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. 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. All social and behavioral research or biomedical projects conducted by the faculty, staff and students of the University are subject to the Policies and Procedures of the Institutional Review Board. 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.

The University of Notre Dame IRB adheres to the principles established by in the Belmont Report and federal policies, such as the United States Department of Health and Human Services (DHHS) announcement in the Federal Register (Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection (May 12, 2004) and Office for the Research Protections’ (OHRP) (Title 45 part 46 of the Code of Federal Regulations).

Additional guidelines regarding the ethical conduct of research may be exist within academic disciplines, such as The American Psychological Association’s Ethical Principles of Psychologists and Code of Conduct and the Code of Ethics of the American Anthropological Association.

The IRB is composed of faculty volunteers affiliated with the variety of disciplines at ND. It also includes a representative from the community.

The University of Notre Dame’s IRB has the authority to disapprove, modify, or approve protocols based upon consideration of human subject protection. IRB approval of research must occur before research begins and approval cannot be given retroactively.

Definition of Human Subject and Research

Federal regulations (45 CFR 46.102(d)) define research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”

For the purposes of this policy, a systematic investigation is an activity that involves a prospective research plan, which incorporates data collection, either quantitative or qualitative, and data analysis to answer a research question. Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the specific study sample), inform policy, or generalize findings.

Federal regulations (45 CFR 46.102(f)) define human subject as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.” Private information includes information that an individual can reasonably expect will not be made public, and information about behavior that an individual can reasonably expect will not be observed or recorded. Identifiable means that the identity of the individual is or may readily be ascertained by the investigator or associated with the information.

Criteria for IRB Approval

The overall criteria for IRB approval are:

1. The risks to subjects are minimized as much as possible.
2. The risks to subjects are reasonable in relation to anticipated benefits.
3. The informed consent is adequate.
4. Where appropriate, the research plan makes provisions for the safety of the subjects during the data collection process.
5. Where appropriate, there are adequate provisions to protect the privacy of subjects and maintain confidentiality of data.
6. Appropriate safeguards are included within the study to protect the rights and welfare of the vulnerable subjects.

The Submission Process

The IRB Process

Meeting Dates

Education and Training

IRB Forms