Page 83 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-006
SOP Title: Study Initiation: eResearch Systems
vii) Study team members have complete the eCOI (electronic conflict of interest statement) located within the eIRB system
viii) Employee delegated regulatory functions for the study has an active institutional email and phone number.
Central IRB (cIRB) & Reliance Agreements
For Studies Using a Central IRB (cIRB) Initial Per Following Outline (See guidance attached to the back of this SOP for submitting a study using a cIRB):
4.1
Reliance Agreements
As part of the continued effort to grow research, our department supports various avenues to fulfil research regulatory review requirements in the educating, supporting, and shepherding of Reliance Agreements for IRB review as appropriate to the scope of our institution. Below are three primary scenarios in which a Reliance Agreement may be relevant:
PI is employed through Children’s Health and the work will occur at Children’s:
Relying Institution: Children’s Health System of Texas (CHST)
Reviewing IRB: IRB of the Institution for which we are seeking a Reliance Agreement
Process: Request the Reliance Agreement from the Reviewing IRB to be sent to: researchcontracts@childrens.com. Upon Receipt of the Reliance Agreement, the RA director will initiate the Reliance Agreement provide updates to the stakeholders, and shepherd the process until completion.
PI is employed by UTSW and the work will occur at Children’s:
Relying Institution(s): CHST & UTSW
Reviewing IRB: IRB of the Institution for which we are seeking a Reliance Agreement
Process: Upon Receipt of the Reliance Agreement, the RA director and team leads will initiate the Reliance Agreement with our legal team, provide updates to the stakeholders, and shepherd the process until completion. The Reliance Agreement for UTSW should be sent to: Kimberly Hawkins, B.A., CIP, Reliance Program Manager, at Kimberly.Hawkins@UTSouthwestern.edu 214.648.3378.
PI is not employed by UTSW and the work will occur at UTSW:
Relying Institution: UTSW
Reviewing IRB: IRB of the Institution for which we are seeking a Reliance Agreement Process: Request the Reliance Agreement for UTSW from the Reviewing IRB. Engage Kimberly Hawkins, B.A., CIP, Reliance Program Manager, at Kimberly.Hawkins@UTSouthwestern.edu 214.648.3378
SPECIFIC PROCEDURE
Log into Velos
i) Type this link in your web browser: https://velos.swmed.edu/velos/jsp/ereslogin.jsp
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