World Medical Association Revises Ethical Principles in Clinical Trials Declaration

By Zachary Brennan contact

- Last updated on GMT

WMA Revises Ethical Principles in Clinical Trials Declaration

Related tags: Informed consent, Clinical trial

Draft revisions to the Declaration of Helsinki (DoH) clarify how placebos should be used and add a general principle for adequate compensation to injured trial participants according to the WMA.

The most recent draft version of the revised declaration​, released earlier this month by the Council of the World Medical Association (WMA), updates what the association considers to be a general statement on the ethical principles of medical research that was first adapted in 1964 and most recently revised in Seoul in 2008​. 

The question of whether to allow the use of placebo was discussed comprehensively during two expert conferences in the run up to this current revision process​,” Nigel Duncan, a spokesman for the WMA, told Outsourcing-Pharma.com.  

The WMA workgroup that drafted the revision “came to the conclusion that the regulation on placebo use in the 2008 version is the most ethically acceptable, however that the wording could be improved and a more systematic approach would cover the ethical issue more comprehensively​.” 

The updated text on the use of placebo adds the phrase “any intervention less effective than the best proven one​,” and “no treatment​” to the list of options for studies. It also adds that patients should not “receive any intervention less effective than the best proven one, placebo or no treatment​” unless they “will not be subject to any additional risks of serious or irreversible harm as a result of not receiving the best proven intervention​.” 

The issue of placebo use continues to be controversial. This is particularly so in situations where a treatment for a particular condition already exists​,” another WMA spokesman who declined to be named told us. “The DoH tries to clarify the very rare circumstances where a placebo controlled trial is acceptable even when a treatment currently exists​.” 

The controversial issue of compensating clinical trial participants was also highlighted by the WMA with a new general principle. “Adequate compensation and treatment for subjects who are harmed as a result of participating in the research must be ensured​,” the association says. 

Post-Trial, Vulnerable Groups​ 

The WMA's updated section of the DoH on post-trial access to treatments for patients who were involved in the study further ensures the safety of trial participants.

Sponsors, researchers and host country governments are called on to “make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the study. This information should also be disclosed to participants during the informed consent process. All study participants should be informed about the outcome of the study​.” 

In addition, the WMA reviewed several suggestions to name certain vulnerable groups explicitly in the DoH and provide specific regulation for them, especially children, the association said. After some discussion, the workgroup agreed that specific vulnerable groups should not be mentioned explicitly, but the statement that all “vulnerable groups need specifically considered protection​” was added to the declaration. 

Biobanks​ 

The issue of biobanks was seen as important by the WMA, and though only an “additional short wording was added​,” more work in this area is expected, the WMA said. 

Research using human tissue stored in biobanks has been developing rapidly in recent years​,” a WMA spokesman said. “Briefly, the main concern is that a research subject might give consent to having a tissue sample used in one way, and then months or years later the researcher may wish to use it for another purpose. There is controversy around whether or not they would need to obtain a new consent or whether the original consent would be sufficient​.” 

The revised draft notes that medical research “using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must normally seek consent for the its collection, analysis, storage and/or reuse​.” 

The revised draft is the result of the workgroup’s analysis of comments submitted in May 2012, following earlier discussions on the use of placebo in research and three expert conferences held in Rotterdam in June 2012, Cape Town in December 2012, and Tokyo in February/March 2013, as well as several workgroup meetings. 

For the latest revision of the DoH, the WMA invites experts and stakeholders to submit comments via email to the WMA secretariat at qbu@jzn.arg​ no later than 15 June 2013.

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