As Principal Investigator, I have ultimate responsibility for the conduct of this research study, its ethical performance, and the protection of the rights and welfare of human subjects. I agree to conduct this research study in accordance with all applicable federal and state regulations, NCI CIRB’s requirements and directives, and Tufts Health Sciences IRB policies and practices governing human subject research.
I confirm that the research team members listed above and I are appropriately qualified and meet the Institutions’ standards for eligibility to conduct research and have completed the Institutions’ research education requirements. I also agree all research team members will complete Institutional continuing education requirements, and I will oversee all members of the research team that will help conduct this study at this site.
I will ensure the safe and appropriate performance of the research at Tufts MC. This includes, but is not limited to:
Complying with the NCI CIRB’s requirements and directives.
Ensuring initial and ongoing qualifications of investigators and research staff;
Overseeing the conduct of the research;
Monitoring protocol compliance;
Maintaining compliance with state, local, or institutional requirements related to the protection of human subjects;
Providing a mechanism to receive and address concerns from local study participants and others about the conduct of the research; and
Investigating, managing, and notifying the Tufts MC IRB and NCI CIRB of any study-specific incidence, experience, or outcome that seems to rise to the level of an unanticipated problem (UP) and/or serious or continuing non-compliance. This notification must include a plan to manage the incident, experience, or outcome, including measures to prevent similar occurrences.
Note: As part of ensuring safe and appropriate performance of research, Tufts MC has the authority to observe any aspect of the research process including observing the consent process. The CIRB retains the authority to direct this to be done when necessary.
I will provide updates in a timely manner to the NCI CIRB and the Tufts MC IRB whenever a Signatory Institution Principal Investigator is no longer the responsible party for a study under the purview of the NCI CIRB.
I will notify the NCI CIRB and the Tufts MC IRB when a regulatory deficiency has been cited during an audit.
I will complete and submit NCI CIRB’s Annual Investigator Worksheet About Local Context, and any other worksheets or forms required by the NCI CIRB for participation.
In the local consent form, I will:
incorporate NCI CIRB-approved boilerplate language into the NCI CIRB-approved model consent form, including boilerplate HIPAA authorization language;
make no language changes to the consent form with the exception of NCI CIRB-approved boilerplate language;
obtain NCI CIRB approval of changes to the boilerplate language prior to implementation; and
obtain NCI CIRB approval of translations of the consent form prior to implementation;
I will maintain a regulatory file for each study under NCI CIRB purview as per local institution and sponsor policy; and
I confirm no prisoners will be enrolled in this research study, as the NCI CIRB is not constituted to review studies enrolling prisoners.