Instructional Guidance and Sources for Human Subject Investigators
The following documents and information sources are to assist investigators as they are designing or modifying their protocols (i.e. guidance materials). To access fillable templates and forms, please visit the “IRB Forms” page (or click here to redirect you to the Forms page).
NTR IRB has created two 15-minute training videos to assist you in navigating our submission process. Please click the below links to watch our helpful videos. Please note that the “Concepts and Resources” video provides the historical background of IRBs, a brief overview of IRB concepts, and NTR IRB specific Resources and Guidance materials. We recommend watching this video first. The IRBNet Tutorial Video is a “How To” video where we cover the basics of how to use IRBNet – which is the electronic submission system used by the NTR IRB.
- What is Human Subject Research?
- Designing Research Protocols
- IRB Protocol Synopsis for Research Projects Involving Human Subjects
- Designing Research-Supported Documents
- Consenting Research Subjects
- Consenting Non-English Speaking Subjects
- IRB Reportable Events
- Data Storage and Security
- CITI Training
- HIPAA Regulations
- Sponsored Clinical Trials
What is Human Subject Research?
- Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
- Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable
NHSR Submission This document explains how to submit a request into the NTR IRB for a “Not Human Subject Research” (NHSR) determination (if needed). If you have any questions regarding whether or not your research project can be determined as NHSR, please set up a consult with the NTR IRB to discuss.
Activities that meet both definitions above (as defined by federal regulations at 45 CFR 46) are considered to be Human Subject Research for which IRB review is required.
Designing Research Protocols
Guidance for Research and Repository Protocols This guidance document is intended to assist NTR IRB investigators with crafting the appropriate information to include in the Protocol Synopsis of a project which is intended to be either a research registry (data bank) or a research repository (tissue/biospecimen bank). Please do NOT use the Chart Review Protocol Synopsis Template for these types of studies. Rather, please use the Master/General Protocol Synopsis Template.
Existing Materials Guidance Document This document contains guidance on the existing materials (data and/or Human Biological Specimens)-related elements that need to be included in the Protocol Synopsis. The existing materials-related elements that are outlined in this document are in addition to the basic protocol elements that are outlined in the main Protocol Synopsis template. Investigators who have projects that involve existing materials should use this guidance document when developing their Protocol Synopsis.
Survey Guidance Document This document contains guidance on the survey-related elements that need to be included in the Protocol Synopsis. The survey-related elements that are outlined in this document are in addition to the basic protocol elements that are outlined in the main Protocol Synopsis template. Investigators who have projects that involve surveys should use this guidance document when developing their Protocol Synopsis.
Focus Group and Interview Guidance: This packet provides guidance to investigators designing focus group/interview research studies. This includes the information required for an effective IRB review as well as guidance regarding consent, recruitment and designing research-related documents for focus group and/or interview studies. We would like to extend our grateful appreciation to Dr. Erika Thompson, Principal Investigator and School of Public Health professor at UNTHSC for permission to use samples of her (IRB-approved) focus group/interview research-related material for educational purposes.
Re-contacting Subjects from Existing Research Studies This document provides guidance and recommended procedures from the North Texas Regional IRB in regard to “re-contacting” research subjects either for future studies or to obtain additional information. This includes information on how to design a protocol to incorporate such element as well as information required for proper IRB review. You must have adobe acrobat capabilities to access this document (pdf).
Guidance on International Research Federal regulations require that all international research with human subjects must have the appropriate safeguards in place to protect the rights and welfare of the subjects. This manual will provide investigators considering or designing international research guidance on the federal requirements for conducting such research. This is a pdf file and you must have adobe acrobat to access it.
Research using Human Biological Materials (Samples) This document offers guidance on research using human biological materials. This piece specifically defines what is considered to be human biological research, evaluates the different levels of risk associated with this research, and how to conduct ethically sound research with human biologics. For more assistance or guidance on this topic, please contact the North Texas Regional IRB.
GUIDANCE NOTE for UNTHSC Projects Only: UNTHSC projects involving the collection and use of any human biological material (e.g., urine, blood, tissue samples, etc.) must also obtain approval from the UNTHSC Institutional Biosafety Committee (IBC). The UNTHSC Biosafety Office is NOT part of the North Texas Regional IRB and the approval process is separate from that of the IRB. However, for North Texas Regional IRB approval, you will need IBC approval if you are working with human biological material. Please note that this requirement is specific to projects in which the Principal Investigator (PI) and researchers are considered UNTHSC personnel (i.e. UNTHSC-driven project).
Please contact the Biosafety Program Office (email@example.com) for more information and submission requirements.
Research involving Chart Reviews This document offers directed guidance on research using review and analytical research of medical records, medical charts (“chart reviews”) as well as case studies on individual patients. Using this special “Protocol Application for Research Involving Chart Reviews” form, the investigator will be directed on how to provide sufficient information for an appropriate and timely IRB review. For more assistance or guidance on the topic of chart reviews and case studies, please contact the North Texas Regional IRB.
Designing Research-Supporting Documents
NTR IRB Recruitment Guidance This document is intended to provide general guidance on various recruitment strategies as well as what should be included within recruitment materials to meet regulatory criteria.
Telephone (Recruitment) Script This document is a sample/ template of a telephone recruitment script. Note that as recruitment is part of the consenting process federal regulations require IRB review and approval of the information presented to subjects (when they are called). Also consider that certain consent elements such as study procedures, contact information, who is conducting research, etc. needs to be included in such script. For further guidance regarding the need for a phone script, please contact North Texas Regional IRB. To view this document, you must have MS Word capabilities. back to top
Consenting Research Subjects
Study Consent Cover Letter Template This document is a template of a consent cover letter. A consent cover letter has the elements of a full-fledge consent document. However, it does not have a section for documenting the consent process (i.e. no subject signature). You must obtain a Waiver of Documentation of Informed Consent to use this type of consent document/method. Please contact the North Texas Regional IRB to see if your study qualifies for such waiver. To view this document, you must have MS Word capabilities.
Guidelines for Re-consenting Subjects This document provides information to investigators regarding re-consenting subjects. In particularly, this guidance piece describes when such step is necessary/ required. As this is a pdf file, your computer must have adobe acrobat to access this document.
When Minors Become Adults (during a research study) This document offers guidance to investigators including consent language regarding the need to re-consent research participating minors once they become adults. Recall that the regulations require that a former child “re-consent” to be in research but now as an adult. You need adobe acrobat to access and download this file.
Consenting Non-English Speaking Subjects
Guidelines for the Use of the Short (Consent) Form This document provides guidance to investigators on how to consent non-English speaking subjects using a Short (Consent) Form. A Short Form is a more “condensed” version of the Informed Consent document and should be used for the occasional and unanticipated recruitment of non-English speaking subjects.
IRB Reportable Events
SAE Guidance This information provides investigators with guidance on how and when to report an on-site SAE for a particular study. You must have pdf capabilities to access this document or you may visit the link “SAE Guidance” for more information.
Reporting Protocol Violations The guidance provided in this document covers the definition of a “protocol violation”, examples, reporting methods and how to avoid such events from occurring. Recall that all protocol violations must be reported within 10 working days of discovery of the event.
Defining Protocol Violations This manual is a lexicon created by Norman Goldfab, Chairman of the PDV Code Governing Committee for understanding and communicating protocol deviations and violations. This document also provides some examples of protocol violations and deviations within human subject research. Please contact the North Texas Regional IRB for any additional guidance on how to report protocol violations.
Data Storage and Security
Data Storage and Security This document provides investigators with IRB recommended language for data storage and security. This verbiage can be incorporated into the protocol synopsis. You must have adobe acrobat capabilities to access this document.
Please visit the Human Subject Research Training for North Texas Regional IRB Researchers webpage for detailed information regarding CITI training, including step-by-step guidance on how to register your account and affiliate with the appropriate institution.
For further assistance contact CITI helpdesk by visiting their “Contact Us” web page. The North Texas Regional IRB does not maintain the CITI website.
HIPAA Compliance Information This provides guidance regarding the Privacy Rule and HIPAA regulations and its application to the realm of human subject research. For additional guidance, please visit “Informed Consent Guidelines” found as a link on our website.
HIPAA FAQs This is a direct link to the Department of Health and Human Services. The information provided in this FAQs section gives general guidance on the privacy provisions of the Health Insurance Portability and Accountability Act of 1986 (HIPAA).
Sponsored Clinical Trials
Registering a Clinical Trial (ClinicalTrials.gov) Recall that public law 110-85 states that all “applicable trials” be registered on the NIH’s website, “Clinical Trials.gov.” This document provides an explanation and guidance on which clinical trials require registering as well as outlines the sponsor’s and principal investigator’s responsibilities regarding such requirement. To view this piece, you must have MS Word capabilities.
FDA Checklist This document outlines the materials investigators must assemble and submit with their application for initial review by the North Texas Regional Institutional Review Board. It is important to note that incomplete submissions will result in the entire application being returned to the Investigator without having undergone IRB review.
This page was last modified on September 15, 2022