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IRB Forms and Submission Guidelines

Reminder:  All Investigators and sponsors in a project must complete CITI Training prior to IRB approval.

• While email submission is preferred, unstapled paper forms and materials can be delivered to the Office of Research and Sponsored Programs, 1102 Blair Hall during regular business hours. 

Full Review Protocols: at the next IRB meeting taking place at least 10 business days after protocol submission

If a protocol is imprecise or is missing information, it will be returned for correction or completion. Review of corrected protocols will be conducted within the timeframe specified above based on receipt of the corrected protocol.

 Tips for a Successful Protocol 

To Request a Review of a New Research Project:

A guide and tutorial for the application can be accessed at: IRB Protocol Submission Guide and Tutorial. In addition, each section heading within the Application has an embedded hyperlink that will direct you to to its corresponding section within this guide. 

• Informed Consent document
  • For guidance regarding informed consent and/or assent, click here.
• If applicable, Assent document or script
• Questionnaires, surveys, tests, or other materials that will be administered to subjects
• Recruitment materials (including e-mails, advertisements, fliers, and/or text of social media posts)
• If applicable, written permission from other institutions or agencies involved in the research (e.g., school board, hospital, agency, prison)
• HIPAA Authorization or waiver of Authorization if your proposed study involves protected health information
• Application for IRB Review Addendum: Additional Co-Investigators (if there is more than one co-investigator)
• Application for IRB Review Addendum Sponsored Research (when applicable)
• In limited circumstances, the IRB may waive the requirement to provide informed consent to potential participants. To request this waiver, complete the Application for IRB Review Addendum Waiver of Informed Consent or Assent
  • Note: this addemdum does not apply when requesting documentation of informed consent. That waiver is requested in the Application for IRB review. 

Note: Course projects that are not intended to contribute to generalizable knowledge, do not place the subjects at more than minimal risk, and are not intended for publication are not to be submitted for IRB review via the Application for Review of Research involving Human Subjects. If an individual research project is being conducted to meet the requirements of a research methods (or similar) course, please review the Course Certification and Course Project Research Page. 

Informed Consent and Assent Guidance:

Informed Consent Process Guidelines

Informed Consent Checklist

Informed Consent Template

Guidelines for Assent

Informed Consent Letter to Parents Template

Students may be required in particular courses to conduct projects involving human subjects. The purpose of such projects is not intended to contribute to advances in generalizable knowledge, nor are the results of such activities to be published, presented, or archived. Rather, the function of these class projects is to contribute to the students’ individual knowledge and training in a particular academic discipline.

IRB review may not be required for most class projects, but the projects are subject to faculty oversight. Course projects can be certified by the IRB either through course certification or course project research review. For forms, criteria and more information, see the Course Certification and Course Project Research Page. 

Post IRB Approval Requests:

Include any updated research materials and/or supplemental materials.

Include protocol summary, including approved modifications since last review and/or proposed changes and Informed consent forms, permission forms, and assent forms, if applicable

When required, submit the Completion of Research Activities form.

The researcher is responsible for informing the IRB of unexpected findings that can affect the risk/benefit ratio. Adverse events are unexpected problems whose nature, severity, or frequency are not as described in the IRB-approved study protocol. The IRB should always be informed of any problems or accidents in a study, including a change in risk to, or breach of, confidentiality. Incidents where subjects have been harmed should be reported to the IRB immediately. The death of a participant, whether related to a study or not, should also be reported to the IRB immediately.

Researchers are also responsible for reporting any suspected non-compliance to an IRB-approved research protocol.

Call or e-mail the IRB Chairperson immediately and submit Report of Adverse Effects or Noncompliance to the Office of Research and Sponsored Programs within 20 working days.

For additional information, resources, and training, visit the IRB Resources and Training webpage.