hrpp_commonrulechanges_2018_3

2018 Common Rule

Final Revisions to the Federal Policy for the Protection of Human Subjects (a.k.a. the "Common Rule") were issued by the Department of Health and Human Services (HHS) on January 18, 2017.  The majority of changes will go into effect on January 19, 2018

A useful resource for changes to the common rule can be found at CITI Final Rule Resoruces. 

Major Regulation Changes

  • Continuing Review  - No longer required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data.  For details, see the UMKC Implementation:  Continuing Review webpage.

  • ExemptionsNew categories and clarification of existing categories.  Some exemptions may require "limited IRB review" (similar to an expedited review process), while others may qualify for "self-determination."  For details, see the UMKC Implementation: Exemption Changes webpage.

  • Informed ConsentA new "Key Elements" section and a rearrangement of content is designed to facilitate a potential subject's decision to participate or not.  For details, see the UMKC Implementation: Informed Consent webpage.

  • Single IRB-of-Record (sIRB) - IRB oversight for most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB (commercial, academic, or hospital-based) starting January 20, 2020.   See Other Regulatory Changes for information about the NIH sIRB policy implementation, as well as other recent NIH policies related to clinical trials.

What to Expect

The new regulations do not impact studies approved prior to January 19, 2018.  

For new studies approved after January 19, 2018, expect to see:

  1. IRB application changes
  2. Informed consent template revisions
  3. UMKC IRB standard operating procedure updates 

For existing studies, after the UMKC implementation date the UMKC IRB may choose to apply the new rules to minimize burden for investigators.

Decisions to be Made

sIRB - The UMKC IRB will continue to assess its criteria for whether UMKC will serve as the single IRB-of-Record or cede review to another institution or a commercial IRB.

Broad Consent - UMKC is currently evaluating the impact of the new regulatory "Broad Consent" option as an informed consent process.  Exemptions 7 & 8, which rely on Broad Consent, may or may not be implemented.

What You Can Do

  1. Check this website periodically for new information.  We will continue to add information through January 2018, as it becomes available.   

Other Regulatory Changes

The National Institutes of Health (NIH) is implementing a variation of the Single IRB-of-Record policy beginning January 25, 2018.  The NIH sIRB policy applies to:

  • NIH-sponsored multi-site studies, where the same protocol is used at multiple sites
  • Domestic research only

NIH CLINICAL TRIAL POLICIES

The NIH has issued several other policies and guidance designed to "enhance the accountability and transparency of clinical research":  

NIH Definition of a Clinical Trial

NIH's definition of a clinical trial is broad, encompassing a wide range of activity which now may include behavioral studies (e.g., studies that manipulate an independent variable to observe a hypothesized modification of a behavioral process). 

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

https://grants.nih.gov/policy/clinical-trials/definition.htm

  • Revised clinical trial definition (1/25/2015) 
  • Required Good Clinical Practice Training (1/18/2017)
  • ClinicalTrials.gov registration and reporting of results (1/18/2017)
  • Use of the new Human Subjects and Clinical Trial form (part of the NIH funding application package, Forms-E) (1/25/2018)