New study submission must include the following (as appropriate):
IRB applications must be submitted through Cayuse. All required documents can be uploaded into the application as attachments.
All individuals working with human participants in research are required to complete an instructional program before the Human Subjects Research Office (HSR) 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.
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 HSR 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 HSR 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 IRB of record 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 HSR 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
- Government agencies
- IRB approval letters or the equivalent from International Sites
- Non-English versions of materials for participants
Plan ahead: It is important that you have all required supporting documents in place before you submit your application so as not to delay HSR review. Some documents such as site authorization, approval from other compliance components, or relevant agreements with collaborating institutions may take extra time to acquire.