IRB 3392010 The Process of Informed Consent The Consenting Process ConversationProcess Voluntary can change their mind anytime Use simple language Only consenting for data no procedures ID: 934613
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Slide1
Department of Surgery Outcomes DatabaseIRB #339-2010
The Process of Informed Consent
Slide2The Consenting Process
Conversation/Process
Voluntary – can change their mind anytime
Use simple language
Only consenting for data; no procedures
Describe information collected and how stored
Risks/benefits
Patient
gets a
copy
of
the signed
ICF
Slide3Clinic Consent Script
Along with the surgical consent we would like your permission to collect your medical information in our Department Quality Database. The reason that we are collecting this information is to help us improve the quality of our patient care. The choice to let the Department of Surgery use your information is up to you and voluntary. You can say no and it will not affect your care in any way. Although your information will be stored in a protected system, there is a small risk that an unapproved person could gain access to your data. The consent form explains the study information in detail. Please feel free to contact the Department using the number located on page 2 with any questions or concerns that you may have in the future. Do you have any questions at this time? Are you willing to join in this study?
Slide4Who Do We Consent?
Patients scheduled for surgery
Non-English
speaking patients need certified interpreters and translators
Do NOT consent
Anyone under 18 years old – Call Joan
Incapacitated patients
Slide5Avoid Consenting Errors
No
extraneous marks or
cross-outs
Sign on the correct lines
Verify the correct date
Slide6Slide7Your Signature
Patient Signature
LAR - Do Not Use
Slide8Spanish Speaking Patient
Short Form – IRB Form, 2 pages
Need additional translator/witness
Patient Only signs the short form
Does not sign the ICF
Person obtaining consent and translator signs both the short form and the ICF
Slide9Short Form, Spanish Speaking
Patient Signature
Your Signature
Translator/Witness
Slide10Questions?
Refer to the manual in clinic
Call Joan Wysocki; 352-262-9770