Human Research

As a Catholic Institution, the University of Notre Dame is committed to compassionate care for the whole person. Thus, in all of its activities, the University of Notre Dame promotes the physical, psychological, spiritual, and social well-being of those we serve. The University of Notre Dame is dedicated to defending and promoting human dignity, health, and well-being.

The University of Notre Dame fosters a research environment that promotes respect for the rights and welfare of individuals recruited for, or participating in, research conducted by or under the auspices of the University of Notre Dame. In the review and conduct of research, actions by the University of Notre Dame will be guided by the principles (i.e., respect for persons, beneficence, and justice) set forth in the "Ethical Principles and Guidelines for the Protection of Human Subjects of Research" (often referred to as the Belmont Report). The actions of the University of Notre Dame will also conform to all applicable federal, state, and local laws and regulations.

In order to fulfill this mission, the University of Notre Dame has established a Human Research Protections Program (HRPP). The mission of the HRPP is to:

  • Safeguard and promote the health and welfare of human research subjects by ensuring that their rights, safety, and well-being are protected;
  • Provide guidance and support to the research community in the conduct of research with human subjects;
  • Assist the research community in ensuring compliance with relevant regulations;
  • Provide timely and high quality education and review of human research projects; and
  • Facilitate excellence in human subjects research.

Policy and Forms

To review the full University of Notre Dame Institutional Human Research Protections Policy, please download this pdf.

All forms relating to informed consent can be found in the Resources Library.

Need More Information?

For more information on the Human Research Protection Policy, please contact the Associate Vice President with responsibility for Research Compliance or email compliance@nd.edu.

eProtocol System

All faculty and students engaged in such research should submit requests for IRB approval prior to beginning their work. This requirement applies to all such research, regardless of the source of support.

To submit a request for approval or to track or review information related to human subjects research, please use the eProtocol system: https://nd.keyusa.net/.

Institutional Review Board (IRB)

On behalf of the University of Notre Dame, the Institutional Review Board’s (IRB) major role is to safeguard the rights and welfare of all human subjects who participate in research. Therefore, in compliance with federal law and institutional policy, all research projects involving human subjects or human material must be reviewed and approved by the IRB.

IRB Appointed Members

  • James Brockmole, PhD, Associate Professor, Psychology
  • Mark Gunty, PhD, Program Director, Office of Strategic Planning and Institutional Research
  • Larry Harding, P.C.A. (Community Representative)
  • Maria Kaczmarek (Community and Prison Representative)
  • Jill Lany, PhD, Assistant Professor, Psychology
  • Kate E. Mueller, PhD, J.D. (Chair), Managing Director, Center for Social Research; Concurrent Assistant Professor
  • Wayne Patterson, PhD, Consultant
  • Susan St. Ville, PhD, Associate Professional Specialist, Kroc Institute for International Peace Studies
  • Abigail Wozniak, PhD, Associate Professor, Economics
  • K. Lira Yoon, PhD, Associate Professor, Psychology

Alternate Members

  • Nakesha Alexander (Alternate Regulatory Member), Research Compliance Coordinator, Notre Dame Research Compliance

Upcoming Meeting Dates

The IRB meets once a month and requires at least ten business days before the meeting to review submitted Full Board protocols. Full Board protocols received less than 10 business days before will be reviewed the following month.

  • August 25, 2016
  • September 22, 2016
  • October 27, 2016
  • November TBD
  • December TBD

Please note that meeting dates are subject to change.

Training

The University of Notre Dame requires that all personnel listed on an IRB protocol must complete online training via an institutional subscription to the Collaborative Institutional Training Initiative (CITI), a consortium of universities that provides convenient and comprehensive online training modules, for all faculty, graduate students, and post-doctoral scholars, prior to approval to work with human subjects.

All researchers must complete the standard Social and Behavioral Research section. As a first time user, when prompted to select the training modules, click on Social and Behavioral Research under the Human Subjects heading. This is the only required module required for human subjects certification.

Also included in this section are the following modules:

  • Belmont Report and CITI Course Introduction (ID: 1127)
  • History and Ethical Principles – SBE (ID: 490)
  • Defining Research with Human Subjects – SBE (ID: 491)
  • The Regulations – SBE (ID: 502)
  • Assessing Risk – SBE (ID: 503)
  • Informed Consent – SBE (ID: 504)
  • Privacy and Confidentiality – SBE (ID: 505)
  • Research with Prisoners – SBE (ID: 506)
  • Research with Children – SBE (ID: 507)
  • Research in Public Elementary and Secondary Schools – SBE (ID: 508)
  • International Research – SBE (ID: 509)
  • Internet Research – SBE (ID: 510)
  • Research and HIPAA Privacy Protections (ID: 14)
  • Unanticipated Problems and Reporting Requirements in Social and Behavioral Research (ID: 14928)
  • University of Notre Dame Institutional Page (ID: 854)

For amended protocols, any personnel being added to the protocol must have a current certification on file. The principal investigator is responsible for assuring that personnel listed in the protocol have completed the CITI Training requirements.

All researchers will be required to refresh their General Certification training every five years. If CITI training course was completed through another institution within the past five years, the training certification will be accepted at Notre Dame. In such cases, it is the responsibility of the researcher to file the certification letter from the previous institution with Notre Dame Research Compliance at Notre Dame.

For additional questions or more information on CITI, please visit https://www.citiprogram.org/. For support on the CITI training program, including how to register, please visit https://support.citiprogram.org/.

Need More Information?

For information on the use of the eProtocol system, please contact the Research Compliance Coordinator or email compliance@nd.edu.