The latest draft revisions of the Declaration of Helsinki (DoH) weaken protections for trial participants in low and middle income countries, Rafael Dal-Ré, director of clinical research at Universidad Autónoma de Madrid, and other researchers argue.
In an analysis piece in this week’s British Medical Journal , the researchers – who, in addition to Dal-Ré included Paul Ndebele, director of the medical research council of Zimbabwe, and Elizabeth Higgs, science advisor to the National Institute of Allergy and Infectious Diseases at the NIH – say that the latest revisions are a step in the wrong direction.
A revision of the DoH from 2008 “specified that research participants are entitled to share in the benefits that result from the studies in which they participate, including access to interventions identified as beneficial in the study or to ‘other appropriate care or benefits.’” The change was made due to the fact that many trials conducted in low and middle-income countries were failing to provide any benefits to trial participants in those countries.
For example, a review of trials conducted between 2004 and 2007 in tuberculosis, malaria, and HIV/AIDS in developed (58%) and developing countries (42%), found that only 1.3% mentioned post-trial provisions.
And to make matters worse, the 2013 version of the DoH -- which was released in April -- omits reference to “other appropriate care or benefits” and limits the scope of possible benefits to interventions “identified as beneficial in the trial,” which the researchers claim “ignores the fact that many trials do not result in an effective intervention.”
The current wording of the DoH “is not sufficient to protect vulnerable individuals from exploitation because of the low chances that a trial will result in a successful treatment,” the researchers claim.
The 2013 version also no longer requires patients entered into a study to be informed about the outcomes of the study.
The researchers question: “Is it fair to ask participants (and their community) to wait at least 3.5 years to gain benefit (being treated with the new drug if still needed) for their participation in the trial, acknowledging that in some 90% of cases this will never happen?”
As far as their recommendations, the researchers say that the DoH “should specify that external funders, host investigators, and research ethics committees are responsible for ensuring that trials in LMICs [low and medium-income countries] do not pose excessive risks and offer a fair level of benefits to participants and host communities, based on the risks and burdens they face and the extent to which others benefit from their involvement in the research.”
“Limiting benefits solely to drugs and vaccines identified as successful within a trial will often mean participants and their communities receive no benefit,” the researchers contend.