Are
there ethical concerns and conflicts of interest I must
consider?
The Objectivity in Research Rule (1995) states that an investigator
must disclose to an official in his or her institution "any
significant financial interests (and those of his/her spouse
and dependent children) that would reasonably appear to be
affected by the research proposed for federal funding. The
institution must report the existence of conflicting interests
to the sponsor prior to any expenditure of awarded funds.
Financial conflicts of interest may be only one type of
conflict that could influence a study. Many investigators
are driven by a desire to contribute to society and improve
health outcomes in their patients as well as the public. Care
must be taken to acknowledge and minimize conflicts when
the researcher is caring for the patient clinically or receiving
incentives to enroll patients into studies. Personal
motivators such as academic appointments, promotions and
tenure, additional grants or prizes, and publications can
be potential sources of conflict. As an investigator,
it is important that you recognize and handle potential conflicts
during your study. NHLBI Guidelines
for Avoiding Conflicts of Interest in Multicenter Clinical
Trials may be helpful in assessing and managing conflicts.
Additional NHLBI guidance on special topics is available
for:
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