1. Do I have to be credentialed?
Answer:
Health System Policy 9.01 requires, "All Principal Investigators, their co-investigators that are not employed by the Health System
will be credentialed by Medical-Dental Staff prior to implementation of a research study. The Health System staff employed by UT Health San Antonio TM
for pursposes of research will be credentialed by Professional Staff Services. Administrative and research personnel who have
knowledge of the subjects' protected health information, even if not in direct contact with the subject will be listed as
authorized personnel on the investigators Research Scope of Practice to the institution. Each will sign a confidentiality statement.
Health System employees must complete departmental competencies if supporting or implementing a research protocol in their area."
2. Do I have to be credentialed if I am solely conducting a survey?
Answer:
Yes, if you have any patient contact you must be credentialed.
3. Does my protocol have to go through the UHS Research Department, if I am conducting a retrospective chart review, survey,
or if the study is determined as full board, expedited, exempt, non-human, non-regulated research, or external?
Answer:
Yes, all protocols that are planned to be conducted within the Health System facilities must go through the Research Office.
4. How long is your approval process?
Answer:
Contact the UHS Research Office at 210-743-6450 regarding your specific study.
5. My IRB approval letter states UHS as a site. Does that cover all Health System facilities?
Answer:
No, only the sites listed on the IRB form Step 1.
6. Can I use my Project number from a previously approved study for one that's pending if I need to get my study started?
Answer:
No, each study is individually contracted.
7. Do my flyers recruiting subjects need approval from your office?
Answer:
Yes, they will be reviewed for approval by UHS Corporate Communications.
8. Once my protocol is approved what do I do if I have a problem with a bill that I have received for support services
for my study? What do I do if one of my patients receives a bill for a procedure that was to be paid by the research study?
Answer:
Please contact the Research Office at 210-743-6450.
9. I have received UT Health San AntonioTM IRB or external IRB approval, may I start conducting research at UHS?