Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

334
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
334
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

312
Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
312
Pharmacovigilance01:19

Pharmacovigilance

1.9K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.9K
Drug Regulation01:25

Drug Regulation

3.2K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
3.2K
Drug Control Governance: Regulatory Bodies and Their Impact01:03

Drug Control Governance: Regulatory Bodies and Their Impact

615
Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
615
Clinical Trials: Overview01:11

Clinical Trials: Overview

5.2K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
5.2K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Endocrinology Expert Witness: Bridging Healthcare and Law to Uphold Standards.

Journal of community hospital internal medicine perspectives·2025
Same author

PLIVA v. Mensing: generic consumers' unfortunate hand.

Yale journal of health policy, law, and ethics·2012
See all related articles

Related Experiment Video

Updated: Mar 1, 2026

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

4.6K

Informed consent: Enforcing pharmaceutical companies' obligations abroad.

Stacey B Lee1

  • 1Johns Hopkins University Carey Business School, 100 North Charles Street, Baltimore, Maryland 21201, USA. staceyb.lee@jhu.edu

Health and Human Rights
|October 9, 2010
PubMed
Summary

Pharmaceutical companies conducting clinical trials abroad face evolving obligations. The Alien Torts Statute (ATS) offers a viable enforcement mechanism for informed consent violations and human rights abuses in US courts.

More Related Videos

Working with Human Tissues for Translational Cancer Research
07:48

Working with Human Tissues for Translational Cancer Research

Published on: November 26, 2015

10.4K
Slow-release Drug Delivery through Elvax 40W to the Rat Retina: Implications for the Treatment of Chronic Conditions
07:49

Slow-release Drug Delivery through Elvax 40W to the Rat Retina: Implications for the Treatment of Chronic Conditions

Published on: September 17, 2014

12.0K

Related Experiment Videos

Last Updated: Mar 1, 2026

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

4.6K
Working with Human Tissues for Translational Cancer Research
07:48

Working with Human Tissues for Translational Cancer Research

Published on: November 26, 2015

10.4K
Slow-release Drug Delivery through Elvax 40W to the Rat Retina: Implications for the Treatment of Chronic Conditions
07:49

Slow-release Drug Delivery through Elvax 40W to the Rat Retina: Implications for the Treatment of Chronic Conditions

Published on: September 17, 2014

12.0K

Area of Science:

  • Pharmaceutical Law
  • International Human Rights Law
  • Clinical Trial Ethics

Background:

  • Pharmaceutical companies conducting clinical trials internationally have faced increasing scrutiny regarding their obligations.
  • International human rights organizations, governments, and media have influenced the development of these obligations.
  • Past and present recommendations for informed consent protections have been insufficient without robust enforcement.

Purpose of the Study:

  • To examine the evolution of obligations for pharmaceutical companies in international clinical trials.
  • To analyze the effectiveness of current protections for informed consent.
  • To propose a viable enforcement mechanism for accountability.

Main Methods:

  • Analysis of past, present, and future recommendations for informed consent.
  • Examination of legal precedents, particularly concerning the Alien Torts Statute (ATS).
  • Discussion of challenges posed by national sovereignty to international enforcement.

Main Results:

  • Existing obligations for pharmaceutical companies in clinical trials abroad lack meaningful enforcement mechanisms.
  • International enforcement is hindered by issues of national sovereignty.
  • Recent federal appellate court interpretations of the ATS provide a pathway for redress for victims of informed consent misconduct.

Conclusions:

  • The Alien Torts Statute (ATS) presents a viable enforcement mechanism for US-based pharmaceutical companies, enabling foreign trial participants to seek redress in US courts.
  • Enforcement through the ATS can hold sponsors accountable for informed consent violations and human rights abuses.
  • Leveraging ATS analysis can enforce substantive informed consent and human rights protections, ensuring the "right to health".