1. Do I have to be credentialed?
Answer:
Health System Policy 9.01 requires, "All Principal Investigators, their Co-Investigators, and Clinical Personnel be credentialed by Medical-Dental Staff prior to implementation of a research study. Administrative personnel and or those who will only perform Administrative duties 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 scope of practice and covered by the signed assurance to the institution. Each will sign a confidentiality statement. Ethics education for these personnel is the responsibility of the Principal Investigator. 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 just conducting a survey?
Answer:
Yes, if you have any patient contact you must be credentialed. However, if the survey is not involving patients, approval may be granted by a Vice President in lieu of the credentialing for staff surveys or non-clinical related protocols.
3. Does my protocol have to go through the UHS Research Department, if I am conducting a retrospective chart review or a survey?
Answer:
Yes, all protocols that plan to conduct Research within the Health System facilities must go through the Research office; recruitment, retrospective chart and medical record reviews are included.
4. Does my protocol have to go through the UHS Research Department, if I am recruiting subjects but my study is being conducted elsewhere?
Answer:
If the IRB in their review designated UH or any of its clinics as a clinical site, recruitment has moved beyond a poster level and as a clinical site we must review and approve. Posters are allowed under the guidelines described in the MEMO section of this web page. More involved recruitment may involve waivers from the IRB with disclosures to our institution. Recruitment Submissions will require all those listed below as well as a disclosure log that must be submitted electronically on a monthly basis. There must be approval from the UTHSCSA IRB for waivers. In lieu of the waivers, signed authorizations from each subject prior to looking at their Protected Health Information (PHI) can be obtained and placed in the medical record.
5. How long is your approval process?
Answer:
Our process goal for each protocol is 10 working business days excluding holidays and weekends. Protocols that require support from multiple departments may take longer for the review of the protocol.
6. Once my protocol is approved what other communications/documentation does the Research Department require for continuation of the protocol?
Answer:
Once your protocol is approved, the office should receive paperwork indicating the following:
· The UTHSCSA IRB provides the Research Department and Research Committee with Adverse events reporting. However, if a major problem results from a research study please notify the research department.
· Please notify the Research department if the protocol requires an AUDITOR to visit, such as in anticipation of an FDA audit.
· Sponsor visits will require an appointment and can be made under the monitoring link on this page.
· Please submit approval by the IRB of all modifications to the protocol or consent form(s) prior to implementation of the change.
· Please submit an assurance update of staff/investigator changes before your continuation so that Professional Staff Services and Information Services can be notified of these changes.
7. My IRB approval letter states UHS as a site. Does that cover all Health System facilities?
Answer:
The IRB letter will specify the HEALTH SYSTEM sites in which patients are recruited, enrolled, and followed at. Approval can only be given to site specified in the IRB Approval letter. The Institutional Components included in the Federalwide Assurance (FWA 00003754) are: University Hospital, University Center for Community Health, University Family Health Center-Southwest, University Family Health Center-Southeast, University Family Health Center-North, University Health Center Downtown, Correctional Health Care Services Located at Bexar County Juvenile Detention Center, Correctional Health Care Services Located at Cyndi Taylor Krier Correctional Health Center, Correctional Health Care Services Located at Bexar County Jail. Please note that individual Clinics that are not operated by the University Health System are not included in this assurance. A Formal memo on the FWA is located in our MEMOs section of this web page.
8. 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:
Each study is individually contracted between UHS and UTHSCSA . Procedures authorized will only be those specified in the contracts from the University Health System and only charges listed will be charged to the project number assigned. Utilizing the colored request slips provided at the time of the contract can help avoid errors in the invoices being sent incorrectly to your subjects.
9. Do my flyers recruiting subjects need approval from your office?
Answer:
UTHSCSA IRB has determined that Recruitment by Poster only will not make UHS a clinical site. If you want to post flyers please follow the corporate guidelines in the MEMO section of this web page.
10. Are there specifics regarding Fiscal Management of a protocol at UHS that I need to know as an investigator?
Answer:
Yes, they are as follows: Fee Schedule can be found on this Web page, this can be used for Budgeting . Each protocol that requires support services will require a contract to be established between the Health System and UTHSCSA . The principal investigator will be required to verify and sign the supplemental page of this contract prior to it being signed by the two institutions and implementation of this study. Color coded request slips are generated for each study help staff correctly enter charges to the research account rather than the patients insurance. They will be provided at the beginning of the study. Please use these throughout your study to request those procedures specific for research charges. Under the Carelink schedule of benefits, research protocols and/or investigational drugs/devices are not covered and become the patients financial liability if not otherwise funded.
11. Do I need to include University Health System as a study site if I am just recruiting?
Answer:
The regulations imply that if a facility's PHI is being used to identify and recruit patients without the patients' prior authorization, that the facility is "engaged in research". Meaning if study personnel are identifying potential subjects by looking at PHI first to see if they may be eligible (under partial waivers) and then contacting them about the study, then we need to be considered a study site and the protocol must be submitted to the Health System Research department for review and approval. Excluding if someone in the middle of providing care and realizes an individual may be eligible and discusses the study with them and providing information, but leaves it to the patient as to whether they contact the investigators.
12. 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:
If problems arise with your bill for services or if one of your subjects receives a bill for services that was to be paid for by Research, please notify the Research Department or Contact Financial Accounting, Special Billing Coordinator at 358-2152.
