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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. NIH 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:

Page Last Updated: September 2013
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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