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Culture of Safety in Research

April 11, 2011

Dear Colleagues:

I am writing to remind all faculty, students, and staff who are involved in human subject research at JHM that it is the responsibility and duty of all individuals on research teams to ensure the safety of research participants.  An essential element of the conduct of research is the commitment of all individuals to a culture of safety. 

When we examine problems in research protocols, we frequently find that someone on the team had concerns but decided to defer to the judgment of the physicians or PIs on the protocols.  I want to emphasize that anyone who has questions about whether an individual participant should continue to have research interventions has a responsibility to pursue these concerns to the extent necessary to protect the rights and welfare of human research subjects. 

Any member of a research team, even someone who is new to the research team or to clinical research, may raise concerns about the continued participation of an individual enrolled in a study and request a discussion to examine safety issues or stop research procedures for safety concerns.  In addition, any concerns about safety may be brought to my attention or to the attention of the compliance team in the Office of Human Subjects Research. 

Please use this email as an opportunity to discuss with your research teams the need to create a culture where it is acceptable to question and improve the implementation of our research protocols. 

Daniel E. Ford, MD, MPH
Vice Dean for Clinical Investigation