To make university research more effective and efficient, the U.S. Department of Health and Human Services drafted voluntary guidelines for reporting research data, but some universities see the guidelines as an overreach of government control.
Anthony DeCrappeo, president of the Council of Governmental Relations, an association involved in the financial and administrative aspects of federally funded research, said these guidelines will have a significant effect on universities and the way they conduct research.
“The level of specificity on how these universities will meet these standards may cause some change for university research,” DeCrappeo said.
The way some universities currently organize or report their research might fall out of compliance, according to the new guidelines.
Despite accusations that these guidelines are an attempt for the government to obtain more control over federally funded projects, DeCrappeo said they are meant to provide a coherent and standard set of principles for institutions to have a rigorous compliance program-particularly in financial areas.
The proposal says that accurate time reporting is a “critical compliance issue” for universities receiving federal money.
Donald White, a spokesman for HHS, said the “voluntary guidelines” are not yet final.
The Office of Inspector General is taking comments from the agencies that may be affected by the new program, including the National Institute of Public Health and the U.S. Public Health Service.
Nicole Buckley, a spokeswoman for the Association of American Medical Colleges, agreed that these drafts will serve as guidance for university research. She added that the AAMC will be putting together a response on the strengths and weaknesses of the proposed guidelines once members of the association express their concerns.
“This new draft guidance does not revise or replace the existing requirements, and it should serve as a useful reminder to grant recipients of the need to continue — and in some cases strengthen — their research compliance programs,” Buckley said. “However, because of the already extensive compliance direction that has been issued by HHS agencies, such guidance from the OIG may be unnecessary.
“Further, this recent draft guidance could be interpreted, despite its disclaimers, as the model performance standard for research compliance programs against which individual research compliance programs will be audited and judged,” Buckley continued.
In an email, Donald Ralbovsky from the Office of Extramural Research at the National Institutes of Health said NIH “is pleased” to see the new guidelines.
“The Office of the Inspector General has published this guidance to promote voluntary compliance programs, to assist institutions in avoiding criminal and civil fraud investigations and to encourage the use of internal controls to monitor adherence to … regulations and program requirements,” he said.
The new guidelines will encourage recipients of Public Health Service Research awards to implement written policies and procedures, designate a compliance office, conduct effective training, develop effective lines of communication, conduct internal monitoring and auditing and respond promptly to any problems.