2018 Common Rule updates

New human research regulations (known as the 2018 Common Rule) went into effect in January 2019. This change was first announced to KU researchers in October 2018. All human research studies will need to be in compliance with the 2018 Common Rule by Jan. 21, 2022.

To ensure that your study is compliant by this date, you must do the following by Jan. 21, 2022 or your study will be closed:

Convert to 2018 Common Rule

1. Update your Consent Form: Additional information will be required in your consent form if your study is approved under an expedited or full committee review category. The additional information includes:
    
   • A "Key Information" section to the beginning of the form with the following included:
     • This project is studying_________.
     • Your participation in this research project is completely voluntary.
     • Your participation will take ________ minutes/hours/days.
     • You will be asked to do the following procedures: [List procedures here]. More detailed information on the procedures can be found below
     • [List possible risks or discomforts related to the study. If none, add statement explaining no risks or discomforts.]
     • [List possible benefits to subjects or others. If none, add statement explaining no benefits.]
     • [List alternatives to participating. For SONA, this may be an alternative assignment or alternative research study. If no alternative, state “Your alternative to participating in this research study is not to participate.”]
        
   • Include this section if you are collecting private information and/or biospecimens from participants:
     
     Explain if identifiers might be removed and used for future research use. Use one of the following examples:
      
     • Example 1: Your identifiable information may be removed from the data and/or biospecimens collected during this project, and the de-identified data and/or biospecimens will be used for future research without additional consent from you.
        
     • Example 2: Your identifiable information and/or biospecimens will not be used or distributed for future research studies even if your identifiable information is removed.
        
2. Submit a MODCR: Submit a Modification AND Continuing Review with your revised consent form so the HRPP can approve and stamp your 2018 Common Rule-compliant consent form.
    
   • Make sure to submit the MODCR in time to be approved by Jan. 21, 2022. We recommend submitting at least three weeks prior to Jan. 21, 2022.
      
   • If your MODCR is not approved by Jan. 21, 2022, your project will be out of compliance and you must stop all engagement with human subjects, or analysis of identifiable human subjects data until the MODCR is approved.

Note: With few exceptions, expedited studies approved under the 2018 Common Rule will not have an expiration date or a requirement for periodic continuing review.

Is your study complete? If so, please submit a Continuing Review in eCompliance to close the study.