Dale Dirks and Dane Christiansen
January 23, 2017
One of the last acts of the outgoing administration was to release the final rule on human research protections (also known as the Common Rule) on Thursday, January 19th—the day before the inauguration. This action represents the culmination of years of debate and deliberation, including comprehensive community feedback on a proposed Common Rule that was released towards the end of 2015.
Patient and research advocates were highly critical of the previous, proposed Common Rule due to privacy concerns and added bureaucracy raised by new provisions. The final rule appears cognizant of community concerns and includes an overview of changes made since the proposed rule was released. These changes include (the below language is from the final notice):
Not adopting 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.
Not expanding the policy to cover clinical trials that are not federally funded.
Not including the proposed standardized privacy safeguards for identifiable private information and identifiable biospecimens.
Not adopting the most restrictive proposed criteria for obtaining a waiver of the consent requirements relating to research with identifiable biospecimens.
Establishing new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process.
Allowing 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.
Creating 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.
Due to the length and complexity of the recently-released Final Rule, many stakeholders are still reviewing specific details. The community will be able to provide additional feedback and the rule will likely be evaluated by the incoming administration.