Research with humans

From The Embassy of Good Science

Research with humans

What is this about?

In research with humans, human beings are not only researchers, but also the main subjects of research. Such research can be observational or interventional, and can be medical (including biology, physiology, and clinical trials) or non-medical (social science, political science). Because of ethical issues arising from human research, this area is heavily regulated, to protect the rights and dignity of research participants.[1]

  1. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. World Medical Association Declaration of Helsinki Special Communication. JAMA. 2013;310(20):2191-4.

Why is this important?

New drugs. procedures and treatments require detailed testing to ensure they are safe, effective and do not harm those undergoing the treatment or taking the drug. While a lot can be answered using in vitro experiments and animal testing, testing on humans is necessary in order to verify the safety and efficacy of novel treatments.

For whom is this important?

What are the best practices?

Throughout history, multiple violations of ethical principles in human research have occurred. The most widely known are perhaps the inhumane experiments conducted by the Nazis and Japanese during the WW2. In the aftermath of the WW2, the Nuremberg Code was published to provide basic guidelines in human research. To further improve the ethics of human research, the World Medical Association developed the Declaration of Helsinki in 1964. While providing some guidance, instances of unethical research persisted. In the United States, a large study was conducted to assess the impact of syphilis, and hundreds of participants were barred from seeking treatment in what was known as the Tuskegee experiment. Following the public outcry, the Belmont report was published in 1978. These documents set important standards in human research and provide the foundations of medical ethics. Some of the important points are respect for the person, personal autonomy (and informed consent), justice, and beneficence. Nowadays, different countries have national laws, informed by the aforementioned international guidance, regarding clinical research and oversight by research ethics committees.

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