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2.2 Full IRB Review

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for: 1) submission of items required for full IRB review; 2) organization, scheduling, and conduct of full IRB meetings; 3) IRB approval criteria; 4) IRB actions; and 5) IRB documentation of actions.

2.0 Policy

It is the policy of the Organization that the IRB will obtain and review sufficient information in order to permit the Board to determine and document that all items which require full IRB review meet all applicable requirements of the following:

  • 2.1. HHS regulations for the Protection of Human Subjects at 45 CFR 46, including Subparts B, C, D (as applicable); FDA regulations for Protection of Human Subjects at 21 CFR 50 including Subpart D, 21 CFR 56, and other FDA regulations as applicable, the regulations and requirements of the other Common Rule agencies as applicable, the HIPAA Privacy and Security Rules at 45 CFR 160, 164, and all other applicable federal, state and local law.
  • 2.2. The HRPP will apply equivalent protections to non-federally funded research. These protections will be based upon the ethical principles in the Belmont Report. In addition, the requirements in 45 CFR 46, Subpart A, B, C, and D will be applied to the greatest extent possible in consideration of the nature of the research.
  • 2.3. The Organization applies the ICH-Good Clinical Practice (GCP) E-6 Guidelines to studies where the sponsored agreement requires compliance with ICH GCP for clinical trials conducted internationally in accordance with HRPP policy 1.13 (Compliance with ICH-GCP Guidelines).
  • 2.4. The IRB will conduct continuing review of research at intervals appropriate to the degree of risk, in accordance with 45 CFR 46.109 and HRPP policy 2.7 (Continuing Review of Research).
  • 2.5. The status of studies reviewed by the full IRB are maintained in the Research Administration (RA) database and Research Support Services (RSS) application system.

3.0 Procedures

  • 3.1. Submission of Items for Full IRB Review Information concerning: 1) procedures for submission, 2) deadlines for submission, 3) ORA processing, 4) review limits, and 5) pre-review are described in HRPP policy 2.1 (Submission of Items for Review).
  • 3.2. IRB Meeting Schedule
    • 3.2.1. The schedule of IRB meeting dates is posted on the IRB website.
      • 3.2.1.1. IRB–01 meets the first Thursday of every month (except January and July), and IRB-02 meets the third Thursday of every month.
      • 3.2.1.2. IRB-04 meets the fourth Tuesday of every month, generally at Children’s Hospital & Medical Center
      • 3.2.1.3. IRB-03 (Rapid Response IRB) meetings are held on demand and convened as soon as possible, as per HRPP policy 1.30 (Use of the Rapid Response IRB).
  • 3.3. Quorum
    • 3.3.1. A full IRB meeting cannot be convened without the presence of a quorum. A quorum must represent a majority of the voting membership of the IRB, including at least one member whose primary concerns are in nonscientific areas.
    • 3.3.2. Each IRB includes one member that is not affiliated with the Institution. It is expected that least one unaffiliated member will be present at each meeting of each IRB as per HRPP policy 1.6 (IRB Composition, Leadership, Qualifications, & Responsibilities).
    • 3.3.3. Some or all IRB members may participate in the meeting by conference call, videoconference or web meeting. Utilization of video conferencing or teleconferencing technology in the conduct of an IRB meeting will only be done at the discretion of the Chair, Executive Chair or IO. Any IRB member participating by conference call, videoconference or web meeting will receive all relevant materials prior to the meeting and must be able to participate actively and equally in all discussions. Voting IRB members cannot participate in the meeting discussions or voting by email.
    • 3.3.4. When the IRB reviews any research involving children, or cognitively impaired persons, an IRB member who is knowledgeable about and experienced in working with that specific population will be present in accordance with HRPP policy 1.6 (IRB Composition, Leadership, Qualifications, & Responsibilities).
    • 3.3.5. When the IRB reviews any research involving other vulnerable populations, an IRB member who is knowledgeable about and experienced in working with vulnerable populations (preferably but not exclusively the particular population is question) will be present in accordance with HRPP policy 1.6 (IRB Composition, Leadership, Qualifications, & Responsibilities).
    • 3.3.6. When the IRB reviews any research involving prisoners, a prisoner representative must be present in accordance with HRPP policy 4.3 (Research Involving Prisoners).
    • 3.3.7. Any IRB member who abstains from voting (for reasons other than a COI as defined in HRPP policy 1.7: IRB Member, Consultant, Staff COI Identification and Management) is included in the quorum. This is recorded as an abstention in the minutes.
    • 3.3.8. Any IRB member who has a COI will be recused in accordance with 45 CFR 45.107(e) [rev 45 CFR 46.107(d)], 21 CFR 56.107(e), and HRPP policy 1.7 (IRB Member, Consultant, Staff COI Identification & Management). If a conflicted member is participating by conference call, videoconference, or web meeting the IRB member’s participation is terminated for discussion and voting. The name of the individual and a statement that the individual was recused due to COI will be recorded in the minutes.
    • 3.3.9. A designated IRB Administrator is responsible for determining quorum requirements, monitoring attendance at the meeting to verify maintenance of quorum, and recording the actions taken on all protocols and other items under review.
    • 3.3.10. If attendance at a convened full IRB meeting falls below quorum (including losing all non-scientist members, or another required member), the meeting will be immediately suspended and no official business will be conducted until a quorum is re-established. If it is not possible to re-establish the quorum, the meeting will be adjourned and the remaining reviews will be conducted at the next available full IRB meeting.
  • 3.4. Assignment of Reviewers and Creation of the Agenda
    • 3.4.1. Reviewers will be assigned by the IRB administrators with advice from the IRB Executive Chair/designee as necessary. At least one of the assigned reviewers for the full board meeting must have the necessary scientific, medical, or other expertise in order to perform an in-depth review of the protocol. When necessary, the services of an expert consultant will be used as described in HRPP policy 1.6 (IRB Composition, Leadership, Qualifications, & Responsibilities).
    • 3.4.2. For new IRB Applications, and tabled IRB Applications the following reviewers will be assigned:
      • 3.4.2.1. For IRB-01 and IRB-02 a primary, secondary and non-scientist reviewer will be assigned
      • 3.4.2.2. For IRB-04 a primary, secondary, and non-scientist reviewer will be assigned; for all research involving drugs a pharmacy reviewer will also be assigned.
      • 3.4.2.3. For IRB-03 a primary and secondary reviewer will be assigned.
    • 3.4.3. For all IRBs, only a primary reviewer will be assigned to applications for continuing review, internal adverse event reports, reports of potential unanticipated problems involving risk to the subject or others, requests for change in protocol and/or ICF, reports of noncompliance and complaints unless it is determined by the IRB Executive Chair/designee that more than one reviewer is necessary.
    • 3.4.4. Two agendas will be created:
      • 3.4.4.1. An abbreviated agenda which lists the new items for review and assigned reviewers. This is attached to the review packet mailed to IRB members who will be attending the meeting.
      • 3.4.4.2. A detailed agenda which is emailed to all IRB members prior to the meeting. A copy is also distributed at the meeting. This agenda contains: 1) education, policy, and informational items; 2) a categorized list of review items; 3) IRB reviewer assignment for each of the items under review, 4) notification of items approved by expedited review (in accordance with HRPP policy 2.3: Expedited Review) and per requirements of 45 CFR 46.110(c), 21 CFR 56.110(c), 5) IRB approval criteria, and 6) IRB actions.
  • 3.5. Review Materials Distributed to IRB Members
    • 3.5.1. All members and alternates scheduled to attend an IRB meeting (in person, or by teleconference or videoconference) will receive paper copies of the following (at least seven days prior to that meeting):
      • 3.5.1.1. Abbreviated (Reviewer) Agenda (per section 3.4.4.1 above)
      • 3.5.1.2. IRB applications for initial review including all consent forms, information sheets, and recruitment materials.
      • 3.5.1.3. Modified IRB applications for tabled research, including the IRB review letter, and the PI response to the IRBs review.
      • 3.5.1.4. Continuing review applications, including the consent form signed by the last subject enrolled in the research, any newly proposed consent form(s), status report on the progress of the research, and as applicable DSMB/DSMC reports, and study reports.
      • 3.5.1.5. Requests for change application, including sponsor’s summary of changes if available
      • 3.5.1.6. Single subject deviation
      • 3.5.1.7. Reports of adverse events
      • 3.5.1.8. Reports of potential unanticipated problems involving risk to the subject or others
      • 3.5.1.9. Reports of noncompliance.
      • 3.5.1.10. Reports of complaints.
      • 3.5.1.11. COI management plans for all protocols where a COI has been identified (in accordance with HRPP policy 1.25: Financial Conflicts of Interest).
    • 3.5.2. Documentation associated with items 3.5.1.2 thru 3.5.1.11 are available to all members through the RSS system at https://net.unmc.edu/rss.
    • 3.5.3. Assigned reviewers for an IRB meeting (as per sections 3.4.2 and 3.4.3 above) will also receive the following:
      • 3.5.3.1. Detailed research protocol, for protocols to which they have been assigned
      • 3.5.3.2. Investigator’s Brochure, for protocols to which they have been assigned, if available
    • 3.5.4. At least two days prior to each meeting, all members and alternates of all Boards receive PDF or DOC files of the following:
      • 3.5.4.1. IRB minutes of the last meeting of that Board
      • 3.5.4.2. Education, Policy and Information items
      • 3.5.4.3. Full agenda for that meeting
  • 3.6. IRB Member Review Procedures
    • 3.6.1. All IRB members must be satisfied that they have sufficient information to make the determinations required for IRB approval in accordance with 45 CFR 46.111; 21 CFR 56.111, and HRPP policy 2.5 (Criteria for IRB Approval).
    • 3.6.2. IRB members are expected to consult the IRB study files in RSS, applicable regulations, and HRPP policies, as necessary during their review of the protocol.
    • 3.6.3. IRB members are expected to submit written reviews, as early as possible, to ORA.
    • 3.6.4. Deficiencies and/or major points of clarification which require revision of the IRB application or other review item should be described fully, and referenced to sections of the submitted application, or to the Criteria for Approval at 45 CFR 46.111.
    • 3.6.5. Deficiencies, errors, inadequate explanations, and excessively high readability level should be described sequentially according to the section of the ICF.
  • 3.7. IRB Meeting Procedures
    • 3.7.1. When a quorum of the Board is present, the IRB meeting is called to order by the IRB Executive Chair, Chair, Vice Chair or designee (subsequently referred to as “Chair” in this policy) and each item on the agenda is acted upon.
    • 3.7.2. The Primary Reviewer will present the review followed by the other assigned reviewers (secondary reviewer, non-scientist reviewer, pharmacy reviewer) as applicable. The protocol is then open for discussion by all IRB members. When the discussion is completed, a separate vote will be taken on each application or other item under consideration.
    • 3.7.3. In order to assist IRB members in their deliberation, the IRB staff have on-line web access to project on a screen to facilitate discussion by the full IRB any portions of applications and associated documents, as well as all applicable federal, state, and local regulations, and HRPP policies. Placemats with the criteria for IRB approval, Subpart B, C, and D determinations and other relevant information are spread throughout the room on the tables.
    • 3.7.4. Whenever a controverted issue arises during an IRB meeting, or when the vote is less than unanimous, members will be asked if they wish to submit written comments or minority opinion. These items will be appended to the minutes of the meeting.
    • 3.7.5. IRB discussion of any one item on the agenda is generally limited to 20 minutes. If the discussion reaches the time limit, the Chair may call the question, or call for a motion to extend discussion. If a motion to extend debate fails to pass my simple majority, the protocol or issue then under discussion will immediately come to a vote of the convened IRB.
  • 3.8. Voting Requirements
    • 3.8.1. The Primary Reviewer will recommend an action which must be seconded by another IRB member, normally the Secondary Reviewer.
    • 3.8.2. IRB voting on each motion will be recorded as the number of members in favor, the number against, and the number of abstentions. Separate votes for each action will be recorded.
    • 3.8.3. Except as specified in other sections of this policy, no motion shall pass unless two-thirds of the IRB members which constitute the quorum are present during the discussion and vote in favor of the motion.
    • 3.8.4. If a member must leave the meeting temporarily before the vote is taken, the vote can be delayed. If the vote is not delayed, the name of the absent member will be recorded in the minutes.
    • 3.8.5. Only those members physically in the room, or attending by conference call, videoconference or web meeting may vote. Absentee voting is not permitted.
    • 3.8.6. If a motion fails to pass by a two-thirds vote, other motions will be entertained. If no further motions are made, the protocol or issue under discussion shall automatically be deemed to have been tabled and shall be referred, as needed, to an IRB subcommittee for further study.
    • 3.8.7. If a protocol or issue has been referred to an IRB subcommittee, the Chair or a member of the subcommittee will present the results of the subcommittee meeting at any subsequent full Board meeting.
    • 3.8.8. The Chair will abstain from voting.
  • 3.9. Criteria for IRB Approval and Other Determinations
    • 3.9.1. Criteria for IRB approval of all human subject are described in HRPP policy 2.5 (Criteria for IRB Approval).
    • 3.9.2. During the review, the IRB must also determine:
      • 3.9.2.1. Whether the research requires continuing review more often than annually, as required at 45 CFR 46.109E; 21 CFR 56.109(a)(2), as appropriate to the degree of risk. The IRB may consider other factors as well:
        • 3.9.2.1.1. The nature of and any risks posed by the clinical investigation.
        • 3.9.2.1.2. The degree of uncertainty regarding the risks involved.
        • 3.9.2.1.3. The vulnerability of the participants.
        • 3.9.2.1.4. The experience of the clinical investigator in conducting the clinical research.
        • 3.9.2.1.5. The IRBs previous experience with that researcher or sponsor (e.g., compliance history, previous problems with the researcher obtaining informed consent, prior complaints from participants about the researcher).
        • 3.9.2.1.6. The projected rate of enrollment
        • 3.9.2.1.7. Whether the study involves novel therapies.
      • 3.9.2.2. Whether the research need verification from sources other than the PI that no material changes have occurred since the previous IRB review, as required at 21 CFR 56.108(a)(2). The IRB will consider:
        • 3.9.2.2.1. Whether the research should have a third party observe the consent process in accordance with HRPP policy 1.2, Section 2.7 (Authority Granted to the IRB by the Organization).
        • 3.9.2.2.2. Whether the current consent form is still accurate and complete.
        • 3.9.2.2.3. Whether the research requires an audit of research records in accordance with HRPP policies 1.21 (Post Approval Monitoring of Research) and 8.4 (Review of Noncompliance Involving Risk to the Subject or Others).
        • 3.9.2.2.4. Whether there are any significant new findings that arise from the review process that might relate to a subject’s willingness to continue participation in the study.
      • 3.9.2.3. When the PI is the lead researcher of a multi-site trial, whether the management of information to the protection of human subjects is adequate, such as reporting of unanticipated problems, interim results, and protocol modifications.
    • 3.9.3. If the research involves an FDA regulated investigational device, the IRB will also determine and document the basis for determination that the investigation involves a significant risk device or non-significant risk device (in accordance with 21 CFR 812.66 and HRPP policy 6.2 (Research involving Investigational and Marketed Devices).
    • 3.9.4. The IRB may determine that some components of the research have met the IRB criteria for approval whereas other components require minor or substantive changes. In this case, the IRB may choose to issue final approval and full release (Section 3.10.1 below) for those components that satisfy the IRB approval criteria. For those components that do not meet the IRB approval criteria the IRB may issue conditional approval (Section 3.10.2 below), table that component (Section 3.10.3 below), or disapprove that component (Section 3.10.4 below).
  • 3.10. IRB Actions
    • 3.10.1. Final Approval and full release; initiation of the research is authorized.
      • 3.10.1.1. All of the criteria for IRB approval are satisfied and no changes are required.
    • 3.10.2. Conditional approval; final IRB approval and full release contingent upon IRB Executive Chair/designee review and acceptance of specified modifications and/or submission of additional documents
      • 3.10.2.1. All of the criteria for IRB approval are satisfied provided the investigator makes the specified changes. The IRB requirements for final approval and release are considered minor and not substantive in nature.
    • 3.10.3. Tabled, full IRB re-review required
      • 3.10.3.1. The IRB requires additional information in order to determine whether the criteria for approval have been satisfied, and/or the IRB had concerns which warrant re-review by the full IRB.
    • 3.10.4. Disapproved
      • 3.10.4.1. Applications may be disapproved if, after thoughtful deliberation, including, as appropriate, discussions with the investigator, the IRB finds serious design flaws that either make obtainment of generalizable knowledge highly unlikely or places subjects at undue risk, or the risk/benefit relationship is unfavorable, or the protocol does not meet institutional policy or requirements, and the investigator is unwilling or unable to make modifications to remedy these situations.
      • 3.10.4.2. The investigator has the right to appeal to the IRB in accordance with HRPP policy 8.6 (Study Hold, Suspension, and Termination).
    • 3.10.5. Decline to complete the review
      • 3.10.5.1. Adequate review of the protocol could not take place because the application is significantly deficient in information and content.
    • 3.10.6. Suspension of IRB approval
      • 3.10.6.1. The IRB requires all research activities be halted immediately in accordance with HRPP policy 8.6 (Study Hold, Suspension, and Termination). This action may be taken in relation to continuing review, complaints, noncompliance, adverse events, and unanticipated problems involving risk to the subject or others.
    • 3.10.7. Termination of the research
      • 3.10.7.1. The IRB requires the study be terminated in accordance with HRPP policy 8.6 (Study Hold, Suspension, and Termination). This action may be taken in relation to continuing review, complaints, noncompliance, adverse events, and unanticipated problems involving risk to the subject or others.
  • 3.11. IRB Review Letters
    • 3.11.1. IRB review letters, which reflect the deliberations and decisions of the Board, are developed by the IRB Administrators, in consultation with the IRB Executive Chair and reviewers.
    • 3.11.2. IRB review letters must be written in a clear, explanatory, and facilitative fashion in order to assist PIs in understanding the rationale for any IRB concerns, clarifications and mandated changes to the IRB application, ICF(s)/information sheet(s) and/or other associated documents.
    • 3.11.3. The IRB review letters will clearly document the determinations of the Board, as referenced above in Sections 3.9 and 3.10 of this policy, including:
      • 3.11.3.1. The decision to approve, disapprove, or require modifications.
      • 3.11.3.2. A list of any modifications/clarifications required by the Board.
      • 3.11.3.3. If the IRB disapproves the action, a statement providing the rationale for the disapproval, and an invitation for the investigator to appeal.
    • 3.11.4. Review letters will include specific findings, comments, requests for clarification and questions related to the materials submitted by the investigator and the IRB’s review of the action.
    • 3.11.5. Review letters will include the following additional documentation as applicable:

      • 3.11.5.1. Documentation of the approval period for research granted full approval and release at the time of initial and continuing review.

        Note: If the IRB conditionally approves a study at initial or continuing review, the IRB review letter generated from the meeting will not contain the “valid until date”. This documentation will appear in the final approval letter (see Section 6.2 below).

    • 3.11.6. Documentation of the level of risk (i.e., minimal risk, greater than minimal risk), and the rationale supporting this classification.
    • 3.11.7. Documentation that the IRB determined that the research satisfies the requirements of 45 CFR 46, Subpart B and the designated category (46.204; 46.205; 46.206). Per Section 2.2 of this policy the IRB will apply Subpart B as required for federally funded research and for non-federally funded research to the greatest extent possible. Any alteration of Subpart B requirements as applied to non-federally funded research will be documented.
    • 3.11.8. Documentation that the IRB determined that the research satisfies the requirements of 45 CFR 46, Subpart C (46.305) and is appropriately classified under the designated category [46.306(2)(i); 46.306(2)(ii); 46.306(2)(iii); 46.306(2)(iv)], as applicable. Per Section 2.2 of this policy the IRB will apply Subpart C as required for federally funded research and for non-federally funded research to the greatest extent possible. Any alteration of Subpart C requirements as applied to non-federally funded research will be documented.
    • 3.11.9. Documentation that the IRB determined that the research satisfies the requirements of 45 CFR 46, Subpart D and has met all the requirements for the designated category (46.404; 46.405; 46.406; 46.407), as applicable. Per Section 2.2 of this policy the IRB will apply Subpart D as required for federally funded research and for non-federally funded research to the greatest extent possible. Any alteration of Subpart D requirements as applied to non-federally funded research will be documented.
    • 3.11.10. Documentation that the IRB considered protocol specific findings for research involving decisionally impaired subjects.
    • 3.11.11. Documentation of the IRB rationale for nonsignificant or significant risk device determinations.
    • 3.11.12. Documentation that the IRB determined that the research satisfies the requirements of 21 CFR.50, Subpart D and has met all the requirements for the designated category (50.51, 50.52. 50.53, 50.54), as applicable.
    • 3.11.13. Documentation that the IRB determined that the research satisfies the requirements for waiver of informed consent/ HIPAA authorization as per HRPP policy 5.2 (Waiver or Alteration of Informed Consent and HIPAA Authorization); under the federal regulations at 1) 46.116(c); or 2) 46 CFR 46.116(d) and 45 CFR 164.512(i)(2)(ii) or 3) 46.408(c), as applicable.
    • 3.11.14. Documentation that the IRB determined that the research satisfies the requirements for waiver of child assent as per HRPP policy 4.4 (Research Involving Children); under the applicable federal regulations at 1) 45 CFR 46.408(a) and 21 CFR 50.55(c)(1); or 2) 45 CFR 46.408(a) and 21 CFR 50.55(c)(2); or 3) 45 CFR 46.116(d) applied under 45 CFR 46.408(a) and 21 CFR 50.55(d).
    • 3.11.15. Documentation that the IRB determined that the research satisfies the requirements for waiver of signed consent as per HRPP policy 5.4 (Waiver of the Requirement to Obtain Signed Consent Form); under the applicable federal regulations at 1) 45 CFR 46.117(c)(1); or 2) 45 CFR 46.117(c)(2) and 21 CFR 56.109(c).
    • 3.11.16. Signature authority is granted in accordance with HRPP policy 1.19 (IRB Signature Authority).
  • 3.12. IRB Meeting Minutes
    • 3.12.1. Basic Information
      • 3.12.1.1. The IRB minutes are based upon the actions of the IRB recorded in detail by the assigned IRB Administrator. The minutes are then developed after the meeting by the IRB Administrators in consultation with the IRB Executive Chair/designee.
      • 3.12.1.2. The IRB minutes consist of the core minutes and addenda (which contain the detailed review letters provided to PIs that reflect the IRBs requirements.
      • 3.12.1.3. Copies of the core IRB minutes are provided via e-mail to: a) IRB members before the next IRB meeting, and b) the IO after the meeting.
      • 3.12.1.4. Complete copies of the IRB minutes including: a) the core minutes, and b) the appended IRB review letters (the IRB minutes addendum) are distributed by email to IRB members and the IO prior to the date of the next IRB meeting. All IRB members, including alternates, receive a copy of all IRB minutes. In addition, all IRB members have access to the complete on-line protocol file which includes documents reviewed and review letters.
      • 3.12.1.5. IRB members for each board have the opportunity to review and correct minutes for the previous convened meeting of that board.
      • 3.12.1.6. The complete IRB minutes will be provided to OHRP, FDA, auditing groups, and other entities in accordance with all applicable federal, state, and Organizational requirements.
    • 3.12.2. Core IRB Minutes:

      • 3.12.2.1. Identification of the individuals present at the meeting: IRB members, non-voting IRB member alternates, consultants, IRB administrative staff, and guests.

        Note: If consultants are present, a brief description of the consultant expertise will be noted as well as documentation that the consult did not vote on any actions.

      • 3.12.2.2. Identification of IRB members classified as non-scientists, and as unaffiliated with the institution.

      • 3.12.2.3. Identification of IRB members, non-voting IRB member alternates and consultants who attended the IRB meeting via videoconferencing or teleconferencing.

      • 3.12.2.4. Identification of alternate IRB members and the IRB member for whom they are substituting.

      • 3.12.2.5. The names of IRB members who have a COI and are recused at the time of the discussion and vote on each board action.

      • 3.12.2.6. The names of IRB members who do not have a COI, but are absent from the room for other reasons at the time of the vote on each board action.

      • 3.12.2.7. IRB special notification items (e.g., items approved by expedited review) per IRB minutes template.

      • 3.12.2.8. Documentation of quorum for each separate vote count for all board actions (i.e., in favor, opposed, and abstentions) in the following categories per the IRB minutes template:

        • 3.12.2.8.1. Previously reviewed (tabled) research proposals
        • 3.12.2.8.2. Initial review of research proposals
        • 3.12.2.8.3. IRB special review items (e.g., single subject protocol deviations requiring review by the full IRB; re-review of a protocol that was conditionally approved but now requires reconsideration by the IRB; unanticipated problem involving risk to the subject or others that is not an adverse event).
        • 3.12.2.8.4. Reports of noncompliance
        • 3.12.2.8.5. Internal adverse event reports that may be unanticipated problems involving risk to the subject or others
        • 3.12.2.8.6. Requests for change in approved research protocols
        • 3.12.2.8.7. Continuing review applications

      • 3.12.2.9. In the event a consultant provided an in-depth review of research the agenda will document the information provided by the consultant and verify that the consultant did not vote.

      • 3.12.2.10. Verification that all IRB members who attended through videoconferencing or teleconferencing were able to actively participate in all discussions and votes.

      • 3.12.2.11. A written summary of the discussion and resolution of controverted issues, which is generally no longer than a quarter to half page of text. A controverted issue is clarified for the purposes of this policy as one, which generated a contentious discussion among members of the IRB over a human subject protection issue.

        Examples include, but are not limited to: a) concerns over the acceptability of the risk-benefit relationship of the research; b) concerns over additional protections for a vulnerable subject population and whether the protocol meets the requirements of Subpart B, C, or D; c) concerns over PI’s qualifications; and 4) concerns related to noncompliance.

      • 3.12.2.12. A written summary of the discussion and resolution of actions taken with regard to significant new findings either provided by the investigator or provided by other sources, which may relate to the subject’s willingness to continue participation in the research.

      • 3.12.2.13. The reason(s) for disapproval of research.

      • 3.12.2.14. A determination of when continuing review is required more often than annually.

      • 3.12.2.15. A determination of which projects need verification from sources other than the PI that no material changes have occurred since the previous IRB review.

      • 3.12.2.16. A determination of which projects should have a third party observe the consent process.

      • 3.12.2.17. A determination of which projects require an audit of research records.

      • 3.12.2.18. Following the effective date of the Revised Rule, the following determinations must also be documented in the minutes, as applicable:

        • 3.12.2.18.1. Rationale for conducting continuing review on research that otherwise would not require continuing review.
        • 3.12.2.18.2. Rationale for an expedited reviewer’s determination that research appearing on the expedited reviewer list is more than minimal risk.
    • 3.12.3. Addenda
      • 3.12.3.1. The IRB minutes addendum consists of IRB review letters to PIs, for all protocol related activities (including, but not limited to, review of tabled and new research proposals, Change Requests in approved research protocols, Reports of Adverse Events and potential Unanticipated Problems, Reports of noncompliance or complaints).

4.0 Deadlines for PI Responses

  • 4.1.1. The PI is given 60 days from the date of the IRB review letter to respond to the IRB’s review by submitting appropriately revised documents. If no response is received by the end of the 60-day period, the PI and Lead Coordinator (if applicable) are contacted by either phone or email to determine the status of their response.
    • 4.1.1.1. Extensions will be granted on a case-by-case basis, as determined by the IRB Administrator in consultation (if needed) with the IRB Executive Chair.
    • 4.1.1.2. If there has been no response by 60 days (or by the expiration of the extension provided per section 4.1.1 above) the study will be withdrawn or closed.

5.0 Review of PI Responses

  • 5.1.1. If the IRB required only minor, directed modifications, the IRB administrator serves as the designated reviewer and is authorized to review and determine the acceptability of the PI’s response. The IRB Administrator will consult with the IRB Executive Chair/designee or IRB reviewers as necessary.
  • 5.1.2. If, on consultation with the Executive Chair, the Administrator determines that the investigator’s response to the IRB review is inadequate, incomplete, or contains significant changes not initially reviewed by the IRB, he/she will refer the submission for review by the full convened IRB.
  • 5.1.3. If the IRB required modifications/clarifications that are more than minor in nature (that is, if the submission was tabled), the investigator’s response will be returned to the full convened IRB for re-review. If possible, the revised submission is assigned to both the IRB that performed the initial review and the original primary and secondary reviewers.

6.0 IRB Approval Periods

  • 6.1. The approval period for protocols for which continuing review is required is based on the date that the convened IRB gave conditional approval of the research. Studies approved with annual continuing review are valid for 364 days from the date of conditional approval; the approval period expires on the 365th day.
  • 6.2. The IRB database will include the following dates:
    • 6.2.1. Date of full Board review.
    • 6.2.2. Date all conditions set by the IRB were determined to be met and the study was granted final approval and release.
    • 6.2.3. Expiration Date (per section 6.1 above).

7.0 Final IRB Approval Letter

  • 7.1. The IRB final approval letter will document the following determinations:
    • 7.1.1. Pertinent dates:
      • 7.1.1.1. Date of full Board review.
      • 7.1.1.2. Date all conditions set by the IRB were determined to be met and the study was granted final approval and release.
      • 7.1.1.3. Expiration Date (per section 6.1 above).
    • 7.1.2. Compliance with applicable HHS and FDA regulations.
    • 7.1.3. Risk determination for the research (with rationale if the IRB’s determination is different than that suggested by the investigator)
    • 7.1.4. Subpart B category for inclusion of pregnant women, neonates, and fetus: viable and non-viable (as applicable)
    • 7.1.5. Subpart C category for inclusion of prisoners (as applicable)
    • 7.1.6. Subpart D category for inclusion of children (as applicable), including the number of parents who must provide and document informed consent (permission).
    • 7.1.7. Waiver or alteration of the requirements for informed consent (as applicable)
    • 7.1.8. Waiver of the requirement for documentation of informed consent (as applicable).

8.0 Review by Other Organizational Committees

  • 8.1. Before the IRB will grant final approval and release, the ORA must receive verification of approval or completion of review by the following committees/offices as applicable:
    • 8.1.1. Pharmacy & Therapeutics Committee
    • 8.1.2. Fred & Pamela Buffett Cancer Center Scientific Review Committee
    • 8.1.3. Institutional Biosafety Committee
    • 8.1.4. Radioactive Drug Research Committee
    • 8.1.5. Investigational Device Review Committee
    • 8.1.6. Conflict of Interest Committee
    • 8.1.7. IT Security and Compliance
    • 8.1.8. Sponsored Programs Administration/ Contracts Office
    • 8.1.9. Research Billing/Coverage Analysis Office

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED MARCH 29, 2018

 INITIAL APRIL 4, 2016

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