Inconsistent Federal Regulations Undercut U.S. Research Productivity, National Academies’ Report Finds


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Barbara E. Bierer, MD

Lee M. Ellis, MD

David Korn, MD

We’re not asking that regulations go away. We’re asking for them to be harmonized and simplified to improve compliance and oversight.

—Barbara E. Bierer, MD

Ask any U.S. academic investigator whether research is hindered by duplicative or confusing federal regulations, and the answer is usually a resounding “Yes.” Now comes a report written by representatives of research administrators, former federal government officials, and principal investigators—including three prominent academic oncologists—making the case for a “course correction” in what they argue has been a continual expansion of requirements.

Regulations address important issues of scientific integrity, use of federal funds, and protections for people and animals involved in research, but these well-intended efforts often needlessly encumber investigators with administrative work, according to a report by the National Academies of Sciences, Engineering, and Medicine.

“We’re not asking that regulations go away. We’re asking for them to be harmonized and simplified to improve compliance and oversight,” said committee member and oncologist Barbara E. Bierer, MD, Professor of Medicine, Harvard Medical School and Brigham and Women’s Hospital, and Faculty Co-Director, Multi-Regional Clinical Trials Center of Harvard and the Brigham and Women’s Hospital.

The release of the report, “Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century,” completes the first phase of the study. Another report is expected to be issued in the spring of 2016.

Scope of the Problem

Although research on the administrative burden is sparse, one study suggests that principal investigators spend 42% of their time on administrative work. “That’s an enormous amount of time to spend on administrative issues and not on science and improving the health of the nation,” Dr. Bierer said.

Academic institutions often receive research funding from multiple federal agencies, but each agency has different formats for commonly required documents, such as an investigator’s biographical information.

The Congressionally mandated report also placed some blame on academic institutions for adding to the administrative burden by imposing additional requirements in their attempts to deal with confusing regulations.

The report calls on Congress to create a research policy board to establish a new regulatory framework to govern government-academic research partnerships and to harmonize requirements across funding agencies. This board should be formally connected to government through a new associate director position at the White House Office of Science and Technology Policy and through the Office of Information and Regulatory Affairs at the White House Office of Management and Budget, the report said.

Key Recommendations

The report offered several key recommendations for Congress, the White House Office of Management and Budget, federal agencies, and universities.

Congress

  • Work with the White House Office of Management and Budget to develop a uniform format for research grant proposals to be used by all funding agencies;
  • Work with the White House Office of Science and Technology Policy and research institutions to develop a single financial conflict-of-interest policy to be used by all research funding agencies;
  • Task a single agency with overseeing and unifying efforts to develop a central database of investigators and their professional output;
  • Direct agencies to align and harmonize their regulations and definitions concerning the protection of human subjects;
  • Instruct the White House Office of Science and Technology Policy to convene representatives from federal agencies that fund animal research and from the research community to assess and report to Congress on the feasibility and usefulness of a unified federal approach to policies and regulations pertaining to the care and use of research animals.

White House Office of Management and Budget

  • Require that research funding agencies use a uniform format for research progress reporting;
  • Amend the new Uniform Guidance to improve the efficiency and consistency of procurement standards, financial reporting, and cost accounting.

Federal Agencies

  • Limit research proposals to the minimum information necessary to permit peer evaluation of the merit of the scientific questions being asked, the feasibility of answering those questions, and the ability of the investigator to carry out that research. Any supplementary information— Institutional Review Board approval, conflict-of-interest disclosures, detailed budgets, etc.—should be provided “just in time,” after the research proposal is deemed likely to be funded;
  • With regard to animal research, reduce and streamline reporting, assurances, and verifications. Agencies should also develop a central repository to house assurances.

Universities

  • Conduct a review of institutional policies developed to comply with federal regulations of research to determine whether the institution itself has created excessive or unnecessary self-imposed burden; and
  • Revise self-imposed burdensome institutional policies that go beyond those necessary and sufficient to comply with federal, state, and local requirements.

In addition to Dr. Bierer, the 18-member committee included two other academic oncologists: Lee M.
Ellis, MD
, Professor of Surgical Oncology and Molecular and Cellular Oncology, and the William C. Liedtke Jr. Chair in Cancer Research at MD Anderson Cancer Center; and David Korn, MD, Professor of Pathology, Massachusetts General Hospital, Harvard Medical School and former Chairman of the National Cancer Institute’s National Cancer Advisory Board.  ■

Disclosure: Dr. Bierer reported no potential conflicts of interest.

 



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