Research Involving Humans

Date: September 2017     Revision: 1

The University has both legal and ethical obligations to ensure that human subjects used in research are treated responsibly.

Research Involving Humans

Federal regulations (Common Rule 45 CFR 46) and University policy require that the Institutional Review Board (IRB) review and approve all research involving human subjects before any human studies commence. This includes projects related to the investigation of new drugs; medical, radiological, engineering, physiological, behavioral, sociological and nutritional studies; projects involving human tissues or blood as well as images, questionnaires, interviews and other procedures.

All personnel who participate in studies involving human subjects must successfully complete an IRB training course. In addition, all studies approved by the IRB require continuing review. Failure to ensure that a project is reviewed/approved by IRB in a timely manner will lead to suspension of the project and any grants related to the study.

Steps to complete prior to beginning a study involving human subjects:

  • Apply to the IRB for review and approval. This requirement applies to all projects, even when federal regulations exempt certain research from full IRB review.
  • Complete the online human subjects training course approved by the IRB. This requirement applies to principal investigators, associate investigators, student investigators, study coordinators, visiting scientists, consultants, laboratory technicians and all assistants who will have direct contact with human subjects of research. Training must be renewed as determined by IRB. The principal investigator is responsible for ensuring compliance with training requirements.

Who to Contact

Research Integrity

Additional Information