INSTITUTIONAL REVIEW BOARDS AND BEYOND: UNDERSTANDING RESEARCH COMPLIANCE AS A NON SCIENTIST

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1 INSTITUTIONAL REVIEW BOARDS AND BEYOND: UNDERSTANDING RESEARCH COMPLIANCE AS A NON SCIENTIST HCCA COMPLIANCE INSTITUTE 2016 ANGELA GAMALSKI, MHSA, CHC, JD CANDIDATE MICHIGAN STATE UNIVERSITY COLLEGE OF LAW, EAST LANSING, MI ALFRED M. PHELEY, PHD, CHRC, DIRECTOR RESEARCH& SPONSORED PROGRAMS ALLEGIANCE HEALTH, JACKSON, MI LEARNING OBJECTIVES EXPLAIN THE GROWING DEMAND FOR SCIENTIFIC EVIDENCE DESCRIBE THE IN THE NON ACADEMIC SETTING IDENTIFY WEAKNESSES IN THE RESEARCH COMPLIANCE RELATIONSHIP DISCUSS STRATEGIES TO ADDRESS THE DISCONNECT 1

2 FIRST HELP US LEARN SOME ABOUT YOUR BACKGROUND AND EXPERIENCE RESEARCH COMPLIANCE PROCESSES CROSS MULTIPLE DEPARTMENTS GME Compliance Lab Research Dept. Ownership of research issues IRB 2

3 DEMAND FOR SCIENTIFIC EVIDENCE Foundation of the health professional education system Scientific information to drive decision making Providers require it Payers demand it Patients expect it Patient Protection and Affordable Care Act funding DEMAND FOR HEALTH DATA Expanding availability of technology and social media applications as data collection, aggregation, storage tools Health professionals Lay public Entrepreneurial endeavors 3

4 Defining research Availability of trained individuals Rigorous science and adherence to research protocols Financial requirements Participant compensation Institutional awareness COMPLEXITIES OF PERFORMING RESEARCH The research process in 30 seconds Formulate the Research Question Generate Hypothesis Develop Methodology Organizational Approval Operationalization Analysis of Data Determine Conclusion 4

5 Beneficence Non malfeasance History of human research Essential ethical principles Equity & Justice Respect for Persons and Autonomy Veracity Fidelity The IRB Role Human Subjects Protections The IRB Process Review of protocol, consent, etc IRB Membership 21 CFR Regulation sets minimum of at least 5 members 1 scientist 1 non scientist 1 non affiliated with the organization sensitive to the community and knowledgeable of institutional commitments and regulations, applicable law, and standards of professional conduct and practice 5

6 The Informed Consent Process Environment Assessment of Capacity to Consent Presentation of Elements of Informed Consent Use of Delayed Consent Procedure Assessment of [Participant s] Comprehension Documentation of Informed Consent Ongoing Consent Conclusion Association of Clinical Research Professionals. The process of informed consent. April, Data security concerns Assure destruction of PHI per protocol/irb What happens to the data? Who owns the data? How do you control the data? Personal Data From Research Institute Found in Trash Bin By Martin Weil Washington Post Staff Writer Saturday, August 18,

7 Education and training or Just because you have a horse, doesn t make you a cowboy. lol fail funny animated horse cowboy horseback/ Education and training or Just because you have a horse, doesn t make you a cowboy lol fail funny animated horse cowboy horseback/ Having a research project doesn t make you a researcher. 7

8 BUILDING A RESEARCH COMPLIANCE PARTNERSHIP Vetted policies, procedures, and guidelines Detection of possible research Detection of possible research issues Organizational training Understanding the limited IRB role Provide Compliance an ex officio seat on the IRB Empowering the IRB Multiple IRB jurisdiction (don t ignore your authority) Dual/Multiple review Central IRB IRB Delegation BUILDING A RESEARCH COMPLIANCE PARTNERSHIP Addressing non compliant research Clear, available policies and guidance Buy in of senior leadership Include Research in the Compliance Dashboard Compulsory stop Sanctions for repeated offenses 8

9 BUILDING A RESEARCH COMPLIANCE PARTNERSHIP Visibility Internal research specific newsletters Institutional publications Regular research education opportunities Trainee education Meetings with departments Targeted current or potential researchers and staff BUILDING A RESEARCH COMPLIANCE PARTNERSHIP Educate and train Make part of the CBL process Required certification; regular renewal for anyone involved in research At a minimum 9

10 BUILDING A RESEARCH COMPLIANCE PARTNERSHIP Educate and train Higher levels of training for staff with greater responsibilities Good Clinical Practices (GCP), e.g., Collaborative Institutional Training Initiative Clinical Trials with Investigational Drugs and Medical Devices FDA Process Clinical Trials with Investigational Drugs and Biologics ICH Focus Clinical Investigations of Devices NIH Introduction to the Principles and Practice of Clinical Research Clinical Research Training On Line for Principal Investigators NIH Bioethics Training SUMMARY More research More complexities More opportunities 10

11 Questions? 11