Forms and Documents
All XU faculty, staff and students who conduct research involving human subjects are required to submit verification of completion of human subject training. The National Institutes of Health Protecting Human Subject Participants free, two hour web-based tutorial is designed for individuals conducting research involving human participants. It satisfies the NIH human subjects training requirement for obtaining federal funds. The tutorial will prompt you to print your verification certificate when you have completed the training.
Click on the form name to open the interactive PDF form. Complete the form electronically, save a copy of the completed form to your hard drive (otherwise your entries will be lost), print and sign the completed form, and send it with accompanying documentation to the IRB office.
Search IRB Policies and Procedures Manual for complete topical information.
- IRB Application Form with Instructions: Submit this form and accompanying documents to initiate IRB review.
- Protocol Summary Document: Submit this document along with the above application.
- IRB application with Authorization Agreement: Submit this form and accompanying documents when there is an authorization agreement in place.
- Notification of a submission through another IRB: Submit this form when the protocol is being approved by another IRB.
- Determining Human Subjects Research: Submit this form prior to submitting an application to determine if proposal is research needing IRB oversight.
- Course Certification Form: Instructor submits this form for each course incorporating course required student-conducted research that involves neither sensitive topic areas nor minor subjects. Student-conducted studies which fall under the category of full board review must be submitted to the IRB, even if the course is certified. All human subject research studies conducted to satisfy master?s thesis or doctoral dissertation requirements must be submitted to the IRB.
- Recommendations and Policies Relating to Online Data Collection and Online Storage: This document is intended to aid researchers with issues pertaining to online data collection and data storage.
- Informed Consent Process with Consent (Adults) and Assent (Children) Form Templates: Submit Informed Consent Form for adult subjects with Submission Form if applicable. Submit Consent Form for parents and Assent Form for child subjects with Submission Form if applicable (children give assent rather than consent).
- Letter of Permission Instructions and Templates: Submit letters of permission from study/recruitment sites and data sources. See instructions and template for more information.
- HIPAA Privacy Rule Waiver Form: Submit this form if obtaining protected health information (PHI) from a covered entity as defined in HIPAA (Health Insurance Portability and Accountability Act)
- Progress Report Form: Submit this form if research was previously approved in the expedited or full review category to request an extension of approval or to report that research has been completed. Your completed, SAVED form may be sent as an email attachment (type your name on the signature line).
- Protocol Modification Request Form: Submit this form to request a modification to a previously approved protocol
- Adverse Event Report Form: Submit this form immediately upon occurrence of an adverse event. Injury to subjects, breaches of confidentiality and unapproved deviations from the protocol are examples of adverse events that must be reported to the IRB and the research halted if necessary.
- International Research and Certificate of Translation Form: This document contains information relevant to a protocol that will be International and requires certification of translation.