The study's recommendations provide a framework for establishing sound policy and practices for how best to disclose financial conflicts of interests to potential participants in clinical research, said Jeremy Sugarman, M.D., senior author of a paper published in the August 27th issue of The New England Journal of Medicine and the deputy director for medicine at the Berman Institute of Bioethics at Johns Hopkins.
The paper drew on five years of research from the Conflict of Interest Notification Study, (COINS), a $3 million project led by Sugarman and funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Overall, COINS gathered information from thousands of patients as well as many clinical trial investigators, and those charged with the ethical oversight of research.
Clinical investigators have long been urged to disclose their financial interests to potential participants in a study through the informed consent process. But in their NEJM paper, the authors questioned what goal this disclosure is hoping to achieve.
Examples of financial interests include corporate funding for the expense of enrolling a patient in a trial or a researcher having a consulting contract or stock ownership with corporate sponsors with a stake in a trial.
"Our study reveals that disclosure to participants by itself is not the remedy that many seek," Sugarman said. "But disclosure may have positive effects on people's satisfaction with and trust in the research process."
The authors recommend that research participants not be the sole decision-makers about the potential risks arising from investigators' financial relationships. They agreed that disclosure during the consent process should be brief and simple, and that trial coordinators should have the information they need to address questions about financial relationships.
Kevin Weinfurt, Ph.D., the lead author of the paper said "multiple studies show that most research participants want to know about investigators' financial relationships, but that this information often doesn't change their minds about enrolling."
The authors said participants likely won't fully understand the nature of investigators' financial interests, but that disclosure encourages transparency, often satisfies participants' perceived right to know, and could foster more trust.
If stock ownership is at play, other management techniques in addition to disclosure should be used. Simply disclosing this information is insufficient the authors said, because research participants are sometimes troubled by investigators' and institutions' equity interests in clinical research.
The authors also agreed that those overseeing conflicts of interest should be explicit about their goals and design plans for managing financial interests that include disclosure requirements toward meeting those goals. The recommendations were offered to investigators, institutional review boards, conflict-of-interest committees and policy makers.
The study was supported by grant from the National Heart, Lung, and Blood Institute.
Other authors are Kevin P. Weinfurt, Ph.D., Joëlle Y. Friedman, M.P.A., and Kevin A. Schulman, M.D., of Duke University and Mark A. Hall, J.D., and Nancy M. P. King, J.D., of Wake Forest University.
Christen Brownlee | EurekAlert!
Antarctic Ice Sheet mass loss has increased
14.06.2018 | Technische Universität Dresden
WAKE-UP provides new treatment option for stroke patients | International study led by UKE
17.05.2018 | Universitätsklinikum Hamburg-Eppendorf
Russian researchers together with their French colleagues discovered that a genuine feature of superconductors -- quantum Abrikosov vortices of supercurrent -- can also exist in an ordinary nonsuperconducting metal put into contact with a superconductor. The observation of these vortices provides direct evidence of induced quantum coherence. The pioneering experimental observation was supported by a first-ever numerical model that describes the induced vortices in finer detail.
These fundamental results, published in the journal Nature Communications, enable a better understanding and description of the processes occurring at the...
In a recent publication in the renowned journal Optica, scientists of Leibniz-Institute of Photonic Technology (Leibniz IPHT) in Jena showed that they can accurately control the optical properties of liquid-core fiber lasers and therefore their spectral band width by temperature and pressure tuning.
Already last year, the researchers provided experimental proof of a new dynamic of hybrid solitons– temporally and spectrally stationary light waves resulting...
Scientists from the University of Freiburg and the University of Basel identified a master regulator for bone regeneration. Prasad Shastri, Professor of...
Moving into its fourth decade, AchemAsia is setting out for new horizons: The International Expo and Innovation Forum for Sustainable Chemical Production will take place from 21-23 May 2019 in Shanghai, China. With an updated event profile, the eleventh edition focusses on topics that are especially relevant for the Chinese process industry, putting a strong emphasis on sustainability and innovation.
Founded in 1989 as a spin-off of ACHEMA to cater to the needs of China’s then developing industry, AchemAsia has since grown into a platform where the latest...
The BMBF-funded OWICELLS project was successfully completed with a final presentation at the BMW plant in Munich. The presentation demonstrated a Li-Fi communication with a mobile robot, while the robot carried out usual production processes (welding, moving and testing parts) in a 5x5m² production cell. The robust, optical wireless transmission is based on spatial diversity; in other words, data is sent and received simultaneously by several LEDs and several photodiodes. The system can transmit data at more than 100 Mbit/s and five milliseconds latency.
Modern production technologies in the automobile industry must become more flexible in order to fulfil individual customer requirements.
13.06.2018 | Event News
08.06.2018 | Event News
05.06.2018 | Event News
25.06.2018 | Physics and Astronomy
25.06.2018 | Earth Sciences
25.06.2018 | Power and Electrical Engineering