Ethics, Regulatory Knowledge, and Support (ERKS)
The ability to initiate and perform clinical and translational research is facing ever increasing regulatory and compliance demands, increased scrutiny and oversight at all administrative levels, severe penalties for the individual and institution for failure to comply, and complicated privacy and ethical issues in the conduct of research. Compliance has become the ever growing "gorilla in the room" that must be addressed in clinical and translational research. Major regulatory issues include investigator and institutional conflict of interest, navigating increasingly complex IRB issues, electronic entry and grant submissions, the multiple committee approvals necessary for clinical and translational research, intellectual property issues, financial concerns including grants management reporting and documentation, effort certification, allowable expenses, cost allocation and funds transfer policies, clinical trials billing, biological and radiation safety requirements, grant routing and layers of sign-offs, coordination of approvals (e.g. IRB consent and clinical trials billing grids), and competing or conflicting institutional policies. In an effort to streamline and improve our process of initiating clinical and translational research, the critical need for centralization, integration and research support infrastructure reorganization, for an electronic research record (NoERR), for increased institutional support to enhance regulatory knowledge and ethics for ACTSI investigators involved in clinical and translational research, and for coordinated regulatory efforts amongst the ACTSI partner institutions.