Newly Revised Common Rule for the Protection of Human Subjects

The Common Rule (45 CFR 690) for the Protection of Human Subjects is a 1981 law involving ethics for research with human subjects. In 2011, the 17 federal agencies covered by the Common Rule began the process of modernizing it. A new rule was published this year and most parts are scheduled to go into effect January 19, 2018. Common Rule agencies are in the process of developing guidance for researchers and Institutional Review Boards (IRBs).

Several important changes in the new regulation are as follows:

Four sets of activities are now “excluded” from the definition of “research”:

  • Scholarly and journalistic activities that focus on a specified individual
  • Public health surveillance activities conducted by a public health authority
  • Information that is collected for criminal justice purposes
  • Operational activities conducted for national security purposes

The categories of “exempt” research have been expanded and revised. The new rule will include eight exemptions (rather than the current six).

Exemption 1, which covers normal educational practices in educational settings, includes new restrictions related to activities that might adversely impact a student’s learning environment, or the assessment of instructors in that learning environment.

Exemption 2, relating to low risk interactions where information cannot be easily linked back to the research subject, remains largely unchanged, although it has been expanded to include some forms of identifiable information collected, which are subject to a process of “limited IRB review.”

The old Exemption 3, which covers research on public officials, has been removed (most activities related to this would be covered under the revised language in Exemption 2), and replaced with provisions for activities involving benign behavioral interventions where either the information collected cannot easily be traced back to the subject, or the disclosure of that information would not place the subject at risk of harm.

Exemption 4, related to the secondary use of identifiable private information or biospecimens, has been revised to remove a requirement that these materials be existing.

Exemption 5, related to public benefit and service programs, has been expanded.

Exemption 6, on taste and food quality evaluation, is unchanged.

Two new exemptions have been added.

Exemption 7 is related to the storage or maintenance of identifiable private information or biospecimens for secondary research.

Exemption 8 is regarding secondary research using identifiable private information or biospecimens – that require broad consent measures for the secondary use of biospecimens.

The exemptions related to identifiable information (7 and 8, and parts of 2 and 3) will be subject to a process of “limited IRB review.”

Among the other major changes to the rule, projects that have undergone expedited review no longer require a continuing review. Additionally, in 2020, the use of a single IRB for U.S. institutions conducting cooperative research in the U.S. will be mandated, though agencies will have the power to determine that single IRB is not appropriate for a particular context.

Further action will be required to clarify these changes. The National Science Foundation plans to have the new guidance posted to the NSF Human Subjects webpage prior to the January 19, 2018 effective date.