FINANCIAL CONFLICTS OF INTEREST AND RESEARCH OBJECTIVITY: ISSUES FOR 
INVESTIGATORS AND INSTITUTIONAL REVIEW BOARDS

Release Date:  June 5, 2000

NOTICE:  OD-00-040

National Institutes of Health
 
Introduction
Objectivity of researchers is an essential value in scientific research and 
the basis for public trust.  Researchers should be led by their data, not by 
other interests that might undermine the scientific integrity of their work.  
Of course, success in research is likely to bring valued publications, grant 
renewals, career advancement, and the satisfaction of accomplishment.  And 
that accomplishment is often linked to rewards such as the development of new 
modalities for saving lives and alleviating suffering.  These incentives are 
widely known and broadly shared.  
 
Any research links with industry raise the prospect that scientific advances 
will bring financial gain as well.  The opportunity for investigators= 
personal financial gain or reward is not intrinsically unacceptable.  
However, recent highly publicized instances of apparent financial conflicts 
of interest have generated concern within the research and lay communities.  
Because of the complexity of the issues and the potential threats to the 
integrity of research posed by such conflicts of interest, the NIH is issuing 
these points to consider and announcing a public consultation to be held on 
this issue in the Summer of 2000.  
 
Why are there concerns? 
Concerns are raised when financial considerations may compromise or have the 
appearance of compromising an investigator"s professional judgment and 
independence in the design, conduct, or publication of research.  Public 
Health Service regulations, promulgated in July 1995, Responsibility of 
Applicants for Promoting Objectivity in Research  
(http://grants.nih.gov/grants/guide/notice-files/not95-179.html) 
require institutions to: 
o  maintain a written, enforced policy on financial conflict of interest, 
o  inform research investigators of that policy, the associated reporting 
responsibilities, and related federal regulations, 
o  report to awarding offices the existence of any conflicting interest(s) 
and assure that the interest(s) have been managed, reduced, or eliminated in 
accordance with the regulations.
Institutions are required, therefore, to know what conflicts might exist, to 
manage, reduce, or eliminate those conflicts, and to report that information to 
the NIH.  (Institutions are not required to provide the details of the 
conflict.)
 
When Institutional Review Boards (IRBs) review specific protocols for the 
procedures to protect human subjects, the IRB must determine that: 
o  risks to subjects are minimized,
o  risks to subjects are reasonable in relation to the anticipated benefits,
o  selection of subjects is equitable,
o  informed consent will be sought from each prospective subject and 
appropriately documented.

When appropriate, the IRB should also determine that the research plan 
makes adequate provision for monitoring the data collected to ensure 
the safety of subjects, to protect the privacy of subjects, and to 
maintain the confidentiality of data.  While there is no regulatory 
requirement for IRBs to consider investigators= financial conflict of 
interest, the protection of human subjects requires objectivity in 
communicating risks, selecting subjects, promoting informed consent, 
and gathering, analyzing and reporting data.  IRBs should refer to 
their institution’s policies and procedures for identifying and 
managing conflicts of interest.  In some cases, IRBs are incorporating 
conflict of interest issues in their deliberations.
  
Some strategies used by IRBs to consider investigators  Conflict of 
Interest
How do individual IRBs deal with the potential that financial holdings 
might interfere with objectivity in research?  Some estimates indicate 
that 25% of IRBs routinely deal with investigators= and IRB members= 
conflicts of interest during IRB deliberations.  Some of their 
approaches include:  
 
o  Make IRBs aware of the conflict of interest policies and procedures 
in their institution and elect to include a statement in the informed 
consent form that all clinical investigators comply with the 
institutional guidelines.
 
o  Ask investigators to complete a short questionnaire in which they 
are asked  whether they or any other person responsible for the design, 
conduct, or reporting of this research has an economic interest in, or 
acts as an officer or a director of any outside entity whose financial 
interests would reasonably appear to be affected by, the research. 
 
o  Provide instruction to IRB members during their orientation on how 
to identify and respond to a perceived financial, academic, or other 
conflict of interest.  
 
Public Consultation
In the summer of 2000, the Department of Health and Human Services 
(DHHS) will host a forum on financial conflicts of interest.  This forum 
will afford an opportunity to discuss sharing of information on the conduct 
of clinical trials between IRBs and compliance offices that deal with 
institutional policies and procedures on investigators  conflict of interest.  
Other topics for discussion will include conflicts of interest pertaining 
to institutions, individual investigators, and IRB members.  The forum will 
take place at the NIH Natcher Building on August 15 and 16, 2000.  Further 
details will appear in the weekly NIH Guide for Grants and Contracts.  

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