IRB Policies and Procedures
Policies & Procedures
- An Overview
- Application Process and Deadlines
- Approval of Research
- Closure or Withdrawal
- Continuing Review
- Deception or Incomplete Disclosure
- Departmental Review Boards
- Dietary Supplements
- European Union’s General Data Protection
- Exempt Review
- Expedited Review
- Full Review
- Incentives in Research
- Informed Consent, Parental Permission and Child Assent
- International Research
- IRB Administration
- IRB Review Process
- Mandatory Reporting
- Mandatory Training
- Non-English Speaking Participants
- Oral History
- Prisoner Research
- Records Retention
- Recruitment of Participants
- Reproductive Risk in Clinical Research
- Research Advisors
- Responsibilities of Investigators and Sponsors
- Revisions to Approved Research
- Separation of Principal Investigators
- Student Research
- Suspension or Termination
- Whistleblower Policy
Purpose and Function
The purpose is to describe the rationale, function, membership and selection of members for the Institutional Review Board (IRB). The IRB safeguards of the rights and welfare of individuals participating in research. The Board reviews and has authority to approve, require modifications in (to secure approval), disapprove, and monitor all research involving human participants conducted at Marywood University or elsewhere under Marywood University sponsorship. The Board may establish policies that allow research posing minimal risk to subjects to be exempt from full review and may delegate some reviews to the department, school, or college level.
The IRB is a decision-making group to approve applications for research involving human participants based on established policies and federal regulations. It serves as the liaison between the University and federal agencies regarding the protection of human participants.
Membership and Selection
Members represent the interests of the University and the community. There are at least eight members with various backgrounds and fields of expertise, including, at least:
- one member from outside the University 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
- one physician, physician’s assistant or medical professional
- two representatives from each college
- one prisoner or prisoner representative (reviews prisoner research only)
Federal regulations require inclusion of at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
The non-voting Director of Human Participants Protection and Research Compliance staffs the committee.
The Provost appoints members, with a view to ensuring cultural, professional and academic diversity. Membership is contingent on year-round availability. When the Board reviews research that involves a vulnerable category, such as children, prisoners, pregnant women, or persons with mental disabilities, consideration is given to the inclusion of one or more individuals who are experienced or knowledgeable about working with these participants.
The Provost appoints the Chair.
The 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. Such individuals will act as consultants and may not have voting privileges.
An appointed member’s term is three years, with possibility of reappointment for one additional term. Eligibility is effective again after a hiatus of one year. If someone fills an incomplete term, they are eligible for two additional 3 year terms. In order to ensure the availability of a physician, physician’s assistant, medical professional, prisoner or prisoner representative to the IRB, the terms of the physician, physician’s assistant or medical professional member and the prisoner or prisoner representative member is not limited to two three-year terms.
Except when an expedited review procedure is used, the IRB may review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.
The Board meets once a month in formal session. In exceptional cases, business may be conducted via telephone conference call. Times of monthly meetings are announced on the Institutional Review Board’s website.
10/20/2017: Updated to align with Institutional policy for the IRB Standing Committee, last revised 07/01/2017