Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Disclosing financial conflicts of interest to research participants may not be enough

27.08.2009
Disclosure of financial conflicts of interests to potential participants in research is important, but may have a limited role in managing these conflicts, according to a new study by Johns Hopkins, Duke and Wake Forest.

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!
Further information:
http://www.jhmi.edu

More articles from Studies and Analyses:

nachricht Win-win strategies for climate and food security
02.10.2017 | International Institute for Applied Systems Analysis (IIASA)

nachricht The personality factor: How to foster the sharing of research data
06.09.2017 | ZBW – Leibniz-Informationszentrum Wirtschaft

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Neutron star merger directly observed for the first time

University of Maryland researchers contribute to historic detection of gravitational waves and light created by event

On August 17, 2017, at 12:41:04 UTC, scientists made the first direct observation of a merger between two neutron stars--the dense, collapsed cores that remain...

Im Focus: Breaking: the first light from two neutron stars merging

Seven new papers describe the first-ever detection of light from a gravitational wave source. The event, caused by two neutron stars colliding and merging together, was dubbed GW170817 because it sent ripples through space-time that reached Earth on 2017 August 17. Around the world, hundreds of excited astronomers mobilized quickly and were able to observe the event using numerous telescopes, providing a wealth of new data.

Previous detections of gravitational waves have all involved the merger of two black holes, a feat that won the 2017 Nobel Prize in Physics earlier this month....

Im Focus: Smart sensors for efficient processes

Material defects in end products can quickly result in failures in many areas of industry, and have a massive impact on the safe use of their products. This is why, in the field of quality assurance, intelligent, nondestructive sensor systems play a key role. They allow testing components and parts in a rapid and cost-efficient manner without destroying the actual product or changing its surface. Experts from the Fraunhofer IZFP in Saarbrücken will be presenting two exhibits at the Blechexpo in Stuttgart from 7–10 November 2017 that allow fast, reliable, and automated characterization of materials and detection of defects (Hall 5, Booth 5306).

When quality testing uses time-consuming destructive test methods, it can result in enormous costs due to damaging or destroying the products. And given that...

Im Focus: Cold molecules on collision course

Using a new cooling technique MPQ scientists succeed at observing collisions in a dense beam of cold and slow dipolar molecules.

How do chemical reactions proceed at extremely low temperatures? The answer requires the investigation of molecular samples that are cold, dense, and slow at...

Im Focus: Shrinking the proton again!

Scientists from the Max Planck Institute of Quantum Optics, using high precision laser spectroscopy of atomic hydrogen, confirm the surprisingly small value of the proton radius determined from muonic hydrogen.

It was one of the breakthroughs of the year 2010: Laser spectroscopy of muonic hydrogen resulted in a value for the proton charge radius that was significantly...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

ASEAN Member States discuss the future role of renewable energy

17.10.2017 | Event News

World Health Summit 2017: International experts set the course for the future of Global Health

10.10.2017 | Event News

Climate Engineering Conference 2017 Opens in Berlin

10.10.2017 | Event News

 
Latest News

Terahertz spectroscopy goes nano

20.10.2017 | Information Technology

Strange but true: Turning a material upside down can sometimes make it softer

20.10.2017 | Materials Sciences

NRL clarifies valley polarization for electronic and optoelectronic technologies

20.10.2017 | Interdisciplinary Research

VideoLinks
B2B-VideoLinks
More VideoLinks >>>