For RAD Participants
IRB Information for RAD Participants 2019
****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 prior 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, 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 2017-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: Friday, February 1, 2019. 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 Friday, February 1, 2019. Do not wait until the RAD deadline, February 13, 2019, 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 through our new electronic system, IRBNet, as soon as possible. Office of Research Compliance recommends not waiting close to the RAD submission deadline (February 13, 2019) 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, submit your IRB Application packet through our new electronic system, IRBNet, BEFORE Friday, February 1, 2019. Any IRB application submitted AFTER Friday, February 1, 2019 will NOT be considered for RAD. NOTE: No paper based submissions are being accepted at this time. Please refer to the North Texas Regional IRB homepage for guidance material on how to register with IRBNet and create a new project.
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 below for additional information about CITI training requirements)
RAD Case Study Reports (single subject-patient)
RAD abstracts or scholarly activity involving single patient medical record “case study” reports no longer require IRB review. Such scholarly activities, although they may be considered as “research” activity, do not meet the federal or university criteria as research activity subject to research subject regulation. Thus, no IRB protocol review and approval is needed for case study reports on a single subject/patient.
However, all faculty, staff and students involved in ”Single Patient Case Study” reports must still follow all appropriate professional, institutional and HIPAA regulations and guidelines regarding the management of protected health information.
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 below 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 SUBJECTS RESEARCH Training Course. 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 SUBJECTS RESEARCH 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 HUMAN SUBJECTS RESEARCH Course requirement.|
This page was last modified on December 4, 2018