Skip to Main Content

Research with Human Subjects

Human Subjects Protection Committee (HSC)

Institutional Review Board

The Mount Saint Mary's University Committee for the Protection of Human Subjects serves as the Institutional Review Board (IRB) for the university as required by federal regulations in Title 45 Part 46. The role of the IRB is to ensure that research involving the participation of human subjects meets all federal guidelines, created to protect participants from harm, as well as providing a means for informing participants of their rights. The establishment of IRBs was a direct result of the Nuremburg Code in 1947, that set standards for ethical research with human subjects. In 1964, The Declaration of Helsinki set guidelines for biomedical research with human subjects. In 1974, as a response to unethical research being conducted in the United States, the National Research Act (PL 93-348) was enacted. Furthermore, in 1978, the Belmont Report was published by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, leading to the revision and expansion of the regulations that safeguard the rights of humans participating in research. [45 CFR 46 subparts A through D]

Application Instructions

In order to ensure that research conducted by MSMU faculty and/or students meets the guidelines for the protection of human subjects, an application to the Human Subjects Committee must be completed, submitted, and approved prior to the implementation of any actual research.

Download the application form and fill it out electronically. The application is a Word document that uses fill-in forms and requires you to enable macros if you are prompted. All applications to the Committee must contain a copy of the Assurance Training Certificate for all personnel who are to participate in the proposed research. Certificates can be obtained through the CITI online training. See the IRB application for details.

Email the completed application form as an attachment, along with any other required documents, to the Human Subjects Protection Committee Chair, Robin L. Gordon. Please fill out the application and other forms electronically and send to

Review of Applications

Review of applications occurs on a rolling basis and begins as soon as the Principal Investigator (PI) has submitted all application materials. Reviews typically can be completed within 2-3 weeks, at which time the Committee Chair will contact the PI with the committee's decision.

Policies on the Use of Human Subjects in Research

For more information on the regulations for using human subjects in research, please go to the website for the Office for Human Research Protections (OHRP).