Sweeping Changes Proposed to Common Rule Governing Human Subjects Research

Sweeping Changes Proposed to Common Rule Governing Human Subjects Research

After years of debate and speculation, sixteen federal agencies have collaborated on a notice of proposed rulemaking (NPRM) with the stated purpose of modernizing, strengthening, and making more effective the federal policy for the protection of human subjects, which was originally promulgated as a Common Rule in 1991. This NPRM solicits comment on the proposals to better protect human research participants, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. While the NPRM does not tackle as many issues as the Advanced Notice of Proposed Rulemaking (ANPRM) of July 2011, it nevertheless proposes a number of bold moves to streamline the clinical trial process.

The most significant Common Rule changes proposed in the NPRM

The U.S. Department of Health and Human Services has identified eight of the proposed changes as “most significant.” These significant changes, which encompass more than 500 pages, are listed below along with links to summaries of the changes prepared by Quorum Review’s regulatory attorneys.

  1. Improve informed consent by increasing transparency and by imposing stricter new requirements regarding the information that must be given to prospective subjects, and the manner in which it is given to them, to better assure that subjects are appropriately informed before they decide to enroll in a research study.
    Read summary of proposed change
  2. Generally require informed consent for the use of stored biospecimens in secondary research (for example, part of a blood sample that is left over after being drawn for clinical purposes), even if the investigator is not being given information that would enable him or her to identify whose biospecimen it is. That consent would generally be obtained by means of broad consent (i.e., consent for future, unspecified research studies) to the storage and eventual research use of biospecimens.
    Read summary of proposed change
  3. Exclude from coverage under the Common Rule certain categories of activities that should be deemed not to be research, are inherently low risk, or where protections similar to those usually provided by IRB review are separately mandated.
    Read summary of proposed change
  4. Add additional categories of exempt research to accommodate changes in the scientific landscape and to better calibrate the level of review to the level of risk involved in the research. A new process would allow studies to be determined to be exempt without requiring any administrative or IRB review. Certain exempt and all non-exempt research would be required to provide privacy safeguards for biospecimens and identifiable private information. New categories include:
    1. certain research involving benign interventions with adult subjects;
    2. research involving educational tests, surveys, interviews or observations of public behavior when sensitive information may be collected, provided that data security and information privacy protections policies are followed;
    3. secondary research use of identifiable private information originally collected as part of a non-research activity, where notice of such possible use was given;
    4. storing or maintaining biospecimens and identifiable private information for future, unspecified secondary research studies, or conducting such studies, when a broad consent template to be promulgated by the Secretary of HHS is used, information and biospecimen privacy safeguards are followed, and limited IRB approval of the consent process used is obtained.
      Read summary of proposed change
  5. Change the conditions and requirements for waiver or alteration of consent such that waiver of consent for research involving biospecimens (regardless of identifiability) will occur only in very rare circumstances.
    Read summary of proposed change
  6. Mandate that U.S. institutions engaged in cooperative research rely on a single IRB for that portion of the research that takes place within the United States, with certain exceptions. To encourage the use of IRBs that are otherwise not affiliated with or operated by an assurance-holding institution (“unaffiliated IRBs”), this NPRM also includes a proposal that would hold such IRBs directly responsible for compliance with the Common Rule.
    Read summary of proposed change
  7. Eliminate the continuing review requirement for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing data or involve only observational follow-up in conjunction with standard clinical care.
    Read summary of proposed change
  8. Extend the scope of the policy to cover all clinical trials, regardless of funding source, conducted at a U.S. institution that receives federal funding for non-exempt human subjects research.
    Read summary of proposed change

NPRM Comment Period

To be assured consideration, comments must be received within 90 days of expected publication in the federal register on September 8, 2015. Generally, with noted exceptions, the compliance date of the new rules would be one year from the publication of the final rule.

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