The HCC IRB can review, approve, and require modifications in, or disapprove research activities conducted by or through HCC using human subjects. The IRB does not assume the role of evaluating the merits of the research design or the legal implications of access to HCC data and information. Rather, the IRB is charged with evaluating each proposed project’s compliance with standards in regard to issues such as informed consent, confidentiality, and any risk to participants. The Board may provide guidance related to access to HCC data, the involvement of HCC employees and facilities, and other aspects of the research process.
Approved research studies are required to follow the approved protocol as well as legal and procedural requirements of HCC and other local, state, and federal regulations. The Principal Researcher must record and report all protocol deviations, exceptions, and violations to the IRB and, when required, to the appropriate regulatory authorities and sponsor. The HCC IRB or Chair has the authority to suspend and require additional conditions be met before research resumes as well as to terminate the research altogether.