After scandals involving tainted toothpaste, poisonous pet food, adulterated milk, contaminated heparin, and counterfeit medicines, and a thriving trade in organs, one shudders to imagine how well human subjects are protected in drug studies performed in China. Apart from an occasional report in the medical literature, there is little easily accessible information about Chinese human protections: the regulations and laws, compliance and enforcement, and professional standards. This information would be interesting in its own right; however, it is all the more essential given trends towards trans-national trials.
A recent report issued the Medical Research Council (UK) provides some indication of China’s system of human protections, and how researchers in countries like UK might proceed when locating trials in China. The executive summary finds that Chinese regulations substantially parallel those of the International Committee on Harmonization (ICH). Informed consent and independent ethics review is required for any study. However, the UK and China “differ greatly in their approaches to enforcing guidelines for the conduct of research at the national level. In China, although there is some scrutiny of clinical trials, there is comparatively little inspection or review of compliance.” Other intriguing mentions are concerns about undue inducement in China: “the high costs of healthcare and medicines, and the dependence on local providers means that particular attention [for UK researchers pursuing studies in China] must be given to potential inducements to participate in research. Collaboration with China may offer attractive opportunities for large-scale recruitment, but potential UK collaborators must be alert to the risk that unethical inducements may be offered to potential participants. … given the high cost of accessing health care in China, a ‘free health check’ may be a relatively greater inducement than it would be deemed to be in the UK.”
A perusal of the Chinese regulations- at least the ones provided in this report- indicate the following:
• China places heavy emphasis on procedure (e.g. IRB review) and informed consent, rather than substance (e.g. prohibitions on certain practices; definitions of minimal risk; categories of patients)
• China seems to take a very permissive stand (like ICH) on the use of placebos. Indeed, there is no mention of studies involving placebo.
• There is no mention of justice considerations- for example, post-trial access or responsiveness.
@Manual{stream2009-87,
title = {Everything You Always Wanted to Know About Clinical Research in China, But Were Afraid to Ask},
journal = {STREAM research},
author = {Jonathan Kimmelman},
address = {Montreal, Canada},
date = 2009,
month = aug,
day = 20,
url = {https://www.translationalethics.com/2009/08/20/everything-you-always-wanted-to-know-about-clinical-research-in-china-but-were-afraid-to-ask/}
}
MLA
Jonathan Kimmelman. "Everything You Always Wanted to Know About Clinical Research in China, But Were Afraid to Ask" Web blog post. STREAM research. 20 Aug 2009. Web. 14 May 2024. <https://www.translationalethics.com/2009/08/20/everything-you-always-wanted-to-know-about-clinical-research-in-china-but-were-afraid-to-ask/>
APA
Jonathan Kimmelman. (2009, Aug 20). Everything You Always Wanted to Know About Clinical Research in China, But Were Afraid to Ask [Web log post]. Retrieved from https://www.translationalethics.com/2009/08/20/everything-you-always-wanted-to-know-about-clinical-research-in-china-but-were-afraid-to-ask/
Under what conditions is it ethical to perform phase 1, translational clinical trials in low and middle-income countries? Together with lead author Alex John London (Carnegie Mellon, Philosophy), I attempt to answer that question in the July 5 issue of Lancet (“Justice in Translation: From Bench to Bedside in the Developing World”).
The article makes three main points. First, we note that much discussion about international research has centered on post-trial access to interventions (that is, should patients enrolled in trials be provided with free drug even after a trial is completed?) However, we argue that this question is irrelevant for phase 1 studies, which test safety rather than efficacy.
Second, we note that most major national and international ethics codes indicate that trials conducted in disadvantaged communities should be responsive to local health needs. We suggest that this is the appropriate standard for determining whether phase 1 trials are consistent with international standards of fairness for clinical research.
Third, we attempt to specify what international policies actually mean by responsiveness. We suggest that a trial is responsive if it addresses an urgent, umet health need of a host community, and if it is part of a process of developing knowledge that can reasonably be projected to be applied in a host community. (photo credit: VCU Tompkins-McCaw Library Collections, 2008)
@Manual{stream2008-144,
title = {Ethics, Phase 1 Trials, and the Developing World},
journal = {STREAM research},
author = {Jonathan Kimmelman},
address = {Montreal, Canada},
date = 2008,
month = jul,
day = 22,
url = {https://www.translationalethics.com/2008/07/22/ethics-phase-1-trials-and-the-developing-world/}
}
MLA
Jonathan Kimmelman. "Ethics, Phase 1 Trials, and the Developing World" Web blog post. STREAM research. 22 Jul 2008. Web. 14 May 2024. <https://www.translationalethics.com/2008/07/22/ethics-phase-1-trials-and-the-developing-world/>
APA
Jonathan Kimmelman. (2008, Jul 22). Ethics, Phase 1 Trials, and the Developing World [Web log post]. Retrieved from https://www.translationalethics.com/2008/07/22/ethics-phase-1-trials-and-the-developing-world/
After scandals involving tainted toothpaste, poisonous pet food, adulterated milk, contaminated heparin, and counterfeit medicines, and a thriving trade in organs, one shudders to imagine how well human subjects are protected in drug studies performed in China. Apart from an occasional report in the medical literature, there is little easily accessible information about Chinese human protections: the regulations and laws, compliance and enforcement, and professional standards. This information would be interesting in its own right; however, it is all the more essential given trends towards trans-national trials.
