Human Subjects Protection in Health Services Research: A Researcher Perspective

1. Human Subjects Protection in Health Services Research: A Researcher Perspective Lisa V. Rubenstein, MD, MSPH HSR&D, 2/07

2. A Fundamental Implementation Researcher Dilemma: Multiple Hats • Researcher • Knowledge expert • Clinical consultant • Police (IRB) • Firefighter (Disasters) • And others…

3. The Researcher “Hat” • The one you can’t take off • Many potential conflicts exist, e.g. • Responsibility for research success vs. responsibility for following guidance • Applying expertise vs. autonomy of stakeholders • Not all of these conflicts are “handled” by IRB compliance

4. Managing Hats is About Applying Ethics Basic Principles (Belmont) • Respect for persons • Beneficence • Justice Key Methods (Helsinki) • Systematic building on prior knowledge • Review by independent, outside groups

5. Other Ethical Considerations for VA Researchers • Taxpayers paid for our salaries and our research projects • We owe them our best work • Our job is to use data to improve care for veterans • Veterans first

6. Helsinki: Review by Independent Outside Groups • This means dialogue with, for example • IRB’s (patients as individuals) • Privacy officers (patients as groups) • Information technology officers (data safety) • Clinical managers (e.g., COS, CMO) (stakeholder and resource perspectives) • QUERI’s (knowledge review) • HSR&D leadership (policy and SOPs)

7. Ethical Dilemmas for Regulators, IRB’s • Fear and wish to keep us safe may cause decisions that , e.g. • Reduce research quality (beneficence) • Cause unnecessary, harmful documentation (beneficence) • Reduce research for subgroups (justice) • Stifle true dialogue (respect & review) • IRBs can become isolated and they need our participation and consultation

8. Active, Thoughtful Dialogue is Necessary • If research is to remain a positive force, researchers, regulators, and stakeholders must take the harder path Research IRB Research IRB

9. Implementation Research (IR) Examples • IR aims to learn how to implement evidence in routine practice • Clinical/research partnerships • Researcher roles as • Knowledge experts • Clinical management consultants • Evaluators

10. Problems Knowledge is complex Unexpected consequences can occur Potential Solutions External input through Guidelines Expert panels Respected organizations Monitor outcomes (HSR DSMB) Implementation Researchers as Knowledge Experts

11. Problems Privacy issues are different Responsibility issues are different Potential Solutions Clinical QI Review: IRB plus privacy officers, Chiefs of Staff, QI Memorandums of Understanding identifying clinical roles/responsibilities Researchers as Clinical Management Consultants

12. Problems Clinical data often used for implementation and evaluation Decisions made by clinical decision-makers may have research implications Clinical settings may desire quick access to results Potential Solutions Ongoing steering committee representing QI, IRB, and relevant stakeholders Implementation Researchers as Evaluators

13. Multiple Hats = Conflicts of Interest • Conflicts are part of daily life • Cannot be escaped • Can only be managed • Management of conflict requires recognition of its effects on our own vision

14. Hats We Don’t Want to Wear Game-Player Criminal Royalty Fireperson Cowboy

15. HSR&D Conflict of Interest Management Goals • Aim for researchers who engage in • Self-awareness • Self-evaluation • Effective ethical dialogue with experts, peers and stakeholders