Page 383 - eBook Version 8 Book 1 of 2 JUL 2022

Research Administration SOP No: R-Rec-101 SOP Title: Consent Process
the memo attached on this SOP explaining our policy about recruiting adults. Please, also see the Adult Recruitment form located on RA sharepoint.
4.2 Location of consent process
Study team members will ensure that the consent location provides appropriate privacy.
4.3 Study discussion
Study team members will provide an overview of the study to explain the basic elements along with any additional elements (when appropriate) to the Legal Authorized Representative (LAR) and/or subject.
4.4 Executing the consent form
Study team members will ensure the ICF and Health Information Portability and Accountability Act (HIPAA) Form are completed.
4.5 Documentation of the Informed Consent and Research Visits
Upon executing the informed consent document, the informed consent process and study visit information should be documents in the subject’s medical record and subject binder. Additionally, policy 7.14 should be followed ensuring that a patient label is affixed to the top, right corner of every page of the ICF and HIPAA form.
5. PROCESS
5.1 Obtain the currently approved Informed Consent Form (ICF)
Study team members will download the most recent version of the Institutional Review Board (IRB) approved Informed Consent Form (ICF) and Health Information Portability and Accountability Act (HIPAA) Form from the electronic Institutional Review Board (eIRB) website.
5.2 Location of consent process
Study team members will secure a location that provides privacy and review the informed consent form with the Legally Authorized Representative (LAR) and/or subject.
5.3 Study discussion
Study team members will review the ICF with the LAR and/or subject by discussing the following elements:
• Statement the study involves research
• The study’s purpose and expected duration of the subject’s participation
• Description of procedures
• Description of any reasonable foreseeable risks or discomforts
• Description of any benefits to the subject or to others
• Disclosure of appropriate alternative procedures
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