Trial by error, Continued: PACE Team’s Work for Insurance Companies Is “Not Related” to PACE. Really?

By David Tuller, DrPH David Tuller is academic coordinator of the concurrent masters degree program in public health and journalism at the University of California, Berkeley. In my initial story on Virology Blog, I charged the PACE investigators with violating the Declaration of Helsinki, developed in the 1950s by the World Medical Association to protect human research subjects. The declaration mandates that scientists disclose “institutional affiliations” and “any possible conflicts of interest” to prospective trial participants as part of the process of obtaining informed consent. The investigators promised in their protocol to adhere to this foundational human rights document, among other ethical codes. Despite this promise, they did not tell prospective participants about their financial and consulting links with insurance companies, including those in the disability sector. That ethical breach raises serious concerns about whether the “informed consent” they obtained from all 641 of their trial participants was truly “informed,” and therefore legitimate. The PACE investigators do not agree that the lack of disclosure is an ethical breach. In their response to my Virology Blog story, they did not even mention the Declaration of Helsinki or explain why they violated it in seeking informed consent. Instead, they defended their actions by noting that they had disclosed their financial and consulting links in the published articles, and had informed participan...
Source: virology blog - Category: Virology Authors: Tags: Information adaptive pacing therapy CFS chronic fatigue syndrome clinical trial cognitive behaviour therapy Declaration of Helsinki graded exercise therapy insurance company mecfs PACE specialist medical care The Lancet Source Type: blogs