Page 401 - eBook Version 8 Book 1 of 2 JUL 2022

The purpose of this Standard Operating Procedure (SOP) is to outline the procedures to be followed when obtaining informed consent by email, regular mail or fax.
2. INTRODUCTION
In the event that research consent or re-consent may not be obtained in person, there are additional methods to obtained informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for continued research study participation. Each of these alternative consenting methods need to be Institutional Review Board (IRB) approved prior to implementing.
Example of when these methods may be approved can be in a circumstance where a two-parent consent is needed (more than minimal risk without the prospect of benefit to the patient) or a re-consent is necessary and the patient no longer follows care at Children’s. These methods would need to be granted in the initial IRB submission, in a modification, or be granted by the IRB as an acceptable way to re-consent if patient is still on-study. This policy applies to the Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) and the study Principal Investigator (PI).
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 current SOP.
4.1 IRB approval
The CRC/CRA will clearly outline the recruitment process in the electronic IBR smart form. The CRC/CRA will also update the recruitment process as the demands of the study change and obtain IRB approval prior to implementation.
Research Administration SOP No: R-Rec-113
SOP Title: Consent by Email, Regular Mail or Fax
1. PURPOSE
Page 2 of 6