Research Involving Human Subjects

If You Plan to Conduct Research Involving Human Subjects…

All research or experimentation conducted at the University involving human subjects as defined below must be reviewed and approved by the Human Subjects Institutional Review Board (HSIRB) prior to the initiation of the research…whether financial support is sought or received. All funding requests submitted to funding agencies will require review and approval by the HSIRB before an award is accepted.

Human Subjects Institutional Review Board (HSIRB)

The HSIRB reviews human subject research at Notre Dame to ensure the ethical and equitable treatment of those individuals under federal and state laws. It also adheres to the principles set forth in the Belmont Report and the federal policies:

Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection - DHHS announcement in Federal Register (May 12, 2004)

“Protection of Human Subjects” in 45 CFR 46 (Title 45 part 46 of the Code of Federal Regulations)

Health Insurance Portability and Accountability Act (HIPAA) regulations.

HIPAA Privacy Information for Researchers

The University of Notre Dame also has an approved Assurance of Compliance on file with Office for Human Research Protections (OHRP) of the Department of Health and Human Services.

NOTE:The University of Notre Dame prohibits research upon primary human tissue or derived cell lines obtained through elective abortion. The University believes that benefits to society do not outweigh the means used to obtain the material.

Human Subjects in Research

In academic research, “Human Subject” is defined as a living individual about whom an investigator conducting research obtains

(a) data through intervention or interaction with the individual, or

(b) identifiable private information including the collection or study of existing data, documents, records, databases, pathological specimens, or diagnostic specimens.

Policies and Procedures
Committees and Dates
Education and Training
Protocol Forms and Guidance
Frequently Asked Questions
Human Subjects Institutional Review Board (HSIRB)
Research Participants from brochure