Setting a Minimum Standard of Care in Clinical Trials: Human Rights and Bioethics as Complementary Frameworks

Abstract

JSTOR is a not-for-profit service that helps scholars, researchers, and students discover, use, and build upon a wide range of content in a trusted digital archive. We use information technology and tools to increase productivity and facilitate new forms of scholarship. For more information about JSTOR, please contact support@jstor.org. AbstractFor the past few decades, there has been intense debate in bioethics about the standard of care that should be provided in clinical trials conducted in developing countries. Some interpret the Declaration of Helsinki to mean that control groups should receive the best intervention available worldwide, while others interpret this and other international guidelines to mean the best local standard of care. Questions of justice are particularly relevant where limited resources mean that the local standard of care is no care at all. Introducing human rights law into this complex and longstanding debate adds a new and important perspective. Through non-derogable rights, including the core obligations of the right to health, human rights law can help set a minimum standard of care.

Understanding women’s motivations to participate in MTN-003/VOICE, a phase 2b HIV prevention trial with low adherence

“…Local clinics are overcrowded, may not offer full preventive healthcare such as pap smears, and may include direct and indirect financial costs to the patients, reducing a woman’s ability to successfully manage her health [38–42]. This imbalance between “standard of care” in trials and in local settings is often debated; nevertheless, it should be acknowledged that the World Medical Association’s revised Declaration of Helsinki endorsed the practice that all trial participants receive the worldwide standard of care [43, 44]. Thus, until there is massive health care reform in these settings, high quality health care offered in trials will likely continue to motivate many.…”

Legal responses to placebo-controlled trials in developing countries

“…48). Some scholars argue that these dispositions would entail an international responsibility of States to regulate clinical trials, establishing a minimum standard of care for research participants (Marouf & Esplin, 2015). In particular, hosting countries should set up an independent evaluation structure of research projects that should be centered on the role of ethics committees; they should evaluate the congruence of collaborative research with international standards, while developed countries, on their own, should foresee a mechanism control for the commercialization of drugs/treatments that have been tested in foreign countries (i.e.…”