Congress recently asked the National Academy of Sciences to evaluate the effectiveness of regulations and policies of federal agencies that support research in universities, and to make recommendations for moving forward.
The report, from the National Academies of Sciences, Engineering, and Medicine, examines the current regulations leading federally funded research.
According to the report, the framework and ethical principles for conducting research involving humans were originally detailed in the Belmont Report by a national commission in 1978. While many of these principles are still relevant in the protection of human research subjects, the industry has changed drastically over the past four decades.
These developments include new research contexts and capabilities, the sharing of personal data, and increasing privacy concerns, all of which raise new questions about how the original principles should be applied.
“These changes, together with the NPRM’s [Notice of Proposed Rulemaking] inadequacies, signal a pressing need for a comprehensive review of the nation’s ethical, legal, regulatory, and institutional frameworks for protecting human research subjects,” the committee study concluded.
Part one of the report was released last fall and recommended that Congress create a Research Policy Board, which would act as a public-private forum to discuss regulations.
“The board should be a government-enabled, private-sector entity that will foster more effective conception, development, and synchronization of research policies,” the study committee recommended.
The report concluded that while regulation is needed, “continuing expansion of federal regulations on research is diminishing the effectiveness of the research enterprise; inconsistent and duplicative regulations are undercutting its productivity.”
Part 2 of the report, which was released in late June, recommended that Congress authorize an independent national commission – to be appointed by the president – which would examine and the ethical, legal, and institutional frameworks governing research involving human subjects.
According to the report, there are several unresolved questions and new contexts that need to be addressed, such as:
- research involving anonymous and de-identified human biospecimens
- research involving large data sets
- clinical trials where the unit of intervention is a cluster or group
- clinical studies comparing the effectiveness of different accepted interventions for a disorder to determine whether one approach may be preferable
- research aimed at clinical innovation and quality assurance and improvement
The study committee also concluded the executive branch should withdraw the Notice of Proposed Rulemaking (NPRM) for the “Common Rule,” which was announced by the US Department of Health and Human Services and fifteen other Federal Departments and Agencies. The NPRM was published on September 8, 2015 and proposed revisions to the regulations for protecting human subjects in research.
According to the report, “The regulatory structure protecting human research subjects should not be revised until the national commission has issued its recommendations and the research community, patient groups, and the public have had a chance to consider and react to them.”
The report also recommended that the Federal Select Agent Program develop and publicize “a reasonable inventory management system” for biological select agents and toxins.
Additionally, the study committee concluded that Congress and the administration support “a robust continuation and renewal” of the Export Control Reform Initiative – an initiative which was designed to strengthen US national security and the competitiveness of manufacturing and technology sectors.
Larry Faulkner, committee chair and president emeritus at the University of Texas, Austin, ultimately said that Congress and the administration “have an opportunity for a course correction that can yield significantly greater value to the public from the nation's investment in research.”
“We hope our recommendations will guide that effort,” he said.
Title: Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century (2016)
Publisher: The National Academies Press
Authors: Committee on Federal Research Regulations and Reporting Requirements: A New Framework for Research Universities in the 21st Century; Committee on Science, Technology, and Law; Board on Higher Education and Workforce; Policy and Global Affairs; National Academies of Sciences, Engineering, and Medicine