Mass-DAC, the data coordinating center responsible
for collecting and analyzing data collected for all adults undergoing
cardiac surgery or a cardiac intervention at Massachusetts Hospitals,
has a Confidentiality Certificate (CC) from the US Government that
adds special protection for the research information collected about
study participants. Note that study participants are surgeons, interventionalists,
and patients. The CC states that Mass-DAC is not required to identify
study participants, even under a court order or subpoena. Still,
Mass-DAC may report medical information (if study participants need
medical help), probable harm to study participants or others, or
probable child abuse, and the Government may see study participant
information if Mass-DAC is audited by the Government. This CC does
not mean the Government approves or disapproves of this project.
Click here
to see a copy of Mass-DAC's Confidentiality Certificate.
Harvard IRB (Institutional Review Board) Approval
Date of last approval: June 27, 2008
The Harvard Faculty of Medicine established the Committee on Human Studies (also referred to as the CHS or IRB) to review research projects and activities that involve human participants, and which oversees the implementation of all policies and procedures for human studies research.
The mission of the CHS is to insure that all participants are protected from any unnecessary risk while involved in a research project, that they make an informed decision to participate, and whenever possible, that there is a benefit to the participant or to society from the research. The goal of CHS is to assist Investigators in developing appropriate research protocols in accordance with federal, and University policies, and within accepted ethical guidelines.
(Taken from the Harvard Medical School/ Harvard School of Dental Medicine Committee on Human Studies website. For more information, please visit http://www.hms.harvard.edu/orsp/human/human.html)
