Institutional Review Board for the Protection of Human Subjects

Description

• Membership

  Position and Term Length	Name	Term Expires
  Administrator Representative	Jeffrey Werner, Chairperson	*
  Member not affiliated with the institution	Katja M. Spradlin-McHugh	*
  Grants & Sponsored Projects	Susan Lushinsky	*
  Non-Scientific Area Representative** (2 years)	Stefani Gomez	8/2027
  Non-Scientific Area Representative** (2 years)	Diana Ebersole	8/2027
  Non-Scientific Area Representative** (2 years)	Liz Schneider	8/2026
  Scientific Area Representative** (2 years)	Myung Song	8/2026
  Non-Scientific Area Representative** (2 years)	Eric Johnson	8/2026
  Scientific Area Representative** (2 years)	Colin Bolger	8/2027

  * Indefinite Term of Office
  ** Appointed by Committee on Committees

• Mission & Bylaws

  MISSION

  The Institutional Review Board (IRB) reports to the University Senate. Its mission is to review
  all human subject research to make sure that no research done under its jurisdiction will expose
  persons who participate as subjects or respondents to unreasonable risks to their health, general
  well-being, or privacy.

  BYLAWS

  1. Composition and Terms of Appointment

     1. Composition
        1. A minimum of five faculty IRB committee members shall be appointed by the Committee on Committees. The Provost will appoint one administrator and a person not affiliated with the university.
        2. The IRB shall include at least two members whose primary concerns are in scientific areas and at least two members whose primary concerns are in nonscientific areas, as defined by the National Science Foundation.
        3. IRB shall include at least one member selected who is not otherwise affiliated with the Kutztown University and who is not part of the immediate family of a person who is affiliated with the institution.
        4. An IRB may, at 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.
        5. The Assistant Provost for Research & Grants serves as the Chairperson.
        6. The IRB will strive for equality of representation among the diverse array of gender identities.
        7. The IRB shall have a minimum of seven members, with varying backgrounds. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of 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. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice
     2. Terms of Appointment
        1. Representatives serve for staggered 2-year terms.
        2. The representative from the Office of Grants and Sponsored Projects serves an indefinite term of office.
        3. The representative who serves as the member not affiliated with the institution serves an indefinite term of office.

  2. Duties of the Members

     1. Committee members must:
        1. Complete the CITI training for IRB committee members.
        2. Attend meetings when they are called.
        3. Read Full Review applications and be ready to discuss them at meetings.
        4. Inform chairperson if unable to attend a meeting, and provide written comments for all Full Review applications.
        5. Review Exempt and Expedited applications as assigned, and provide written comments to the chairperson.
        6. Perform committee duties as assigned.
        7. Review the IRB's Mission Statement, Bylaws, and Operating Guidelines on an annual basis.
        8. Inform University Senate if proposing any changes in structure, membership, or mission.
     2. Chairperson must:
        1. Schedule meeting times.
        2. Set agenda and provide members with applications to review in a timely manner before each meeting.
        3. Coordinate staff support to take meeting minutes, or designate a committee member to take minutes if a staff member is not available.
        4. Coordinate staff support to assign Exempt and Expedited applications to committee members.
        5. Recognize the service of committee members, by providing an end-of-year letter to each member.
        6. Provide a yearly report of actions taken to the Senate.

  3. Meetings

     The IRB will meet once in the beginning of the fall semester to review the IRB process,
     once when Full Review applications are submitted, and on an as needed basis.

  4. Voting

     1. All qualified members—including the Chair—have full voting privileges.
     2. Motions are passed with a simple majority of those present (or voting by proxy).
     3. A member not able to attend a meeting may email comments and designate another member to vote by proxy on his or her behalf.
     4. When decisions need to be considered outside regularly scheduled meetings, electronic voting by all members is allowed to pass motions.

  5. Agenda

     1. The Agenda shall consist of the following in order of priority:
        1. Call to Order
        2. Announcements
        3. Old Business
        4. New Business
        5. Adjournment

  6. Rules of Order:

     1. The rules contained in the current edition of Robert’s Rules of Order Newly Revised shall govern this committee in all cases to which they are applicable and in which they are not inconsistent with these bylaws and any special rules of order this committee or University Senate may adopt.
     2. A quorum will consist of 50% of the voting members of the full committee.
     3. In order to have a vote at the face-to-face meetings, there must be a quorum.
     4. Amendment of the bylaws shall require a two-thirds majority of the voting membership.

  7. Approved

     University Senate – December 2, 2023

  8. Last Review (all dates reviewed)

     October 2023
• Meeting Times

  None submitted at this time.

• Agenda & Minutes

  None submitted at this time.