Common Rule Implementation

Changes to the Common Rule and Implementation at UNC Charlotte

Revisions to the federal regulations for the protection of human subjects in research (45 CFR 46) were issued in January 2017.  The changes to the regulations were expected to take effect on January 19, 2018, but have been delayed until January 21, 2019.

The following highlight some of the significant changes. 

  • Certain activities are no longer considered research and therefore will not require Institutional Review Board (IRB) review. 
    • Most scholarly and journalistic activities that focus directly on specific individuals.
    • Public health surveillance activities conducted by a public health authority.
    • Criminal justice and criminal investigation activities.
    • Agency-authorized activities in support of intelligence, defense, and homeland security. 
  • The revised Common Rule adds new and expanded Exemption categories.
    • Investigators may propose Exemption eligibility; however, Exemption determinations will continue to be made by the Office of Research Compliance (ORC) and IRB. 
    • Some Exemption categories will require Limited Review.
  • Continuing review (renewal) will no longer be required for most studies (Exempt and Expedited studies) that do not undergo full IRB review.
  • Informed consent documents must now include concise key information to facilitate participant comprehension. This will include organizing consent information to present the key information first.
  • Single IRB review is required for cooperative/multi-site research. This change aligns with the National Institutes of Health (NIH) single IRB policy.

The following highlight some of the impacts.

  • The Common Rule changes will impact new studies submitted on/after January 21, 2019. 
  • Existing studies (approved prior to January 21, 2019) will continue to follow the current regulations. ORC and the IRB will evaluate active protocols on a study-by-study basis to make a determination as to application of the current regulations or transition to the revised regulations. 

The Office of Research Compliance is working to update University policy, guidelines for research, standard operating procedures, etc. In addition, changes to the IRBIS system are in development. 

FAQs

How do these changes affect my current (approved prior to January 21, 2019) research?

  • Existing studies (i.e., studies approved prior to January 21, 2019) will not be impacted immediately as the current regulations (pre-2018) will continue to be the standard applied.  However, to benefit from the burden-reducing provisions of the revised rule, each study will be evaluated during the subsequent renewal period. Further guidance is forthcoming.
  • ​The old rule (pre-2018) will still be implemented for studies that have external funding with limited exceptions (e.g., study is now in the data-analysis stage).  Further guidance is forthcoming. 

I am planning to start my research in January 2019; what do I need to do?

  • The Office of Research Compliance has always provided recommended timelines for researchers to plan their IRB submissions, including when to submit for IRB review when aiming for a January research start time.  These deadlines as posted are not changed and are the recommendations regardless of the Common Rule changes. As such, if you plan to start your research in January 2019, the IRB application should be submitted by late October to early November, 2018.  ORC recommends November 16 as the latest submission date for research needing to start in January.
  • NOTE: This timeframe is dependent upon the researcher’s responsiveness. If resubmission by the PI is not timely, the protocol may not be approved before January or before the Common Rule changes become effective. Thereby requiring additional rounds of review in order to adjust the protocol to the revised Common Rule and revised IRIBS system.  

I am planning to start my research in mid-January or early February 2019; what do I need to do?

  • You may continue to submit your application in IRBIS prior to the revised Common Rule implementation. Please expect a slower review process as we transition to the revised Common Rule given changes to the IRBIS system to comply with the revised Rule. 

I am expecting to get funding in December 2018 or January 2019; what should I do?

  • Please submit your IRB application now if the sponsor award release may occur in December 2018 or January 2019. Otherwise, you may submit your application ASAP as soon as you receive the notice of funding approval in January.  Please also immediately notify the IRB staff in the Office of Research Compliance of having received favorable notice of funding or an award notice. 

 

Questions:  uncc-irb@uncc.edu

This page will be updated as more information and materials are developed and finalized.   

For further details:

Other Resources:

Office of Human Research Protections

Council on Governmental Relations – Policy Issues – Human Subjects

Federal Register – Published Common Rule

CITI Program – Final Rule Resources