Frequently Asked Questions

• How does the Revised Common Rule impact studies ongoing before January 21, 2019?

  A study that was initially approved by the MSU IRB or determined exempt before January 21, 2019 is subject to the pre-2018 requirements UNLESS the MSU IRB transitions the study to the 2018 requirements.

  However, there is NOT a requirement to transition to the 2018 requirements. A study may be voluntarily transitioned to the 2018 requirements by the MSU IRB (excluding studies subject to the requirements of the U.S. Food and Drug Administration and the U.S. Department of Justice).

  MSU plans to consider whether to transition studies on a study by study basis at the time of annual renewal.  The PI will be consulted about whether to transition a study to the 2018 requirements.

• I have a non-exempt study approved by the MSU IRB before January 21, 2019 and it will expire soon. Do I still need to submit a renewal?

  Yes. The study is subject to the pre-2018 requirements and annual continuing review. A renewal must be submitted if you are still conducting human subject research.

  When you do submit the renewal, the MSU IRB will consider whether to voluntarily transition the study to the 2018 requirements with input from the PI. Only if the study is transitioned to the 2018 requirements AND it meets the requirement for eliminating annual renewal will the requirement to submit a renewal be removed. Modifications are still required.

• How do I know if my study is subject to pre-2018 requirements or 2018 requirements?

  Approval or determination letters issued by the MSU Human Research Protection Program and the IRB on or after January 21, 2019 include this information on the letter.

• What changes most impact me as a researcher?
  • Removes the requirement to conduct annual renewal review of ongoing research for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow up in conjunction with standard clinical care. Modifications are still required.
  • New requirements regarding information that must be given to prospective research subjects as part of the informed consent process
  • Establishes new exempt categories; under some of the new categories, exempt research would be required to undergo limited IRB review
• Have the consent templates been updated with the Revised Common Rule requirements?

  Yes, the consent templates have been revised to incorporate the Revised Common Rule requirements. They are available at: https://hrpp.msu.edu/templates/consent.html

• Is there help information available on what is considered a concise and focused presentation of key information?

  Yes, a guidance document for the concise and focused presentation of key information is available at: https://hrpp.msu.edu/templates/consent.html