Common Rule Revisions

Common Rule Changes – Implementation date January 21, 2019

  • The “Common Rule,” also known as the Federal Policy for the Protection of Human Subjects (45 CFR 46), is the common ethical standard for publicly funded research in the United States. Changes to the Common Rule were issued by the Department of Health and Human Services (HHS) in January 2017. Most changes will go into effect on January 19, 2019. 
  • The WSIRB will apply the revised rule to all new applications approved on or after January 21, 2019. IRB applications submitted in the weeks prior to January 21 may not be reviewed by the IRB in time for the “pre-2018” rule to apply and will therefore be reviewed under the New Common Rule.

What you need to know

  • Research approved prior to 01/19/2019 may be converted to the New Common Rule, which will be determined on a case-by-case basis, based on whether it can easily meet all the new requirements and will offer review process streamlining. Existing studies will NOT be automatically transitioned.
  • Unless there are PI requested revisions to consent forms - existing studies do NOT need to change their existing consent forms to include the new required statements. However, an existing study cannot be transitioned to the New Common Rule unless it meets all the New Common Rule requirements including the new consent elements.
  • The WSIRB will not adopt the option for broad consent until further guidance about implementing the option is available from OHRP/SACHRP. This applies to the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens.

 

Consent Form

Consent forms will now need to start with a 'clear and concise summary' of 'key information' for the subject. Talk to WSIRB staff for further clarification of this requirement.

Consent forms for clinical trials will be required to be posted on a (yet-to-be-determined) federal website within 60 days after the last study visit.

Additional information that will now be required on consent forms:

  • Whether information or biospecimens will or will not be used for future research
  • Whether research results will be returned to subjects or not
  • Whether research will include whole genome sequencing
  • Whether biospecimens will be used for commercial profit

Exempt Studies

Studies that are determined to be Exempt: must meet specific criteria as described in 45 CFR 46.104. 

What has changed. The New Common Rule expands the categories of research that may be determined Exempt. This means that more studies will qualify for Exempt status. Some of these changes include:

  • New exempt categories for 'benign behavioral interventions' in adults with consent §46.104(3)(i,ii,iii)
  • Revision to educational exempt category §46.104(d)(1)
  • Secondary use of de-identified records can now include prospective records

Exceptions to Exempt status: Certain types of studies may not be determined to be Exempt. These include studies that are:

  • Regulated by the Food and Drug Administration (FDA)
  • Funded by the federal Department of Justice

Continuing Review

  • WSIRB will still require an annual Continuation Approval Request submission to determine if the study is still ongoing and have an annual compliance review.

    • In accordance with 45 Code of Federal Regulations (CFR) Part 46 Section 46.109, Washington State Agency Policy on Protections of Human Research Subjects, and Washington State Institutional Review Board Procedures Manual, the WSIRB shall conduct continuing review of research at intervals appropriate to the degree of risk for each study. Revised Code of Washington 42.48.020 requires ongoing monitoring of studies within WSIRB’s jurisdiction to ensure confidentiality and security of state data for research.  The state requirements include “…specific safeguards to assure the continued confidentiality and security of individually identifiable records or record information...” as a condition for allowing research professionals access to state records.  This language is also in existing Confidentiality Agreements. The requirements of state statute and Agency Policy are more stringent and the added protections meet the criteria for providing a rationale for Continuing Review as required in 45 CFR 46.109.