Financial conflicts

ORI Introduction to RCR: Chapter 5. Conflicts of Interest

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Personal interests and the prospect of financial gain shouldnot, but unfortunately can, improperly influence a researcher’s fundamental obligation to truth and honesty. Although researchers should not, they can find ways to delay unfairly a competitor’swork in order to secure a patent or some other financial advantage for themselves.
 
Financial interests can provide a strong incentive to overemphasize or underemphasize research findings or even to engage in research misconduct (Chapter 2). Financial conflicts of interest are situations that create perceived or actual tensions between personal financial gain and adherence to the fundamental values of honesty, accuracy, efficiency, and objectivity (Section I).
 
Financial interests are not inherently wrong. Researchers are permitted to benefit financially from their work. A 1980 Congressional law known as the Bayh-Dole Act encourages researchers and research institutions to use copyrights, patents, and licenses to put research ideas to use for the good of the public. Prior to this time, there were no uniform policies regulating the ownership of ideas developed with public funding. Bayh-Dole essentially gives that ownership to research institutions as an incentive to put ideas to work for the overall good of society. It not only approves of but,in fact, strongly encourages researchers and research institutions to have financial interests as a way of ensuring that the public’s investment in research is used to stimulate economic growth.
 
While financial interests should not and in most instances do not compromise intellectual honesty, they certainly can, especially if the financial interests are significant. Universities are currently starting hundreds of new businesses based on researchers’ ideas. Some of these businesses will generate significant profits (hundreds of thousands to millions of dollars each year). If the difference between commercial success and failure rests on one key publication, the pressure to put the best face on that publication can be considerable.
 
Financial conflicts also arise from the ever-present pressure researchers have to secure funds to support their research. A private sponsor might withdraw support from a project if it does not produce the “right” results. Success in the stiff competition for research grants can rest on having the “right” preliminary results. Research is expensive, funding often in short supply. The pressure simply to survive, much less profit personally, can and does create financial conflicts of interest.
 
Federal policies. Concerns about the actual or potential adverse effect of financial interests on research prompted the Public Health Service (PHS) and the National Science Foundation (NSF) to adopt conflict of interest policies in the mid-1990’s. These policies require research institutions to establish administrative procedures for:
  • reporting significant conflicts before any research is undertaken;
  • managing, reducing, or eliminating significant financial conflicts of interest; and
  • providing subsequent information on how the conflicts were handled.
Significant financial conflict is defined as:
  • additional earnings in excess of $10,000 a year, or
  • equity interests in excess of 5 percent in an entity that stands to benefit from the research.
The financial interests of all immediate family members are included in these figures.
 
State and local policies. Although the Federal requirements apply only to PHS- and NSF-funded research, many research institutions have adopted global policies that apply to all researchers. Many also use different values for defining significant, to as low as any financial interest. Researchers therefore should check their local conflict-of-interest policy to find out when and what they are required to report. They also need to keep in mind that many states have their own conflict-of-interest policies, which apply to all state-paid employees.
 
Professional societies and journal policies. A number of professional societies have issued reports or made -recommendations on appropriate ways to handle conflicts of interest. Similarly, more and more journals now require researchers to disclose real or potential financial conflicts. Sometimes disclosure must be made to the journal editor, who decides what, if any, action is needed. Sometimes disclosures must be included in the publication itself. Before submitting an article to a journal for publication, researchers should carefully check and make sure they have followed that publication’s conflict of interest policies.

Bayh-Dole Act

PHS Policy

AAMC Task Force

New England Journal of Medicine

 


Source URL: https://ori.hhs.gov/content/Chapter-5-Conflicts-of-Interest-Financial-conflicts