- Complete Protocol Application Form This form is to be used for all types of human subjects research (exempt, expedite, and full board review). Please provide answers to all of the following questions. All projects submitted for review must be typed (no handwritten proposals accepted). If a question does not apply put not applicable. Do not leave any answers blank.
- Attach Documents to Application Attach the following applicable documents as appendices to the application. It is recommended that you include a table of contents identifying all appendix materials. Use titles that are consistent with those that you might reference in the text of the application.
- Conflict of Interest Statement for PI and Co-I
- Consent Form/Information Sheet
- Parental Permission Form/Minor Assent Form
- Recruitment Materials
- Site Authorization Letter (for study conduct and/or access to administrative records)
- Data Collection/Abstraction Form
- Grant Applications (cover to cover)
- Investigator’s Brochure (for clinical trials only)
- Device Manual (if using an approved or investigational device)
- Any other documents related to the research
- Submit Application After review by the Department Review Committee and all signatures have been obtained, please forward their opinions and comments along with the signatures on the Assurances to the Human Subjects Protection Program Office. Only one copy is required and will be retained for the Human Subjects Protection Program files and eventually archived for a permanent record. The preferred method of submission is via email at: Research@pvamu.edu
Please submit all documents to:
Office of Regulatory Research Compliance,
Delco, Suites 133
P. O. Box 519, MS 2800
Prairie View, Texas, 77446
If you have any questions or need assistance completing this application, please call (936) 261-1553 or email Research@pvamu.edu
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