While supporting most of the proposed changes to rules governing misconduct in federally sponsored research, representatives of professional research societies and US medical schools are expressing "serious concerns" and "strong objections" to several changes that would, among others, shift the burden of proof in investigations from institutions or the government to individual scientists.

For example, if records were missing, the scientist would have to prove that he or she did not commit misconduct. "We are concerned that the proposals are inconsistent with the presumption of innocence," Robert D. Wells, president of the Federation of American Societies for Experimental Biology (FASEB), wrote in a letter to the Office Of Research Integrity (ORI) in the Department of Health and Human Services (DHHS), which includes the National Institutes of Health and other research funding agencies. "This undercuts the protections for honest error. The burden of proof should remain the responsibility of ORI and not be shifted to the accused scientist."

In a letter submitted collectively to the ORI, four other associations representing US research universities, medical schools, and medical societies also objected to the proposed change. "The institution should have the full burden of proving each and every element of research misconduct, including intent, recklessness, or knowing disregard of applicable standards," wrote the presidents of four organizations—the Association of American Medical Colleges, Association of American Universities, the Council on Governmental Relations, and the National Association of State Universities and Land-Grant Colleges.

DHHS proposed the changes to Public Health Service (PHS) regulations in April. The changes are intended to update and standardize the definition of misconduct and the process for investigating and adjudicating complaints, replacing regulations originally approved in 1989 and amended several times since. The ORI had been soliciting comments until June 15.

While continuing to define misconduct as "fabrication, falsification, or plagiarism," the rules would extend the government's reach to include scientists engaged in peer review for funding or publication in a scientific journal. But the research and academic organizations objected on grounds that to do so would exceed the scope of PHS authority. "Absent federal funding, those who engage in misconduct need to be punished by the journal or their home institution," wrote FASEB's Wells.

"We are truly grateful that they incorporated some of the key and fundamental pieces of the federal policy," said Carol Blum, an associate director at the Council on Governmental Relations. "But we were concerned that the PHS is extending or claiming jurisdiction or scope that's much broader than what we think is appropriate for a single federal agency," she told The Scientist.

The American Society for Microbiology (ASM) joined other organizations in expressing concern over a proposal to replace the three-member research integrity panel with a single administrative law judge to try misconduct cases. "This procedure would constitute a substantial modification of the current process," ASM President Thomas Shenk wrote in a letter to the ORI. Scientific expertise is frequently needed in these hearings to determine if research misconduct had occurred, he said.

The organizations generally supported other proposals, including extending misconduct policy to research that is conducted under contract, setting a 6-year time limit on filing allegations of research misconduct, and clarifying the role of a whistleblower as that of a "complainant" who does not participate in the process beyond being a witness.

ORI Director Chris B. Pascal told The Scientist he would analyze the comments and present them to DHHS for consideration. Final regulations are expected to be published later this year.