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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.

 

Person Signing Consent Form

ISU has established a Human Subjects Committee to review, approve, and monitor studies involving human participants.  The Human Subjects Committee serves as ISU's Institutional Review Board (IRB).  

A Human Subjects Manual is available to provide detailed procedures and guidance.

Please contact the Human Subjects Committee Coordinator at (208) 282-2179 or humsubj@isu.edu if you have questions regarding Human Subjects research at ISU.

 

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