NIH bioethicist defines research misconduct

[Guest guest]

NIH bioethicist defines research misconduct

March 28, 2008--

University of Delaware - Newark,DE*

http://www.udel.edu/PR/UDaily/2008/mar/conduct032808.html

Resnik, a bioethicist at the National Institute of

Environmental Health Sciences (NIEHS), talked about the different

kinds of research misconduct, their official definitions and the

associated repercussions in a lecture Thursday afternoon, March 27,

in Wolf Hall.

Co-sponsored by the University of Delaware Chapter of Sigma Xi and

the Research and Graduate Studies Office, Resnik's

lecture, " Misconduct in Research--What It Is, Why It Happens, How to

Deal with It and How to Prevent It, " was preceded by a catered

reception and introductory speech by Stanley Sandler, Henry Belin du

Pont Professor of Chemical Engineering, and included a slide show to

illustrate the finer points of what research misconduct really is.

" Usually, when a misconduct finding happens, the government just

agrees that the researcher or researchers will not receive funding

for a specific duration of time--say, another five years, " said

Resnik, after opening his lecture with a summary of several

notorious cases of flawed or fraudulent scientific research over the

past 30 years. " However, there is the possibility that when you

commit misconduct, you could be held liable for civil fraud or

criminal fraud, because basically what you are doing is deceiving

the government. "

Resnik elaborated on this by citing the historical case of research

misconduct by nationally recognized drug therapy researcher,

E. Breuning, who in 1988 became the first scientist to be

prosecuted, fined and incarcerated for falsification of scientific

research.

Because a large part of research funding for major scientific

experiments typically comes from government-affiliated agencies,

such as the National Science Foundation (NSF) and the National

Institutes of Health (NIH), Resnik said that as more high-profile

cases of flawed research came to light in recent years, the

government began to look more closely at its definition of

misconduct.

The 1986 Thereza Imanishi-Kari case (a case which also involved

Nobel Prize-winning biologist Baltimore and eventually

resulted in their exoneration), and the 2006 convictions of American

medical scientist Poehlman, and South Korean biomedical

scientist Hwang Woo-Suk, Resnik said, were three key research

misconduct incidents in recent years that caused the United States

government to tighten its definitions of--and its penalties for--

fraudulent research.

" In terms of South Korea, this was a problem for them, because they

didn't really have a proper procedure in place for investigating

research misconduct, " Resnik said.

Because the internationally respected journal Science had been the

first to publish Hwang Woo-Suk's findings, however, Resnik said, and

because all major scientific breakthroughs have a worldwide impact,

Hwang Woo-Suk's research caused the American Association for the

Advancement of Science (the organization that publishes Science) to

rethink its policies.

" They were ashamed that something as obvious as [the flawed data

presented by Hwang Woo-Suk] should have slipped through, " he

said. " And so their new policy stated that really high-impact papers

would be given extra scrutiny. "

NIH also adopted a more cautious approach, Resnik continued, and in

the wake of Poehlman's debunking, a debate ensued in the United

States about the definition of research misconduct and about

preventive measures.

" As a result of this debate, the 'serious deviation' terminology in

the existing federal definition of research misconduct was

eliminated as too general and too difficult to police, " Resnik

said. " So they turned the focus to the three terms of fabrication,

falsification and plagiarism. "

The federal definition of research misconduct, finalized in 2005 and

accepted by almost all federal agencies, Resnik emphasized, now not

only is more watertight, but also covers more ground, including at

the outset in grant proposals, where the rules also apply.

" The new definition really covers a lot of areas of research, "

Resnik said. " It now states that 'research misconduct means the

fabrication, falsification or plagiarism for proposing, performing

or reviewing research, or in recording research results.' Misconduct

does not, however, include honest error or differences of opinion. "

That is important, Resnik said, " because sometimes there have been

constructive disputes of methodologies. "

At NIEHS, which is part of the National Institutes of Health, Resnik

coordinates several ethics programs and helps develop institutional

policies that promote research integrity and compliance with federal

research policies and regulations. He assists researchers and

administrators with ethics issues and concerns and is also vice

chair of the NIEHS Institutional Review Board.

Additionally, he conducts interdisciplinary research on ethical,

legal and social issues in environmental health, spanning such areas

as environmental toxicology, environmental genomics, public health,

biotechnology, bioterrorism, HIV/AIDS, genetic testing, gene

therapy, stem cell research, drug development, medical decision-

making and scientific methodology.

Resnik holds a master's degree and a doctorate in philosophy from

the University of North Carolina at Chapel Hill and a law degree

from Concord University and has authored more than 100 articles on

various topics in philosophy and bioethics, as well as six books. He

serves on several editorial boards and is an associate editor of the

journal Accountability in Research.

Article by Becca Hutchinson