Institutional review board

Since 1985, the North Texas Institutional Review Board (IRB) at Medical City Dallas (MCD) has monitored the clinical studies under its purview with three overarching goals in mind: meeting the highest ethical standards, proving scientific validity and ensuring patient safety. The North Texas IRB at MCD has successfully undergone a total of three routine FDA audits, the last in 2014, to ensure compliance with federal regulations. Board members are represented by physicians of various specialties, nurses, non-scientist personnel and external community members. With a strong focus of safety and rigid adherence to federal regulations, the North Texas IRB at MCD is dedicated to promoting innovative research programs that position Medical City Dallas and affiliated institutions as a healthcare leader. If you have any questions or require further information about the IRB and submitting a research protocol, please contact Kristye Palmquist, IRB Coordinator, by phone at (972) 566-6060 or email Kristye.

The IRB office is available as a resource for researchers, staff, and interns conducting human subject research at Medical City Dallas and affiliated institutions. The office can provide guidance and assistance with:

• Protocol and informed consent form (ICF) development
• Research education and training
• Information and direction on federal research-related regulations and guidance, state laws and institutional policies

The IRB office is also available to advise on monitoring investigator research, preparing for site visits (for example, sponsor or FDA inspections), and to orienting new researchers to human subject protection matters. The IRB also enters into reliance agreements for multi-site studies as a reviewing IRB and a relying IRB. For further information about the IRB and submitting a research protocol, contact Kristye Palmquist, CIC, IRB Coordinator, by phone at (972) 566-6060 or email Kristye.

The Medical City Dallas Department of Clinical Research is staffed by a professional team of research scientists, engineers, and administrative specialists that work closely with the IRB to ensure that all approved research studies are seamlessly integrated into the everyday operations of the hospital. The expertise of the staff covers a wide range of disciplines including: biostatistics, cardiopulmonary physiology, life sciences, medical biophysics, nursing and research administration.

The North Texas IRB at Medical City Dallas is registered with the Office for Human Research Protection (IRB 00000852) and 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

Applicable regulations include but are not limited to:

• 45 CFR 46, generally known as the Common Rule, and subparts B, C and D
• 21 CFR 50, Protection of Human Subjects, Informed Consent, and Additional Safeguards for Children in Clinical Investigations
• 21 CFR 56, Institutional Review Boards
• 21 CFR 312, Investigational New Drug application
• 21 CFR 812, Investigational Device Exemptions

Medical City Dallas maintains an approved Federal-wide Assurance (FWA) of Compliance FWA00000220 with the Office for Human Research Protection (OHRP). For more information relating to this assurance, visit the OHRP website.

In carrying out its responsibilities, the IRB has the authority to approve, require modifications of, or disapprove all human research that falls within its jurisdiction. The IRB monitors and conducts continuing review of approved research at intervals of at least once per year. The IRB has the authority to observe or have a third party observe the consent process. The IRB takes actions to comply with federal regulations or other applicable laws, including action to suspend or terminate the approval of research. The IRB must report to the appropriate institutional and federal government officials of any funding agency, any suspension or termination of research, any unanticipated problems involving risks to subjects or others and any serious continuing noncompliance with IRB requirements. A full listing of IRB policies and procedures can be found on IRBNet under forms and templates.

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.