Institutional Review Board at Medical City Plano
Medical City Plano has been involved in clinical research since 1975. To meet the institution’s vision of becoming an excellent research facility, Medical City Plano established an Institutional Review Board (IRB) in July of 2009. Protecting research subjects at Medical City Plano 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 for researchers, staff, and interns conducting human subject research at Medical City Plano 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 Carolyn David-Graves, IRB Coordinator, at (972) 396-4044 , email Carolyn David-Graves or Mary Bailie, Director of Clinical Innovation at (972) 519-1223 , email Mary Bailie.
Accreditation is a public affirmation of an organization's commitment to protecting research participants. Medical City Plano Institutional Review Board has full accreditation through the Association for the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP).
ICH GCP Compliance Statement
Medical City Plano Institutional Review Board has full accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). 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.
FDA and FWA
Medical City Plano IRB maintains an approved Federal-wide Assurance (FWA) of Compliance IORG0005943 AND FWA00014788 with the Office for Human Research Protection (OHRP). For more information relating to this assurance, visit the OHRP website.