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

By McGregor, Molly | Suffolk Transnational Law Review, Winter 2007 | Go to article overview

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


McGregor, Molly, Suffolk Transnational Law Review


I. 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)

II. 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)

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. …

The rest of this article is only available to active members of Questia

Sign up now for a free, 1-day trial and receive full access to:

  • Questia's entire collection
  • Automatic bibliography creation
  • More helpful research tools like notes, citations, and highlights
  • Ad-free environment

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items

Items saved from this article

This article has been saved
Highlights (0)
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

Citations (0)
Some of your citations are legacy items.

Any citation created before July 30, 2012 will labeled as a “Cited page.” New citations will be saved as cited passages, pages or articles.

We also added the ability to view new citations from your projects or the book or article where you created them.

Notes (0)
Bookmarks (0)

You have no saved items from this article

Project items include:
  • Saved book/article
  • Highlights
  • Quotes/citations
  • Notes
  • Bookmarks
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

1

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited article

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

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Full screen

matching results for page

Cited passage

Style
Citations are available only to our active members.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

"Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited passage

Welcome to the new Questia Reader

The Questia Reader has been updated to provide you with an even better online reading experience.  It is now 100% Responsive, which means you can read our books and articles on any sized device you wish.  All of your favorite tools like notes, highlights, and citations are still here, but the way you select text has been updated to be easier to use, especially on touchscreen devices.  Here's how:

1. Click or tap the first word you want to select.
2. Click or tap the last word you want to select.

OK, got it!

Thanks for trying Questia!

Please continue trying out our research tools, but please note, full functionality is available only to our active members.

Your work will be lost once you leave this Web page.

For full access in an ad-free environment, sign up now for a FREE, 1-day trial.

Already a member? Log in now.