Research Principles & Professionalism

1. Research Principles & ProfessionalismK. Lynn Cates, M.D.Assistant Chief Research & Development OfficerDirector, PRIDEMay 30, 2012

2. Research Principles & Professionalism “Culture of Compliance” vs. “Culture of Professionalism”

3. Declaration of VA Research Principles VA Research commits to the protection of research participants as its highest priority.

4. Declaration of VA Research Principles VA commits that in the conduct of clinical research, VA will: • Undertake clinical research only if it is reviewed, approved, and monitored by appropriate VA committees that ensure the research study is properly designed, does not involve undue risks, and includes safeguards for participants.

5. Declaration of VA Research Principles VA commits that in the conduct of clinical research, VA will: • Ensure that all members of the research team conduct themselves as professionals, upholding the highest standards of quality and ethics in their work.

6. Declaration of VA Research Principles VA commits that in the conduct of clinical research, VA will: • Clearly explain that participation in a research study is voluntary and only occurs with consent, and that participants have the right to change their mind at any time without affecting their VA health care or benefits.

7. Declaration of VA Research Principles VA commits that in the conduct of clinical research, VA will: • Educate individuals who are considering enrolling in a research study about the study and its possible benefits and risks.

8. Declaration of VA Research Principles VA commits that in the conduct of clinical research, VA will: • Safeguard subjects’ information.

9. Research Principles & Professionalism VA investigators & research team members will: • Have the proper qualifications and expertise to perform research • Demonstrate integrity and transparency in all research activities • Apply rigorous scientific methods so the contributions of research subjects result in true evidence-based knowledge

10. Research Principles & Professionalism VA investigators & research team members will: • Comply with all requirements for conducting research, including those related to conflict of interest • Cooperate fully with oversight and monitoring

11. Declaration of VA Research Principles Everyone in the medical center is responsible for making sure these principles are followed as a top priority.

12. Research Principles & ProfessionalismNational Academies of Science Committee “The health and credibility of the research enterprise ultimately depends upon the integrity of the research process – the adherence by scientists and their institutions to honest and verifiable methods in proposing, performing, evaluating, and reporting research activities.”* *From the Project Outline for the NAS Committee on Responsible Science

13. Research Principles & ProfessionalismNational Academies of Science Committee • “Responsible Science: Ensuring the Integrity of the Research Process” • What is the state of knowledge about modern research practices? (e.g., Internet, data storage) • What are the impacts on integrity of changing trends in IRB review (e.g., central review), intellectual property, handling of data and specimens, etc.? • What are appropriate roles for the government? • Should there be more guidance on responsible conduct of research?

14. Research Principles & Professionalism National Academies of Science Committee • Research Misconduct • Fabrication • Falsification • Plagiarism • Should the definition change? • Research impropriety • Questionable research practices

15. Research Principles & Professionalism • Declaration of VA Research Principles can be posted throughout VA facilities • If anyone feels these principles have not been met, they are encouraged to contact the Patient Advocate Office

16. Research Principles & Professionalism We are grateful to all the Veterans who participate in VA research studies, making important health care advances possible and turning hope into reality.