Borders, International Ethics and Standards

The bedrock of clinical research is built on the scientific method: a methodical and logical process by which we can query a hypothesis by rigorous testing. In order to prove a hypothesis true, we must have challenged it in as many ways as possible to tease out truths. In the context of clinical research, this might involve testing interventions in a variety of settings to try and produce consistently supportive data and evidence indicating efficacy.

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However, not all humans are the same, and genetic diversity, environment and backgrounds can all play a role in the prevalance of disease, as well as the efficacy of given treatments in given demographics. For this reason, research cohorts should be as diverse as possible. Sometimes this means conducting clinical trials in multiple countries across legal and ethical borders. So how might ethical practices vary from country-to-country? How can you adhere to best practices and uphold participant wellbeing and safety when operating worldwide?

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Thankfully, the US Department of Health and Human Services has compiled a comprehensive list of all legal and ethical requirements in countries where human participant research is conducted. The International Compilation of Human Research Standards outlines over 1,000 standards in human research in 131 countries. Standards are separated into the following categories:

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• General, I.e. applicable to most of all types of human subjects research
• Drugs and Devices
• Clinical Trial Registries
• Research Injury
• Social-Behavioural Research
• Privacy/Data Protection
• Human Biological Materials
• Genetic
• Embryos, Stem Cells and Cloning

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Ethics Committee Definitions

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The cornerstone of ethical research is the provision of an ethics committee to fairly review experimental protocols and documents and ensure that participants are safe and protected. If you are already working in this space, you will likely already be familiar with some of the following terminology. These terms are often used synonymously but vary from region-to-region.

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Institutional Review Board (IRB)

United States: In the U.S., the term commonly used is Institutional Review Board (IRB). IRBs are responsible for reviewing and approving research involving human subjects conducted at their institution.

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Research Ethics Board (REB)

Canada: Canadian institutions typically have Research Ethics Boards (REBs) that review and approve research involving human subjects.

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Ethics Committee (EC)

Europe: In many European countries, the term Ethics Committee (EC) is commonly used. Each European Union member state may have its own regulations and structures for ethical review.

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Research Ethics Committee (REC)

United Kingdom: The United Kingdom often uses the term Research Ethics Committee (REC) for the bodies responsible for reviewing and approving research involving human participants.

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Ethics Review Board (ERB)

International Organizations: Some international organizations, such as the World Health Organization (WHO), may use the term Ethics Review Board (ERB) for overseeing research ethics.

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Institutional Bioethics Committee (IBC)

Latin America: In some Latin American countries, you may find committees referred to as Institutional Bioethics Committees (IBCs).

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Human Research Ethics Committee (HREC)

Australia: In Australia, the term Human Research Ethics Committee (HREC) is commonly used.

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National Ethics Committee (NEC)

Some Countries: In certain countries, there may be National Ethics Committees (NECs) that oversee and coordinate ethical review processes on a national level.

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Independent Ethics Committee (IEC)

International Pharmaceutical Industry: In the context of pharmaceutical industry-sponsored clinical trials, the term Independent Ethics Committee (IEC) is sometimes used.

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Keep up-to-date!

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While the information outlined by the US Department of Health and Human Services is currently versioned in 2021, every few years the information is critiqued and updated. To find the most up-to-date information provided by the US Department of Health and Human Services, click here.