Abstract
BackgroundParticipants are recruited into clinical trials under the assumption that the research will contribute to medical knowledge. Therefore, non-publication trials—and, more recently, lack of data sharing—are widely considered to violate the trust of trial participants. Existing practices regarding patient consent to publication and data sharing have not been evaluated. Analyzing informed consent forms (ICFs), we studied what trial participants were told regarding investigators’ intention to contribute to medical knowledge, publish trial results, and share de-identified trial data.MethodsWe obtained 98 ICFs of industry-funded pre-marketing trials for all (17) antibiotics approved by the European Medicines Agency and 46 ICFs of publicly funded trials from the National Heart, Lung and Blood Institute Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) data repository. Three authors independently reviewed ICFs to identify and extract what was stated or implied regarding: (1) publication of results; (2) sharing de-identified data; (3) data ownership; (4) confidentiality of identifiable data; and (5) whether the trial will produce knowledge that offers public benefit. Consensus was obtained from the two reviewers with the greatest overall agreement on all five measures. Disagreements were resolved through discussion among all authors.ResultsFour (3%) trials indicated a commitment to publish trial results; 140 (97%) did not commit to publishing trial results; six (4%) indicated a commitment to share de-identified data with third party researchers. Commitments to share were more common in publicly funded trials than industry-funded trials (7% vs 3%). A total of 103 (72%) ICFs indicated the trials will or may produce knowledge that offers public benefits, while 131 (91%) ICFs left unstated who “owned” trial data; of those with statements, the sponsor always claimed ownership. Patient confidentiality was guaranteed in 137 (95%) trials.ConclusionsOur results suggest that consent forms rarely disclose investigators’ intentions regarding the sharing of de-identified data or publication of trial results.
Highlights
Participants are recruited into clinical trials under the assumption that the research will contribute to medical knowledge
The non-publication of clinical trials has long been considered a violation of the trust of clinical trial participants who enrolled under an assumption of contributing to medical knowledge [1, 2] and in recent years, the research community has increasingly come to consider clinical trial data sharing to be another fundamental ethical obligation of trialists [3, 4]
These ethical norms are supported by survey data which show that people enroll in clinical trials with an assumption of altruism—that their participation will benefit others [5–7]
Summary
Participants are recruited into clinical trials under the assumption that the research will contribute to medical knowledge. The non-publication of clinical trials has long been considered a violation of the trust of clinical trial participants who enrolled under an assumption of contributing to medical knowledge [1, 2] and in recent years, the research community has increasingly come to consider clinical trial data sharing to be another fundamental ethical obligation of trialists [3, 4]. These ethical norms are supported by survey data which show that people enroll in clinical trials with an assumption of altruism—that their participation will benefit others [5–7]. ICFs themselves have largely escaped being the focus of comparative studies because ICFs are generally treated as confidential by investigators, institutional review boards, and regulators
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