The use of human subjects in research requires approval from the IRB before the research procedures are implemented and data are collected.
- The IRB requires that internal reviews be conducted by the academic department/School before contacting the IRB.
- Materials for review are then submitted to the IRB chair via the Human Subjects Approval for Research I form
- The IRB chair shall then advise the Department Chair/Dean and project investigators within ten working days whether the project is exempt or requires an expedited or full review.
- If necessary, the IRB chair will call a meeting of the full committee within ten working days (i.e., excluding weekends) of receipt of the materials.
- Review results will be given to investigators within an additional ten days of the meeting.
- Researchers are required to submit documentation of completed training in Responsible Conduct of Research according to NDUS policy 410.0.
All completed IRB proposals should include the following:
- Completed IRB Human Subjects Approval Request I form (HSAR I).
- Completed IRB Human Subjects Approval Request II form (HSAR II) as required.
- The following forms and statements must accompany the proposal as required by the project parameters:
- An Informed Consent Form(s)
- Signed letter of permission from an authorized institutional representative, if research is to be conducted in an institution such as a school, hospital, etc.
- Debriefing Statement
- All forms and statements above are required for Expedited and Full Reviews
VCSU Graduate Students
Graduate students must complete the following before applying to the IRB:
- Proposal Approval form and a two chapter proposal approved by their advisor.
- If subjects are over 18 and do not belong to any protected population, complete a debriefing form and an Informed Consent form.
- If the study is taking place in an institution such as a school or disciplinary facility fill out the Administrator's consent form. This is not necessary if the institution has its own IRB process.
- If the students are under 18 years old, complete a Debriefing form and a Parental Consent form.
All forms except the Proposal Approval Form are found on the IRB site under Resources and Forms. Graduate Students should submit their IRB paperwork and proposals to their advisor for approval. The advisor will forward the IRB package to Misty Lindgren in the Graduate School office. All other IRB Proposals should be submitted to email@example.com via the Human Subjects Approval for Research I form.