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Investigators' Responsibilities and Rights

Arch Surg. 2002;137:639-640.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Based on recent reports,^1-9 there are increasing concerns about the control of the scientific data obtained from clinical trials sponsored by industry. Many of the problems encountered are the result of restrictions contained in the research contracts that participating investigators are asked to sign. A number of solutions have been suggested to ensure the integrity of clinical trials, including the establishment of appropriately constituted trial oversight committees, negotiating noninterference pledges from industry sponsors, and creating proactive support of investigators' rights by organized medicine.¹⁰

As surgical journal editors, we stand opposed to inappropriately restrictive contractual agreements governing company-sponsored clinical trials of devices or drugs, such as those containing clauses that deny the investigators proper control over the scientific aspects of the trial or restrict access to the data and its timely publication. We believe that responsibility for the scientific data from clinical trials and its analysis, interpretation, and publication should rest . . . [Full Text of this Article]