All Required Documents for IRB Submission
Category
Required For
Details
IRB Application Form
(also called “IRB
Protocol”)
All studies
- All new UTA Human Subjects Research studies are required to include the appropriate
version of the IRB Application Form. There are two versions:
1. Initial IRB Application for Primary Research Studies
2. Initial IRB Application for Secondary Research ONLY
- Complete only one version of the IRB Application & upload in electronic system
Informed Consent
Document(s)
All studies where it is
possible for researchers to
obtain consent from adult
subjects
- Consent Templates are available on IRB Forms & Templates Page
- Keep all consents clear, concise, & as close as possible to an 8
th
grade reading level
- Include all the information that a reasonable person would want to know about the
study before they make a decision about whether or not to participate
- If needed, create multiple consent versions for different groups of participants for
clarity
- Submit both English and translated versions of consents for non-English fluent subjects
Informed Assent
Document(s)
All studies involving minors
(children) where it is possible
to obtain assent from the
child; also applies when a
legal guardian must provide
consent for an adult
- Template for Parental Consent & Child Assent is available on Forms & Templates Page
- If a child is under age 3 or is developmentally not able to provide valid assent, explain
this in the IRB Application Form and describe how the researchers will honor the child’s
behavior and cues indicating that they do not wish to participate
- For adults that cannot provide consent for themselves, an assent should be provided in
appropriate language for the potential subject’s level of understanding; consent must
also be obtained from the subject’s Legally Authorized Representative (LAR)
Request for Waiver or
Alteration of Consent
Studies that involve
deception or incomplete
disclosure; federally funded
studies where a signed
consent will not be obtained
- Complete & upload Form 3, Request for Waiver or Alteration of Consent
Recruitment Materials
All studies where the
research team will request
participation in the study
from potential subjects
- Often includes multiple methods, such as posted flyers, emails, and visiting
classrooms to read a verbal script; describe all methods in IRB application form
- Upload copies of all recruitment flyers, emails, online postings, ads, verbal scripts, etc.
- We do not provide templates; however, for guidance on how to create IRB
approved recruitment materials, please visit this link from Northwestern University
Data Collection &
Screening Instruments
All studies
- Upload instruments, questionnaires, or tools for screening subjects
- Upload all instruments/tools utilized for collecting subject data, such as surveys,
questionnaires, interview questions, focus group questions, tests, cognitive tasks,
score sheets, game instructions, computerized assessments, etc.
All Required Documents for IRB Submission
Vulnerable Population
Forms
As Applicable
- Mentally Incapacitated
- Pregnant Women
- Prisoners
- Children
Site Permission Letters
As Applicable
- Documented approval from a site to use their facility for research purposes, if the
facility is privately owned (school, private business, clinic, church)
- Documented approval if permission is needed to recruit subjects (for example,
approval from clinic to recruit patients or approval from ISD if conducting research
procedures in a high school)
Medical Devices
All studies which will use a
device to collect data or
perform an intervention on
human subjects
- Form 4 for Medical Devices
- Device Manual or specs
- FDA IDE if applicable
- 510(k) clearance letter from FDA or other documentation of FDA status
- Lab-related SOPs for using the device
Drugs/Chemicals
As Applicable
- Safety information, manufacturer, drug label/package insert, Investigator's Brochure if
available
- FDA IND if applicable
- Lab-related SOPs for using the drug(s)
Grant Application or
Contract
Funded Projects
- Copy of the grant application or contract
- Documentation of any requested changes to the human subjects research plan from the
study sponsor
Formal Agreements
Collaborations, Data
Transfer Projects, etc.
- MOUs
- Data Use Agreements (DUA)
- Collaborating site IRB documents
Data Safety
Monitoring Plan
Funded Projects, if
required by sponsor;
FDA-Regulated Research &
Clinical Trials
Plan templates and guidance found at these links:
- Pages 2-3 here
- "Implementation" section, including checklist here
- Examples available here
Supplemental
Information
As Needed for 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
