Risk Management & Clinical Research

1. Risk Management & Clinical Research Duke University Health System Orientation 2008 Clinical Research Coordinators Douglas Borg, MHA, ARM, CPHRM, DFASHRM Director of Insurance Duke University Health System 1 January 25, 2008

2. Agenda • Risk Management • Insurance Coverage • Exposures Associated with Clinical Research • Legal Climate • Informed consent 2 January 25, 2008

3. What is Risk Management? • Function is to identify, evaluate and control risk exposures: • Professional liability - malpractice • General liability - premises, equipment • Proactive - Prevention of loss • Reactive - Management of loss 3 January 25, 2008

4. Proactive Risk Management • Policy and procedure review and development • Inservice educational programs • On-call assistance • Providing data for performance improvement 4 January 25, 2008

5. Reactive Risk Management • Evaluation of incidents when they occur that either cause harm or have the potential to cause harm • Claim investigation 5 January 25, 2008

6. Your PL Insurance • Durham Casualty Company, Ltd. • Coverage for work within the Duke Health System • Does not cover: • criminal conduct • civil rights violations • inappropriate sexual contact/conduct 6 January 25, 2008

7. Typical Exposures for CRCs • Inappropriate selection of research subjects • Inadequate informed consent • Failure to adequately monitor the patient for problems related to the research • Failure to remove a patient from a study • Failure to document patient’s participation • Scope of practice issues • Not adhering to Standard of Care 7 January 25, 2008

8. Addressing the Risk… Inappropriate selection of research subjects • Don’t pressure • Don’t make overblown promises of success • Don’t minimize risks • Be aware that compensation can be considered coercive – compensate for travel and time, but payment must be a fair reflection of the subject’s expenses and inconvenience for participating 8 January 25, 2008

9. Addressing the Risk… Inadequate informed consent • Consent document easy to read & understand (below 8th grade reading level) • Don’t rely on strict adherence to IRB requirements • Informed consent process is important – if it is delegated to someone other than the PI, ensure that their knowledge of the study is adequate, and evaluate their communication skills • Ask questions to ensure understanding 9 January 25, 2008

10. Addressing the Risk… Failure to adequately monitor the patient for problems related to the research • Safety first • Track & document compliance with required visits • Track & document compliance with study instructions • Be familiar with signs and symptoms of adverse reactions to medications or treatment • Don’t hesitate to pull someone out of a study 10 January 25, 2008

11. Addressing the Risk… Scope of practice issues • Understand your role • Licensure v. Job Requirements • May lead to insurance coverage issues 11 January 25, 2008

12. Addressing the Risk… Not adhering to Standard of Care • Research-related treatment and procedures must be managed in accordance with standard of care • It may still be malpractice! 12 January 25, 2008

13. Limiting Your Liability • Do not practice outside the scope of your training. • Be familiar with a task before performing. • Ask for assistance. • Be familiar with written policies and procedures. • Practice good documentation. 13 January 25, 2008

14. Medical Negligence • In general, in NC health care providers must: • Use his/her best judgment • Act with reasonable care and diligence • Act within the standard of care • Violation of any one duty can be negligence 14 January 25, 2008

15. What is the Standard of Care? • Standard of practice among peer providers • Can be set by: • Expert testimony • Policies and procedures • Textbooks, articles • Does not guarantee perfect outcomes 15 January 25, 2008

16. Informed Consent • NC Statute is protective where provider acted in accord with usual standard of practice • Disclose usual and most frequent risks, and most severe risks even if unlikely • If evidenced in writing, presumed valid consent 16 January 25, 2008

17. Your Best Defense? Documentation is critical • Care of the patient • Success of the study • Defense from claims of malpractice 17 January 25, 2008

18. Proving Your Treatment • Document patient response to treatment • Document refusal of treatment • Use hospital approved abbreviations • Note time of treatment of assessment • Date and time late entries • Document consideration of the whole patient 18 January 25, 2008

19. Contacting Risk Management • Phone:684-3277 - During regular business hours • Page:970-2404 - After hours and weekends • Fax:681-8618 • On-Line Report (SRS)https://srs.duhs.duke.edu/Default.aspx • Email:risk.management@duke.edu 19 January 25, 2008