Research Project Approval (A multistep process)
1) Is a project research?
- Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 45CFR46.102(d)
- If a project is contemplated to produce results that will be published or disseminated publicly, on a functional basis it should be considered research.
2) What are recommended sequences for USU investigators to obtain research project approval ?
- USU Site approval
- VPR Form 3208 (usu access only)
- Legal agreements
- Collaborative, Material Transfer, Data Sharing
- For multi-site studies Performance Site and Facility Clearances, Clinical Trial Agreement
- Import/Export filings for international collaborations, use of foreign material
- For FDA regulated product evaluation, particularly if the product is not marketed or marketed for a different purpose, IND or IDE filing. Some funders, such as NIH, often require FDA clearance prior to submitting a funding application.
- Some funding organizations, such as NIH, integrate Scientific Review with funding evaluation
- Scientific Review
- If not performed previously, VPR can arrange for independent scientific review on request
3) Obtaining Permissions
Usually obtaining permission submissions should be done in parallel and not sequentially. Examples include:
- For survey research, DoD or OMB clearance
- Human Subject Protection (IRB)
- Privacy Board (for USU combined with IRB review)
- Animal Use
- Anatomic Materials
- Clinical trial registry listing
- Food & Drug Administration clearance if indicated and not done previously
Recommended Research Project Approval Sequence (click for graphic)
Compliance Operations - Overview Part One - Risk Adjusted Oversight (click for document)