The University of North Florida provides staffing, office space, computer equipment, filing cabinets and sundry supplies to support the effective administration of the IRB.
As appropriate and when institutional resources permit, a faculty associate may be appointed to work with the IRB staff and members. The faculty associate may provide training for staff members, IRB members, faculty, and students and will serve as a liaison to faculty and departments within the institution.
B. IRB Relationship to UNF
The IRB is comprised of individuals who serve voluntarily from UNF and the community. Board determinations are made autonomously, without influence from UNF administration. No officials, committees, or others have the authority to approve any human subject research that has not been approved by the UNF IRB.
1. The Chair
The Vice President for Academic Affairs appoints the chair of the IRB, typically for the term of two years. Under special conditions, a one-year appointment may be made. The Vice President for Academic Affairs may remove the chair for nonperformance of his/her IRB (or other associated) duties. The chair is required to have a faculty commitment to the Institution. As appropriate and agreed upon by the chair, the chair’s department chair, the associate vice president for research, and the Vice President for Academic Affairs, the chair may be compensated for service through reassigned time or receipt of a stipend.
The IRB Chair is required to complete mandatory OHRP training associated with the federal assurance process and to maintain current certification through the Collaborative Institutional Training Initiative (CITI) modules or other IRB-approved training. The IRB Chair should participate in other training as available and appropriate.
The responsibilities of the IRB chair are defined as follows:
- Convene and chair the IRB meetings.
- Communicate the decisions of the Board to the investigators.
- Develop and initiate appropriate changes in IRB policy in consultation with the assistance vice president for research, as the institutional official.
- With the assistance of the IRB administrators, prepare the annual report to the Vice President for Academic Affairs, which includes a list of the members, accomplishments, recommendations, problems, concerns and future strategies.
- Review continuing review reports that may be reviewed on an expedited basis (45 CFR 46.110 and 21).
- Appoint appropriate Board members to review continuing review reports and serve as primary reviewer for full Board presentation of continuing review reports that require full Board review.
- Determine which studies need verification from sources other than the investigators that no material changes have occurred since the previous IRB review.
- Review and approve closing reports.
- Provide expedited review of new protocols in conjunction with other members of the board.
- Review and approve requests for exemption from review.
- Represent the IRB, in collaboration with the associate vice president for research, in intra- and extra-mural deliberations with individuals or agencies regarding IRB activities or protocol management.
- Monitor federal regulations and changes therein that impact the Board activities and administrative management of protocols and report these changes, as appropriate, to all IRB members.
- Make recommendations for Board membership.
2. Board Members
The Vice President for Academic Affairs appoints board members for a term of up to three years. The Board shall include sufficient numbers of members to provide adequate review of protocols. Expertise shall be appropriate to the types of protocols reviewed and, in addition, there shall be expertise in legal, ethical, and behavioral areas.
It is the responsibility of each member to attend all meetings of the IRB. In the event that a member cannot attend, the IRB administrator should be notified prior to the distribution of protocols for review. Members who miss successive meetings or have a high incidence of absenteeism will be contacted with regard to future service on the committee, and may be replaced.
With the exception of the Chair and ex officio members, members will all be required to review one or more protocols per month. It is critical that members review those protocols for which they are responsible as soon as they are received so that they may contact other members of the IRB, contact the investigator, or ask the IRB Chair or IRB coordinator to contact the investigator, if necessary, to clarify any issues well before the meeting. A lead reviewer will be appointed by the chair in consultation with the IRB administrators for each protocol requiring full Board review.
2.2.3. Expectations of Lead Reviewers
Lead reviewers are expected to do the following:
- Present the protocol to the rest of the convened Board at the meeting and provide a recommendation for approval, approval with modifications or disapproval based on the evaluative criteria defined in 45 CFR 46.111.
- Risks to subjects are minimized.
- Risks to subjects are reasonable in relation to the anticipated benefits.
- Selection of subjects is equitable.
- Documented, informed consent is obtained from each prospective subject or the subject’s legal guardian or healthcare decision-maker.
- Informed consent will be sought from each prospective subject or the subject’s legally authorized representative to the extent required by 45 CFR 46.116.
- Informed consent is appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117.
- When appropriate provisions are made for the protection of the privacy of subjects and confidentiality of data is maintained.
- Provisions are made for monitoring the data collected to ensure the safety of subjects.
- Safeguards are included to protect members of vulnerable population groups (45 CFR 46.111).
- Review all consent forms for general adherence to IRB guidelines and for ethical/scientific concerns and provide written editorial comments as appropriate on the consent forms for the protocols that they are charged with reviewing.
- Complete the IRB reviewer checklist with respect to the protocol and subject consent form and its contents.
- Treat all material as strictly confidential. None of these materials are to be treated as refuse, but must be either shredded or returned to the IRB office for shredding.
- Evaluate scientific validity to the extent that if the project is judged as frivolous (e.g., clearly provides no scientific or clinical benefit), the study is not acceptable ethically because the risk-benefit ratio for subjects would not justify approval for participation.
- Seek additional information or clarification about the project as needed by contacting the principal investigator directly or through the IRB Chair or IRB coordinator prior to the meeting. If the questions or issues are not adequately addressed in that interaction, the reviewer should confer with the Chair
- Notify the chair if an outside consultant is needed. The consultant may be invited to attend the meeting to discuss the protocol. In either case, the consultant will be acting as an ad hoc member and will not be afforded voting privileges.
- Notify the IRB coordinator if the investigator should be invited to the Board meeting to provide clarification of a study.
- Lead discussion of the protocol and supporting materials at the meeting and respond to questions from other members.
2.2.4. Responsibilities in Voting for All Board Actions
After presentation of a protocol and consent form at the meeting, any member may make a motion to:
- Approve the study;
- Approve with modifications to the study; or
- Disapprove the study.
Following standard rules, a vote will be taken and the numbers of ayes, nays and abstentions recorded along with the members who are voting on the motion. A majority is more than one-half of the members in the room. The IRB Chair will vote only to break a “tie vote” by the Board. Proxy votes are not allowed. Any member who is out of the room is neither counted in the quorum nor counted in the vote.
No additional review/approval of IRB actions by others within the institution is required, and override of disapprovals is prohibited.
2.2.5. Conflict of Interest
Members with whom an investigator is a partner, or who works closely with the investigator may wish to abstain from deliberations and voting. There will be no specific requirement to abstain simply by virtue of departmental or divisional affiliation. However, members should seriously consider their collaborative relationships with investigators and act responsibly and in accordance with state law and university policy with regard to conflict of interest.
Any individual with a personal conflict of interest must abstain from the vote and should not be present during discussion of the protocol unless requested to provide information by the IRB [45 CFR 46.107(e)]. The only required absence from the meeting room during discussion about the study and voting is that of investigators on the protocol and those with a conflict of interest. A notation in the minutes will be made of any member who chooses to abstain for reasons of conflict of interest (COI).
2.2.6. Educational Responsibilities
Members are required to maintain current certification through CITI and other requirements as established by the Office of Human Research Protection or through other federal and state regulations. Members are given an IRB manual of regulations and supplementary materials. Members are expected to attend scheduled sessions for education in ethics and regulatory compliance. These sessions are designed to ensure that all members have sufficient background and awareness of trends in both the principles of and regulations for protecting human research participants.
D. IRB Meetings
IRB meetings will be scheduled at least once a month during the academic year and once a month in May, June, and July. The IRB will not meet during August unless needed. The schedule of IRB meetings for the semester will be posted on the IRB web site. Although IRB meetings are not public meetings under the Florida Sunshine laws, guests may attend meetings with the permission of IRB administrative staff and the IRB chair.
The duration of the meeting is approximately 1-2 hours. All members should expect to be available for the entire meeting. Attendance is required by at least one non-scientist for the IRB to obtain a functional quorum. A quorum for each IRB meeting is greater than one-half of the number of voting IRB members. Any decision made by an IRB must be made with both a numerical and a functional quorum. If either quorum is lost, no decisions can be made until a quorum is reconstituted. Otherwise, the meeting must be adjourned.
As approved by OHRP, the Board reserves the option of holding a convened IRB meeting via a telephone conference call or videoconferencing. For such a meeting, each member must 1) receive all pertinent material prior to the meeting and 2) be able to actively and equally participate in the discussion of all studies. Minutes of such meetings must clearly document that these two conditions have been satisfied in addition to the usual regulatory requirements (e.g., attendance; initial and continued presence of a majority of members including at least one non-scientist member, and individual from outside the institution; actions taken by the IRB; the vote on such actions; discussion and resolution of controverted issues).
All members receive the following documentation for review before the meeting: the meeting agenda; minutes from the previous IRB meeting; documentation for each protocol to be reviewed by the full Board including the “Application for Approval of Research Involving Human Subjects,” recruitment materials and advertisements (if any), participant consent forms including parental permission and child assent, and copies of all surveys and instruments to be used in the study.
The lead reviewer for a study funded by Health and Human Services (HHS) or other federal grant will receive a copy of the grant application. The complete documentation is available to all Board members for their review, both before and during the meeting.
Minutes are maintained for all IRB meetings as outlined in subsection E. Minutes are a primary way the IRB informs institutional members, including the institutional official and university administrators, about IRB deliberations, considerations, and actions.
E. IRB Recording Requirements
The IRB Office shall maintain the following records and documents:
- A list of the current IRB members and their qualifications (e.g., earned degrees, representative capacity, indications of experience such as Board certifications and licenses sufficient to describe each member’s anticipated contribution to IRB deliberations and any employment or other relationship between members and UNF).
- Written standard operating procedures for the IRB.
- The most recent version of IRB forms.
- Agendas and minutes of the meeting including attendance of members, recorded discussion of issues including discussion of controverted issues, records of IRB decisions, and records of the vote along with the members who are voting on the issue. Minutes should provide sufficient detail to show attendance (including any consultants/guests shown separately) at the meetings; absences during the meeting; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution. The minutes should include documentation of actions since the last convened meeting, including exemptions granted, expedited protocols approved, and protocols requiring continuing review that have been extended.
- All documentation surrounding federal assurances.
- Any agreement documents generated in the conduct of the IRB policy and procedures.
- Archival copies of study files up to 5 years after close of the study for federally funded studies and 3 years for non-funded projects.
- Records of complaints regarding IRB policy and regulation.
- FWA and related documents and correspondence.
- All IRB files, open and archived, including the following information:
- All research proposals, investigator brochures, consent forms, adverse events reports, budgets, copies of correspondence, including verification of review, between the Board and the investigator, and any other correspondence relevant to IRB business;
- Statements of significant new findings provided to participants whenever appropriate; and
- Records of continuing review activities.
F. Appeal of IRB Decisions and Processes
When the convened IRB disapproves or requires modifications to proposed research, PIs may appeal the IRB decision in writing to the IRB. All appeals of full board decisions will be reviewed by the full board. Only the IRB may change or overturn a decision not to approve a study. Institutional officials may, however, overturn approval of a protocol by the IRB.
Appeals on procedural matters should be directed by the associate vice president for research. As the institutional official responsible for matters of research integrity, the associate vice president for research has the authority to require an IRB to reconsider a protocol if evidence suggests that the IRB did not follow established procedures or acted in violation of federal regulations or UNF institutional policy.
G. Internal Monitoring of Compliance and Annual Reports
1. Internal Audit of Procedures
The IRB office shall conduct an annual self-audit of its policies and procedures, records and database to ensure that all implemented guidelines are appropriate. When requested, the IRB chair prepares an annual review in the format of an annual report. A copy of this annual report is kept on file in the Research Integrity Unit.
2. Revisions to Standard Operating Procedures
The standard operating procedures are reviewed annually by the IRB administrators in conjunction with the IRB chair and revised when warranted. Approval of the standard operating procedures, either new or revised, requires review and signature of the (a) Associate Vice President for Research as the institutional official, (b) the Office of the General Counsel, and (c) the Vice President for Academic Affairs of the University. Each revised standard operating procedure will supersede all previously-approved versions and will be effective on the date of the most recent signature.
3. Revisions to IRB Forms
IRB forms are reviewed annually by the IRB administrators in conjunction with the IRB chair and revised when warranted. Approval of IRB forms, either new or revised, will be effective when approved by the Associate Vice President for Research after consultation with the IRB chair.