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Protections for clinical trials in low and middle income countries need strengthening not weakening

BMJ 2014; 349 doi: (Published 04 July 2014) Cite this as: BMJ 2014;349:g4254
  1. Rafael Dal-Ré, director1,
  2. Paul Ndebele, director 2,
  3. Elizabeth Higgs, global health science adviser 3,
  4. Nelson Sewankambo, professor and principal 4,
  5. David Wendler, head 5
  1. 1Clinical Research, BUC (Biosciences UAM+CSIC) Program, International Campus of Excellence, Universidad Autónoma de Madrid, E-28049 Madrid, Spain
  2. 2Medical Research Council of Zimbabwe, Causeway, Harare, Zimbabwe
  3. 3Division of Clinical Research, Office of the Director, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland, USA
  4. 4College of Health Sciences, Makerere University, Makerere, Uganda
  5. 5Unit on Vulnerable Populations, Department of Bioethics, NIH Clinical Center, Bethesda, Maryland, USA
  1. Correspondence to: R Dal-Ré Rafael.dalre{at}

The latest revision of the Declaration of Helsinki weakens protections for trial participants in low and middle income countries. Rafael Dal-Ré and colleagues argue that this is a step in the wrong direction

Debate over how to ethically balance the risks and benefits generated by clinical research has been ongoing for over 25 years. This is especially challenging for clinical research conducted by entities from high income countries in poorer countries. In particular, there is concern that funders and investigators from high income countries may exploit participants in low and middle income countries (LMICs). People living in impoverished communities with limited access to adequate healthcare may be more willing to accept the risks and burdens of trial participation than those with better access to resources, while their relative lack of power undermines their ability to claim a fair share of the benefits that result from the trials.

The World Medical Association’s Declaration of Helsinki was established to guide the ethical conduct of medical research. Successive revisions to the declaration, which sees its 50th anniversary this year, have provided increasing protection for research participants in LMICs. The 2008 version 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 (table 1).” This change was made in recognition of the fact that many trials conducted in LMICS 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 (n=23), malaria (n=67), and HIV/AIDS (n=222) in developed (58%) and developing countries (42%), found that only 1.3% mentioned post-trial provisions.5 Unfortunately, the 2013 version of the declaration omits reference to “other …

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