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Clinical Research and Outcomes Registry Workshop Creating an Informed Consent Form

Clinical Research and Outcomes Registry Workshop Creating an Informed Consent Form. Daniel Ford, MD, MPH Joseph Carrese, MD. What is the purpose of the study?. Basic science discovery (ex. Biomarkers) Understand treatment and outcomes relationship Quality improvement at group level

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Clinical Research and Outcomes Registry Workshop Creating an Informed Consent Form

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  1. Clinical Research and Outcomes Registry WorkshopCreating an Informed Consent Form Daniel Ford, MD, MPH Joseph Carrese, MD

  2. What is the purpose of the study? • Basic science discovery (ex. Biomarkers) • Understand treatment and outcomes relationship • Quality improvement at group level • Quality improvement at individual level

  3. Characteristics of Sample • All patients • Highly motivated patients • Patients with very well characterized disease state

  4. What are biggest risks to patients? • Loss of privacy • Impact on insurability • Financial obligations (copays for services) • Risks of assessments/procedures (ex, radiation risk) • Clinicians acting on research data when value of information is not proven

  5. Fundamental Questions • How will participants be recruited? • What data will be collected? • Who can access the data? • Under what circumstances? • Group or individual level data? • What will be allowed in terms of followup? • How can a participant leave the study?

  6. What data are collected? • Standard of care assessments • Patient history, physical, lab and imaging tests, treatment received • Research questionnaires • Research physical assessments • Research laboratory data • Research biospecimens • Research imaging data 52-0595110

  7. Recruitment • Clinician investigators recruit research participants during visits • Other clinicians recruit research participants during visits • Ask for HIPPA waiver to directly contact potential research participants

  8. Access to Data • Only research team • Feedback all data to clinicians • Feedback only “extreme and actionable” data to clinicians • Copy of data to participants • Copy of data in EMR/medical record • Broad access to “group level data”

  9. Followup • Recontact for reassessments – improve precision through multiple measurements • Ability to followup after leave health system • How long will the study last? • Social security number

  10. Leaving the study • Need to emphasize leaving study will not impact on their ability to get care • What happens to biospecimens when patient asks to leave study?

  11. Practical Questions • Who obtains informed consent? • Conflict of interest issues • Do you want a consent form with several options? If so, who keeps track of options checked. • Do you want separate consent forms? • Incidental findings policy • Genetic testing policy

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