Use of Human Subjects in Research  

Case Studies  

Clinical / Records 

At Stanford, the most frequently-conducted EXEMPT research activity is:

The study or collection of existing records or samples (e.g., pathological specimens, data) if these sources are publicly available or if the information is recorded by the investigator so that subjects cannot be identified directly or through identifiers linked to subjects.

Which of the following is the best course of action for you and your colleague?

1. Contact the 100 patients directly by phone to obtain their consent to use their medical charts, assuring that they will not be identified.
   
   
2. Obtain the medical histories without any personal identifiers and proceed to conduct the study.
   
   
3. Submit a protocol to the Human Subjects Panel to obtain the data with personal identifiers.
   
   

This case study continues with a brief analysis of each of these alternatives.