Conducting Research at Baylor St. Luke's Medical Center
Baylor St. Luke’s Medical Center (BSLMC) supports top-tier clinical research through its collaborations with academic and private practice investigators.
Prior to enrolling participants in any research project conducted at BSLMC, it is the responsibility of the Principal Investigator to obtain both:
- IRB approval from a BSLMC-accepted IRB, and
- Administrative approval from the BSLMC Research Office
Baylor St. Luke's accepts decisions from the following IRBs:
- Baylor College of Medicine
- Biomedical Research Alliance of New York (BRANY)
- CHI Institute for Research and Innovation
- National Cancer Institute Central IRB (CIRB)
- University of Texas Health Science Center – Houston
- Western IRB (WIRB)
The resources below provide information on research conduct procedures and services at BSLMC. Please contact the BSLMC Research Office with any questions (BSLMC_Research@bcm.edu; 713.798.6024).
- Guide to Conducting Clinical Research at BSLMC– Detailed information on all aspects of conducting clinical research at BSLMC, including:
- Administrative application process (see link to application under Forms)
- Research pricing – complete the Request for BSLMC Pricing form found in Forms section below and contact the Office of Research (BSLMC_Research@bcm.edu or 713-798-6024) for research pricing and pricing questions
- Procedures for research billing
- Procedures for patient scheduling
- Obtaining hospital approval for device studies
- BSLMC Clinical Research Center Investigator’s Manual– Services, study initiation, visit scheduling and visit management information for the BSLMC Clinical Research Center.
BLSMC Research Credentialing
Non-clinical, non-BSLMC employees who are involved with any research study at BSLMC must complete the following steps to obtain site access, EPIC & other IT system accesses, and an issuance of a BSLMC badge. Note: BSLMC HR System (Workday) applications expire 60 days from the date of initiation.
- Initial Application:
- Submit the following documents to the BSLMC Research Office
- BSLMC Research Credentialing Initiation Questionnaire
- TB Symptom Review Form
- Immunization Records
- Immunization/Testing Checklist
- BCM employees –
- Download pdf of Complete Service History/Health Screening record as a .pdf from MyOHP from following link: https://intranet.bcm.edu/as/ohpis/index.cfm
- Titer/vaccination/testing is performed at no charge by BCM Occupational Health Program located at Baylor Clinic, Suite 1375, Phone: 713.798.7880
- Negative Drug Screen – performed through BSLMC for no additional cost. Once orders have been completed, you can complete the urine drug screen at a participating Quest location (bring government-issued photo ID with you).
- You will be contacted via email by your assigned Workday Manager for next steps.
- Renewal (Annual):
- Once approved, your Workday non-employee contract will be valid for one year. It is your responsibility to renew. Watch for notifications from the Workday system in advance of contract expiration and submit immunization records, proof of annual influenza vaccination and TB testing prior to expiration for renewal to BSLMC Research Office (email@example.com).
- Checklist for BSLMC Application for Administrative Review
- Application for Administrative Review of Research– All research conducted at BSLMC must obtain administrative approval before study activities are initiated.
- Investigational/Humanitarian/Postmarket Device Impact Assessment Request Form –Required form for all device studies. To be submitted as early in study process as possible.
- Request for Clinical Research Center (CRC) Support
- Request for Access to PHI for Research Purposes
- BSLMC Call Center Registration Form for Research Visits
- BSLMC CRC Call Center Registration Form for Clinical Research Center Visits
- Supplement for Studies Managed by CHI Institute for Research and Innovation (CIRI) or CHI IRB (CHIRB)
- Electronic Signature Certification (21 CFR Part 11)
- Request for BSLMC Pricing
- Administrative Review – Research
- Associating Patient Records with Informed Consents - Research
- Billing Compliance – Research
- Expanded Access - Compassionate and Emergency Use of Test Articles – Research
- Impact Assessment of Investigational/Humanitarian/Postmarket Devices – Research
- Tissue Collection Process - Research
- Ethical and Religious Directives - Language for Informed Consent Forms - Research