Institutional Review Board (IRB)

The TWU Institutional Review Boards (IRBs) review research projects that involve human subjects to protect their rights and welfare. Therefore, it is the policy of TWU that all research conducted by any TWU faculty member, staff member, or student using human subjects must have prior approval from a TWU IRB before the research is initiated. Human subjects research at TWU is governed by TWU's Federalwide Assurance, Policy, and IRB Procedures.

RESPONSE TO COVID-19

Investigators conducting human subjects research were notified that all face-to-face human subjects research must be halted to ensure the safety of the study participants and researchers. During this time, face-to-face meetings and interventions must be stopped or replaced with alternatives such as phone or video conferencing using tools such as Skype/Google Hangout/Zoom or online survey software. The IRB, in partnership with IT Solutions, has developed a document to provide guidance with possible online / virtual alternatives. 

Per the general policy for re-opening research at TWU issued on May 29, some faculty human subjects studies can resume face-to-face contact on June 15 with approval from the Vice Provost for Research and Innovation. Requests for resuming these faculty studies must be made to the Vice Provost for Research and Innovation using the Request Exception to Resume Face-to-Face Human Subjects Research form. This plan also stated on July 1 face-to-face human research studies in which Covid-19 risk can be mitigated to a minimal level may resume if a PI has modified the IRB protocol to add the risk of Covid-19 exposure to the procedures and consent form, included necessary safety measures, and re-consented new or continuing participants. A guidance for minimizing the risk of exposure to COVID-19 in human subjects research can be found here. Studies where the Covid-19 risks cannot be mitigated, or are not modified to address risks associated with Covid-19, cannot resume face-to-face procedures at this time. Please note that the date for resuming these studies is now July 20 unless the Except Request Form (see above) is submitted and approved. 

These target dates will be highly dependent on ongoing updates to federal, state, local, and institutional policies related to physical distancing and allowed activities and based on continuous monitoring of the guidelines. Any changes to study procedures must be approved in advance by the IRB. By working remotely, the TWU IRBs plan to remain fully functional, and you may contact Ms. Sandy Owens (Denton and Dallas IRB Analyst) @ sowens6@twu.edu or Dr. Madhura Maiya (Houston IRB Analyst) @ mmaiya@twu.edu with questions.

Page last updated 4:27 PM, June 30, 2020