Q1: I have UTMB physicians, faculty, residents, and/or medical students working on a study. Do I have to submit paperwork to both the UMC Brackenridge/Seton IRB and UTMB IRB?
A1: No. You only need to submit the protocol packet to the UTMB IRB for review. However, for studies that will be conducted at Seton sites the study must also be submitted to the Seton Clinical Research Steering Committee for review.
Q2: I am filling out the UTMB IRB submission paperwork and have questions. Is there a local person that I can meet or speak with or do I have to contact Galveston?
A2: Rene Sewell is the IRB Coordinator for both the UMC Brackenridge/Seton IRB and UTMB IRB. She is located in the Office of Research Administration and by phone (512) 324-7991 (# 4). Heather Gipson (Director, Human Subject Protections & Research Services) can also be reached at ext. 88310.
Q3: Can you tell me the difference between full, expedited, and exempt review processes?
A3: Full Committee Review: The standard type of review described in the Federal regulations.
It must be used for the initial review of all studies that are not eligible for expedited review or exemption status. The review must be conducted at a convened meeting of the IRB.
A majority of IRB members (a quorum) must be present at the meeting.
Expedited Review: Federal regulations permit the IRB chairperson or one or more experienced members to review a study if it involves no more than minimal risk for the subjects and if it fits within 1 of 9 specified categories.
Exempt Review: Federal regulations specifically define 6 categories of human subjects research that are exempt from the other provisions of the regulations. Federal Guidance indicates that applying exempt status to a project is a decision to be made by the IRB. The investigators can not make this determination for themselves. The determination must be made prior to initiation of research or of the activity; it cannot be made retroactively.
Q4: How long should I expect it to take for the IRB to review a protocol?
A4: This depends on the level of review. It will take between 4-6 weeks for a Full Board review, while an expedited review usually takes between 2-3 weeks. None of these reviews can begin until all relevant documents have been submitted.
Q5: When I see the words “expedited review,” I think “fast.” How long should I realistically expect an expedited review by the IRB to take?
A5: The Office of Human Research Protections is considering changing the term “expedited review” to “delegated review” because of the confusion in using the term ‘expedited.’ In reality, the Full Board has delegated the responsibility for review of minimal risk studies or minimal risk action items to 1 or 2 members. The expedited review of protocols involves a thorough review of all documents and can be completed within 2-3 weeks of final submission.
Q6. How many copies of all documents do I need submit to the IRB?
A6: Full Board Review: 20 complete packets. Expedited and Exempt submission: 4 complete packets.
Q7: Do case reports or case studies require IRB review?
A7: Yes. If a case report is deemed to be no-greater-than-minimal risk, it generally falls under an “exempt” category. However, there have been case reports that contain “sensitive” content and therefore would be reviewed either under the “expedited” or “full” review procedures. The determination of whether a case report meets the exempt criteria is made by the IRB. If a case report is determined to be “exempt,” the investigator does not have to follow the procedures for continuing annual review.
Q8: I just had an amendment approved. Do I still need to submit a continuing review for that study?
A8: Yes. Approval of an amendment indicates specific approval of that change only. A continuing review is a review of the entire study and includes the current protocol that contains all the previously approved amendments, the currently approved consent form, a study progress report, and reports for any audits or data safety and monitoring board (DSMB) reviews that occurred during the preceding review cycle. The purpose of the continuing review is to determine whether the study continues to meet all requirements for approval. Studies can be approved for a period that cannot exceed one calendar year.
Q9: What is minimal risk?
A9: Minimal risk is defined in the federal regulations as situations wherein “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” This is interpreted to mean the usual risks experienced in daily life by healthy individuals.
Q10: Are there any resources in the Office of Clinical Research Administration to help me with budget creation?
A10: If you are a Seton employee or an external Principal Investigator/Research Coordinator wishing to conduct a study at a Seton Family of Hospitals facility, you can contact Ben Long. Ben is located in the Office of Clinical Research Administration and may be reached by phone at (512) 324-7991 (option 2). If you are a UTMB employee or wish to conduct a study at a UTMB facility, you can contact Joni Koenig. Joni is located in the Clinical Education Center at Brackenridge and can be reached by phone at (512) 324-7000 (extension 88242).
Q11: Are there any resources in the Office of Clinical Research Administration to help me with contract review?
A11: If you are a Seton employee or an external Principal Investigator/Research Coordinator wishing to conduct a study at a Seton Family of Hospitals facility, you can contact Heather Gipson. Heather is located in the Office of Clinical Research Administration and may be reached by phone at (512) 324-7000 Ext. 88310. If you are a UTMB employee or wish to conduct a study at a UTMB facility, you can contact Joni Koenig. Joni is located in the Clinical Education Center at Brackenridge and can be reached by phone at (512) 324-7000 (extension 88242).
Q12: How many copies of documentation do I need to submit for the Clinical Research Steering Committee (CRSC) review?
A12: The CRSC submission requires 2 complete packets with:
1. CRSC Submission Form
2. IRB Approval letter or IRB Waiver Letter (if using a central IRB)
3. Protocol
4. Consent/Assent
5. Anticipated Budget
6. Investigator or product brochure
7. Procedures and Services Request Form
8. CRSC drug / device checklist
9. Contract
10. Steering submission fee paid (ON HOLD)
Q13: What is the objective of the Patient Load Form (PLF)?
A13: The Patient Load Form (PLF) identifies research participants who are also patients within the Seton system. This identification allows hospital and clinic administrators to follow proper billing and accounting procedures.
Q14: How do I access the Patient Load Form?
A14: Study coordinators or PIs can fill out the PLF online via a secure link to the Clinical Research Steering Committee SharePoint site or they can find a printable version of the form on the Clinical Research website. Also, coordinators or PIs can email the content of the PLF to Ben Long at balong@seton.org.
Q15: Are the clinical research seminar series opened to everyone?
A15: Yes. The clinical research seminar is open to the public and free.
Q16: Is it necessary to pre-register in order to attend the clinical research seminar?
A16: No pre-registration is necessary at this time.
Q17: Who are required to do the CITI human subjects’ protections training?
A17: The CITI training is required for all research personnel who are involved with clinical research within Seton Family of Hospitals (principal investigator, co-investigators, offsite collaborators, coordinators, data managers, or any other study team member).
Q18: Is CITI training required before final IRB approval?
A18: Yes. The IRB will not grant final approval of a new protocol unless required CITI training has been completed by all study team members.
Q19: Do CITI training certificates expire?
A19: Yes. CITI certificates expire 3 years from the completion date. Every three years you will be required to take the refresher course. CITI will automatically contact you to remind you that it is time to take the refresher course.
Q20: Are any continuing education credits available after I complete the CITI course?
A20: Yes. Accreditation is available for: * Physician CME Credit * Psychology Credit * Nursing contact hours
There is a fee that you must pay to obtain CE credit for taking these courses. The CE fee is NOT paid by SETON.
Go to http://www.citiprogram.org/citidocuments/cme/cmepage.htm for more information.
Seton is proud to have four hospitals – the only hospitals in Central Texas - that have earned the