Ethics & Oversight

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Thank you for participating in NYC FREE. Your safety is important to us.

The Principal Investigator of NYC FREE, Dr. Leonardo Trasande, will make sure that this study follows all guidelines to protect our participants.

This study is being supervised by the NYU Grossman School of Medicine Institutional Review Board (IRB).  The IRB is responsible for protecting the wellbeing, rights, and privacy of people participating in research. The IRB reviews and approves all study documents before any participant may be enrolled. Any changes to the study will also be approved by the IRB. If any changes are made to the consent form that you have signed, the IRB will decide if you need to complete another consent form. The study team will notify you of any changes that affect your participation.

NYC FREE is designed to keep you safe with “minimal risk.” This means that the amount of harm or discomfort expected in the research are not greater than those usually met in daily life.

The research team will regularly assess participant safety. Safety data will be reviewed monthly and reported as required by the IRB.

If unexpected events involving participant safety occur at any time, they will be immediately reported to the IRB. We will make the best efforts to determine if these events were study-related. Any new information that changes the risks or potential benefits of the research will also be reported. Once approved by the IRB, these changes will be communicated with you.

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