For RAD Participants

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. North Texas Regional IRB approval is necessary for ANY research being conducted by NTR IRB affiliated personnel (e.g., UNTHSC personnel students and faculty/staff, JPS employees, and UNT Dallas faculty/staff and students) involving human subjects (or data derived from human subjects) in order to comply with federal regulations and institutional 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 North Texas Regional IRB Protocol Number (e.g., IRB 2017-XXX); or IRB Number from reviewing IRB
  • Full Title of that IRB-Approved Protocol
  • Name of Principal Investigator holding that IRB Protocol Number
  • If IRB approval was granted by another institution (i.e. not a NTR IRB affiliated project), please provide upload a copy of the IRB Approval letter covering your research activity

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. Please see the RAD website for submission deadlines. 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 well BEFORE the RAD submission deadline.  Do not wait until the RAD deadline to confirm whether or not your project already has IRB approval. Please see the RAD website for deadline dates.

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. The North Texas Regional IRB recommends not waiting close to the RAD submission deadline  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 three weeks (if not more) for an IRB review. Note: When submitting your project, please also inform the North Texas Regional IRB office that this project is being submitted for presentation at RAD – this note can be included within your initial submission comments in IRBNet and within the IRB Wizard/New Project Application (under the section regarding project deadlines).

Note that UNTHSC student driven research projects must have a UNTHSC faculty or staff member as Principal Investigator (PI) on the IRB application. Physician, mentors, etc. from other hospitals or institutions CANNOT be the PI on a North Texas Regional IRB application.

For these NEW projects, submit your IRB Application packet through our new electronic system, IRBNet, BEFORE the IRB RAD submission date. Please see the RAD website for submission deadlines. Any IRB application submitted AFTER the IRB RAD submission deadline  will NOT be considered for RAD.

Please refer to the North Texas Regional IRB homepage for guidance material on how to register with IRBNet and create a new project. Please also review our training videos and educational materials for additional guidance and instruction.

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)

Chart Reviews (involving more than one patient)

Please submit the following documents (in addition to completing the Wizard Application Form in your IRBNet submission):

  • 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 purposes of this research project.
  • Proof of human subject protection training (e.g., CITI) completion for all key personnel (see below for additional information about CITI training requirements).

Secondary analysis of data already collected or analyses of existing specimen, records, charts, etc.,

Please submit the following documents (in addition to completing the Wizard Application Form in your IRBNet submission):

  • General Protocol Synopsis
  • A Waiver of Informed Consent Application
  • If applicable, letter of authorization for the use of data or specimen already collected
  • If applicable, IRB approval notice of parent study
  • If applicable, a HIPAA Waiver Application (for the use/analysis of identifiable health information)
  • Proof of human subject protection training (e.g., CITI) for all key personnel (please see below for 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.

CITI Training Requirements

For UNTHSC:

Researchers should affiliate with the “University of North Texas Health Science Center” and must take the Basic of the Human Subjects Research Course (not the Refresher Course) found within the Human Research Curriculum. This is the basic standard training requirement for all faculty, staff, employees and students engaged in research involving human subjects. This training is valid for three (3) years.

For JPS:

Researchers should affiliate with the “North Texas Regional IRB” and must take the Biomedical Research Basic Course. Note: For any questions regarding this any of the other trainings that may be needed for JPS-specific researchers, please reach out the JPS Office of Clinical Research at ResearchSubmissions@jpshealth.org.

For UNT Dallas:

Researchers should affiliate with the “University of North Texas at Dallas” and must take the “Social and Behavioral Research (SBE)” Basic Course. Note: For any questions regarding this or any of the other trainings that may be needed for UNT Dallas-specific researchers, please reach out the Director Alicia Brossette (Executive Director, Office of Sponsored Projects at UNT Dallas) at Alicia.Brossette@UNTDallas.edu.

Other Institutions:

If you are affiliated with another institution that has different requirements, affiliate that institution with your CITI account and take their required course / training. If any of your key study personnel have completed training from a different institution, please include a copy of the full transcript of modules completed (for that individual) in your submission to the NTR IRB.

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 October 17, 2022