Impact on New and Ongoing Studies

Studies that Must Comply with the Revised Common Rule (2018 Requirements)

The revised Common Rule (2018 requirements) will apply to research, with limited exceptions:

  • Initially approved by the MSU IRB on or after January 21, 2019.
  • Determined exempt by the MSU HRPP on or after January 21, 2019.
  • Studies pending on January 21, 2019 will be subject to the 2018 requirements with limited exceptions.

Studies that Must Comply with the Pre-2018 Requirements

The pre-2018 requirements apply to research, with limited exceptions:

  • Initially approved by the MSU IRB before January 21, 2019.
  • Determined exempt before January 21, 2019.
  • This research is NOT required to comply with the 2018 requirements. However, studies may be transitioned by the MSU IRB from the pre-2018 requirements to the 2018 requirements. If a study is transitioned to the 2018 requirements, it must comply with all of the 2018 requirements. Studies will be transitioned on a project by project basis. 

Exceptions

  • Research that is subject solely to the U.S. Department of Justice requirements must comply with the pre-2018 requirements. 
  • Research that is regulated by the U.S. Food and Drug Administration must ALSO comply with the FDA requirements; the stricter requirement applies (e.g. cannot eliminate continuing review).
  • Research that is subject to the U.S. Department of Justice and also a Common Rule department or agency must comply with both the pre-2018 and 2018 requirements. The stricter requirement applies (e.g. cannot eliminate continuing review). 
  • For studies where MSU is relying upon another institution's IRB as IRB of record, that institution's policies and procedures would apply.

Transition

  • A study that was initially approved by the MSU IRB or determined exempt before January 21, 2019 may be transitioned to the MSU IRB, excluding studies subject to the requirements of the U.S. Food and Drug Administration and the U.S. Department of Justice. There is not a requirement to transition to the 2018 requirements.
  • A transitioned study must comply with the entirety of the 2018 requirements, with limited exceptions.
  • MSU plans to consider whether to transition studies on a study by study basis at the time of continuing review. 
  • When determining whether to transition an ongoing study, factors considered may include:
    • Enrollment status
    • Consent process and/or form(s)
    • Reliance agreement(s)
    • Review level
    • Funding
    • Regulatory oversight

Revised Common Rule