5 years ago

A systematic review finds underreporting of Ethics Approval, Informed Consent, and Incentives in Clinical Trials

In this study, we aim to review researchers' reporting practices of the ethics statement, financial incentives, and local ethical committees' profile in their clinical trials. Study design and setting A systematic search was done through top ranked 50 medical journals (Scimago Ranking) to retrieve 2000 latest publications. Only primary clinical trials were included with no restriction to language or participants. Result Among the 927 included trials, 14 (1.5%) trials did not report an ethical statement and two third (63%) did not completely report the investigated components (Institutional Review Board approval, Helsinki Declaration, and informed consent). Moreover, 21 (2.26%) trials reported motivational incentives with the method and amount of payment for participants. Of them, 15 trials offered monetary incentives to participants in different forms. In the remaining 6 trials, the incentives were mainly medical benefits. Only one trial reported the profile or quality of local Institutional Review Board. Conclusion A potential gap in the reporting practices of ethics statement and financial incentives was addressed in this review. Authors are urged to fully report all ethical components related to their study, including incentives and compensations plan. Medical journals are also recommended to implement further publication requirements concerning ethics reporting.

Publisher URL: www.sciencedirect.com/science

DOI: S0895435616308241

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