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Regulatory Compliance

Regulatory Compliance

The Institutional Review Board

IRB Membership as prescribed by law:

The representative membership of the Institutional Review Board (IRB), as specified in the federal statute, is as follows:

  • At least five members, with varying backgrounds…including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes;
  • No IRB may consist entirely of members of one profession;
  • Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas;
  • Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution;
  • No IRB may have a member 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; and
  • An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.

IRB Membership at Eckerd College

The five members of the IRB at Eckerd College shall include the following:

  • Three faculty members, one representing the Natural Sciences, two representing the Behavioral Sciences; and
  • One member from the community whose interest or affiliation is in a scientific area; and
  • One community member unaffiliated with the College or with any employee of the College.

The IRB members shall be appointed/re-appointed for two-year terms by the Dean of Faculty. The Chairperson of Eckerd College's IRB shall be an employee of Eckerd College; he/she will be elected by the IRB's membership to serve a one-year term with the opportunity for re-election to serve subsequent one-year terms.

A list of IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications, licenses, etc., sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution; for example: full-time or part-time employee, member of governing panel or board, paid or unpaid consultant" shall be maintained in the office of the Dean of Faculty.

IRB Meetings and Voting

The Board will meet three times per year: once each in fall and spring semesters and once during the summer. Each meeting must be attended by a majority of the membership and that majority must contain at least one member whose representation is non-scientific. This constitutes a quorum.

If the quorum requirements for a regularly scheduled meeting can not be met, the official meeting will be rescheduled within that same semester.

The full Board does not need to meet to address each request for an Exempt/Expedited Review. Rather, the Board's Chairperson or his/her designee can make that determination of Exemption for individual research projects.

If it is necessary for the IRB to meet in addition to its regularly scheduled meetings in order to address the specifics of a research proposal submitted for review but not approved under the conditions for Exempt/Expedited Review, the Board will meet within five working days of the request for special consideration of that proposal. Each member will cast one vote and a decision to approve or not approve a research project will be made by simple majority. The Board will complete its review and notify the researcher of its decision, including the reason(s) for the decision, within two working days of its meeting.

If, because an IRB member has a vested interest in a research project that comes before the Board for Full Review and that member recuses him/herself from voting, the Dean of Faculty will serve as a voting member for that Review if the votes of the participating four IRB members result in a tie.

Records of IRB Work

The minutes of the regularly scheduled IRB meetings shall follow a format that will provide sufficient information to a reader to understand who was in attendance, the issues addressed, the results of any voting that occurred and actions taken, and the raising of issues to be addressed in subsequent meetings.

The IRB will review the operating Policies and Procedures for Reviews of Research Involving Human Subjects at least every five years. Minutes of those reviews and the related actions taken will be maintained in the office of the Dean of Faculty until after the subsequent periodic review the operating Policies and Procedures for Reviews is completed.

The minutes of the three regularly scheduled IRB meetings shall be maintained in the office of the Dean of Faculty. The written results regarding decisions of the IRB meetings when Full Review of proposals is required also shall be maintained in the office of the Dean of Faculty for at least three years as prescribed in federal law.

Research at Eckerd

One of the hallmarks of a science education at Eckerd is the ability of students to do hands-on research. The purpose of this site is to outline the steps we take to ensure that our research is in compliance with a variety of guidelines and regulations.