Review for the Protection of Human Research Subjects

Any use of human subjects, animals, biohazardous materials, or radioisotopes for research purposes must be reviewed and approved by the Office for Research Protections before the research is conducted. This approval cannot be obtained retroactively and cannot be granted by dissertation advisers or doctoral committees.

This review is part of the University’s policy on ethics in research. It provides legal assurance for the commitment that the University has made to the federal government regarding the protection of human and animal subjects. Violations of the University’s policies on these matters are a serious breach of the trust placed in researchers by the scholarly community and society. 

If you have questions regarding this requirement or how to obtain the necessary approvals, please contact:  

Office for Research Protections 

212 Kern Building 

University Park, PA 16802  

Tel #: 814.865.1775 

Fax #: 814.863.8699 

E-Mail: ORProtections@psu.edu 

HUMAN SUBJECTS REVIEW 

According to Title 45 Code of Federal Regulations (CFR) Part 46.102(d), research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge (Federal Register, 56, p. 28013). All research proposals involving human subjects, including the secondary use of previously collected data, must be submitted to the Office for Research Protections (ORP), via CATS (Centralized Application Tracking System) for review. See https://www.research.psu.edu/irb/sirb for complete instructions.

Dissemination of findings to a scientific audience is a sufficient, but not a necessary, criterion for defining research. Dissemination includes, but is not limited to, doctoral theses; paper or poster presentation at a scientific meeting, conference, or competition; submission to or publication, paper or electronic, in a scientific journal; and Internet postings. If the proposed project falls under this definition of research, review and approval of a human subject’s research protocol by ORP is required. Information about human subjects proposal submissions is available at: http://www.research.psu.edu/orp. 

The materials to be submitted for review to the ORP committee should be prepared according to established University guidelines. The application requires the approval of the dissertation committee chair and the Associate Dean for Graduate Programs and Research in the Ross and Carol Nese College of Nursing. When approval has been granted by the ORP, the student may commence gathering data or conducting the project. A copy of the approval letter received from the Office for Research Protections should be forwarded to the Chair of the student’s committee. 

Research involving utilization of other facilities may require approval from that institution as well as PSU. Please be sure to obtain approval from all institutions involved before proceeding with any aspect of your research or project.