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.
Common Rule Changes
On January 21, 2019, changes to the regulations under which the IRB reviews human subjects research (the "Common Rule") are planned to go into effect. The changes have required minimal revisions to the IRB protocol submission form, and will primarily affect the way different types of research are submitted and reviewed. The new Common Rule primarily does the following:
- Eliminates continuing review for most research that is determined to be minimal risk
- Adds new Exempt categories of research
- Revises the required elements of informed consent
For more information about these changes, please review the following Quick Reference Guide on Common Rule Changes. If you still have questions about your research, and how it may be affected, please contact ND Research Compliance at firstname.lastname@example.org or (574) 631-1461.
Policy and Forms
All forms relating to informed consent templates, HIPAA-related forms, and request forms for specific types of research can be found in the Resources Library.
Need More Information?
All faculty and students engaged in such research involving human subjects, must submit requests for IRB review and 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/. NOTE: Access to the eProtocol system requires a Notre Dame NetID and password.
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 materials collected from humans (data, samples, etc.) must be reviewed and approved by the IRB.
IRB Appointed Members
- Brooke Ammerman, PhD, Assistant Professor, Psychology
- Mark Berends, PhD, Director, Center for Research on Educational Opportunity (CREO)
- Jennifer Burke Lefever, PhD, Managing Director, William J. Shaw Center for Children & Families; Professor, Psychology
- Eric Felde, JD, CIP, Director, Research Compliance
- Matt Hall, PhD, (Chair) Associate Professor, Political Science
- Larry D. Harding, Retired C.P.A. (Community Representative)
- Geoffrey Layman, PhD, Professor, Political Science, Interim Director, Rooney Center for the Study of American Democracy
- Christian Poellabauer, PhD, Associate Professor, Computer Science and Engineering
- Holly Rivers, MA, Associate Director, Kellogg Institute for International Studies
- Guangjian Zhang, PhD, Associate Professor, Psychology
- Mark Fox, M.D., PhD, Associate Dean & Director of Indiana University School of Medicine-South Bend and Professor of Medicine & Pediatrics at Indiana University
Full Board IRB 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.
Please note that the meeting schedule above only applies to full board studies. Meeting dates are subject to change.
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 (including faculty advisor (if applicable) as well as all personnel listed) must complete the standard sections for either Social and Behavioral Research or Bio-Medical Research depending on the area of research to be undertaken. 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 three years. If CITI training course was completed through another institution within the past three years, the training certification will be accepted at Notre Dame. In such cases, it is the responsibility of the researcher to file the completion certification from the previous institution with Notre Dame Research Compliance at Notre Dame. Please use the "Log In Through My Institution" option within CITI.
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/.
Information for Human Research Participants
Notre Dame Research Compliance has developed the following information to assist potential research participants decide whether or not to participate in a research study.
At some point in time, many people will be asked to participate in research. In many cases, the research involves completing a survey, participating in a focus group, or being interviewed. In other cases, the research may involve exercise, physiologic measurements, psychological exams, or clinical trials. Each type of research involves risk and the level of risk will depend on several factors including the research design and procedures, type of interaction, and the vulnerability of the participant or participant population. Participants must be aware of the level of risk and weigh the risk versus the potential for benefit when deciding whether or not to participate.
If being asked to participate in a research study, the researcher should offer and be able to provide the participant with answers to questions about the research, what the participant will be asked to do, the risks of the research, and whether there is any benefit to participating. Participants should feel free to contact the researcher with questions at any time before, during or after the study.
Participation is voluntary and participants may decide not to participate or to stop participating at any time. A decision to not participate will not affect your relationship with the University of Notre Dame in any way.
To view frequently asked questions about human research, visit our Human Research Participant FAQs page.
Need More Information?
For information on the use of the eProtocol system, please contact us at email@example.com.