Common Problems for Investigators submitting Protocols for IRB Review at UT Dallas
- Investigators not returning requested modifications is a timely manner.
The investigator shows confusion about whether the project qualifies for exempt, expedited or full board review status.
- Information regarding the funding status and complete grant application is incomplete (when applicable).
- Protocol describes consent as having an appropriate person sign a consent form rather than a communication process that continues throughout the
- All supporting documents (questionnaires, advertisements, etc) necessary for review are not submitted.
- The screening part of the recruitment process is not included as part of the investigation or described clearly during the consent process. The
investigator does not document how s/he will respectfully inform screening participants that they have not been selected for the main part of the
investigation. This is especially important when screening criteria are described in terms like "normal intelligence" and a participant could infer that
his lack of selection means that "he is abnormal."
Protocol does not document all of risks (i.e., physical, emotional, social, economic, etc.) nor describe appropriate provisions for minimizing these
- Protocol does not describe the "Procedure" to be used in the investigation consistently or thoroughly in all of the documentation submitted.
- The scientific significance of the investigation is not justified with appropriate justification and literature citations.
- Protocol is written with technical language that is above the 6-8th grade recommended reading level.