Risk Management & Clinical Research Duke University Health System Orientation 2008 Clinical Research...
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Risk Management & Risk Management & Clinical Research 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
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Transcript of Risk Management & Clinical Research Duke University Health System Orientation 2008 Clinical Research...
Risk Management & Risk Management & Clinical ResearchClinical Research
Duke University Health System
Orientation 2008
Clinical Research Coordinators
Douglas Borg, MHA, ARM, CPHRM, DFASHRMDirector of InsuranceDuke University Health System
1January 25, 2008
Agenda
Risk ManagementInsurance CoverageExposures Associated with Clinical ResearchLegal ClimateInformed consent
2January 25, 2008
What is Risk Management?
Function is to identify, evaluate and control risk exposures:Professional liability - malpracticeGeneral liability - premises, equipment
Proactive - Prevention of lossReactive - Management of loss
3January 25, 2008
Proactive Risk Management
Policy and procedure review and developmentInservice educational programsOn-call assistanceProviding data for performance improvement
4January 25, 2008
Reactive Risk Management
Evaluation of incidents when they occur that either cause harm or have the potential to cause harmClaim investigation
5January 25, 2008
Your PL Insurance
Durham Casualty Company, Ltd.Coverage for work within the Duke Health SystemDoes not cover: criminal conduct civil rights violations inappropriate sexual contact/conduct
6January 25, 2008
Typical Exposures for CRCs
Inappropriate selection of research subjectsInadequate informed consentFailure to adequately monitor the patient for problems related to the researchFailure to remove a patient from a study Failure to document patient’s participationScope of practice issuesNot adhering to Standard of Care
7January 25, 2008
Addressing the Risk…
Inappropriate selection of research subjectsDon’t pressureDon’t make overblown promises of successDon’t minimize risksBe 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
8January 25, 2008
Inadequate informed consentConsent document easy to read & understand
(below 8th grade reading level)Don’t rely on strict adherence to IRB
requirementsInformed 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…
9January 25, 2008
Failure to adequately monitor the patient for problems related to the researchSafety firstTrack & document compliance with required visitsTrack & document compliance with study
instructionsBe familiar with signs and symptoms of adverse
reactions to medications or treatmentDon’t hesitate to pull someone out of a study
Addressing the Risk…
10January 25, 2008
Scope of practice issuesUnderstand your roleLicensure v. Job RequirementsMay lead to insurance coverage issues
Addressing the Risk…
11January 25, 2008
Not adhering to Standard of CareResearch-related treatment and procedures must
be managed in accordance with standard of careIt may still be malpractice!
Addressing the Risk…
12January 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.
13January 25, 2008
Medical Negligence
In general, in NC health care providers must:Use his/her best judgmentAct with reasonable care and diligenceAct within the standard of care
Violation of any one duty can be negligence
14January 25, 2008
What is the Standard of Care?
Standard of practice among peer providersCan be set by:Expert testimonyPolicies and proceduresTextbooks, articles
Does not guarantee perfect outcomes
15January 25, 2008
Informed Consent
NC Statute is protective where provider acted in accord with usual standard of practiceDisclose usual and most frequent risks, and most severe risks even if unlikelyIf evidenced in writing, presumed valid consent
16January 25, 2008
Your Best Defense?
Documentation is critical
Care of the patientSuccess of the studyDefense from claims of malpractice
17January 25, 2008
Proving Your Treatment
Document patient response to treatmentDocument refusal of treatmentUse hospital approved abbreviationsNote time of treatment of assessmentDate and time late entriesDocument consideration of the whole patient
18January 25, 2008
Phone: 684-3277 - During regular business hours
Page:970-2404 - After hours and weekends
Fax: 681-8618On-Line Report (SRS) https://srs.duhs.duke.edu/Default.aspx
Email: [email protected]
Contacting Risk Management
19January 25, 2008
