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May 2, 2017

Conflict of Interest and Legal Issues for Investigators and Authors

Author Affiliations
  • 1The JAMA Network, Chicago, Illinois
JAMA. 2017;317(17):1761-1762. doi:10.1001/jama.2017.4235

Investigators have legal duties and responsibilities that span the long arc from study design and patient enrollment to well beyond publication of results of clinical trials and other types of studies in peer-reviewed journals. Duties extend to human research participants, institutional review boards (IRBs), data and safety monitoring boards, funders and research sponsors, employers, and finally, journals and their readers.

“Scientific misconduct” includes a host of offenses, ranging from plagiarism to fabrication, false claims of authorship, and omission. Among the affirmative duties of authors is making a candid disclosure of the financial interests and affiliations that could affect their judgment and objectivity.1 Investigators who are employees, officers, or owners of for-profit companies, or who have patent or copyright interests, have additional responsibilities and are especially vulnerable to legal and ethical risks. This Viewpoint will focus on the duty of investigators who are authors to report their potential conflicts of interest (COI) and the legal and professional consequences for all involved when authors make COI omissions.