Investigator Responsibilities: What should we expect from researchers? Office of Human Subjects Research Institutional Review Board (IRB) Open House Investigator Responsibilities: What should we expect from researchers? Frederick W. Luthardt, DBE, MA Manager, OHSR Compliance Monitoring Program Suzanna Roettger, MA Senior Compliance Monitoring Specialist Bryan Moore, MA, CCRP May 11, 2018 JHM OHSR Open House

Domains of Responsibilities Regulatory/Legal Following the Law and Institutional Policies Good Clinical Practice (“CGP”) Guidelines Scientific Scientific method, acceptable “best” practices Contributing to “generalizable knowledge” Society Achieving benefits for society and humanity Ethical Moral principles of respect for persons, promote benefit/reduce harm, and justice/fairness to research participants and society at large

Investigator Responsibilities: To the Law… Understanding and following regulations and requirements Federal (FDA, HHS, DoD/DoE, etc.) Good Clinical Practice (GCP) Guidelines Institutional Review Board policies and guidelines Supervision: Controlling the study’s progress Direct participation Knowing what’s going on Following the IRB approved study exactly Protecting the rights, well-being, and safety of research participants Informed consent Eligibility assessments Management of AEs/SAEs “The buck stops with the Investigator”

Investigator Responsibilities: To Science… Design: Scientifically Sound and Acceptable Conclusions must contribute to “generalizable knowledge” Positive Findings Negative or Neutral Findings also count! Performance Conforms to “best practices” to achieve reliable results Monitored for regulatory requirements Day-to-Day compliance with study procedures Data is checked for completeness, consistency, correctness

Investigator Responsibilities: To Society… Research findings should help individuals in society Precision Medicine (what works best for me as a patient?) Preventative Medicine (what life-style or behavioral changes can improve health?) New drugs, devices, diagnostics, etc. (what new medicine will be a needed cure?) Research should lead to benefits for society at large or “Public Health” Across the social “arc” Neighborhoods, cities, countries, and the world Accountable to Vulnerable People The poor, disabled, exploited, displaced, etc. Research must be sensitive to cultural needs and interests

Investigator Responsibilities: To be Ethical Practical Conduct Compliance (Doing what’s required) Responsible Conduct of Research (Doing what maximizes data integrity) Ethical Conduct Respect for Persons: Trust Transparency Treated Fairly Maximizing Benefit, Minimizing Harm Justice: Fair, equitable recruitment Just distribution of risks and benefits Awareness of needs of vulnerable populations

Conclusion: Investigator Duties To be aware of the requirements and regulations to assure compliance and maximize human subject safety. RECOGNITION To conduct human subjects research in a manner that is responsible to scientific standards, while seeking to achieve outcomes for the good of society. RESPONSIBILITY To understand that ethical principles are rooted in the respect for research participants that strives to strengthens the bonds among investigators, participants, the community, and society. RELATIONSHIPS