Regulatory Affairs / IRB
Office of Research Contacts for VIICTR Institutional Participants
Each of the research institutions participating in the Virtually Integrated Institutes for Clinical and Translational Research (VIICTR) are committed to protecting the welfare of subjects involved in research in accordance with the federal regulations, 45 CFR 46 and the ethical principles established by the Belmont Report. Resources that are available to support new and experienced investigators in the conduct of research are available through the Research Resources Office in the Dan L. Duncan Institute for Clinical and Translational Research (ICTR), the physical home for VIICTR, or through the respective institutional offices of research.
- Research Resources Office
- Baylor College of Medicine Office of Research
- University of Houston Division of Research Offices
The Dan L. Duncan Institute for Clinical and Translational Research (ICTR) Research Resources Office
Regulatory support available through the ICTR Research Resources Office provides coordinated and comprehensive researcher-focused support for researchers at participating VIICTR institutions. This includes all regulatory aspects of investigator-initiated, NIH cooperative group, and industry sponsored studies. The Research Resources Office has an experienced team of regulatory professionals who utilize best practice methodologies and tools to promote quality levels of compliance, reduce process inefficiencies, and encourage effective research implementation. The Research Resources Office is located on the 1st floor of the Jewish Wing at Baylor's main campus; a satellite office is located on the 14th floor of the Feigin Center at Texas Children's Hospital.
Services can be requested by completing an online request form.
Regulatory services include:
- Assistance with IRB submissions, e.g., BRAIN submission (Biomedical and Assurance Information Network, BCM’s online system for submission of protocols and conflict of interest disclosures)
- Processing and submission of protocol amendments and renewals
- Assistance with informed consent development and translation
- Assistance with development of Data Safety Monitoring Plans and implementation
- Liaison with federal agencies and pharmaceutical sponsors
- Assistance with applications to hospital review committees, IBC, etc.
- Assistance with IND / IDE submissions, including regulatory form (1571s, 1572s, etc.)
- Assistance with Certificate of Confidentiality submissions
- Creation and maintenance of master regulatory files for each protocol
- Administrative coordination with outside sponsors and investigators
- Electronic maintenance and distribution of protocols and consent forms
- Storage of research records
- Timely reporting of AE/SAE and unanticipated problem reports to required agencies, sponsors and collaborators
- Assistance with required reporting to clinical trials databases (e.g., clinicaltrials.gov)
- Oversight and coordination of external audit preparations