Academic journal article Suffolk Transnational Law Review

Un-Informed Consent: The United Nation's Failure to Appropriately Police Clinical Trials in Developing Nations

Academic journal article Suffolk Transnational Law Review

Un-Informed Consent: The United Nation's Failure to Appropriately Police Clinical Trials in Developing Nations

Article excerpt


In 1996, Pfizer, Inc. (Pfizer) distributed an unapproved antibiotic to patients in a field hospital in Kano, Nigeria. (1) Many children suffered and died as a result of this trial, and Pfizer has endured severe criticism for its failure to properly register its clinical trial. (2) Pfizer is not the only member of the international pharmaceutical industry that has gone overseas to test experimental drugs. (3) Other large pharmaceutical companies have also gone abroad in search of less stringent regulations and lower costs. (4) This desire among companies to avoid regulation and lower costs has contributed to the globalization of drug testing. (5)

This Note explores the United Nation's ineffective regulation of international clinical trials with human subjects. (6) Part II of this Note traces the evolution of U.N. efforts to police international clinical trials, including the World Health Organization's (WHO) International Clinical Trials Registry Platform (ICTRP). (7) Part III discusses a Nigerian family's recent lawsuit against Pfizer and suggests that that suit is indicative of the failure of past regulatory efforts. (8) In light of Pfizer's conduct in Nigeria, Part IV analyzes the ICTRP's potential effect upon international clinical trials, specifically dealing with the issue of informed consent. (9) Part V concludes that the ICTRP will only minimally aid in preventing the abuse of human participants in international clinical trials. (10)


Pharmaceutical companies cannot market a drug without first providing documentation that the medication is proven effective and safe for human use. (11) Despite the regulations, the number of American pharmaceutical companies testing their products abroad on human subjects in clinical trials has surged in recent years. (12) The WHO defines a clinical trial as "any research study that prospectively assigns human participants ... to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc." (13) The pharmaceutical industry, and its supporters, advocate for international clinical trials to facilitate and speed the entry of drugs into the market, providing aid to individuals in developing nations. (14) Others claim that pharmaceutical companies treat human beings as guinea pigs and take advantage of those most in need. (15)

A. The International Community's Effort to Promote Informed Consent

Informed consent is one of the most fundamental aspects of an ethical clinical trial. (16) Informed consent requires researchers to adequately convey to participants the risks and benefits of the trial, their rights, and an opportunity to decide whether to participate. (17) The information communicated to the patient must fully contain the choices available to her, so that she may make a meaningful choice. (18)

The international community first codified informed consent in 1949 with the creation of the Nuremberg Code. (19) The Code was a reaction to the Nazis' medical experimentation conducted during WWII. (20) It emphasized that knowing and voluntary consent must be a requirement in clinical studies, and highlighted that consent is only voluntary if the participants are able to consent, are free from coercion, and are capable of comprehending the potential risks and benefits involved. (21)

With the 1964 Declaration of Helsinki, the World Medical Association built upon the concept of informed consent by suggesting that the subject's consent should be obtained in writing. (22) However, the Declaration did relax the standard by providing that therapeutic research does not require informed consent where the researcher believes that it is unnecessary or difficult to obtain. …

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