Page 394 - eBook Version 8 Book 1 of 2 JUL 2022

5.2
A.
B. C.
Research Administration SOP No: R-Rec-102
SOP Title: Type of Consent Processes and Documentation
B. Ensure that the most recent version of the IRB-approved consent form is used by logging in to the eIRB system and printing the most recently approved consent document.
C. The consent discussion must take place in a location that provides privacy for the subject and anyone attending the visit with the subject.
D. review the informed consent form with the legal representative and/or subject by discussing all of the elements of the consent form. These elements include;
• Purpose
• Procedures
• Risks and benefits
• Drug and comparative agent (if applicable)
• Alternatives to participation
• Research-related procedures
E. Allow the legal representative and/or subject time to read the document and ask questions
F. Encourage input from family members and other care providers, if appropriate
G. Assess the level of comprehension, ensure the consent form is understood and
verify that the subject is voluntarily agreeing to be in the study
H. If the subject is considered to be a legal minor, obtain consent from the legal
representative.
• The UTSW IRB has established that subjects aged 10 to 18 are old enough to
provide assent for their research participation. The assent of a minor section may be included as part of the informed consent document or there may be a separate form to document the minor’s assent. Inform subjects aged 10 to 18 about the study to the extent compatible with the subject’s understanding If mentally/physical capable, have the subject sign and date the assent section of the informed consent or the separate assent document.
I. The person obtaining consent signs the consent form where indicated.
J. Explain the HIPAA regulations and the HIPAA authorization form.
K. Afterallofthesubject/legalguardian’squestionsaresufficientlyanswered,give
him/her the option to sign the HIPAA authorization form, along with the person obtaining consent.
Language Line Consent Process
In order to utilize the Language Line for a consent visit, you must have a fully translated consent and HIPAA. A short form consent must have an in-person interpretation. This is because the Language Line offers translation services only; therefore, the patient/family will be able to read the entire document. However, a certified medical interpreter will be trained to answer specific questions.
i. A certified interpreter must still be present to answer questions but will not need to sign the documents.
Prior to accessing the Language Line, you must have an access code.
i. Your department’s access code can be found via a badge buddy or
through your supervisor.
Ensure that your consent visit will take place in an area equipped with speaker phones or be prepared to pass the phone back and forth.
Page 3 of 5