alexa The Declaration of Helsinki, 50 years later.
Medicine

Medicine

Family Medicine & Medical Science Research

Author(s): Paul Ndebele

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Fifty years and 7 revisions later, the 2013 version of the Declaration of Helsinki includes several important changes. By changing the format and including several subsections, the revised declaration enhances and improves clarity regarding specific issues. By having specific issues covered under these subsections, the declaration is now “ bolder” in the way it addresses specific issues. The new formatting will also be welcomed by readers because the subsections improve the readability of the document. By so doing, the Declaration of Helsinki is a better and more important authority at what it is aimed at achieving—providing guidance on conducting medical research involving humans. The increase in international studies over the past few decades has contributed to serious debate about the ethics of research conducted in various settings. Most of the debate centered on issues related to limited resources and justice: use of placebo and posttrial access to interventions. Through this and previous revisions, the World Medical Association (WMA) has demonstrated that the declaration is a living document that considers current issues in medical research. Important documents such as the declaration are expected to respond to new areas of need or areas that require revision. The Declaration of Helsinki was born from the history of abuses of human research subjects. Over the years, research oversight has improved but has led to the underrepresentation of certain groups in research investigations.1 This has disadvantaged such groups because they have not benefitted from some advances that others have experienced from the conduct of research. The new version of the declaration addresses this development in paragraph 13 by recommending that access to clinical trials for underrepresented groups needs be increased so these groups also can benefit from research. Instead of excluding groups that have been ordinarily excluded from research, such as minority groups, women, and children, researchers need to clearly justify why these groups have been excluded from research. There are current discussions about compensation and treatment for individuals who are harmed as a result of their participation in research. Some funders of research have been unwilling to address this topic over the years.2 However, India has issued a law that requires all trial participants to receive treatment and financial compensation for trial-related injuries or death. The law has disrupted the conduct of clinical trials supported by one of the major funders of medical research in that country.3 The issues of compensation and access to treatment for research-related injuries are important for limited-resource settings in which the majority of trial participants are not insured. By clearly stating that trial participants need to be treated and compensated for trial-related injuries, the new declaration is likely to lead to further discussions by certain research funders who would like to avoid the cost of insuring trial participants. In the past some important stakeholders in medical research have preferred to adhere to older versions of the declaration as a way of avoiding dealing with certain provisions included in newer versions.4 The new version of the Declaration of Helsinki is more relevant to countries with limited resources because it includes clear terms that address issues of importance in these settings, such as posttrial access to interventions and care for participants from limited-resource settings. In limited-resource countries, there have been concerns that communities may be used for testing interventions that will not be accessible to their citizens because of high costs and other reasons such as logistical challenges in delivering the new interventions outside the research environment. The new version of the declaration is clear on the requirement to have plans for ensuring access to an intervention if it is proven to be effective. This requirement serves to recognize that research can play an additional role of improving access to care in limited-resource settings. In further recognition of the role of research in improving access to care in limited-resource settings, the new version of the declaration also addresses the issue of use of unproven interventions. The 2013 version of the Declaration of Helsinki recommends use of unproven interventions in cases for which proven interventions do not exist, after the physician has sought expert advice as well as the patient’s informed consent.

This article was published in JAMA and referenced in Family Medicine & Medical Science Research

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