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Revised Common Rule for the Protection of Human Subjects

Gordon MacFarlane Ph.D.

Sr. Mgr Regulatory Affairs, ICON plc

Melanie Crystal

Director, Project Management, Medical Device and Diagnostics Research, ICON plc

On 19 January 2017, revisions to the Common Rule were published in the Federal Register, which will take effect in January 2018.  The Common Rule is the template (45 CFR Part 46) for human subject protections. It was approved, with department-specific modifications, by federal departments and agencies that sponsor or conduct human subjects research.  

In September 2015, proposed modifications to the Common Rule were presented to the public for review to enhance protections for research participants and improve efficiency of research oversight.  The resulting public comments and final rationale for accepting or rejecting individual proposals are now available and published with the final Common Rule.

The major changes to the Common Rule are summarized below:

  • Applies to Institutional Review Boards (IRB) that do not hold a Federal Wide Assurance (FWA), primarily independent IRBs.
  • Revisions establish new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process.  This information involves consequences of early withdrawal and termination procedures, and any potential commercial benefit that may accrue to the subject. The revisions also require that key study information must be summarized at the beginning of the consent to better streamline the informed consent process.
  • Allows the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens.  Broad consent will be an optional alternative that an investigator may choose instead of (1) conducting the research on nonidentified information and nonidentified biospecimens; (2) having an IRB waive the requirement for informed consent; or (3) obtaining consent for a specific study.
  • Establishes new exempt categories of research based on the study risk profile.  Under some of the new categories, exempt research would be required to undergo limited IRB review to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens.  These new exempt categories primarily involve educational and survey research.
  • Creates a requirement for U.S.-based institutions, engaged in cooperative or multi-site research, to use a single IRB for that portion of the research that takes place within the United States, with certain exceptions.  This requirement becomes effective three years after publication of the final rule.
  • Removes the requirement to conduct continuing review of ongoing research for studies that (1) undergo expedited review; (2) that have completed study interventions; (3) that are merely analyzing study data; or (4) that involve only observational follow up in conjunction with standard clinical care.

The revisions also sought to clarify the definitions of clinical trials and human subjects as listed below:

  • Clinical trial means 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 the interventions on biomedical or behavioral health-related outcomes.
  • Human subject means a living individual about whom an investigator (whether professional or student) is conducting research:
    • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens.
    • Intervention includes (1) both physical procedures by which information or biospecimens are gathered (e.g., venipuncture), and (2) manipulations of the subject or the subject’s environment that are performed for research purposes.
    • Interaction includes communication or interpersonal contact between investigator and subject.
    • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens

Private information includes (1) information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and (2) information that has been provided for specific purposes by an individual, and that the individual can reasonably expect the information will not be made public (e.g., a medical record).

For most manufacturers, the revisions to the Common Rule should not incur any significant burden.  For in vitro diagnostics manufacturers in particular, the availability of broad consent for biospecimens should prove very beneficial, since these consents may provide an alternative to waiving consent and reduce study administrative timelines. 

As a result of the Common Rule revisions, expect informed consents to change over the year to accommodate the requirements to allow a clear understanding of the study for which subjects volunteer. This will largely impact the format and order of current informed consent templates. 

On that front, ICON is already ahead of the curve in creating innovative ways of making patient consent forms more user friendly. An ICON-supported research study at Carnegie Mellon University, for example, found that these forms could be shortened significantly without losing critical understanding or sacrificing the content required by ethics boards. The research also found greater patient engagement when using a shorter paper form in conjunction with a video developed for ICON’s FIRECREST Patient Portal, compared with more traditional, paper-based approaches.

Perhaps the most challenging aspect of the Common Rule revisions will be for academically based IRBs to work through the logistics of ceding oversight responsibility to a coordinating center IRB for cooperative research.  There are successful models that have been implemented that can serve as examples over the three-year implementation horizon for this particular Common Rule revision (January 2020). But this may be a difficult adjustment for primarily academic-based researchers.

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