IRB Application Forms

You must obtain IRB approval before initiating any research activity involving human subjects. If you think you may publish or present the results of your project in the future (e.g., in a journal, at a conference), it is considered research and you must obtain IRB approval before beginning the project. The IRB does not grant retroactive approval.

If changes occur during the course of a project that could impact human subjects (e.g., protocols, sponsor or investigators, informed consent procedures) you must obtain IRB approval prior to initiating the changes.

Which form to use

*Handwritten forms will NOT be accepted*

Full and expedited IRB review

An application for initial review is to be submitted before initiating any research activity involving human subjects.

An application for continuing review of approved non-exempt research is to be submitted before the current approval’s expiration date.

Informed consent

HIPAA de-identification

UPIRTSO reporting

Investigators must promptly report to the IRB any “unanticipated problems involving risk to subjects or others” (UPIRTSO). That is, any problem or event which in the opinion of the local investigator was unanticipated, serious, AND at least possibly related to the research procedures.

Request for IRB review exemption

Category 1 Investigational Strategies in Educational Setting (Word)

Category 2 Surveys/Interviews, Standard Educational Tests, Observation of Public Behavior (Word)

Category 3 Public Officials, Surveys/Interviews, Educational Tests, Observation of Public Behavior (Word) 

Category 4 Existing Data: Records Review, Pathological Specimens (Word)

Category 6 Food Quality and Consumer Acceptance Studies (Word)

Appendices

Form: Additional Investigators (Word)

Appendix A: Sponsored Projects (Word)

Appendix C: Prisoners as Subjects (Word)

Appendix E: Drugs and/or Biological Products (Word)

Appendix F: Use of Devices in Research (Word)

Appendix H: Use of Protected Health Information (PHI) (Word)

Appendix I: Targeting/Inclusion of Vulnerable Populations (Word)

Appendix J: Student as PI (Word)

Appendix K: International Research (Word)

Appendix L: Field Work (Word)

Appendix M: Research in Schools (Word)

Appendix N: Debriefing for Research Involving the Use of Deception (Word)

Appendix P: Research Methods Class Protocol (Word)

Appendix R: Use of Radiation (Word)

Form: Ionizing Radiation in Human Subjects Research (Word)

Appendix T: Tissue and Sample Storage (Word)

Appendix W: Informed Consent Waivers (Word)

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