IRB Policies and Procedures

An Overview

Purpose

The purpose is to outline the policies and procedures for review of human research.

Definitions

An agent is an individual who: (1) acts on behalf of the institution; (2) exercises institutional authority or responsibility; or (3) performs institutionally designated activities. Agents can include employees such as faculty or staff, or students, contractors, and volunteers, among others, regardless of whether the individual receives compensation.

Auto-ethnography is a qualitative research approach which uses self-reflection and writing to analyze an investigator’s personal experience in order to explore and understand one’s culture.

To be engaged in research activities, an institution’s employees or agents, for the purposes of research must obtain: (1) Data about the subjects through intervention or interaction with them; (2) identifiable private information about the subjects; or (3) The informed consent of human subjects for the research.

Policy

The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human subjects recruited to participate in research activities conducted under the auspices of Marywood University. Marywood University seeks to comply with all federal, state and local laws and regulations requiring the establishment and operation of such a board (See "Code of Federal Regulations," 45 CFR 4621 CFR 50 and 21 CFR 56). The IRB is charged with the responsibility of reviewing, prior to its initiation, all research involving human subjects, whether or not funding is sought.  Where research qualifies for exemption, the Exempt Review Committee (ERC) performs review.

The IRB or ERC reviews research which:

  • is sponsored by or through Marywood University
  • engages Marywood University's employees or agents in research
  • is conducted by or under the direction of any employees or other agents of Marywood University in connection with their institutional responsibilities, regardless of location
  • is conducted by or under the direction of any employees or other agents of Marywood University using any property or facility of the institution
  • even if approved by another IRB:
    • is conducted under the auspices of another institution on the premises of Marywood University
    • involves the use of Marywood University’s non-public information to identify or contact potential human subjects or use data about them

IMPORTANT 

No human research activities, including subject recruitment, enrollment, the consent process, data collection or data analysis, may begin until official IRB or ERC approval has been granted.

Members of the research team may not enroll in their own projects as subjects, except where auto-ethnography is proposed.

Institutional Policy and Review

Marywood University's Policies and Procedures Manual contains its Institutional Review of Research Involving Human Participants policy under Academic Affairs. Research which receives the approval of the IRB or ERC may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by the IRB or ERC [45 CFR 46.112].


History

06/08/2017 - Updated ERC link and corrected office name
06/12/2017 - Adjusted regulatory reference
07/18/2017 - Correction to punctuation
06/12/2018 - Added information and links to the Institutional Policy pages
09/21/2018 - Updated regulatory links
06/25/2019 - Updated as a result of the Revised Common Rule
12/16/2021 - Added a definition and clarified what is reviewed