When an alternate member replaces a primary member. Conditions or stipulations of approval and the basis for requiring changes in research. The basis for disapproving research. A written summary of the discussion of controverted issues and their resolution. The names of IRB members who leave the meeting because of a conflict of interest along with the fact that a conflict of interest is the reason for the absence. Page 5 of 9
For initial and continuing review, the approval period. Required determinations and protocol-specific findings justifying those determinations for: Waiver or alteration of the consent process. Research involving pregnant women, fetuses, and neonates. Research involving children. Unless the FDA has issued an IDE, an IDE exemption, or has made a non-significant risk device determination, the rationale for determining that risk associated with using a medical device in a study is significant or non-significant. The Aurora IRB meeting minutes will also address a research study s compliance with HIPAA privacy standards. 1.5.1. Recording: The Research Compliance Analyst and RSPP Director will take notes for each convened IRB action using the IRB Minutes Template (Form FO 303-B). These protocol notes will be turned into the draft meeting minutes. The RSPP Director is ultimately responsible for preparing draft minutes for IRB approval. 1.5.2. Convened IRB review of minutes: Draft minutes will be distributed for review to the same IRB team at a subsequent IRB meeting. The minutes will be discussed at a subsequent meeting, and considered for approval. Corrections requested by the IRB will be made by the RSPP Director or designee. Minutes requiring corrections that are more than editorial in nature will be printed in final form and made available to members at a subsequent IRB meeting. The IRB Chair and the RSPP Director shall sign and date final minutes as reviewed by the convened IRB. The IRB Coordinator will maintain the original paper version of the reviewed minutes, as well as the agenda and pertinent materials (see Policy FO 305). 1.5.3. Notification of IRB actions to Organizational Officials A copy of each set of draft minutes is sent to the Institutional Official, as well as the Vice President of Research and Academic Relations. These draft minutes may be shared with site administrators where research is to be conducted as deemed necessary A copy of the final, approved minutes may be requested of the RSPP Office as necessary. Page 6 of 9
1.6. Telephone and Video Conferencing Use 1.6.1. IRB Member attendance at convened meeting via telephone conferencing/video conferencing Should a member not be able to be physically present during a convened meeting, the member can attend using telephone conferencing or video conferencing. The member who is not physically present will be connected to the rest of the members via speaker phone or video conferencing technology. In this manner, all members will be able to discuss the protocol even though the member(s) is not physically present. Members participating by technology may vote, provided they have had an opportunity to review all materials the other members have reviewed prior to the meeting. The member will send their voting ballot to the IRB coordinator electronically. The minutes shall record that the voting member attended the meeting via telephone conference call or video conference call, and that he/she received all pertinent meeting materials prior to the meeting. The minutes shall also record that the member was able to actively and equally participate in the discussion of all protocols. 1.6.2. Meetings Conducted Via Telephone Conference or Video Conference Calls On rare occasion, an IRB meeting may be convened via telephone conference call or video conference call. A quorum (as defined above) must participate for the conference call meeting to be convened. To allow for appropriate discussion to take place, all members must be connected simultaneously for a conference call to take place -- telephone polling (where members are contacted individually) will not be accepted as a conference call. 1.7. Voting Members not present at the convened meeting and who did not participate via telephone conference call or video conference call may not vote on an issue discussed during a convened meeting (no voting by proxy). For a member s vote to count toward the final decision on a study, the member must be present or connected for the entire discussion and deliberation of the study. Voting at the convened IRB meeting will occur by coded ballot. The ballots are coded so that the RSPP staff can ensure that no member with a known conflict Page 7 of 9
2. SCOPE of interest inadvertently voted. Members of the IRB vote following discussion of the recommendations made by the Primary Reviewer, and after deliberation, and consideration of the regulatory criteria for approval (see SOPs RR 402 and RR 404). The votes are tallied by the IRB coordinator and reflected in the minutes. Voting ballots are not retained. These policies and procedures apply to all research submitted to the Aurora IRB. 3. APPLICABLE REGULATIONS, GUIDELINES AND STANDARDS 45 CFR 46.115(a)(2) 21 CFR 46.115(a)(2) 45 CFR 46.103, 46.108 45 CFR parts 160 and 164 21 CFR 56.108, 56.109 FDA Information Sheets, 1998 OHRP Guidance on IRB Meetings Convened via Telephone Conference Call (March 28, 2000) OHRP Compliance Activities: Common Findings and Guidance, Section G (July 11, 2002). OHRP Guidance on Written IRB Procedures (January 15, 2007) AAHRPP Elements II.1.D., II.1.E., II.2.C., and II.5.B. 4. REFERENCES TO OTHER APPLICABLE SOPS SOP 202 SOP 402 SOP 403 SOP 404 Page 8 of 9
SOP 501 SOP 702 SOP 1201 Page 9 of 9