Regulatory & Compliance

Ensuring our research is safe, ethical and compliant

Baylor Scott & White Research Institute has several departments that work together to make sure our research is not only innovative but that it follows require regulations and standards for quality research that is safe and ethical.

Institutional Review Board

The Institutional Review Board, or IRB, is a federally mandated committee responsible for ensuring the protection of the rights and welfare of human research subjects. Unlike other healthcare systems performing research, Baylor Scott & White Research Institute has four IRBs comprised of scientific and non-scientific members as well as unaffiliated community representatives.

IRB responsibilities include:

  • Review with authority to approve, require modifications in or disapprove research activities
  • Ensure all requirements for approval are satisfied in accordance with federal regulations
  • Report any serious or continuing non-compliance by investigators to the appropriate institutional officials, the Office for Human Research Protections, the Food and Drug Administration and any other appropriate regulatory agencies
  • Suspend or terminate research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects
  • Require that information given to subjects as part of informed consent is in accordance with federal regulations
  • Conduct continuing review of research at intervals appropriate to the degree of risk but not less than once per year, including the authority to observe or have a third party observe the consent process and research
  • Review all changes or modifications to research study protocols
  • Review all studies and teams to assure there are no conflicts of interest in research projects that could affect human subject participation and protection.
  • Review pertinent marketing and/or advertising content developed in support of study awareness generation and information sharing
  • Monitor and review any adverse event reporting, progress made on the project and any other relevant research activity involving human subjects

Contact Us

Managers of Quality Assurance & Regulatory Affairs

Clinical Research Regulatory & Ethics

Clinical Research Regulatory & Ethics (CRRE) makes sure there are adherence to the study protocols, Good Clinical Practice (GCPs), Federal Regulations, and research standard operating procedures; ensures the integrity of the scientific data; and determines that the rights and welfare of human research subjects are being or have been adequately protected. CRRE consults with the directors, managers, investigators, and research coordinators on study findings and ensures that corrective action plans are implemented. The staff is comprised of monitors whom have a vast knowledge of State, Federal and International laws and guidelines, which govern clinical research and know where and whom to go to for guidance and direction, e.g. Research Compliance.

Clinical Retention and Training

Clinical Retention and Training (CRT) provides trained Clinical Research Coordinators (CRCs) to assist investigators with clinical trials.

Coordinators hired by CRT include qualified registered nurses and non-medical staff with varied undergraduate and post-graduate degrees, often in other health care fields. CRT also provides classroom education in addition to one-on-one ongoing mentoring and training for CRCs while they work in their assigned areas. CRCs are trained in all aspects of clinical trial conduct, including training on federal research regulations and research Good Clinical Practice (GCP).

Role of Clinical Research Coordinators (CRCs)

The role of the CRC varies depending on the investigator’s need and the research protocol requirements. In general, the CRC is responsible for organizing each research trial from inception to completion. The CRC works with the investigator to ensure that all required procedures are conducted and that the subsequent data is reported accurately for analysis.

Under the guidance and supervision of the investigator, the duties of the CRC may include the following:

  • Designing and maintaining organizational tools that will aid in the conduct of the study.
  • Assisting with training for site personnel and other staff on the study protocol
  • Recruiting and screening the potential subjects according to the protocol’s inclusion and exclusion criteria
  • Obtaining and managing proper written informed consent from each study subject prior to participation in the study and documenting the consent process
  • Scheduling study subjects’ visits and defining the study visit activities completely and accurately by providing appropriate documentation in the case history
  • Reporting all adverse events (AEs), and serious or unexpected adverse events (SAEs) to the investigator and assisting with reporting to the Sponsor/IRB
  • Maintaining adequate and accurate case report forms (CRFs) and source documentation for each study subject that record all observations and data obtained during the study
  • Completing the CRFs for the study accurately and completely as determined by the investigator (Note: While Study Coordinators may fill our CRFs, the ultimate responsibility for the content and accuracy of a CRF rests with the Investigator, who reviews and may be required to sign each CRF indicating they confirm all information contained within a CRF)
  • Assigning study subject numbers and maintaining accurate and complete records of the receipt, dispensing and return of all clinical supplies-noting all discrepancies
  • Aiding in communications with the sponsor to discuss the study and review study data in association with or as directed by the Investigator
  • Following all Baylor Scott & White Health / Baylor Scott & White Research Institute policies associated with the handling of the investigational products and providing clinical care
  • Assisting with preparation for site visits from the FDA and other regulatory agencies by collecting and organizing all clinical sources of subject data pertinent to the clinical trial

Upon eligibility, all CRCs are required to pass a national certification exam for research professionals administered by the Society of Clinical Research Associates (SoCRA).

Contact Us

Central TX Region: 254.771.4858

North TX Region: 214.820.2687

Institutional Biosafety Committee

The Institutional Biosafety Committee, or IBC, is a federally-mandated committee responsible for ensuring the safe and ethical use of recombinant DNA and other biohazardous agents.

The IBC:

  • Ensures that activities involving the use of recombinant DNA or biohazardous material meet the ethical and legal requirements for such usage.
  • Establishes and maintains policies and guidelines for the conduct of activities involving the use of recombinant DNA and/or biohazardous material.
  • Maintains and promotes an open and cooperative relationship with investigators and the community.
  • Educates the community concerning the regulatory requirements for the use of recombinant DNA and biohazardous material.

The IBC reviews all research that involves:

  • Biological toxins
  • Microbial agents or other agents that are infectious to humans, animals or plants
  • Recombinant DNA molecules, and/or genetically altered organisms or agents, including organisms and viruses containing recombinant DNA molecules
  • Synthetic DNA molecules
  • Human or non-human primate derived cells, tissues or OPIM
  • Nanomaterials

Contact Us

BSWRI, Biosafety Officer