Docket Management
Docket: 02N-0475 - Financial Relationships and Interests in Research Involving Human Subjects
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Dr. Michael Maher Date/Time 2003-04-03 11:08:07
Organization University of Baltimore
Category Individual

Comments for FDA General
1. General Comments Nothing in these proposed rules demonstrates that financial interest is relevant to the consideration of safety or protection of human subjects. If an IRB considers the safety and protection of subjects as its paramount responsibility, I cannot see how the financial interest of the investigator matters one way or another. What is the difference between a financial interest, an intellectual interest, or a career interest in having research come out one way or another. Ultimately, peers and other research must demonstrate the validity or shortcomings of research methodologies and conclusions. The job of the IRB is simply to protect the human subjects. It can do that by focusing on any methods or protocols that might compromise such safety.

EC -1