Appendix D

Procedure for Full Committee Review

1. Applicability. This procedure describes the requirements and process for review of human subject research via a fully convened IRB and applies to initial and continuing review of research proposals as well as amendments to research proposals that are not exempt and that do not qualify for expedited review procedures. All members of the IRB review research the proposals that require full review, and unanimous recommendation to approve the proposals is required prior to initiating the research protocol. Full review is required when the research involves more than a minimal risk to human subjects and/or involves members of protected classes. Changes in the conditions or protocols of research that gained IRB approval by full review within the last year must be reviewed for approval by the IRB.
2. Meeting Dates and Distribution of Materials. The IRB meeting dates/times are determined by the Office of Academic Research and IRB. Approximately one week prior to the meeting, research-related documents required by members to conduct a thorough review are made available to all members expected to attend the meeting. The IRB reserves the discretion to limit the number of protocol submissions scheduled for each meeting so that the IRB can give reasonable and due consideration to each protocol.
   
   Primary, secondary, and regulatory reviewer systems may be used by an IRB, as determined by the IRB Chair and Director of the Office of Academic Research. However, all IRB members will be provided access to the full information for each agenda item, either through distribution, having files available for review by IRB members in the IRB office as well as having copies of the full protocol record at the convened IRB meeting. The primary, secondary and administrative reviewers and IRB members should use the Full Review Checklist as a guide while reviewing a project.
3. Materials Provided to Members for Review. Before any meeting at which a protocol is to be reviewed, each Committee member should have or have ready access to regulatory information and review checklists and should receive a copy of and have an opportunity to review the following protocol-related information:
   1. Initial Review
   1. Application, including detailed protocol and copy of full research proposal
   2. CITI Training Completion Report(s)
   3. Recruitment plan, including, if applicable, HIPAA authorization or request for waiver for recruitment
   4. Recruitment materials (letters, advertisements, postings, e-mail announcements, etc.)
   5. Consent form(s) or request for waiver of consent
   6. Assent form, if applicable
   7. HIPAA authorization form(s) or waiver application, when appropriate
   8. Site authorization letter (approval to conduct research), if applicable
   9. Sponsor’s protocol if applicable
   10. Device manual, if applicable
   11. Funding application, when applicable, to primary or regulatory/administrative reviewer
   2. Responses to Research Determined by the IRB to Require Substantive Revisions
      1. Revised protocol in “track changes” format, or other document describing where in the protocol the change has been applied, as applicable.
      2. Revised consent/authorization form(s) in both “track changes” and clean copy format, as applicable.
      3. Any other documentation requested by the IRB at its prior review.
   3. Continuing Review (Re-approval)
      1. Request for Reapproval Form
      2. A summary of the protocol and any amendments (so long as the primary reviewer receives or has access to the full protocol, including all modifications)
      3. A status report on the progress of the research, including
         1. the number of participants accrued and description of participants
         2. a summary of anticipated adverse events that have occurred at a frequency or magnitude greater than anticipated
         3. a description of any unanticipated problems involving risks to participants or others and of any serious, unanticipated adverse events which have not previously been provided to the IRB
         4. a summary of any withdrawal of participants from or complaints about the research
         5. a summary of any recent literature, findings, or other relevant information, especially
         6. information about risks associated with the research
         7. a copy of the current informed consent document(s)
   4. Adverse Events, Reports of Unanticipated Problems Involving Risks to Participants or Others, and Noncompliance
      1. Completed adverse event or unanticipated problems involving risks to participants or others form(s)
      2. Proposed corrective action plan, if applicable
      3. Revised consent form and revised protocol (if applicable), with rationale for changes
   5. Proposed Changes to Protocol and/or Consent Form
      1. Amendment form, either through submission of signed form or electronically authenticated
      2. Detailed description of proposed changes
      3. Rationale for the changes
      4. Revised protocol if applicable, preferably in “track changes” format
      5. Revised consent/authorization form(s) in both “track changes” and clean copy format, if applicable.

4. Administrative, Primary and Secondary Reviews. Administrative reviews of new protocols are conducted by the IRB Research Coordinators or Director when the protocol is submitted to the IRB to ensure that all required elements are included and addressed in accordance with University requirements using the appropriate review checklist(s). Missing elements will be brought to the attention of the principal investigator for inclusion in the final materials to be distributed to the IRB members.

   Primary reviews are conducted by an IRB member assigned by the IRB Research Coordinator or Director (possibly based on suggestions by the investigator) after the administrative review is complete and the protocol is assigned to a meeting agenda. When the project is deemed by the coordinator to involve subjects likely to be vulnerable to coercion or undue influence, the IRB Research Coordinator or Director ensures that at least one IRB member knowledgeable about or experienced in working with such subjects will be present at the meeting.

   The IRB Coordinator or Director selects a primary reviewer whose experience and background will afford a thorough scientific and ethical review of the protocol. Commonly, an IRB member in the same or similar academic discipline who is not involved in the research nor has a potential conflict of interest is appropriate to serve as the primary reviewer. Primary reviewers are responsible for presenting the study to the IRB and leading the IRB discussion of the protocol. Primary reviewers should review the protocol in accordance with the Protocol Review Checklist and any other applicable checklist or guidance material. Protocol deficiencies or issues requiring clarification may be brought to the principal investigator’s attention for clarification prior to the IRB meeting so as to facilitate thorough discussion by the IRB. The primary reviewer may also seek consultation from individuals whose expertise will ensure thorough scientific review of the protocol.

   Secondary reviews may be conducted by an IRB member assigned by the IRB coordinator or Director (as above) on new protocols to afford an in-depth review of ethical considerations raised by the research, in addition to the review provided by the primary reviewer.

   The IRB research coordinator or director assigns primary reviewers to protocols submitted for continuing review or amendment in a similar manner as for initial review. The primary reviewer presents the study to the IRB,as described above. The administrative review is conducted after the submission is assigned to a meeting agenda, but before the scheduled meeting. The administrative reviewer should work with the primary reviewer if protocol deficiencies or issues requiring clarification are identified prior to the meeting in order to allow opportunity for the principal investigator to clarify issues or correct problems so as to facilitate the IRB’s review.

5. Quorum Requirements. An IRB is considered to be convened when a quorum of the membership is present. Quorum requires that a majority of members are present and must include at least one physician/scientist and at least one member whose primary activities are in nonscientific areas. Teleconference or videoconferencing may be used by one or more members of the IRB, with the teleconferencing member still counted towards meeting quorum. Should the quorum fail to be maintained during the course of a meeting (e.g., those with conflicts recuse themselves, early departures, loss of all non-scientists, etc), the meeting is terminated from further votes unless the quorum can be restored. The group may, however, deal with other such issues as do not require a quorum such as providing comments on protocols or approving studies which would otherwise qualify for expedited review until such time as quorum is restored and full discussion or action can be taken.

6. Review and Discussion by the Convened IRB. The primary reviewer should be present at the meeting to introduce the research and provide the first comments. At the discretion of the Chair, however, a written commentary may be submitted by the primary reviewer in his/her absence. The discussion of each new research proposal, continuing review progress report, amendment or other agenda item is led by the Chair and any designated reviewer(s). Discussion should consider the adequacy with which the protocol conforms to the requirements for IRB approval described in IRB Policy Review of Research Proposals as well as any additional requirements for populations requiring additional protections for vulnerable populations.

   At the end of the discussion, a vote is taken to determine the status of the protocol submission (for, against, abstention) and recorded in the minutes. Note that if a consultant is present, the consultant may not vote as he/she is not a member of the IRB. The interval for continuing review is determined with review intervals generally one year unless the convened IRB considers a shorter interval to ensure protection of research participants. Actions of the IRB require agreement by the majority of members present (half the present voting members, plus one). Note that abstentions have the same effect as a vote against as they do not contribute to the majority.

   The IRB may approve protocols for up to one year. Shorter approval periods may be appropriate any time there is a concern by the IRB regarding investigator compliance with IRB requirements, or when IRB oversight would be enhanced by review of more frequent progress reports. Initial protocols approved by the IRB for one year expire at the end of 365 days from the date of the convened IRB meeting (366 in the case of leap years). Protocols which require specific minor revisions but are otherwise approvable following confirmation of requested revisions also expire 365 days from the date of the last convened IRB meeting at which they were discussed irrespective of when the responses are reviewed and approved by an expedited review process.

   IRB members are reminded of IRB conflict of interest policies prior to the start of each meeting. Any member with a conflict of interest, including but not limited to involvement in the project, providing student supervision to a project, or financial interest in the outcome of the research (e.g. financial interest in the company sponsoring a proposed research project or competitor), must excuse him/herself from the room before the discussion of and vote on the research proposal takes place, except that the member may remain long enough to answer any questions regarding the protocol. The absence of the member should be documented in the IRB minutes as recusal.

7. Review Outcomes and Response by the Investigator
   1. Approval

   The IRB may determine that the protocol as reviewed meets the requirements for approval. Approval expires as determined by the IRB but in no case is approval longer than 365 days (366 days for leap years) from the date of the convened IRB meeting.

   2. Defer - Specific Minor Revisions

   The IRB may require specific minor revisions (e.g., editing provided in writing) to a protocol and/or consent form to secure approval. In this case the revised materials do not require review at another convened IRB meeting. The principal investigator is asked to submit a revised protocol and/or consent form, as indicated, in response to the IRB’s request for specific revisions.

   The revisions should be submitted in a timely manner and are reviewed by the Chair or the Office of Academic Research. Once the reviewer confirms that the investigator has satisfied all requested modifications or an IRB determined acceptable justification for not implementing the change(s) has been provided by the PI, the Chair or the Director affirms approval. The date of approval is the date of the determination by the Chair or Director that all specific requirements have been satisfied. Expiration of approval cannot be later than one year from the date at which the convened IRB reviewed the protocol. When, in the opinion of the reviewer or chair, an investigator fails to respond adequately to the stipulated requirements of the IRB, the investigator's response is referred for reconsideration at a convened meeting.

   3. Defer - Substantive Revisions Required

   The IRB may require substantive revisions to a protocol. Responses to a research proposal which requires substantive revisions are re-reviewed by the fully convened IRB that originally reviewed the study. The revised submission should be submitted in a timely manner and will be reviewed by the IRB at the next scheduled meeting (depending on deadlines) following the submission of the required information to the IRB office. The investigator may, at the discretion of the IRB, present information to the IRB in person during the convened meeting. If the IRB approves the revised protocol without requiring further response(s) from the principal investigator, the approval date is considered the date of the latest full IRB meeting.

   4. Disapproval

   The IRB may determine that the study does not meet the requirements for IRB approval and does not expect that the project could be approved even with substantive revisions. In this case investigator responses, if any, to the disapproval will be reviewed at the next available convened IRB meeting. The investigator subsequently may resubmit the protocol should there be reason to believe that the concerns of the IRB can be addressed at that later time.

   5. Formatting requirements

   Significant protocol amendments should be incorporated into the current written or electronic protocol to ensure that there is only one complete protocol, with the revision dates noted on each revised page and the first page, or by date stamp in the electronic record.

8. Record Keeping and Notification Requirements. IRB minutes will include a summary of the IRB’s discussion and resolution of substantive issues as well as any specific determinations made with regard to risk level, review period, consent waivers or inclusion of participants requiring additional protections. Minutes must also include a tally of the votes by category (for, against, and abstaining) as well as the names of individuals who recused themselves from the discussion and vote due to a potential conflict of interest.

   The IRB’s decisions regarding protocols will be documented and sent to the principal investigator and any indicated correspondent(s). Correspondence on protocols that have not been approved will provide a detailed description of the IRB’s concerns and reasons for not approving the protocol. Correspondence related to approved studies will indicate the approval period and the investigator’s responsibilities during the approval (e.g., adverse event reporting, amendment requests, etc.).

   Protocols and associated correspondence between the IRB and the investigator will be maintained by the IRB for at least three years from the end of the study. Records may be held beyond three years if necessary for funding, patent or other matters.

   Minutes and protocol correspondence are available to the Institutional Official at all times. Summaries of IRB activities are provided periodically to the Institutional Official.