For RAD Participants- 2015
IRB Information for RAD Participants 2015
****Note that all RAD abstracts must have a UNTHSC faculty member as Principal Investigator (PI) on the IRB application. Physician, mentors, etc. from other hospitals or institutions CANNOT be the PI on a UNTHSC IRB application.****
If you are presenting a research project which involved or involves human subjects at RAD, this project must have priori IRB review and approval at the time of RAD submission. UNTHSC IRB approval is necessary for ANY research being conducted by UNTHSC personnel (students and faculty/staff) involving human subjects (or data derived from human subjects) in order to comply with federal regulations and UNTHSC policy.
Note that involvement of human subjects in research can either be through direct, physical interactions (survey, blood samples, physical intervention, etc.) or indirect measures (secondary data analysis, retrospective chart review, case studies, etc.). In other words, data obtained or derived from human subjects must receive IRB approval before executing study procedures AND presenting the data (e.g., RAD, journal articles, etc.).
If your research project (poster, abstract, etc.) already has IRB approval, or is part of a larger IRB-Approved study…
For RAD applications that are studies involving an already IRB-Approved project (for example, analyzing data collected in a UNTHSC investigator’s long-running clinical study, or a sub-study analyzing a mentor’s behavioral or epidemiological data, etc.) indicate on your RAD application the following items:
- Current UNTHSC IRB Protocol Number (e.g., IRB 2009-XXX)
- Full Title of that IRB-Approved Protocol
- Name of Principal Investigator holding that IRB Protocol Number
This information will assist the RAD Office in making a timely verification of the IRB status of the RAD submission. The deadline for this information (for a RAD application that is part of an already IRB-Approved protocol) is the same as for RAD applications in general: Thursday, March 5, 2015. Be certain that your RAD submission is, in fact, a component of an existing IRB-Approved project. RAD applications that cannot be verified as having existing IRB-Approval, or applications that incorrectly state that they are already IRB-Approved may be rejected.
NOTE: In order to avoid your abstract being rejected, please verify the above information BEFORE Tuesday, February 24, 2015. Do not wait until RAD deadline, March 5, 2015, to confirm whether or not your project already has IRB approval.
If your research project is NEW and does not yet have IRB-Approval study…
If your research project has NOT yet received IRB review, please submit it as soon as possible to the Office of Research Compliance (ORC). Office of Research Compliance recommends not waiting close to the RAD submission deadline (March 5, 2015) to submit your project for IRB review. This is necessary in order for the IRB to carry out an effective review of the research project as required by the federal regulations. Also note that if any clarification or documentation is needed during IRB review this could delay your submission to RAD. Therefore, please allow at least two weeks for a thorough IRB review.
Note that all RAD abstracts must have a UNTHSC faculty member as Principal Investigator (PI) on the IRB application. Physician, mentors, etc. from other hospitals or institutions CANNOT be the PI on a UNTHSC IRB application.
For these NEW projects, send your IRB Application packet directly to ORC (CBH-160) BEFORE Tuesday, February 24, 2015. Any IRB application submitted to ORC (CBH-160) AFTER Tuesday, February 24, 2015 will NOT be considered for RAD.
Additionally, for these NEW projects, please be available during this time of IRB review to answer any questions about the protocol or make any necessary revisions. Again, best advice is NOT to wait until the deadline to send it in.
Submission Guidance (for NEW IRB Protocols)
For studies involving chart reviews (involving more than one patient), please submit the following document:
- Protocol Application for Research involving Chart Reviews (Application bundles protocol synopsis with IRB application and Waivers of Informed Consent and HIPAA)
- A letter, or email of authorization to access medical charts/records for research project
- Proof of CITI training completion for all key personnel (see table below for additional information about CITI training requirements)
For studies involving a single patient chart review (case study), please use this shorter form: "Single Subject Case Study Form". Submit this specific form for a case study along with proof of CITI training completion for all key personnel (see table below for additional information about CITI training requirements).
For secondary analysis of data already collected or analyses of existing specimen, records, charts, etc., please submit the following documents:
- Research Involving Materials (data, records) Already Collected Protocol Synopsis
- Exempt Application
- If applicable, letter of authorization for the use of data or specimen already collected
- If applicable, IRB approval notice of parent study
- Proof of CITI training for all key personnel (please see the below table for CITI training requirements)
CITI Training Requirements
Note that the various “Refresher Courses” offered through CITI (Biomedical- Clinical, Social-Behavioral, Interdisciplinary, etc.) are NOT a substitute for the HUMAN SUBJECT RESEARCH Basic Course for first time CITI learners. The Refresher courses are only allowed for persons who have already successfully completed the HUMAN SUBJECT RESEARCH Basic course(s) required by the UNTHSC IRB.
Additionally, completion of the CITI Good Clinical Practice (GCP) Course or any other CITI course (such as Responsible Conduct of Research - RCR) is NOT a substitute for the HUMAN SUBJECT RESEARCH Basic Course. While completion of the GCP and RCR courses may be required by other departments or units at the UNT Health Science Center, these courses do not meet the basic 𠇎ntry level” requirement of the ORC/IRB for human subjects research.
Please note that selecting and completing an inappropriate CITI training course may delay ORC and IRB review and approval of the protocol/application.
For more information about how to submit your research project, please visit the following links on our website.
- Categories of Review (Exempt, Expedited or Full Board review)- This intro page can help you determine what level of review your project may receive.
- How to fill out the forms- This guidance section will indicate how to fill out the appropriate form for your project (Exempt, Expedited or Full Board application)
- How to submit to the IRB- this guidance piece informs you on what documents, applications and other components to the IRB packet are necessary for IRB submission
If in doubt, or if you have any questions regarding IRB review and RAD, contact the Office of Research Compliance (ORC) at 817-735-0409.