REVISED FORMS AVAILABLE RIGHT SIDE BAR (PDF NOT CURRENTLY AVAILABLE)
REVISIONS TO FEDERAL REGULATIONS (COMMON RULE) IMPLEMENTATION BEGINS JANUARY 21, 2019
Human Participants IRB
The role of the High Point University Human Participants IRB is to assure that human research participants are treated with dignity, respect, and with due regard for their welfare. All research involving the use of human research participants must be reviewed and approved by the HPU IRB before the research can be initiated.
Federal regulations define “research” as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” “Human participant” is defined as “a living individual about whom an investigator (whether professional or student) conducting the research (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generated identifiable private information or identifiable biospecimens.”
Please note that the IRB cannot approve a protocol submitted after the research is initiated, nor can the IRB sanction any human participants data collected without approval.
General Protocol Submission Guidance
All submissions must be complete prior to review and approval. Please note that policy, procedures, and forms changed January 21, 2019. The following items are necessary for a complete submission:
- A protocol application form that is fully completed and signed (instructions on form).
- Informed consent documentation
- All recruiting materials
- All research instruments (questionnaires, surveys, stimulus materials, etc.)
- Completion Reports of training for responsible treatment of human participants (CITI program).
The complete application must be submitted electronically to the Chair of the IRB, Dr. Kimberly Wear. Incomplete applications will result in a delay of approval.
Exempt Review (Level 1)
Some research projects using human participants raise no substantial risk to anyone. These projects receive limited IRB review, and if approved, are exempted from further oversight. Please refer to the Exempt from Review section in the HPU Procedures document (revised January 21, 2019). A completed Exemption Checklist will be required with the application.
Protocols that do not meet the criteria for exempt review (i.e., minimal or greater than minimal risk studies) receive more extensive IRB review.
Sample consent forms are provided in the Forms section of the website. Please use these as a template. If you are requesting a Waiver of Informed Consent, please fully complete the relevant sections of the protocol application. Please note significant changes as of January 21, 2019.
Students and Faculty Mentors
When a student is the principal investigator for a study, it is their responsibility to:
- Read the Student Researcher’s Guide to the IRB.
- Complete the Protocol Application form.
- Indicate student status on the application form and indicate the faculty mentor for the study.
- Have the faculty sponsor review the protocol application and complete the faculty mentor assurance section.
- Submit certificate of completed training for responsible treatment of human participants for student and faculty mentor.
Modifications to an Approved Protocol
The IRB must be notified before a change is made to an approved protocol. Changes may include change in study design, in location for data collection, in investigators, of study materials, to consent form, or to recruiting methods or materials. The Protocol Modification should be submitted electronically to the Chair of the IRB.
When a study is complete, a Protocol Completion Report is required. This report should be submitted electronically to the Chair of the IRB prior to the anniversary of the approval date.