All individuals working with human participants in research are required to complete an instructional program before the Office of Human Subjects Protections (OHSP) will review an application. This policy reflects UTD’s commitment to the protection of the rights and welfare of human participants in research. This training requirement covers not only Principal Investigators, but also all individuals identified as study personnel.  Personnel external to UT Dallas who conduct human subjects’ research at or with UT Dallas must also complete the required training or provide proof of equivalent training.

The required training must be completed through an online tutorial, accessed by logging into CITI.

Upon successful completion of human subjects protection training, a completion certificate must be retained by the researcher for their records.

eLearning Training Module. Human subjects protection training is no longer supported via eLearning. However, certificates of completion obtained prior to 2/28/2022 will continue to be accepted for a period of 3 years from the completion date. All investigators using eLearning completion certificates must upload a copy to the Cayuse application form for each study on which they are listed. 

Human subjects Protection training must be renewed every 3 years.

Additional trainings may be required, depending on the study and funding. Please see IRB Trainings for more information

For studies supported by a sponsored project, a copy of the submitted / awarded proposal or Sponsored Research Agreement is needed. There is a place in the application form to include the Proj ID assigned to the study by the Office of Sponsored Projects. If this is known, please input for our records and the OHSP can obtain the required documentation.

Advertisements and recruitment materials for human research subjects are considered an extension of the informed consent and subject selection processes. Accordingly, final versions of all advertisement and recruitment materials must be submitted with the IRB application and approved prior to use. Examples of recruitment materials:

• Advertisements and flyers (printed, online, audio, and video)
• Recruitment scripts (verbal, email, phone, etc.)
• Press releases (when the study is open to accrual)

No investigator may involve a human being as a participant in research unless legally effective informed consent of the participant or the participant’s legally authorized representative is obtained.

The OHSP created consent form templates that include all required elements.  The PI is encouraged to use the template most appropriate for the study.

Consent to Participate in Research

Utilized for most projects involving collection of sensitive and / or identifying information. To be used with participants who are 18+. Signature is required.

Web Survey Consent

Appropriate for Exempt Studies with no interaction between participant and investigator. No sensitive or identifying information is being collected and no signature is required.

Consent Information Sheet

Appropriate for Exempt Studies and Class Projects. No sensitive or identifying information is being collected and no signature is required.

Parental Consent Form

For studies recruiting minors (under 18). Parental consent will outline all experimental procedures and a parent will consent on behalf of the child. Signature is required.

Children’s Assent (ages 7 – 17)

Documented assent is required for studies involving minors aged 7+. Language used should be appropriate for the child’s age group and simplified to highlight what the child will experience during the experimental procedures.

Children’s Assent (ages 6 and under)

Verbal assent is required for children under the age of 6 (as applicable), involving a conversation between the child participant and the investigator. A script of the information to be presented to the minor must be submitted with the application form.

Sponsor or Lead Site-approved Consent Forms

Studies that have a non-UTD affiliated Reviewing IRB will need to provide a copy of the approved consent form with their Cayuse application for their Reliance study.

Waiver of Written Documentation of Consent

Utilized for projects involving collection of highly sensitive information when the research could not practicably be conducted without the waiver of signatures. Documented verbal consent is required.

Studies involving deception (false or incomplete information to participants) should debrief participants after the experimental procedures have concluded. The OHSP template debriefing document can be used for this purpose.

Copies of all surveys, interview questions, stimuli, etc. must be submitted with your application.

• Survey questions
• Interview questions
• Focus group questions
• Scales and measures
• Participant observation checklist
• Case report forms
• Audio/ video / image prompts

When devices are used during the experimental procedures, sufficient information about the device must be included in the application to inform Reviewers what the device is, how it works, and whether or not there are safety concerns. This does not include common devices such as laptops or iPads.

• Package insert / investigator brochure
• Product labeling / specifications
• Device instructions
• Verification of each Investigational Device Exemption (IDE) number:
  • Sponsor protocol with the IDE number
  • Communication from the FDA or sponsor with the IDE number

Can include but are not limited to those listed below:

• Data Safety Monitoring Board Report
• Executed Agreements (Material Transfer, Data Use, etc.)
• Certificate of Confidentiality
• Letters of Support from sites where research activities will occur
  • Schools
  • Hospitals
  • Clinics
  • Government agencies
• IRB approval letters or the equivalent from International Sites
• Non-English versions of materials for participants

• Ensure your application provides sufficient detail.
  • The application should provide the IRB a complete outline of your study, step-by-step from start to end.  Even the most minute details should be included, explained, and justified. 
  • Ensure the objective of the project is clear.
  • Provide appropriate justification of the scientific significance of the investigation.
  • The application should be a stand-alone document.  Avoid referring the IRB to outside articles, websites, etc.
• Use language that is clear and concise.
  • Write all responses in plain English; do not include academic jargon, abbreviations, citations, etc. All language should be written at a 6^th grade reading level.
  • Study details must be consistent throughout the application. Contradictory information will only result in delays in the review process.
  • “Confidential” is confused with “anonymous”.  Very few studies are truly anonymous.
    • “Confidential” refers to the researcher’s plan to handle, manage and disseminate the participant’s identifiable private information. Researchers should only collect identifiable information when needed.
    • “Anonymous” studies are those in which the Subjects’ identities are unknown to the investigator, not requested, and not given. It is a guarantee of privacy by virtue of recording data collected so that there is no way for anyone (including the investigator) to be able to identify participants by the data collected.

• Show that risks to participants are adequately recognized and addressed.
  • It is important that the investigator recognizes the risk involved and that study procedures do not unnecessarily expose participants to risk.
  • Risks should be outlined in the application as well as in consent documents.
  • Investigators should have a detailed plan for how risk to participants will be mitigated.
    • Data security, privacy of participants, monitoring of participants, etc.
  • If there are no direct benefits to participants, this is completely normal.  In minimal risk research, direct benefit to subjects is rare.
    • Compensation is not a benefit of research.
• Address consent and provide complete the appropriate consent documents.
  • Consent must be addressed for all studies, even when requesting a waiver in documentation of written consent.
  • Use the appropriate Consent Form Template to help ensure all required elements of consent are included.
  • Carefully review draft documents for edits and readability, appropriate language/reading level, and appropriate for the proposed consent process.
  • Include assent documents if the study involves working with children or other vulnerable populations.

• Ensure all study personnel have completed human subjects protection training within the last 3 years. Human Subjects Protection courses can be accessed through CITI.
• Ensure UTD Key personnel (PI, Co-PI, Faculty Sponsor) have completed an annual Conflict of Interest (COI) disclosure.
  • If you are unsure about an individual’s COI status, contact the COI Office.
• Ensure all documents are finalized and clean versions (no draft documents or tracked changes) and ready for review.
• Review the application and supporting documents to ensure consistency.
  • Ensure numbers (time commitment, number of subjects, age of subjects, compensation, inclusion criteria, etc.) are consistent across all sections of the application and all documents.
  • Ensure risks and benefits are consistent in the application and consent, etc.

• Additional information provided in response to comments should be made directly into the application form and not within the comments section alone. IRB Reviewers evaluate information in the form and not that contained within the comments section.
• Contact the assigned OHSP Specialist if you do not understand the IRB’s feedback.

• Begin your project, only after final IRB approval has been provided.
• If participants are providing signed, written consent, use only documents with the IRB approval stamp.
• Retain documents and data in accordance with the approved application and campus policies.
• Create and submit Modification applications to propose updates or modifications to the study as needed.
• Create and submit Renewal applications well in advance of expiration dates if the research activities need to continue.