RESEARCH PROGRAM UPDATE Sarah Castro, MPH Senior Research Support Liaison

Mission Genesis Health System Mission Genesis Health System exists to provide compassionate, quality health services to all those in need.

Philosophy Our goals: Provide research opportunities in our community Support and encourage clinicians to combine research activities with patient care Provide diverse clinical settings for research We believe: Everyone benefits when we make it possible for professionals to develop new skills and stay abreast of emerging technologies Research is an investment

Research Department Staff Research and Grants Administration – Senior Research Support Liaison – Research Program Coordinator/Financial Analyst Cardiac and Other Research – Three Clinical Research Coordinators Oncology Research – One Clinical Research Coordinator

Services Provided - Administration  Research Development and Dissemination – Protocol Development – Informed Consent Development – Data Analysis – Manuscript Preparation  Contracts  Study Budgeting and Billing  Institutional Review Board – Determination of Research – Application Development

Services Provided – Research Coordinators  Study Start-up – Qualifying questionnaires – Medicare Coverage Analysis – IRB application  Participant Enrollment – Screening – Consenting  Implementation – Study devices or medication – Procedure assistance – Patient follow-up  Data Collection and Reporting  Sponsor and IRB Correspondence

Genesis Institutional Review Board The Genesis IRB protects the rights, safety and welfare of human research participants The IRB is responsible for: – Reviewing new studies – Ensuring no unreasonable risk – Providing ongoing review of studies – Reviewing proposed changes to studies – Considering adverse events – Assessing researcher misconduct

Genesis Institutional Review Board 11 members Diverse backgrounds Scientific and Non-scientific members Community members

Research Volume Total Projects: 111 studies Internal: 64 External: 47 Number of New Researchers = 17

Categories of Research Cancer - 80 Cardiac - 9 Nursing - 6 Orthopedic - 5 Multi-disciplinary - 3 Primary Care - 3 Physical Therapy – 2 Occupational Therapy – 1 Blood Donor – 1 Psychology - 1

Resources – Information for Researchers – Genesis IRB – Genesis Research Summit – Clinical Trials