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IRB Submission Checklist

Category Required For Details
Training All research personnel

- Human Subjects Protection (HSP) Training

- Responsible Conduct in Research (RCR) Training, required for NSF-funded projects

GCP if applicable

Conflict of Interest (COI) Disclosure All Research Personnel reponsible for the design, conduct, or reporting of research ("covered individual")

- Submit a new Mentis COI Disclosure, or

- Recertify (with or without changes) an existing Mentis COI Disclosure

Non-UTA Research personnel All personnel not currently affiliated with UTA as a faculty, staff, or student

- Collaborator Form - Available within the IRB Electronic System in #5 - FORM ATTACHMENTS, DOWNLOAD BLANK FORMS section, "Non-UTA - Letter of Collaboration"

- Certificate/documentation of training (comparable human subject training is accepted such as University training, CITI, or NIH training)

- Documentation of research COI disclosure for "covered individuals" - steps for this process may be found here

IRB Protocol Application Form All protocols

- Non-Exempt Studies: Submit Form 1 addressing the IRB's Criteria for Approval

- Exempt Studies: Submit Form 1A

FORM 1 and FORM 1A available within the Electronic System in #5 - FORM ATTACHMENTS, DOWNLOAD BLANK FORMS section

Informed consent or request for waiver All adult subjects

- Informed Consent Documents (written or verbal scripts). If non-English versions will be used, submit translated documents. Templates are provided within the IRB Electronic System in #5 - FORM ATTACHMENTS, DOWNLOAD BLANK FORMS section. Option for non-exempt and exempt protocols listed below: 

  • ICD Non-Exempt - Adult Informed Consent Template - ONLINE Copy Use
  • ICD Non-Exempt - Adult Informed Consent Template - WRITTEN-Hard Copy Use
  • ICD Exempt - Adult Template

- Waiver of Consent/Assent: Submit Form 3 if applying for a waiver of consent or an alteration of consent requirements. Form 3 provided within the IRB Electronic System in #5 - FORM ATTACHMENTS, DOWNLOAD BLANK FORMS

Informed assent Minor subjects, as appropriate

- Assent documents or script for obtaining child assent. Templates are provided within in #5 - FORM ATTACHMENTS, DOWNLOAD BLANK FORMS section. Options for non-exempt and exempt protocols listed below, including parent informed consent built-in template

  • ICD Exempt - Parent and Child Template
  • ICD Non-Exempt - Parent and Child Template
Recruitment All protocols - Recruitment Flyers, Messages, Letters, Emails or Scripts
Data collection All protocols

- Instruments, questionnaires, or tools for screening subjects

- Any instruments/tools utilized for collecting subject data, such as surveys, interview questions, focus group questions, tests, etc.

Additional forms As applicable

All forms available within the Electronic System in #5 - FORM ATTACHMENTS, DOWNLOAD BLANK FORMS section

- Form 2A for Mentally Incapacitated

- Form 2B for Pregnant Women

- Form 2C for Prisoners

- Form 2D for Children

- Form 5 for tissue collection

Approval letters As applicable

- Documented approval if permission is needed to recruit subjects (for example, approval from clinic to recruit patients or approval from ISD if recruiting in a high school classroom)

- Documented approval from a site to use their facility for research purposes, if the facility is privately owned (school, clinic, church)

Devices As applicable

- Manual or specs

- FDA IDE if applicable

- 510(k) clearance letter from FDA

- Lab-related SOPs

Drugs/chemicals As applicable

- Safety information, drug label/package insert, Investigator's Brochure if available

- FDA IND if applicable

- Lab-related SOPs

Grant application Funded projects

- Specific aims list

Data safety monitoring plan Funded projects if required by sponsor, FDA-regulated research, clinic trials

Plan templates and guidance found at these links:

- Page 2-3: Click Here

- "Implementation" section, including checklist: Click Here

- Examples available: Click Here

Formal Agreements Data transfer projects or collaborations

- MOUs

- Data Use Agreements (DUA)

- Collaborating site IRB documents

Supplemental Information As needed to supplement IRB review

- SOPs that relate to subject interaction or safety (lab instructions for blood draws, safety/emergency response plans, etc.)

- References/literature that pertain to your study topic or provide evidence of safety for human subjects in previous studies

- CVs or resumes of research personnel for documentation of qualifications/expertise

Printable version of this table available here: IRB Submission Checklist