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Respond to the NPRM

Recent Information

01/19/2017: Common Rule revisions published in the Federal Register.  Many changes proposed in the NRPM were not adopted into the final rule.  Plus, because of the timing of the final rule release, it could be nullified under the provisions of the Congressional Review Act (“CRA”).  See the HRPP Policies web page for more information.

01/04/2017: The final version of the proposed Common Rule changes has been sent to the Office of Information and Regulatory Affairs (OIRA).  OIRA review is a last step in the process for finalizing federal regulations.  See PRIM&R's blog post for more information.

06/29/2016: The National Acadamies of Sciences, Engineering and Medicine (NAS) proposes the Common Rule Notice of Proposed Rulemaking (NPRM) be withdrawn.  Read the news release and their report. 

May 2016:  The Council on Government Relations (COGR)  compiled an analysis of the 2,816 public comments on the Common Rule Notice of Proposed Rulemaking (NPRM). This analysis includes comments submitted by you, as individual researchers, and U-M's Human Research Protections Program (HRPP)

Proposed Changes to the Common Rule

The Department of Health and Human Services (HHS) recently proposed revisions to the Common Rule, which defines the regulations for federally funded human subjects research. THIS IS NOT A FINAL RULING.  HHS is soliciting your feedback as an investigator engaged in human subjects research.

Among other changes, the proposal expands the definition of a human subject to include all biospecimens (e.g., blood, urine, biopsy specimens) regardless of whether or not identifiable information about the donor accompanies the specimen.  With this expansion, almost all research using biospecimens would require broad informed consent (using a proposed government template as yet not developed).  Consent for the ongoing use of biospecimens in research would be limited to 10 years and would not likely be waived.

Current vs. Proposed Changes: Biospecimens 

The HRRP is especially concerned about the proposed changes to research with biospecimens.  Since the proposed changes appear in several sections of the NPRM document a summary is provided below and in the References & Resources section:

Current

Informed consent generally is required to:

  • Acquire biospecimens for a specific research study
  • Use biospecimens when accompanied by identifying information

Secondary use of non-identified biospecimens for research (e.g., those obtained for clinical purposes or excess specimens from other studies) usually is excluded from the IRB review process, or informed consent for their use is waived.

Proposed Changes

  • Broad informed consent will be required for specimens collected after the date of implementation
  • Broad consent will include an option to allow or prohibit future contact about opportunities for research participation
  • Tracking will be required to determine who did/did not consent to research with biospecimens or future contact
  • Tracking will be required for renewal every 10 years of consent

Example of Impact

To demonstrate how the proposed revisions might affect biospecimen use in research, consider a study wishing to access to fully non-identified pathology specimens of all patients who had a liver biopsy over a six-month period for clinical purposes:

  • Today, these specimens would not be considered to constitute research with human subjects (no IRB oversight needed) as they are fully non-identified. Informed consent is not required under the current regulations.
  • Under the proposed rule, research must be approve by the IRB and is permitted with only those specimens for which the patient had given informed consent for research utilization (which is limited to 10 years) and/or re-contact. This would require massive institution-wide tracking of who did and did not provide consent and when the consent must be updated.

U-M Response

U-M, through the HRPP, along with organizations such as COGR and SACHRP and other universities, submitted comments regarding the impact of the proposed revisions on research institutions and individual research projects.  If the proposed revisions are implemented, we foresee that there will be a/an:

  • Significant decline in the number of biospecimens available for research
  • Significant increase in the cost of using biospecimens in research
  • Increase in the amount of administrative work to track informed consent and renewal
  • Potential for a decrease in the dollars for research, as more direct funds may be needed for resources to provide informed consent and track consent

References and Resources

  • UMICH NPRM Comments

    Finalized comments on the notice of proposed rule making submitted by the University of Michigan on January 5, 2016

  • NPRM Summary of Change: Biospecimens

    Describes the proposed NPRM changes to the use of biospecimens in research.  Compiled by SACHRP.

  • NPRM Summary of Changes

    Describes all of the 2015 NPRM proposed changes for human subjects protections

  • NPRM Decision Trees Decision charts identifying if reserach activity will be subject to the proposed regulation changes.  Compiled by Verrill Dana, LLP. 
  • U-M Comment Guidelines & Template

    Information (e.g., required elements, sample structure) to make effective comments to the HHS on the NPRM

Questions?

To ask a question, express concerns, or provide suggestions about human research protections at U-M, please send a message to hrppumich@umich.edu.

To submit your comments on the NPRM, go to regulations.gov.