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Human Subjects in Research

"Using human subjects" covers a wide range of project types - from gathering simple and informal opinion polls to performing highly-controlled sleep studies -- Investigators should plan and train prior to using human subjects in research.

Idaho State University believes in the value of research involving human participants, and accepts an ethical responsibility for safeguarding their rights and welfare with due consideration to ethnic and cultural issues.

The Human Subjects Committee (HSC), also designated as the Institutional Review Board (IRB), is the body responsible for reviewing and monitoring studies involving Human participants.

Human Subjects Committee (HSC) - The Human Subjects Committee, also designated as the Institutional Review Board (IRB), is the body responsible for reviewing and monitoring studies involving Human participants. The HSC Coordinator may be contacted at (208) 282-2179 or humsubj@isu.edu.

Human Subjects Manual - A Human Subjects Manual & Guide details everything you need to know about working with Human Subjects at ISU, including:

  • Protocol preparation
  • Definitions
  • Exempt Research

Human Subjects Research is defined as:

Federal research regulations and the Health Insurance Portability and Accountability Act of 1996 (HIPPA) define research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”  The first of these two elements—the use of a systematic investigation—may be a characteristic of both research and non-research projects.  Public health practice, quality assessment (QA) and quality improvement (QI) programs, resource utilization reviews, and outcome analyses are examples of non-research activities that frequently use statistical and other scientific methods to collect and analyze data in a manner that is identical to research studies… The primary goal of the activity must be to develop or contribute to generalizable knowledge to be called research.

A list of activities that are not Human Subjects Research is:  Quality Assessment, Quality Assurance, Case Report or Case Series, Needs Assessment, Medical Practice and Innovative Therapy, Medical Practice for the Benefit of Others, Public Health Practice, Outcome Analysis, Resource Utilization Review, and Education.

If your proposed research meets this definition please see the Human Subjects Committee page for information on preparing and submitting your proposal.

U.S. Regulations