Institutional Review Board

Medical City Plano has been involved in clinical research since 1975 and in July of 2009 established an Institutional Review Board (IRB) that provides ethical oversight for research conducted in Medical City Plano and affiliated hospitals within the North Texas Division of HCA. The IRB works to protect the rights and welfare of individuals who volunteer to participate in research in our institution. The IRB is guided by the ethical principles set forth in the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research report, called the Belmont Report.

Protecting research participants at Medical City Plano and affiliated hospitals is a shared responsibility, with the institution, researchers, IRB committee, and the IRB Office working together toward this common goal.

The IRB office is available as a resource to provide regulatory guidance for researchers, staff, and interns conducting human subject research at Medical City Plano and affiliated institutions. For further information about the IRB and submitting a research protocol, contact the IRB Office at (972) 396-4044 or via email.

The Institutional Review Board (IRB) is comprised of a diverse membership while maintaining the expertise needed to fulfill its functions. The Board typically meets on the second Wednesday of each month.

The IRB member roster consists of the following disciplines:

• Oncologists/Hematologists
• Cardiologists
• Pediatric Intensivist
• Emergency Medicine
• Pharmacists
• Registered Nurses
• Advanced Practice Registered Nurses
• Community Members

A current IRB roster may be obtained by contacting the IRB Office at MCPL.PlanoResearch@medicalcityhealth.com

Please log into IRBNet to access the complete forms library. All of the current forms for Medical City Plano IRB can be found there. Forms should be submitted through IRBNet once completed in order to obtain IRB review.

• IRBNet Energizers (Step-by-Step Submission Instructions)
• MCP IRB Policy Manual
• Research Policies
• Investigator Guidance Tools and Resources
• IRB Fee Schedule
• Protocol Template
• Informed Consent Form Template
• Guidance with the Wizard Application for New Study Submissions
• Reliance Request / Waiver of Oversight Form
• Doctoral Research Program (i.e. DNP, PhD, EdD, etc.)
• Submission Forms

If you have questions about which forms to use please contact the IRB Office for further assistance.

MCP IRB operates in compliance with Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) Guidelines insofar as those guidelines are consistent with the U.S. Food and Drug Administration regulations (21 CFR Parts 50 and 56) and the Department of Health and Human Services regulations (45 CFR 46) pertaining to the protection of human subjects in research.

The Medical City Plano IRB is registered with the Office for Human Research Protection (OHRP) and Food and Drug Administration (FDA) through the IRB registration site with the Department of Health and Human Services (DHHS) under IRB Registration Number: IRB00007165.

Medical City Plano holds a Federal Wide Assurance from the Office for Human Subject Protection (OHRP) in the Department of Health and Human Services (HHS). An FWA is required for any institution that is engaged in human subjects research that is not otherwise exempt, which is conducted or supported by any agency of the U.S. Department of Health and Human Services (HHS).

A FWA is an assurance of compliance with HHS regulation pertaining to the protection of human subjects.

Assurance Identification No. FWA00014788

The Quality Assurance (QA) Program supports research that is subject to the authority of the Medical City Plano Institutional Review Board in accordance with applicable IRB requirements, principles of research ethics set forth in The Belmont Report, institutional policies and procedures, and federal, state, and local regulations. The program focuses on identifying educational opportunities, implementing best practices, and instituting systemic improvement.

• Dates and deadlines
• Getting started with the IRB
• IRB resources
• Research study participants