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 (pdf).
The TWU IRB has revised the procedures, effective June 7, 2018. The primary change in procedures is that of record retention for files. IRB records will now be kept three years from the file close date rather than four years. Other changes are non substantive and are intended to provide clarification regarding individual roles, definitions of key terms, and procedures and processes.
Implementation of Final Rule
Final revisions to the Federal Policy for the Protection of Human Subjects (a.k.a. the "Common Rule") were issued by the Department of Health and Human Services (HHS) on January 18, 2017. Originally, the majority of changes were scheduled to go into effect on January 19, 2018, but an Interim Final Rule has now been published extending the implementation date to July 19, 2018. The major impacts will be in the areas of informed consent requirements, exemption categories, continuing review of expedited studies, and the single IRB of record requirement (which will not be implemented until January 2020 except for NIH-funded studies). The TWU IRBs are working on the implementation and transition to the new requirements. More information and training sessions will be announced once the implementation date is established.
View basic information about whether IRB review is required, levels of review (exempt, expedited, and full), the process when more than one IRB is involved, guidance on obtaining student data and using TWU email lists, data management, and other resources.
Access all the forms and materials required to submit a new application (including a guide to writing a consent form and sample consent forms), modification, extension, and file-close request.
View requirements and links on the basic human subjects' protection training requirements for investigators and research team members.
Page last updated 4:02 PM, June 7, 2018