Department of Surgery Outcomes Database IRB # The Process of Informed Consent

The 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

Clinic 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?

Who 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

Avoid Consenting Errors No extraneous marks or cross-outs Sign on the correct lines Verify the correct date

Your Signature Patient Signature LAR - Do Not Use

Spanish 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

Short Form, Spanish Speaking Patient Signature Your Signature Translator/Witness

Questions? Refer to the manual in clinic Call Joan Wysocki;