|Procedure Number: ||IS57-02
|Title: ||Institutional Review Board
Date Approved: 12/09/21
Updated & Approved:
The Lakeland Community College Institutional Review Board (IRB) is designed to be sufficiently qualified through the expertise, experience, and diversity of its members, including race, gender, and cultural background; to be sensitive to community issues and attitudes and to promote respect for its advice and counsel in safeguarding the rights and welfare of those participating in research.
1. To ensure that Lakeland Community College properly and adequately discharges its responsibilities for protecting the rights and welfare of any and all human subjects of research, as "research" is defined in federal regulations and campus policies, that is conducted at or sponsored by the college, regardless of whether the research is subject to federal regulation or funded, in whole or in part, by federal funds.
2. To ascertain the acceptability of the proposed research in terms of college commitments and regulations, applicable law, and standards of professional conduct and practice.
3. To approve, require modifications, or disapprove all research activities that fall within its jurisdiction as specified by the federal regulations and college policy. Research that has been reviewed and approved by the IRB may be subject to review and disapproval by officials of the college. However, college officials may not approve research if it has been disapproved by the IRB.
1. The IRB will be comprised of no fewer than seven (7) members. All IRB members shall be trained in the IRB process.
2. Standing members shall include:
a. Associate provost and dean of faculty
b. Associate vice president and dean of students
c. A member of the general public who is unaffiliated with Lakeland and will be selected by majority vote by the Academic Integrity Committee with the goal of bringing diversity to the IRB.
3. Additional members assigned to the IRB will be appointed by the Academic Integrity Committee as a subcommittee. These appointments will be made by nomination and majority vote by the Academic Integrity Committee during the first meeting of the fall semester of every academic year as necessary to replace members whose terms have expired. A member's service on the IRB is defined by their term on the Academic Integrity Committee.
The members shall include the following constituencies:
a. One individual representing life or physical scientific disciplines.
b. One individual representing social and behavioral sciences.
c. One individual representing non-science disciplines.
4. Additional members may be appointed as needed to ensure that the following conditions are also met:
a. gender, ethnic and cultural balance
b. balance among social and physical sciences, humanities and other non-scientific expertise
c. balance among faculty and professional/technical staff
d. individual(s) capable of discerning potential risk to human subject(s), including those from vulnerable populations/protected classes of individuals (children, prisoners, persons with disabilities, and/or pregnant women, etc.).
5. No selection or appointment to the IRB shall be made based solely on the basis of gender or profession.
6. No IRB member shall participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
7. The IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of issues requiring expertise beyond or in addition to that available within the IRB members. Such individuals may not vote on any research review application. If employees are a subject, Human Resources should be consulted, and general counsel should be consulted.
Meetings are scheduled by the IRB chairperson (associate provost and dean of faculty). The first meeting will be in September to communicate requisite certificates and training required of the membership. Monthly meetings will be recommended during the course of the academic year based on the need to review current proposals submitted.
IRB Reviews shall be conducted as follows:
1. Review determinations can only be made by the IRB upon receipt of a complete Request for IRB Review application form.
2. Exempted, expedited and full review determinations shall be made by the chair and the vice chair within five business days of receipt of a complete Request for IRB Review application form; exempted review is for projects involving less than minimal risk and no vulnerable subjects; expedited review is for projects involving less than minimal risk, and full committee review includes projects involving significant risk;
3. In the event that the chair and vice chair cannot agree on the determination, at least one additional member of the IRB shall be identified, and the decision made within five business days of the identification of the third member reviewer;
4. Expedited and full review determinations shall be made by the chair, the vice chair, and a third member of the IRB within five business days of the identification of the third member reviewer;
5. Full reviews shall be made by the full IRB at the regular meeting, using approved operational procedures for voting;
6. Annual (continuing) reviews shall be made using the same process of the original review and ruling, e.g., exempt, expedited, or full, except in the event of a change in the research design, and/or an individual involved in the research being harmed and/or there is the potential or risk of harm to a participant;
7. In the event that an individual involved in the research is harmed or there is the potential or risk of harm, the principal investigator has an affirmative requirement to notify the IRB according to published guidelines, and the research design shall be subject to a full review process;
8. The results of all review requests and of the reviews themselves shall be reported to the Academic Integrity Committee at its regular meetings.
E. The IRB shall develop additional operational procedures to govern its decision-making processes and maintain an IRB manual. The IRB chair will maintain the appropriate up-to-date training required of a community college to conduct IRB reviews.
F. The IRB shall prepare and maintain adequate documentation of its activities. The IRB chair and designee will assist in documenting IRB requirements.
G. Dissemination of Policy:
1. As appropriate, priority will be given to discussion of the IRB policy and related legal guidelines in division and department meetings throughout the college.
2. The policy statement will be published in suitable in-house publications at appropriate times and will be posted on division and department boards throughout the college. A link to the IRB policy and procedure also will be available on the college's website.
3. Federal resource information regarding IRBs will be maintained in the college library.