Page 368 - CHST Research Administration eBook 2 of 2 (Q4 2021)

5.2
A.
B.
C. D.
Research Administration SOP No: R112
SOP Title: Type of Consent Processes and Documentation
C. Theconsentdiscussionmusttakeplaceinalocationthatprovidesprivacyforthe subject and anyone attending the visit with the subject.
D. reviewtheinformedconsentformwiththelegalrepresentativeand/orsubjectby 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. Allowthelegalrepresentativeand/orsubjecttimetoreadthedocumentandask 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. Ifthesubjectisconsideredtobealegalminor,obtainconsentfromthelegal
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
InordertoutilizetheLanguageLineforaconsentvisit,youmusthaveafully 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.
PriortoaccessingtheLanguageLine,youmusthaveanaccesscode.
i. Your department’s access code can be found via a badge buddy or
through your supervisor. Ensurethatyourconsentvisitwilltakeplaceinanareaequippedwithspeaker phones or be prepared to pass the phone back and forth. Youmaythencarryoutyourconsentvisitfollowingthestandardprocedureforan interpreted visit, with each party signing only the forms written in his/her native language where indicated.
i. Remember, when the document is fully translated, the interpreter must be present but will not need to sign.
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