Use of Human Subjects in Research  

Case Study  

Clinical / Records 

Option C.

Submit a protocol to the Human Subjects Panel to obtain the data with personal identifiers.

Among the options presented, this is the best choice.

This option maximizes the researchers' flexibility in carrying out this study.

Although this is not exempt research, it may qualify for an expedited review. This decision is made by the Panel, but the researchers can facilitate the review by incorporating the protection of subjects into their design.

Patients will need to give informed consent to participate in this study. If they are selected for a follow-up, the initial contact should be made by their treating physician to determine whether or not they are interested in further participation. This could be recorded by means of a postcard sent back by the patient to the researchers.