When Completing the Application Form
- Ensure you are using the correct application form.
- Minimal Review and Class applications should be submitted through the online portal OAR.
- Expedited / Full Board Review should be submitted via the Expedited / Full Board Review form.
- If you are unsure which type of review your study should receive, contact the IRB Office.
- Complete each section of the application.
- If a section or question does not apply to your study, instead of leaving it blank include a justification to explain why the question / section does not apply.
- If there are non-affiliated personnel or performance sites, this should be listed in the application.
- 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 6th grade reading level.
- Study details are not consistent throughout the application and /or are contradictory.
- “Confidential” is confused with “anonymous.” Very few studies are truly anonymous.
Maintaining confidentiality of information collected from research participants means that only the investigator(s) or individuals of the research team can identify the responses of individual subjects; however, the researchers must make every effort to prevent anyone outside of the project from connecting individual subjects with their responses.
For a study to be anonymous, either no identifying information of individual subjects (e.g., name, address, Email address, etc.) is collected, or the project cannot link individual responses with participants’ identities. A study should not collect identifying information of research participants unless it is essential to the study protocol.
- 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.
Before you submit an application to the IRB Office
- Ensure all study personnel have completed human subjects protection training within the last 4 years.
- 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 (no draft documents) and ready for review.
- Ensure the application is signed by Principal Investigator, Co-Principal Investigator/Faculty Sponsors.
- Review the application and supporting documents to ensure consistency.
- Ensure numbers (time commitment, number of subjects, age of subjects, compensation, etc.) are consistent across all sections of the application and all documents.
- Ensure risks and benefits are consistent in the application and consent, etc.
During the Review Process
address and respond to IRB comments or questions.
- Do not make additional revisions, beyond those requested by the IRB.
- Track or highlight all revisions to the protocol and provide this copy along with a clean copy to the IRB Specialist administrating the protocol application.
- Contact the assigned IRB Specialist if you do not understand the IRB’s feedback.
After Approvals are Released
- 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 requests to propose updates or modifications to the study as needed.
- Create and submit Continuing Review applications well in advance of expiration dates if the research activities need to continue.
If you have questions at any point in the submission or approval process, contact the IRB Office.