Use of Human Subjects in Research  

Case Study  

Clinical / Records 

The protocol review process seeks to maintain an appropriate balance between the achievement of valuable research results, on the one hand, and the protection of human participants, on the other. It is important that both objectives be realized.

The IRB system has been developed to assure that society's interests in advancing knowledge are balanced with the mandate to protect the rights and welfare of research subjects.

Where a research project poses no more than minimal risk to human subjects, i.e., no more than they would otherwise experience in day-to-day life, regulations allow for a more efficient protocol review process. Certain categories of "minimal risk" projects may qualify for an expedited review, while other categories may be exempt from the requirement for review.

Those decisions are made by the Administrative Panel, on the basis of the project design and the information provided by the researchers.

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