Application for Use of Human Participants in Research Request for Protocol Review and Approval
The Committee on Human Research Participation (CHRP) and Institutional Review Board (IRB) is an administrative body established under federal requirements to protect the dignity, rights, and welfare of human participants involved in research conducted by any University of Western States (UWS) faculty, staff or student.
The IRB has the authority to approve, require changes to, or disprove all research activities that fall within its jurisdiction as specified by both federal regulations (45 CFR 46) and UWS policy (policies 8002 and 8003).
The university accepts the responsibilities for research as described in the UWS Policy Handbook only if appropriate policies are followed, including approval of research by the UWS IRB. However, it is still the responsibility of the principal investigator to establish and maintain acceptable ethical practices in research.
Research is defined as “a systematic investigation designed to develop or contribute to generalizable knowledge” (45 CFR 46.102(d))
Human Subject, as it pertains to research involving human subjects in the Department of Health and Human Services (DHHS) regulations (45 CFR 46.102(f)), is defined as “a living individual about whom an investigator conducting research obtains
- data through intervention or interaction with the individual, or
- private information”
Other important human subjects information can be found at https://humansubjects.nih.gov/.
Levels of Review
There are three levels of review for UWS/IRB applications:
1. Exempt from review
2. Expedited review
3. Full board review
Exempt means review by the IRB chair, sometimes in consultation with others. Research activities may be determined exempt if the only involvement of human subjects fall in one or more of the following categories (45 CFR 46.101(b)):
- Research conducted in established or commonly accepted educational settings, involving normal educational practices
- Research involving the use of educational tests (e.g., cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior
- Research involving the collection or study of existing data
Expedited means review by the IRB chair and one or more experienced reviewers. Research activities may be determined expedited if it is determined to involve only minimal risk, does not include intentional deception, does not engage sensitive populations or topics, and includes appropriate informed consent procedures (45 CFR 46.110).
Full Board Review is required for research that is not eligible for exempt or expedited review. Research that is determined to involve more than minimal risk and/or involves protected populations must undergo a full IRB review.
The level of review is determined by the UWS IRB based on the amount of risk to the human participants in accordance with University Policies. Further guidelines for the protection of human participants may be found in 45 CFR 46, which is available at https://www.hhs.gov/ohrp/policy/ohrpregulations.pdf.
Important Note: The use of human participants may commence only after this approved, signed application is returned to the principal investigator including your approval letter from the Chair of the UWS IRB. UWS IRB approval is good for the specified time stated on your approval letter through the approval expiration date. Should the use of human participants, the use of identifiable data, or data analysis be required past the approval period, the application must be renewed using the IRB Annual Renewal Form. Once the use of human participants is completed, the protocol must be closed with the Study Closure and Final Report Form that can be obtained from the UWS IRB.
Investigators are not permitted to make changes to the research without IRB review.
You must notify the IRB to any changes in your study by completing the Study Modification Form before any changes can be implemented. For personnel changes, please submit a Personnel Change Form.