Institutional Review Board for the Protection of Human Subjects

 

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I. Name

The name of this board shall be the Institutional Review Board (IRB) for the Protection of Human Subjects of Tennessee Technological University.

II. Purpose

The primary purpose of the board is to serve as the Institutional Review Board for the protection of human subjects in research for the University in accordance with, and fulfillment of federal mandates in, Code of Federal Regulations (45CFR46) and in accordance with the University’s Federal-Wide Assurance (FWA) approved by the Office of Research Protection (OHRP).   

As a federally-mandated board, the board maintains decision-making independence in the review, approval, oversight, and continuing review of all human subject research conducted by faculty, staff, students, or agents of TTU. In accordance with federal law, TTU administration can enforce stricter requirements than those determined by the IRB in the approval of a human subjects research project; however, the administration cannot approve a project that the IRB did not approve or that the IRB disapproved through a Full Board Review. In accordance with 45CFR46, all multi-institutional agreements pertaining to human subjects research are subject to IRB approval before initiation of the agreement.

Primary duties include:

• Maintaining an active FWA.
• Maintain compliance with OHRP-approved FWA.
• Maintaining compliance with (45CFR46).
• Review, approve, provide oversight for, and conduct continuing review of all research involving human subjects conducted by faculty, staff, students, or agents of TTU.
• Review and approve all multi-institutional agreements related to the review, approval, oversight, and continuing review of human subjects research.

Other duties include:

• Establish and implement policies and procedures for protection of human subjects in funded and non-funded research.
• Establish and recommend guidelines for classroom activities involving human subjects. These guidelines are for implementation by academic departments within the University.
• Establish and recommend policies relating to ethics and misconduct in research and related activities dealing with human subjects.
• Review and act on matters referred by the Administrative Council, Academic Council, President of the University, Research & Economic Development, Faculty Research Committee, administrators, and faculty.

III. Membership

The board shall consist of the following members appointed by the University President in accordance with the approved procedures for appointment:

• A minimum of five (5) persons as members with varying backgrounds to promote complete and accurate review of research and related activities.
• A membership that includes (1) at least one member with purely scientific interests, one member with non-scientific interests, and one member who is not affiliated with the University and who is not part of the immediate family of a person affiliated with the University (2) both male and female members, and (3) as many departments, college/school representatives with interests in human subjects as is appropriate to ensure disciplinary diversity.
• All members appointed to the board shall be able to ascertain acceptability of proposed research and related activities in terms of institutional commitment and regulations regarding research, applicable law, and standards of professional conduct and practice.
• All members shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.

Alternate member(s) may be appointed and their appointment should be based on expertise similar to that of the regular voting member(s). Alternate
member(s) may vote only when the regular voting member is absent. 

Members shall serve on the board for a period of three years with appointments becoming effective at the beginning of each fall semester. Appointments are made so that terms of the members are staggered with no more than three members' terms expiring at the same time. All appointments are subject to renewal at the discretion of the President.

A roster of the Institutional Review Board (IRB) membership should be maintained that provides the names of the members, gender, degrees earned, primary scientific or non-scientific specialty, affiliation with the institution, and comments (e.g., prisoner representative, advocate, alternate member, etc.).

IV. Officers

Chairperson

The Chairperson shall be elected annually from and by the membership at the first meeting of the academic year. The Chairperson shall:

• Receive, prepare, and distribute research proposals for review by the board or board subcommittees.
• Conduct continuing reviews of approved nonexempt applications.
• Review and approve Institutional Authorization Agreements (IAA) for individual multi-institutional studies.
• Review and approve External Researcher Requests.
• Preside at all meetings or designate a member to serve in his or her absence.
• Prepare and distribute a tentative agenda to board members at least two working days prior to the meeting.
• Provide for the recording of minutes.
• Call special meetings and appoint ad hoc subcommittees when necessary.
• Inform the administration and faculty of actions taken by the board.
• Assume responsibility for the preparation and distribution of the annual report (in collaboration with the Executive Officer) to the Administrative Council and the President of the University.
• Assume responsibility for the execution of board policies through the Executive Officer.

Executive Officer

The President will appoint a staff member, who will normally be the Associate Vice President for Research, to serve as the Executive Officer. The Executive Officer shall:

• Review and approve all Memoranda of Understanding (MOU) for IRB review, approval, oversight, and continuing review for all human subjects research projects in multi-institutional programs. 
• Serve as a consultant to the board and provide assistance in the conduct of board business.
• Attend all meetings without voting privileges.
• Provide administrative support and assistance to the Chairperson in the conduct and coordination of activities of the board.

V. Required Training and Certification

Members of the IRB are required to take and pass the CITI Program training modules. Faculty and staff must complete the module entitled, “IRB Members,” and community members must complete the module entitled “IRB Community Members.” Required passing score for each module is 80%. All modules must be completed in order to earn the certification required for IRB members. Certification is valid for three years from date of completion. List of required CITI modules for IRB members .

Additionally, in accordance with TTU Policy 750.IV.E, all IRB members must complete the “Social and Behavioral Responsible Conduct of Research” training through CITI.

VI. Meetings and Attendance

Meetings

There will be a minimum of two meetings of the board each semester. Special board meetings and sub-board meetings may be called by the Chairperson as necessary for the performance of responsibilities. Meetings of the board will be held in September, November, January, and April. The exact day shall be determined each semester by the membership. Changes in the date and time of regular meetings shall be made known to the membership as soon as the change is necessitated.

Applications requiring Full Board Review shall be distributed and/or made available by the IRB Chairperson to members for review prior to scheduled meetings. 

The agenda for the meeting shall be adopted at the beginning of each meeting.

At least one non-scientist must be present in order to conduct meetings.

Sixty percent (60%) of the membership shall constitute a quorum including the non-scientist.

Attendance

If a member must be absent from a meeting and an alternate member has been designated, notice should be given to the Chairperson or the Executive Officer and the name of the person who will attend for the member provided.

A "representative" for the absent member must be approved by the Chairperson since special expertise is required for board membership. However, voting by proxy is prohibited.

Absence from fifty percent (50%) of regular meetings by a member without due cause will result in a request by the board to the President of the University for replacement of that member.

VII. Amendment of Procedures

These procedures shall be amended at any regular meeting of the board by a majority vote of the membership present provided that the amendment has been submitted in writing to the members at least one week prior to the meeting where the voting will take place.

VIII. Effective Date of Implementation

These procedures shall become effective upon review by the Administrative Council and approval by the President of the University.

IX. Parliamentary Authority

The rules for small boards contained in the most current edition of Roberts Rules of Order, Newly Revised shall govern the board in all cases to which they are applicable and in which they are not inconsistent with the procedures contained in this document.