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.

Submission Instructions:

Application forms, along with all other required materials, may be submitted electronically to irb@nwhealth.edu. Electronic submissions must be emailed directly from the principal investigator’s NWHSU email address. If the Principal Investigator is a student, the faculty advisor must be copied on the email.

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.

• Initial Review of Clinical Research (Word)
• ‌Initial Review of Social Science Research (Word)
• Medical Record Chart Review (Word)

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

• Continuing Review of IRB-Approved Clinical Research (Word)
• Continuing Review of IRB-Approved Social Science Research (Word)

Informed consent

• Clinical Research Sample Consent Form (Word)
• Social Sciences Sample Consent Form (Word)

HIPAA de-identification

• HIPAA De-identification Certification Form (Word)

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.

• UPIRTSO policy
• UPIRTSO form (Word)

Request for IRB review exemption

• Category 1 Investigational Strategies in Educational Setting (Word)
• Category 2 ‌Surveys/Interviews, Standard Education Tests & Observations 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 B: Pregnant Women, Human Fetuses and Neonates Involved in Research (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)

• HIPAA Authorization (Word)
• Data Use Agreement (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)