Research Question

1. Dissemination Data Analysis/Study Close-out Data Collection Recruitment and Enrollment Ethical Review Scientific and Conflict of Interest Reviews Protocol Development Research Question

2. Responsible Research Overarching Goal for National System Protect Every Research Participant  Ensure that ALL human research is carried out under the purview of an HRPPP irrespective of funding source or research facility.

3. Research Organization Sponsor IRB Safety Monitoring Board Investigator Responsible Research What is an HRPPP?  An HRPP is a system of functional elements that come together for the purpose of ensuring participant protection.(Excerpted from Figure 2.2)

4. Responsible Research The leadership of the organization must be explicitly and publicly committed to the highest ethical standard of protection for human participants.

5. Responsible Research Components are: • accountability • adequate resources • ethical education programs • transparency Investigators [and all who make decisions] must be trained in ethics

6. Responsible Research • HRPPPs require that specific conditions be pervasive within the research culture in order sustain robust protection activities. (Figure 2.3)

7. Responsible Research Refocus protocol review: Scientific Review Financial Conflict of Interest Review Ethics Review and rename IRB to Ethics Review Board

8. Responsible Research Informed consent to be a process, not a moment. The process includes: • the culture of the institution • participant involvement in research design • investigator training in ethics • demanding review of science merit • rigorous examination of conflict of interest • reconstituted and refocused Ethics Review Board • simplified forms

9. Responsible Research Risk appropriate monitoring: • Simple but powerful phrase • Handling multi-site studies • Feedback to sponsors, investigators, and Ethics Review Board

10. Responsible Research Compensation for injury and costs: • Previous reports have recommended this be studied • We recommend it be done, and that • Compensation for loss of income be studied

11. Responsible Research Maintain Vigilance  Collect data about the national system for use in quality improvement and basic performance assessments*  Enhance safety monitoring of protocols, particularly those posing high risks to participants*  Continuously improve HRPPP performance quality  Manage potential conflicts of interest at the individual and institutional levels  Monitor and assess the performance and evolving needs of the national protection system* *Will require federal involvement or facilitation for full implementation

12. Human Research Participant Protection Program Comprehensive Protocol Review Ethically Sound Participant-Investigator Interactions Ongoing Safety Monitoring Quality Improvement and Compliance Responsible Research  Although the particular elements of an HRPPP may vary by protocol the essential functions are fundamental and fixed (Figure 2.4)

13. Responsible Research What about accreditation?