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Common Rule Changes

OHRP published the Final Rule for the Protection of Human Subjects in research on 1/19/2017. This is the first major revision of the Common Rule since 1991. The Rule became effective on 1/21/2019. The Stanford Common Rule page provides implementation information.


Do I need an IRB Submission?

To submit a 'Determination of Human Subject Research' form log into eProtocol, select 'Create a Protocol' on the 'My Dashboard' webpage. After completing the requested information, select 'Human Subject Research (HSR)' as your type of review. Complete the application and attach the Human Subject Research (HSR) Determination Form for review (there is also a link to this form in the attachments section of the protocol application).

Possible results of the HSR Determination review are: 

  • Not Research (e.g. QA/QI or a case study)
  • Not Human Subjects Research
  • Human Subjects Research

After the IRB has made its determination, the IRB will "Keep" or "Withdraw" the HSR application. Withdrawn applications DO meet the definition of human subjects research, and require that an IRB protocol be submitted and approved prior to any research activities being conducted, including recruiting or consenting prospective participants. 

To view the IRB's determination in eProtocol: 

Go to 'My Dashboard' and select 'Non-Active Protocols'. Open the protocol number in question.  Click the bottom left red tab, "Print View" for a PDF of the HSR application -- the HSR determination will be on page 2.

Forms and Processes

Medical Research

    Clinical trial documents: The following checklists are from the FDA E6 Consolidated Guidance for Good Clinical Practice:

Nonmedical Research