Use of Human Subjects in Research  

Case Study  

A post-graduate fellow contacts you about a preliminary study to identify potential factors associated with breast cancer. He wants to compare the medical histories of 50 patients who have had breast cancer with those of 50 people who have not.

The medical histories are available in the hospital charts of two clinics at Stanford Hospital. This study could also include follow-up with patients to determine their cancer status.

You both believe that if existing, publicly available data are used, and if there is no way to identify the subjects involved, the project might be exempt from protocol review.

You are very interested in this project, and you know there are several ways to proceed. This case discusses some alternatives.