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. Please see here for more information.

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), sign the completed form and send it with accompanying documentation to the IRB office. A free version of Adobe Acrobat reader is available here. https://get.adobe.com/reader/  If you download this version, do not allow it to install any of the non-acrobat add-ons.

Primary Forms

These forms are the most commonly used forms.

• IRB Application Form with Instructions: Submit this form and accompanying documents to initiate IRB review.
• Determining Human Subjects Research: Submit this form prior to submitting an application to determine if proposal is research needing IRB oversight.
• 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. See this guidance document for additional details. Modification requests are necessary when proposed changes are substantive. Substantive change involves study amendments that impact the participant experience or materially alter the study (e.g., changes to a study’s purpose or procedures, such as adding a survey/questionnaire; changing a manipulated variable; changes to the sample targeted for recruitment; new or revised compensation structures). Minor changes tend to be editorial (e.g., wordsmithing, but not altering, interview or survey questions; adding a new phone number for recruitment) and do not require submission of a modification request. If you have questions about whether your modification would be considered substantive or minor, please email the IRB (irb@xavier.edu).
• 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.

Secondary Forms

Search IRB Policies and Procedures Manual for complete topical information.

• IRB application with Authorization Agreement: Submit this form and accompanying documents when there is an authorization agreement in place.
• Certificate of Translation: Submit this form when a language translation is required.
• International Research and Certificate of Translation Form: This document contains information relevant to a protocol that will be International and requires certification of translation.
• 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.
• 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)
• Notification of a submission through another IRB: Submit this form when the protocol is being approved by another IRB.
• Reasons protocol are returned: Top 10 reasons why protocols are returned to investigators.

Resources

• Informed Consent Process with Consent (Adults) and Assent (Children) Templates: Submit Informed Consent Form for adult subjects with Submission Form if applicable. Submit Consent From for parents and Assent Form for child subjects with Submission Form if applicable (children give assent rather than consent).
• 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.
• Letter of Permission Instructions and Templates: Submit letters of permission from study/recruitment sites and data sources. See instructions and template for more information.
• Demographics Document: This document is intended to aid researchers measuring demographic questions regarding sex and gender, race and ethnicity, and sexual orientation.