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

3. 3 January 25, 2008 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. 4 January 25, 2008 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. 5 January 25, 2008 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. 6 January 25, 2008 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. 7 January 25, 2008 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. 8 January 25, 2008 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. 9 January 25, 2008 Inadequate informed consent  Consent document easy to read & understand (below 8 th 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 Addressing the Risk… 9 January 25, 2008

10. 10 January 25, 2008 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 Addressing the Risk… 10 January 25, 2008

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

12. 12 January 25, 2008 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! Addressing the Risk… 12 January 25, 2008

13. 13 January 25, 2008 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. 14 January 25, 2008 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. 15 January 25, 2008 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. 16 January 25, 2008 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. 17 January 25, 2008 Your Best Defense? Documentation is critical Care of the patient Success of the study Defense from claims of malpractice 17 January 25, 2008

18. 18 January 25, 2008 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. 19 January 25, 2008 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 Contacting Risk Management 19 January 25, 2008