Institutional Review Board at Medical City Dallas
Since 1985, Medical City Dallas (MCD) Institutional review Board (IRB) 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 MCD IRB 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 Medical City Dallas IRB is dedicated to promoting innovative research programs that position Medical City Dallas as a healthcare leader. The remainder of this document is designed to help you with the submission process for your studies to the MCD IRB. If you have any questions or require further information about the IRB and submitting a research protocol, please contact Kristye Palmquist, IRB Research Coordinator, at (972) 566-6060 or Kristye.firstname.lastname@example.org.
IRB Policy and Procedures
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 appropriate MCD institutional and federal government officials and any funding agency any suspension or termination of research, any unanticipated problems involving risks to subjects and any serious continuing noncompliance with IRB requirements. A full listing of IRB policies and procedures can be found here.