1. Marianne M. Elliott Office of Research Integrity and Ethics Bureau of Medicine and Surgery U. S Navy

2. 2 Investigator Education: Training for Accountability in Human Research Protection Programs Concurrent Session 3.03Thursday, April 22, 2004 Marianne M. Elliott, M.S., C. I. P. Director, Clinical Investigation & Responsible Conduct of Research Programs Office of Research Integrity and Ethics, U. S. Navy

3. 3 Disclaimer: The opinions expressed in this presentation are solely those of the author and do not reflect the official position or views of the United States Navy, the Department of Defense or the U. S. Government.

4. 4 Objectives: Training for Accountability 1. Explore the ‘landscape’ of education: ‘responsible conduct of research’ 2. Describe ‘sowing and growing’ strategies 3. Suggestions for ‘feeding and weeding’

5. 5 Landscape Rough terrain – jungles, mountains & valleys NIH Policy effective October 2000 NIH Policy effective October 2000 ORI Policy – still pending ORI Policy – still pending Institutional policies - variability Institutional policies - variability

6. 6 Landscape Where are the ‘roots’ of education & accountability? Family ‘Tree’ values – individuals Family ‘Tree’ values – individuals Community ‘forest’ – neighborhoods Community ‘forest’ – neighborhoods Education – grade & high school, college Education – grade & high school, college On-the-Job training – adult learning On-the-Job training – adult learning

7. 7 Sowing & Growing Creating a culture of integrity & accountability: values – established early in life values – established early in life attitudes – can be difficult to change attitudes – can be difficult to change behavior – observable, can be altered behavior – observable, can be altered

8. 8 Sowing & Growing Create a culture: awareness of ethical principles awareness of ethical principles understanding regulatory requirements understanding regulatory requirements applying guidance applying guidance clear expectations of standards-norms clear expectations of standards-norms

9. 9 Sowing & Growing Start early and integrate: Kindergarten – ‘garden of children’ Kindergarten – ‘garden of children’ respect, sharing, working together Grade school and high school Grade school and high school basic science, language arts integrity, honesty, team work

10. 10 Sowing & Growing College College sciences, research methods, humanities integration & application Graduate & Professional Graduate & Professional integration & application teaching, mentoring, roles & responsibilities

11. 11 Feeding & Weeding On-the-Job training – late start, intervene now initial orientation to expectations initial orientation to expectations acceptable values & behaviors (norms) specific to roles & responsibilities on-going awareness & confirmation on-going awareness & confirmation meeting expectations

12. 12 Feeding & Weeding OJT: Adult learning principles tailored to individual needs tailored to individual needs applicable & relevant to ‘work’ (role) applicable & relevant to ‘work’ (role) set clear expectations set clear expectations appropriate methodologies appropriate methodologies integrated integrated

13. 13 Feeding & Weeding Many methods & approaches: Traditional ‘classroom’ - face-to-face seminars, lectures, workshops Traditional ‘classroom’ - face-to-face seminars, lectures, workshops e-learning - flat or interactive, distance e-learning - flat or interactive, distance

14. 14 Feeding & Weeding Achieving accountability through: on-going evaluation of education programs on-going evaluation of education programs on-going monitoring of direct application on-going monitoring of direct application

15. 15 Feeding & Weeding Evaluate education programs clear objectives & expectations clear objectives & expectations content & presentation content & presentation individual & aggregate feedback individual & aggregate feedback revise & update revise & update

16. 16 Feeding & Weeding Evaluate direct application: post approval monitoring of research post approval monitoring of research feedback from research team, supervisors feedback from subjects IRB assessment – continuing review, observation Institutional assessment – other HRPP components documentationtransparency

17. 17 Feeding & Weeding Evaluate direct application: continuous quality improvement -HRPP continuous quality improvement -HRPP review & verify publications & presentations review & verify publications & presentations

18. 18 Feeding & Weeding Disclose actual performance: marketing & public relations marketing & public relations community – sharing results, good & ‘not so good’ community – sharing results, good & ‘not so good’ presentations – local, national, global presentations – local, national, global

19. 19 Conclusion Education for accountability in HRPP ‘Change’ the landscape, create the culture ‘Change’ the landscape, create the culture Sow early & intervene now Sow early & intervene now Clear expectations – values, behaviors Clear expectations – values, behaviors Monitor direct application Monitor direct application Share & communicate Share & communicate