Page 382 - eBook Version 8 Book 1 of 2 JUL 2022

1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to outline the procedures to be followed when you are presenting a consent to a possible study subject.
2. INTRODUCTION
The purpose of the consent form is to ensure the possible study subject or his/her legal guardian understand the requirements for the study and understand that by signing the consent form they are agreeing to participate in the study and adhere to the schedule of the study.
The consent process is an ongoing dialogue between the study staff and the person being consented. It may also include the subject’s parents or legal guardian if the subject is a minor. The person responsible for signing the consent form should be given time to read the consent thoroughly in a setting where they feel relaxed and not pressured. It is ideal if the person is able to read through the consent prior to the first meeting so that any questions they have may be answered prior to the actual consent discussion. If this is not possible then the person needs to be given as much time as needed to read the consent and formulate questions during the screening visit. The coordinator or PI may also read through the consent with the person and answer questionsastheycomeup. Duringtheconsentdiscussionthepersonbeingconsented needs to be made aware that the consent process is ongoing and that they are encouraged to ask questions at any time during the study, not just during the initial consent discussion.
3. SCOPE
This SOP applies to all persons approved by the Institutional Review Board (IRB) as study team members. Those who have been delegated consenting responsibilities by the Principal Investigator (PI) may obtain consent as identified on the study Delegation Log.
Additionally, as it is our institution’s mission to make life better for children, please see the memo attached on this SOP explaining our policy about recruiting adults. Please, also see the Adult Recruitment form located on RA Sharepoint.
4. RESPONSIBILITIES
The study team is advised to complete informed consent under the FDA guidance and UTSW HRPP ongoing COVID-19 modifications including completing informed consent virtually whenever possible and permissible. For studies under the purview of the FDA, Docusign and the HRPP link are both 21 CFR 11 compliant, however, they come with a cost and must be reconciled with research finance and UTSW contracts where applicable before proceeding with these methods. All other research may utilize one of the methods outlined in the SOP R113.
4.1 Obtain the currently approved Informed Consent Form (ICF)
Study team members will ensure that the most recent version of the Institutional Review Board (IRB) approved Informed Consent Form (ICF) and Health Information Portability and Accountability Act (HIPAA) Form is used in the informed consent process. Additionally, as it is our institution’s mission to make life better for children, please see
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Research Administration SOP No: R-Rec-101 SOP Title: Consent Process