Information on Final Rule

New Final Common Rule Published

On Wednesday, January 18th, the federal government released the Final Rule for research with human subjects. This rule has been released to address the changing nature of human subject research, such as the increase in the amount and the diversity of the research being done; increase in number and types of clinical trials; as well as observational studies and cohort studies, the expansion of social and behavioral research; the increase in use of analytic techniques in studying human biospecimens; and the growing use of electronic health data and digital records that allow to analyze sizeable datasets. All of these growing changes in human subject research necessitated accompanying changes in the oversight system, but was left unanswered for two decades, until the release of this ‘Common Rule’ that came out Wednesday.

Below you will find some major takeaways of the Final Rule and on how the Final Rule differs from the Notice of Proposed Rulemaking (NPRM), including many proposals the Final Rule did not adopt. All of which come from the Federal Register:

• “ The final rule does not adopt the proposal to require that research involving nonidentified biospecimens be subject to the Common Rule, and that consent would need to be obtained in order to conduct such research.
• To the extent some of the NPRM proposals relied on standards that had not yet been proposed, the final rule either does not adopt those proposals or includes revisions to eliminate such reliance.
• The final rule does not expand the policy to cover clinical trials that are not federally funded.
• The final rule does not adopt the proposed new concept of “excluded” activities. Generally, activities proposed to be excluded are now either described as not satisfying the definition of what constitutes research under the regulations or are classified as exempt.
• The proposed revisions to the exemption categories have been modified to better align with the long-standing ordering in the final rule. The final rule does not include the proposed requirement that exemption determinations need to be made in specified ways.
• The final rule does not include the proposed standardized privacy safeguards for identifiable private information and identifiable biospecimens. Aspects of proposals that relied on those safeguards have been modified or are not being adopted.
• The final rule does not adopt the most restrictive proposed criteria for obtaining a waiver of the consent requirements relating to research with identifiable biospecimens.”

Below you will find the significant changes the Final Rule has made to the Common Rule. All of which come from the Federal Register:

• “Establishes new requirements regarding the information that must be given to prospective research subjects as part of 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, for example, conducting the research on nonidentified information and nonidentified biospecimens, having an institutional review board (IRB) waive the requirement for informed consent, or obtaining consent for a specific study. 
• Establishes new exempt categories of research based on their 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.
• Creates a requirement for U.S.-based institutions engaged in cooperative 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 3 years after publication of the final rule.
• Removes the requirement to conduct continuing review of ongoing research for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow up in conjunction with standard clinical care.”

Appalachian State University’s Office of Research Protections will be factoring this in as we are revising our policy this year. The Final Rule is effective on January 19, 2018. The compliance date for the 2018 requirements is January 20, 2020, 3 years after the date of publication of the Final Rule. Please keep in mind that it still remains to be seen whether the Final Rule will remain with a new administration coming out this year. None of these changes will come into effect this year, so the IRB process will not begin to change until January 19, 2018, assuming that the Final Rule is not repealed.

Check out these helpful links if you are more interested in this development:

Federal Register Published Document
Higher Ed Article on a highly-desired change that the Final Rule delivers
U.S. Department of Health & Human Services Press Release


Director of Research Protections
Robin Tyndall

Assistant Director of Research Protections
Monica Molina

Assistant Director of IACUC and IBC Programs
Shante' Mathes

Compliance Coordinator
Dennis Gabriels

QEP Global Learning