Xavier University Institutional Review Board - Application for Approval of Research Involving Human Subjects - General Instructions

Sep 29, 2026

Uploaded by Marglet

Xavier University’s Institutional Review Board provides general instructions for preparing and submitting an IRB application for research involving human subjects. The guidance explains how to assess whether the proposed activity meets the regulatory definitions of “research” and “human participants,” how to complete required sections, and how to include an electronic signature. It details supporting attachments such as informed consent forms, research instruments, recruitment-site permission letters, HIPAA documentation when applicable, and CITI training certificates for all project personnel.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages13

Reading Time33 min

AccessFree to download

General Instructions

Determining Whether Proposed Activity Is Human Research

Submission Requirements and Supporting Attachments

XAVIER UNIVERSITY INSTITUTIONAL REVIEW BOARD Application for Approval of Research Involving Human Subjects GENERAL INSTRUCTIONS ** Please download this form and then complete using Adobe Acrobat. ** 1. Review the guidelines and definitions for the protection of human subjects [in research at](in research at Xavier.edu/irb)[ ](in research at Xavier.edu/irb)[Xavier.edu/irb](in research at Xavier.edu/irb). 2. If you are unsure that your study constitutes “Research” as defined by the Determining Research form, complete the Determining Whether Proposed Activity is Human Research According to DHHS or FDA Regulatory Definitions [http://www.xavier.edu/irb/documents/1DeterminingHumanResearchForm10-9-12.pdf](http://www.xavier.edu/irb/documents/1DeterminingHumanResearchForm10-9-12.pdf and send it)[ and send it](http://www.xavier.edu/irb/documents/1DeterminingHumanResearchForm10-9-12.pdf and send it) to the IRB office. IMPORTANT NOTE: If you are confident that your study constitutes "Research" as defined by the Determining Research form, the form may be submitted as part of, rather than in advance of, the full application. The form is included below. 3. Complete this application submission form by completing all sections and providing your electronic signature at the end. 4. Attach a copy of all Informed Consent forms that will be used. 5. Attach a copy of all research instruments (e.g., questionnaire, survey, semi-structured interview guide) . 6. Attach letters of permission of study/recruitment sites as appropriate. 7. Attach completed HIPAA form if you answer “Yes” to Question 1 in Section IV of the application. 8. Attach a copy of CITI training certificates for all project personnel (PI, co-investigators, research assistants, etc.) . NOTE: Because the NIH training has been taken offline, and because that training is out of date based on the changes to the Common Rule, we will only be accepting CITI training. To complete the CITI training: -Go to the CITI Course [www.citiprogram.org](www.citiprogram.org) to register for the CITI online training. -Click Register -Under "Select your organization Affiliation" type Xavier University. -Next, proceed to create your own username, password. -Select Curriculum. Questions one and five are the only questions that you are required to answer. -Question 1 will ask which learner group. All submitters will need to complete 1 of the 2 following courses a. Undergraduate students doing research solely to satisfy course requirements or b. All investigators and project personnel on IRB submissions (other than undergrad class projects) -Select the appropriate group. -Question 5 asks if you would like to take the conflict of interest course. You only need to take this course if it is relevant to your protocol. Once you have completed the preceding steps you are logged in and Registered for the course. You may begin the appropriate course or log out and return at another time. If you chose to log out, when you return to the CITI homepage you will NOT need to register again. You will login with the username and password you have already created. Upon completion of the course, you will receive a certificate of completion. General instructions: [https://www.xavier.edu/irb/Training-for-Human-Participant-Researchers.cfm](https://www.xavier.edu/irb/Training-for-Human-Participant-Researchers.cfm) CITI training web site: [http://www.citiprogram.org](http://www.citiprogram.org) 9. When all information has been captured, submit the application. (Student submissions go to your Faculty Advisor. All other submissions go directly to the IRB.) All forms are available at [http://www.xavier.edu/irb](http://www.xavier.edu/irb. If you have questions)[. If you have questions](http://www.xavier.edu/irb. If you have questions), call the IRB office at (513)745-2870 or email [irb@xavier.edu](irb@xavier.edu). ** Please download this form and then complete using Adobe Acrobat

FAQs

How do I determine whether my proposed activity is considered human research under DHHS or FDA definitions?

The determination requires that both “Research” and “Human participants” are true. The activity must be a systematic investigation designed to develop or contribute to generalizable knowledge, and it must involve intervention or interaction with human participants as defined in the determination form.

What sections must be completed in the IRB application submission form?

Complete all sections of the submission form and provide an electronic signature at the end. Ensure all required information is captured before submitting.

What documents must be attached to the IRB application?

Attach informed consent forms to be used, copies of research instruments such as questionnaires or interview guides, and letters of permission for study or recruitment sites as appropriate. If HIPAA applies based on the specified question in Section IV, include the completed HIPAA form as well.

Sep 29, 2026

Uploaded by Marglet