BREAST IMAGING NON-CANCER STUDIES

1. BREAST IMAGINGNON-CANCER STUDIES Sharon Harris, Clinical Research Coordinator

2. SEND PROTOCOLS TO: University Research Administration (URA) Clinical Trials Review Committee (CTRC) Institutional Review Board (IRB) Weekly Review by Data and Safety Monitoring Board (DSMB)—for studies that are more than minimal risk) Annual Review by the Scientific and Accrual Monitoring Committee (SAM) Annual Continuing Review by the IRB STUDY APPROVAL PROCESS

3. RESEARCH APPROVAL COMMITTEES • Clinical Trials Review Committee (CTRC) • Reviews scientific integrity and feasibility for all University of Chicago cancer studies • Looks at • Scientific validity • Coolness of study • Scientific priority/accrual competition within disease program • Interdepartmental collaboration arrangements • University Research Administration (URA) • Negotiates contract terms for ALL Clinical Trials Agreements (CTAs) • Reviews study budget • Adequacy of funding • Items billed as standard of care (SOC) versus research • Institutional Review Board (IRB) • Protects the rights and welfare of human subjects • Requires CTRC and URA approval prior to review • Data and Safety Monitoring Board (DSMB) • Reviews adverse events and ongoing data considerations • Scientific and Accrual Monitoring (SAM) Committee • Evaluates study accrual and progress towards study endpoints • Can shut down study for not making adequate progress

4. REQUIREMENTS TO ENGAGE IN CLINICAL RESEARCH • Completing Conflict of Interest (COI) • http://researchadmin.uchicago.edu/policies_compliance/conflict_interest/ • Completing CITI Research Training • Citiprogram.org • Amending the IRB submission to include you as a researcher

5. OTHER REVIEW COMMITTEES • Radioisotopes and Radioactive Drugs Research Advisory Committee (RADRAC) • Review, approval and surveillance of radioactive drugs as well as the purchase and use of radioisotopes in humans • Nursing Research Committee (NRC) • facilitate research that builds a scientific base for nursing practice and promotes the profession as a scientific discipline. • Institutional Bio-safety Committee (IBC) • Reviews biohazards, as defined as potentially infectious agents, organisms or materials, biological toxins, organisms containing recombinant DNA and other genetically altered organisms and agents, in laboratory and clinical settings. • Institutional Animal Care and Use Committee (IACUC) • Review, approval and surveillance of all research and teaching protocols involving the use of animals

6. Faculty and Staff Training Requirements for the Conduct of Clinical Research • The BSD requires training for all researchers per policy “Faculty and Staff Training Requirements for the Conduct of Clinical Research. • Log onto the CITI website (www.citiprogram.org) to complete this training requirement. • AURA, the new electronic IRB submission and review system.

7. COMMON QUESTIONS ABOUT CLINICAL RESEARCH • Collaboration with other institutions • Study must be reviewed by all institutions involved • Submit Protocol to the IRB • All submissions should be routed using the University-wide IRB system, AURA.(http://aura.uchicago.edu/) • Copies of cancer protocols and consents • https://webres.uccrc.org/login/login_ad • IRB Exemptions • Still require an IRB submission • Prospective research databases • If patients are not consented, their data cannot be used in the analysis