What is the responsiblity of the researcher?
Researchers are responsible not only for obtaining the required approval from the IRB but also for doing their best to protect the rights and welfare of human subjects. This includes complying with all provisions of the Tufts FWA and the Code of Federal Regulations, following the prescribed protocol, requesting IRB approval for any changes to the approved protocol using the modification form, using only the approved version of a consent form, keeping accurate and complete records (including a complete, original, signed consent form for every subject), protecting subject privacy, making a good faith effort to present the consent form in a manner and setting that is conducive to the subject’s understanding of it, reporting at least annually to the IRB on the progress of the research using the continuing review form, and informing the IRB in a timely manner of any adverse or unexpected events using the adverse report form that occur in the course of the research. Proposed changes to an ap
