1. 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, JHM OHSR Open House

2. 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

3. 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”

4. 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

5. 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

6. 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

7. 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