Un-informed consent: the United Nation's failure to appropriately police clinical trials in developing nations.

• Author: McGregor, Molly

1. INTRODUCTION

   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)

2. HISTORY OF INTERNATIONAL LAW MONITORING CLINICAL TRIALS

   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)

   1. 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. (23) In 1964 the medical community articulated its own standard of informed consent with the Declaration of Helsinki. (24) While the Declaration of Helsinki has received acclaim, it is also a non-binding proposal. (25)

      The aforementioned international standards have established informed consent as one of the main safeguards in place to protect the rights and welfare of research subjects. (26) Drawing from prominent international guidelines, there are several universally accepted components of informed consent including an explanation of the procedure in a language that the participant understands, without using medical jargon, and a requirement that researchers should obtain consent without pressuring individuals. (27) Despite the clarity and general acceptance of informed consent, there is still a large gap between the theoretical ideal of informed consent and the reality of its application in international clinical trials. (28)

   2. U.N.'s Involvement in Policing International Clinical Trials

      The United Nations established the WHO in 1947 in an effort to aid individual in attaining the highest level of health. (29) The WHO and the United Nations worked together to expand the Declaration of Helsinki, and created the International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS Guidelines). (30) The Guidelines were intended to serve as a model for states drafting legislation on human research. (31)

      The Guidelines require the investigator to follow specific steps to obtain consent as part of the comprehensive approach to consent. (32) The investigator must inform the subject of alternative procedures or treatments available. (33) Additionally, the guidelines further regulate how researchers, funded by developed countries, should subject the research to ethical and scientific review, including a call for host countries to establish local ethical review committees. (34) U.N. efforts to regulate international clinical trials have been largely ineffective despite the CIOMS Guidelines and other regulatory efforts. (35) Part of this inefficiency stems from the fact that national legislatures are unwilling to deal with the problem of regulating trials within their countries because of their own desperation to import medical research for their citizens. (36) The United Nations is unable to combat these forces, and consequently has failed to create binding mechanisms, leaving states to act in their own narrow and economic self-interest. (37)

   3. International Clinical Trials Registry Platform

      In 2006, the United Nations launched the ICTRP in an effort to establish international norms and standards, and to facilitate greater public trust in clinical trials. (38) The United Nations believed that an effective way to facilitate fulfilling ethical responsibilities to patients would be to urge institutions and companies to register all medical studies. (39) Unlike past attempts at regulation, the United Nations has moved beyond international agreements, and instead approached the problem through private companies and institutions. (40) The WHO standardizes the way information on medical studies is available to the public through a process called registration. (41) It is important to note, however, that registration is voluntary, as are past guidelines like the CIOMS. (42) The WHO is not the first international organization to register clinical trials. (43) Yet, it believes that this particular registration will help manage and uphold ethical obligations, such as informed consent. (44)

      1. The ICTRP Initiative

         The WHO has worked on the ICTRP project for the past two years by enlisting the help of representatives of governments, pharmaceutical companies, journal editors, registry owners and independent research companies. (45) Ultimately the WHO established a standard twenty pieces of information research conductors should reveal about their clinical trial at the beginning of the trial. (46) It is important to note that the WHO did not create its own registry when it formed the ICTRP, but rather established standards and a structure of how existing registries should operate. (47) Under the ICTRP, the clinical trials are registered and given a unique tracking number that allows the international community to search the registry worldwide. (48) The ICTRP functions in a hierarchical manner: properly reported clinical trials will alert ethical boards and research-funding agencies of the existence of the trials, whose review will in turn ensure that such trials are ethical in both conduct and the prioritization of funding. (49)

      2. The WHO's Hopes

         Proponents of the ICTRP argue that registration will protect the participants and subjects in human trials because the ICTRP will provide greater disclosure of the clinical trial process. (50) The WHO ultimately believes that public registration of clinical trial data will contribute to more informed decisions and policy making in future clinical studies by alerting funding sources which research follows clinical trial regulations. (51) The WHO hopes that the positive changes envisioned by the ICTRP, international clinical trials will once again gain the public's trust. (52) Despite the WHO's positive attitude, the pharmaceutical industry has raised concerns about the ICTRP because it believes that these new requirements could jeopardize academic and commercial competitive advantages. (53)

3. THE DISASTER IN KANO

   The clinical trial of Trovan (Trovafloxacin) in Kano, Nigeria offers an example of the international community's failure to protect vulnerable people in Africa from an unregulated international clinical trial. (54) On August 29, 2001, thirty Nigerian families brought suit against Pfizer in federal court. (55) The families brought suit pursuant to the Alien Tort Claims Act and sought to recover damages for violations of international law established under: the Declaration of Helsinki, the Nuremberg Code, the International Covenant on Civil and...