Research- Compliance Clinical Research Project

Clinical Research Project Planning and Activity Sequence

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
  • 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.
  • Funding
    • 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
  • Permissions

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
  • Biosafety
  • 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)