When Completing the Application Form
- 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 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.
Before you submit an application to the HSP Office
- 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.
During the Review Process
- Promptly address and respond to Reviewer comments or questions.
- 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 HSP 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 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.
If you have questions at any point in the submission or approval process, contact the HSP Office.