Chapter 12 - Procedures Specific to Protocols Reviewed by the Convened IRB

These procedures are specific to those protocols undergoing review by the convened IRB. Please refer to Chapter 8 for those procedures that are relevant for review of all protocol submissions.

Meeting Assignment and Review

Meeting Assignment

  1. Human subject research requiring full-board IRB review and approval will be assigned by the IRB Office staff to the next scheduled full-board IRB meeting (i.e., subject to the availability of IRB committee members with appropriate expertise as determined by review of IRB Member Rosters). Meeting agendas will typically be limited to no more than 30 protocols with a maximum of 6 to 7 new applications. In rare circumstances, exceptions can be made to these limits by senior IRB staff.
     
  2. Research submissions will be assigned to a committee where there is sufficient expertise. The schedule for IRB meetings can be found on the IRB website.
     
  3. Protocols previously voted by the IRB for reconsideration will generally be assigned to the same IRB committee that previously reviewed the initial submission. As necessitated by time constraints, the principal investigator of the research may request reconsideration of the research submission at the next scheduled full-board IRB meeting. If the next available meeting involves a committee which was not involved in the previous review of the submission, the primary IRB reviewers involved in the previous review of the research submission will be given the opportunity to provide written comments regarding the resubmission. The principal investigator will be invited to attend the full-board IRB meeting at which the protocol is being reconsidered.
     
  4. Protocols previously voted by the IRB for disapproval are required to be submitted as a new protocol and will be assigned to the first available committee with appropriate expertise to review the study.
     
  5. Audit reports (including modification submissions related to auditing findings), unanticipated problems involving risks to human subjects or others and issues related to serious or continuing non-compliance are assigned to Committee F. All other research submissions will be assigned to one of the general IRB committees. If appropriate, an UP or audit report may be reviewed by an alternative IRB committee with appropriate expertise.

Reviewer Assignment

  1. For initial review, three IRB members serve as reviewers (i.e., a primary, secondary, and tertiary reviewer).
     
  2. For subsequent reviews, studies will be assigned to primary and secondary reviewers. If deemed necessary, a tertiary reviewer will also be assigned.
     
  3. For research involving primarily biomedical intervention(s), the primary reviewer will be a physician or health care practitioner with adequate expertise in the area of the research; the secondary reviewer will be a scientific member of the committee; and the tertiary reviewer, if applicable, will be a member whose primary responsibility will be review of the consent document to present the perspective of a potential subject.
     
  4. For research involving primarily psychosocial interventions, the primary reviewer will be a scientific member with adequate expertise in the area of the research; the secondary reviewer will be a scientific member of the committee; and the tertiary reviewer, if applicable, will be a member whose primary responsibility will be review of the consent document to present the perspective of a potential subject.
     
  5. For research that purposefully requires the inclusion of children with disabilities or individuals with mental disabilities and is funded by the National Institute on Disability and Rehabilitation, the protocol, regardless of level of risk, will be reviewed by at least one individual who is primarily concerned with the welfare of these research subjects. This representative will have the appropriate scientific or scholarly expertise to serve in this capacity and will serve as either a primary or secondary reviewer. In the absence of an appropriate reviewer, the IRB will identify a consultant to serve in this role. This will be documented in the minutes generated by the Full Board RRC.
     
  6. For the review of research involving prisoners by the convened IRB Committee, the following membership requirements must be met:
  • the prisoner representative must be listed on the Committee roster as a voting member if a protocol involving prisoners is on the agenda;
  • one or more individuals who are prisoners or prisoner representatives must be present (in person, by phone, video-conference or webinar) at the meeting during the discussion and vote of the proposed research study or the study cannot be reviewed or approved;
  • the prisoner representative must be assigned as a reviewer on research studies involving prisoners and should focus on the requirements of Subpart C;
  • the prisoner representative will have access to the same materials as all Committee members as outlined under “Distribution of Materials;”
  • the prisoner representative must present his/her review orally at the convened meeting of the IRB when research involving prisoners is reviewed;
  • a majority of the IRB must have no association with the prison involved, apart from their membership on the IRB.

Meeting Materials

Distribution of Meeting Materials

  1. The committee meeting agenda and review materials for both paper and electronic submissions will be distributed to the IRB committee members at a minimum of five days prior to the scheduled IRB committee meeting. Due to the nature of the information reviewed by Committee F, which may require immediate attention, the five day minimum will not apply to this committee.
     
  2. The agenda indicates:
    • the meeting date, time and location;
    • educational topics for discussion;
    • conflict of interest disclosure;
    • previous meeting minutes for review and approval;
    • previously approved exempt/expedited research proposals, full board studies and full board; modifications for review;
    • adverse event information to be reviewed;
    • new proposals, modifications, renewals, and other unanticipated problems.
       
  3. Electronic Submissions (New Projects, Reconsidered Projects, Renewals, Renewals with Modifications and Modifications for studies initially submitted through the OSIRIS system)

    All members will have access via laptop to the complete submission for IRB review which includes the following, when applicable:

    • OSIRIS protocol application;
    • Renewal Report Form;
    • Modification Cover Sheet;
    • investigator written or sponsor-provided protocol;
    • informed consent documents;
    • recruitment materials to include advertisements, flyers, phone screening procedures, scripts, and/or screening questions;
    • measures that will be utilized in the study, e.g. survey instruments, questionnaires, interview scripts, recruitment material, etc.;
    • scientific evaluation ;
    • DHHS approved grant; DHHS approved-sample consent; DHHS-approved protocol;
    • information relevant to humanitarian use devices;
    • other materials specific to the proposed study (e.g. investigator’s brochure or investigator correspondence with applicable regulatory agencies. etc.).
       
  4. Paper Submissions (Renewals, Renewals with Modifications, and Modifications for studies in existence prior to inception of OSIRIS)

    Paper submissions will be scanned into the OSIRIS system so that all members will have access to a copy of the complete submission which includes the information listed in #3 above.

Review of Materials Prior to the Meeting

  1. Vice Chairs and assigned reviewers are expected to conduct an in-depth review of all materials in advance of the meeting. Reviewers are provided with access to the IRB Reviewer Checklists as a guide to ensure inclusion of the regulatory criteria and informed consent requirements that must be met as per 45 CFR 46.111 and 21 CFR 56.111 (if applicable). In addition, assigned reviewers are expected to evaluate informed consent documents from the perspective of addressing the required and additional elements of informed consent addressed under 45 CFR 46.116, 21 CFR 50.20 (if applicable) and any other relevant ethical or compliance considerations.
     
  2. For electronic submissions, reviewers are expected to document concerns through the use of the Reviewer Note tab. For paper submissions, reviews are expected to be documented by submitting the IRB Reviewer Report Form to IRB staff prior to the convened meeting.
     
  3. In addition to reviewing the above material, the primary reviewer will also be responsible for ensuring general consistency between (where applicable) the federal grant application, sponsored protocol and/or investigator brochure.
     
  4. Committee members who are not assigned as reviewers are expected to review the provided materials in advance of the meeting in enough depth to be familiar with the materials and prepared to discuss them at the meeting.

Meeting Activities

Verification and Maintenance of Quorum

  1. Except when an expedited review procedure is authorized and used, the IRB will review proposed research at full board convened meetings at which a majority (i.e., > 50%) of the IRB members are present. A quorum will also require at least one non scientific member.
     
  2. In order to ensure the presence of a quorum, alternate IRB members and members of a different standing IRB committee may be requested to participate as members of an IRB committee scheduled to review proposed research. IRB minutes will indicate if the members present at the meeting is an alternate as well as the IRB member for whom the alternate is substituting.
    • With the exception of the IRB Executive Committee (Committee F), at no time may the voting membership of an IRB committee include more than four members who are also an IRB Chair or Vice Chair or a member of the IRB Office staff.
    • A consultant may attend the meeting to participate in the review and discussion of the research study; however, s/he may not vote or count towards quorum. His/her comments are recorded either in memo format or on a reviewer report form.
       
  3. Quorum includes those participating in the meeting via teleconference. Members present via teleconference are noted as such in the meeting minutes. Such members must receive all pertinent information prior to the meeting and be able to actively and equally participate in all discussions.
     
  4. The Research Review Coordinator assigned to the meeting will be responsible for ensuring that quorum is maintained. If at any time during the conduct of a convened IRB committee meeting the quorum is not maintained, proceedings of the meeting will be suspended until the quorum is re-established. If quorum is not realized, the meeting will be adjourned.

Education

The Associate Director of Education is responsible (in conjunction with the IRB Chair) for preparing monthly educational topics for review at all convened IRB meetings. In order to ensure consistency in the presentation of material, it is the Associate Director of Education's responsibility to review the material at all meetings and to encourage discussion regarding the topic.

IRB members will receive continuing education credit for preparation and participation in the IRB meeting. This is further discussed in Chapter 22.

Conflict of Interest

Potential conflicts of interest are assessed at every meeting as outlined in Chapter 20.

Notification of Protocols Reviewed Via Expedited Process

All IRB Committee members are provided with a list of protocols approved through an expedited review mechanism since the last meeting. This includes exempt and expedited submissions as well as full board studies that required a response to comments. Reviewers raising concerns about protocols approved in this manner should contact the HRPO for access to the submission.

Review of Meeting Minutes from Prior Meeting

Before each meeting, the Vice Chair will poll the members to determine if the meeting minutes from the prior meeting are approvable as submitted or if any modifications to the prior meeting minutes are warranted. A vote will be taken for this action and documented in the minutes. The Research Review Coordinator assigned to the meeting will be responsible for making any corrections to the previous minutes. If requested changes affect the correspondence that was forwarded to the principal investigator, a correction will be issued.

Presentation of IRB Materials

Each research study requiring review and approval by the full board IRB will be addressed separately at the convened meeting of the IRB committee.

The primary reviewer leads the discussion of the study at the IRB meeting and will provide a brief summary of the proposed research followed by:

  • a presentation of significant concerns related to the research and informed consent document(s);
  • recommendations regarding the risk level (i.e., minimal, greater than minimal) of the research;
  • recommendations for full approval, approval subject to modifications, reconsideration, or disapproval of the conduct of the proposed research.

The secondary reviewer and non-scientific reviewers will subsequently provide any additional comments or concerns.

Following the reviewer presentations, the research protocol and informed consent document(s) will be discussed by all IRB committee members.

Pertinent comments and concerns of the IRB committee members will be recorded by the Research Review Coordinator assigned to the meeting for inclusion in the minutes of the committee meeting.

Absence of Primary Reviewers

When the primary reviewer is absent, the IRB Chair or Vice Chair will be responsible for ensuring that at least one IRB member or consultant with adequate expertise in the areas of the research is in attendance at the convened meeting and has conducted an in-depth review of all submitted materials. The IRB Committee will consider the written comments of an absent primary reviewer in its review of the research. However if there is not at least one IRB member or consultant with adequate expertise in the areas of the research in attendance at the convened meeting who has conducted an in-depth review of all submitted materials, the IRB will table consideration of the research. If the study involves prisoners, the prisoner representative must be present during the discussion and vote or the study cannot be reviewed or approved.

IRB Determinations

At the conclusion of the primary reviewer presentations, the IRB will deliberate on the following items, which will be included in the IRB minutes.

Applicable Regulatory Issues

For all research studies, a determination will be made and the minutes documented as to whether the criteria under 45 CFR 46.111 or 21 CFR 56.111 (if applicable) are met. Members are provided a laptop during the meeting and the approval criteria is displayed on the landing page when logging into IRB meetings. In addition, research involving the following subject matter, the IRB Chair or Vice Chair will review with the IRB members a checklist of requisite additional criteria for approval of the research and, if applicable, additional consent form requirements. Regulatory checklists are available in OSIRIS.

  • Vulnerable Subjects Documentation Forms
    • Child Documentation Form
    • Fetal Tissue Documentation Form
    • Neonate Documentation Form
    • Pregnancy Documentation Form
    • Prisoner Documentation Form
    • Proxy Documentation Form
       
  • Waiver Forms
    • Waiver of Consent & HIPAA
    • Waiver of Consent to Identify Subjects
    • Waiver of Informed Consent
    • Waiver to Obtain a Signed Consent
    • Waiver of HIPAA Authorization
    • Waiver of HIPAA for Recruitment
    • Waiver of HIPPA Exempt
    • Waiver for Emergency Research Documentation Form
       
  • Non – local research Forms
  • Non significant risk devices Forms
  • IND checklist
  • Department of Defense

The Vice Chair of the meeting should ensure that all points are discussed during committee deliberations. The Research Review Coordinator is responsible for documenting the applicable points during preparation of the meeting minutes for final concurrence by the Vice Chair.

Level of Risk

When considering risks, the IRB considers physical, psychological, social, economic and legal risks.  IRB members will be polled to determine the risk level (minimal, greater than minimal) of the proposed research.  The basis for this determination will be documented, with justification, in the meeting minutes.

Frequency of IRB Continuing Review

For research studies involving greater than minimal risk or other significant human subject protection concerns, the IRB determines if continuing review is warranted on a more frequent basis than the requisite annual review and, if so, establishes the parameters for an appropriate continuing review interval. In making this determination, the following may be taken into consideration by an IRB Committee:

  • Phase I and II clinical trials involving use of an unapproved investigational drug or device
  • Involvement of recombinant DNA or other types of gene transfer protocols;
  • Research activities that pose a significant likelihood of a life-threatening or serious adverse event to involved subjects;
  • Research where multiple adverse events have been observed during the conduct of the study
  • Previously raised concerns about an investigator during an audit;
  • Recommendations from other institutional committees (e.g., RDRC, IBC,CTRC);
  • Any other concern raised by an IRB member.

New Information

Throughout the lifespan of a research protocol, the IRB may determine that currently enrolled subjects need to be notified of new information or significant new findings that alter the risk benefit ratio and may affect their willingness to continue study participation.   New information may be presented to research participants via an addendum consent form or a modified consent form (See Chapter 13).

Verification from Other Sources

Protecting the rights and welfare of participants sometimes requires that the IRB verify independently, utilizing sources other than the investigator, that no material changes occur during the IRB designated approval period.  Additional sources may include: audit by the Education and Compliance Office for Human Subject Research (ECO-HSR), investigational pharmacy records, incident reports, radiation safety or source documents, as well as information from staff, research participants, families, sponsors or others.  

Criteria for determining if verification is required will include, but not be limited to:

  • Complex protocols involving unusual levels or types of risks to subjects;
  • Protocols conducted by investigators who previously have failed to comply with Federal regulations or the requirements or determinations of the IRB;
  • Protocols where concern about possible material changes occurring without IRB approval have been raised based on information provided in continuing review reports or from other sources.  

Monitoring of Informed Consent

For research determined to be of greater than minimal risk or if potential conflict -of-interest or coercion concerns exist, the IRB members may request that random monitoring of the informed consent process be undertaken by a representative of the ECO-HSR.  The Research Review Coordinator assigned to the IRB meeting will notify the ECO-HSR of this request.

Possible IRB Committee Actions for Research Studies

The following are actions that may be taken by the IRB during the review of protocol submissions.  In addition to the actions noted below, there are also actions in Chapter 17 that are utilized by the IRB Executive Committee (Committee F) when reviewing unanticipated problems involving risk to human subject, as well as serious, or continuing noncompliance:

  • require that a study be submitted for continuing review at an interval less than annually;
  • request an audit of the informed consent process;
  • request a complete audit of the study;
  • request that the investigator appear before the Committee to provide information related to the submission;
  • request review of a federally funded research study by the Secretary, DHHS if designated for approval under 45 CFR 46.407 (Subpart D – Additional Protections for Research Involving Children). If the study is not federally funded, review by an independent expert panel will be sought;
  • request review of a federally funded research study by the Secretary, DHHS if designated for approval under 45 CFR 46.207 (Subpart B – Additional Protections for Pregnant Women, Human Fetuses and Neonates involved in research). If a study is not federally funded, review by an independent expert panel will be sought;
  • terminate or suspend any or all research activities or  University IRB approval of the research study.

When terminating or suspending some or all research activities, the University IRB will consider what additional actions the principal investigator or institution should take in order to protect the rights and welfare of current human subjects.  These additional actions may include but are not limited to:

  • Transferring the human subjects to another research study (i.e., based on equivalent inclusion/exclusion criteria);
  • Making arrangements for clinical care outside the research;
  • Allowing continuation of some research activities under the supervision of an independent monitor;
  • Requiring or permitting follow-up of the human subjects for safety reasons;
  • Requiring adverse events or outcomes to be reported to the University IRB and the sponsor;
  • Notifying current and/or former human subjects of the University IRB’s decision to terminate or suspend the research study;
  • Recommending suspension of the PI’s privileges to serve as a PI or requiring a replacement of the PI for the research study in question. This recommendation will be placed on the agenda for a Committee F (Executive Committee) meeting for final disposition.

Types of Motions

Based on its review of initial or ongoing review of research, the IRB decides to approve, reconsider, disapprove or stipulates specific modifications of the proposed research and/or consent document(s) as required to secure IRB approval of the research.  Following is a brief description of each of the possible motions.

Full Approval: No changes to the research or informed consent document(s) required.  The investigator may initiate the research immediately upon receipt of the written notification of full approval to conduct the research.

Approval Subject to Modifications: Conduct of the research can be granted full approval by the IRB Chair or IRB Vice Chair pending principal investigator concurrence with specific revisions stipulated by the IRB with directive comments.  The principal investigator may not initiate the research until such time that s/he has modified the research protocol and/or informed consent document(s) to comply with the specific revisions stipulated by the IRB; such revisions have been reviewed and approved by the IRB Chair or IRB Vice Chair; and the principal investigator has received written notification of full approval to conduct the research.

Reconsideration: Approval to conduct the research requires substantive clarifications or modifications of the research design or procedures or substantive revisions of the informed consent document(s).  The principal investigator must respond to the identified concerns, clarifications, modifications or revisions and resubmit the revised research and/or informed consent document(s) for full-board IRB review.

Disapproval: The proposed research has fundamental design problems and/or presents significant ethical or safety concerns to involved human subjects.  The principal investigator must undertake a major revision of the research before it can be resubmitted for full-board IRB review.

Tabled: Insufficient information is available to review the proposed research in an adequate manner.  The principal investigator must provide this information before it can be resubmitted for full-board IRB review.  The proposed research may also be tabled due to loss of quorum or lack of appropriate expertise present at the meeting.

Call for Vote

Following open discussion of the above applicable referenced items, the IRB Chair or Vice Chair will call for a vote of the committee to grant full approval, approval subject to modifications, reconsideration, or disapproval of the proposed research.

  • IRB members in attendance at the full meeting, but absent from the meeting during the discussion of the research protocol and the vote will not be counted in the committee vote.
  • The absence of members due to a conflict (i.e., a listed investigator, financial or other conflict) during the discussion of the research protocol and the vote will be documented in the minutes of the full board IRB meeting to include the reason for their absence (e.g., listed investigator on research study under consideration, financial interest in sponsor of the research or the technology being evaluated).
  • IRB members who provide written comments regarding the proposed research and informed consent documents, but who are not present at the meeting, will not be counted in the committee vote.
  • The vote of the majority of the IRB members present at the meeting will determine the final approval status (i.e., full approval, approval subject to modifications, reconsideration, disapproval) of the conduct of the proposed research.

Meeting Minutes

 Attendance

The minutes of the IRB meetings will specify the members of the committee who were present at the meeting; members who were absent, but provided written comments, and members who were absent. IRB Office staff (i.e., not serving as members of the committee), consultants to the committee, and guests will be listed separately.

Protocol Specific Information

Each research submission reviewed by the IRB will be listed separately by IRB number, principal investigator name, and protocol title. For each research submission, the minutes address:

  • the action (i.e., full approval, approval subject to modifications, reconsideration, disapproval) taken by the committee and the corresponding numerical vote;
    • Documentation of the numerical vote will address the number of IRB members voting for or against the action taken by the committee; the number of IRB members abstaining from the vote; and any IRB members listed as being present at the committee meeting, but who were absent during the discussion of the research submission and subsequent vote. The vote will be reflected as the number for the action, the number against the action and abstentions (e.g., 13 members for the action; 0 members against the action; 1 abstention).
  • the risk level of the research as determined by the committee;
  • the IRB approval interval designated by the committee;
  • pertinent comments and concerns of the primary IRB reviewers and pertinent comments and concerns expressed during open discussion of the research submission, to include significant new findings to be communicated to research subjects and a summary of controverted issues and their resolution (when the IRB reached consensus).
    • In order to ensure that human subject protection issues are fully addressed at the IRB meeting, many times housekeeping problems (i.e., grammatical and typographical errors) are not presented for committee discussion. However, in preparing the meeting minutes, which are used directly to generate IRB response letters to the involved investigators, these housekeeping problems are included; especially as they relate to the consent form and ensuring its understanding by potential research subjects.

Additional Documentation Requirements

  • Reconsideration or Disapproval of Protocols

    For research submissions voted for reconsideration or disapproval, the following information should be recorded in the minutes:

    • a summary of the primary reason(s) for such determination by the full-board IRB;
    • where applicable (i.e., wherein there was a vote for reconsideration or disapproval in the face of majority vote for approval), a summary of the unresolved controverted issues.
  • Regulatory Forms

    The research review coordinator will ensure that all criteria outlined on the regulatory forms are included in the meeting minutes.

Approval and Utilization of Minutes

Minutes of the IRB committee meeting will be reviewed and accepted by the IRB Vice Chair overseeing the meeting and/or, if present at the meeting, by the IRB Chair or another IRB Vice Chair. Following their acceptance by an IRB Vice Chair or IRB Chair, the minutes of the IRB committee meeting will be directly used to generate written notifications of IRB decisions regarding the approval status of the research submission for dissemination to the listed principal investigator.

The minutes of the IRB committee meeting will be included with the materials prepared for review at the next convened meeting of the IRB committee, and will be voted for approval at the convened meeting. The minutes will be modified as necessary to obtain approval of the IRB committee. If modifications to the minutes affect the approval status of a research study, the Principal Investigator will be notified.

The Institutional Official has access to all approved IRB minutes through the OSIRIS system, including a listing of research studies granted final approval by the IRB.

version 10.9.2015