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Clinical Research and the Law provides thoughtful and practical information on a broad range of legal topics related to clinical research, with an emphasis on subject injury liability. The book is useful for anyone who is not an expert in a particular area of law, with numerous citations for further investigation. The legal implications of conducting clinical research and trials are becoming more complex. Everyone involved in clinical research increasingly needs to be aware of not only the ethical issues at stake but also how the law affects medical practice and research.

Much of clinical research and trial law and litigation is comparatively recent and researchers need to ensure current compliance on a wide range of issues. Clinical Research and the Law comprehensively discusses these topics and provides the answers to the legal questions and potential pitfalls encountered in medical research. This book is also a key resource for medical students, postgraduate research students, practicing attorneys and counselors for teaching hospitals and institutions undertaking clinical research and contract research organizations. Enter your mobile number or email address below and we'll send you a link to download the free Kindle App.

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Ethical Issues in Clinical Trials (Lecture-49)

What is Clinical Law? A law firm with focus. Who does Clinical Law serve? How is Clinical Law different?

Top US institutes still aren’t reporting clinical-trial results on time

Clinical Law. Section 5 2 of the Act states that " [c]ontrols of any kind may be imposed for the purpose of giving effect to any Community provision or other international obligation of the United Kingdom. In practice it is most common for Orders in Council made under the Act to be in furtherance of European Union objectives, an example being under Title V of the Treaty on European Union provisions on a common foreign and security policy.

Although there is guidance from the EU on trading and engaging with rogue states for instance the European Union Code of Conduct on Arms Exports the regulations are not all-encompassing. Matters of defence and foreign policy are still within the proper domain of member states and since both of these areas are governed to a large extent in the UK by the Royal Prerogative it is not difficult to see instances where partnering with questionable regimes would be possible since it had not been specifically proscribed by the EU.


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Whether or not B has had a positive impact on foreign trade and the ability to partner with rogue regimes is difficult to say, since exemptions can be made under it if they are certified by the Secretary of State. Although this is not an ideal safeguard, it does force politicians to publicly declare the reasons for partnering with such a regime.

As the costs of research increase it is no wonder that pharmaceutical companies are looking to developing nations to conduct much of their research. Much of the marketing of multinationals is now trumpeting their commitment to human rights and the environment. Yet in the same breath these companies are lobbying in Washington in an attempt to have the Alien Tort Claims Act repealed by propagating the fiction that it will make it impossible for well-intentioned companies to know what conduct might subject them to liability or that it will stifle foreign investment. It is not cynical to suggest that this is the case because the Global Compact and the UN Norms do not contain a word about enforcement.

It is evident that in the absence of any effective international legal framework to address the dilemmas and complexities of research in vulnerable populations we are set to see the further abuse of human rights. It must be the case that if companies or states are going to reap the benefits of conducting research on vulnerable groups they carry out they requisite appropriate consultation.

Ethical review boards cannot be a 'one size fits all' but must take into account local concerns and address those concerns in liaison with local representatives and further in-roads must be made into the entrenched hostility on the part of drug companies to post-trial medical care. The greater the atmosphere of vulnerability the greater the level of consultation must be; in settings with foreseeable human rights violations, such violations much be captured.

The time is ripe for an international legal instrument to address these concerns and upon ratification in national legislatures to provide a substantive cause of action without excessive restrictions on locus standi which result in companies never being brought to book as 'victims' never make it to court. These are complex issues that demand attention, and in the absence of an international convention, it falls to creative and bold jurists to push for these issues in courts of law and various international fora.

Updated trials

We have previously listed considerations for conduct in difficult to protect populations, and these previous recommendations are updated here. These recommendations recognize that research is often required within specific populations, but that research should be health promoting, rather than risking placing specific or large groups of a population at risk of violence, detention, or other state-led abuses.

While no list is exhaustive and each setting is likely to be substantially different, these considerations address specific issues that are applicable to oppressed populations, where the likelihood of harm is impending. We predominantly argue that where oppression exists, the argument for conducting research in that population needs to substantially outweigh the negatives of not conducting the research. The central argument is the optimal balance between ensuring the safety of participants while advancing the needs of science.

The "intentionality" of the research endeavour should not only be to advance scientific knowledge but also offer practical benefits, or at least the hope of future benefits for the oppressed population.

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Researchers need to bear the burden of proof and strive to minimize coercion. They need to identify representative leaders who represent the diversity of opinions, conduct public deliberations in the spirit of participatory decision-making and try to ensure decision making as much as possible at the local level.

Some authors argue for a " modus vivendi " approach that favours decision-making via compromise rather than rational consensus. Good intentions alone are likely to be insufficient in protecting potential participants and so extra caution and planning is required. As the medical research world becomes increasing globalized, there is a need to make research both methodologically valid and culturally valid.

In the examples that we have highlighted, conducting research within oppressed populations stretches the current norms of medical ethics as well as stretching the current capabilities of international law. Human lives are inherently complex and no single ethical framework, including ours can claim to capture the complexity of research and understand the ethical dilemmas that arise in these diverse settings.

Paradoxically, legal course is least available to oppressed populations where the need is greatest. Ethical principals and legal approaches outlined above are not intended to be rigid inflexible pillars, rather as signposts along the way for researchers interested in grappling with this challenge of conducting research within vulnerable populations. In accordance with universal principals of justice, the "effective " participation of oppressed populations in decision-making will be an instrumental step in combating the social, economic and political forces of globalization that constrain human capabilities.

National Center for Biotechnology Information , U. Journal List Global Health v. Global Health. Published online Nov 8. Edward J Mills 1, 2 and Sonal Singh 2, 3, 4. Author information Article notes Copyright and License information Disclaimer. Corresponding author. Edward J Mills: gro. Received Apr 23; Accepted Nov 8. This article has been cited by other articles in PMC. Abstract Background Clinical trials evaluating interventions for infectious diseases require enrolling participants that are vulnerable to infection.

Discussion Using examples of HIV prevention trials in Thailand, hepatitis-E prevention trials in Nepal and malaria therapeutic trials in Burma Myanmar , we address the inadequacies of current ethical guidelines when conducting research within oppressed populations. Background There is an overarching assumption that medical research, in general, is a good thing. Thailand Conducting trials within a population that is not just marginalized but is actually under direct threat from government action poses its own problems for researchers.

Burma Myanmar In the examples of Thailand and Nepal, we present cases of clinical research that could have been conducted in populations other than the oppressed participant populations. Discussion These case studies illustrate the complexities and potential pitfalls of examining research from simply an ethical or simply a human rights legal framework.

United Kingdom There is not one exhaustive statute that deals with preventing government and the private sector partnering with rogue states or abusers of human rights. It provides: "If Considerations for the Conduct of Research within Oppressed Populations As the costs of research increase it is no wonder that pharmaceutical companies are looking to developing nations to conduct much of their research.

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Medical Research/Clinical Trials | Baker Donelson

Table 1 Considerations for conducting research in oppressed populations. Health Promoting For clinical effectiveness interventions, interventions should be health promoting and address a clearly population relevant illness. There should be a clear plan for how research findings will assist community, based on a priori agreement on how findings will be used.

This requires active engagement with target groups and plans for how findings should be interpreted with target group members. Opportunities to avoid exposures should be afforded to participants Exposures may include exposures to the target diseases or to human rights violations. This should include education e. Planned efforts to determine the human rights status of a particular population This may include formative research and background reviews of human rights NGO literature.

Community participation commensurate with level of political oppression There are few reliable ways to measure oppression. Due to the large geographical and cultural heterogeneity, there may not be a unified voice and so we need minimum standards for Community Advisory Boards CABs. CABs must include mixed levels of education, oppressive situations, age and gender They should be able to inform on the importance of the research and therefore, acceptability.

CABs may need to be outside target areas i.