***New Name and structure for the Institutional Review Board***
The UNTHSC Institutional Review Board (IRB) has changed its name to reflect a new partnership and collaboration with the John Peter Smith (JPS) Health Network. The new name is “The North Texas Regional IRB “. The North Texas Regional IRB is a collaboration involving UNTHSC and the John Peter Smith (JPS) Health Network to provide human subject protection review services to both UNTHSC and JPS researchers…in a single IRB framework. As a Regional IRB, other collaborations are possible throughout the North Texas region, hence the name “North Texas Regional IRB”. As new collaborating partners become involved with the North Texas Regional IRB, announcements will be sent out regarding these new partnerships and opportunities.
Practical implications for UNTHSC researchers:
- The IRB website and all IRB forms and applications have been modified to reflect this name change.
- In addition, some IRB forms have new elements to reflect the partnership with JPS. We recommend using the new forms for all IRB applications and processes (new, continuing review, final reports, etc.).
- Materials using old versions of the forms and templates that have already been submitted will still be reviewed (no need to re-submit these documents)…but we encourage the use of the new forms as soon as possible. The “old” IRB application forms and templates will not be accepted after March 1, 2018.
For additional information about this, please visit our “Frequently Asked Questions about North Texas Regional IRB” (click on the hyperlink). You may also contact us at 817-735-0409.
NORTH TEXAS REGIONAL IRB
The North Texas Regional Institutional Review Board (IRB), a part of the Office of Research Compliance (ORC) at UNTHSC, will be the premier regional human research protection program and a leading innovator in education, training, and positive “value-added” investigator-IRB relationships.
Protect research participants, serve the community, and enhance the human research enterprise of its collaborating partners in collaboration with John Peter Smith Health Network (JPS).
The North Texas Regional Institutional Review Board operates a regional human research protection program to review and approve all research involving human subjects. This program has two important components: the administrative support and outreach regarding the Protection of Human Subjects by the Office of Research Compliance (ORC) and regulatory review provided by the North Texas Regional Institutional Review Board (IRB).
Reporting to the Vice President for Research, the Office of Research Compliance (ORC) is an administrative staff department that oversees human subjects’ protections through program oversight, education, policy setting, and outreach. The ORC conducts initial review for all research projects involving human subjects and refers their findings and recommendation to the North Texas Regional IRB for formal in-depth review and approval. Further, on behalf of the IRB, ORC is authorized to monitor all research involving human subjects under their Federal Wide Assurance (FWA) jurisdiction. ORC provides administrative support to the IRB committees, provides assistance to investigators who are preparing IRB applications, and maintains records of IRB reviews and approvals for investigators.
The IRB is a volunteer member review committee that is empowered to review all human subjects research proposals – funded or not – which are conducted by UNTHSC and JPS faculty, staff, employees, students, residents, as well as designated community research partners. IRB members are appointed by the Institutional Official (in our case, the Vice President for Research) and serve 3-year terms on the Board (renewable). Note that the IRB is essentially an “independent committee” and must follow federal regulations as well as institutional policies in evaluating the scientific and ethical merits of human subject research.
The North Texas Regional IRB is committed to reviewing biomedical and behavioral research involving human subjects under rigorous ethical principles. The ORC and the IRB have been established to comply with existing regulations of the federal government in accordance with U.S. Department of Health and Human Services (DHHS) regulations in 46 CFR 46, with the Food and Drug Administration (FDA) regulations set forth in 21 CFR 50, 56, and with Federal Wide Assurance (accepted by the DHHS, Office for Human Research Protections (OHRP)).
Further, the North Texas Regional IRBwill adhere to the statement of ethical principles as described in The Belmont Report: Ethical Principles and Guidelines for the Human Subjects of Research found in the Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; and the IRB is cognizant of the International Conference on Harmonization Good Clinical Practice Consolidated Guidelines regarding organization and operation of Institutional Review Boards (IRBs).
This fundamental commitment to the protection of human subjects applies to all research involving human subjects regardless of whether the research is funded through government, non-profit or industry sponsors, through University or JPS Health Network funds, or not funded at all, and regardless of the location of the research.
Before any human subject research project is initiated, it must be reviewed and approved by the ORC and where appropriate, the IRB. While the principal investigator has primary responsibility for the conduct of the study, the UNTHSC ORC and IRB are responsible for protecting the rights and welfare of study subjects under FWAs granted by DHHS to the University. The North Texas Regional IRB and its researchers adhere to federal, Texas, and local regulations and laws as appropriate. Ethical and procedural guidelines by recognized professional organizations are also used for achieving best practices.
This page was last modified on February 7, 2018