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Regulations and ethics of clinical trials

By Naveen Dha, News Medical

Clinical research is designed to improve human health and increase our understanding of human biology, ultimately leading to significant advances in scientific knowledge. The number of registered clinical trials has increased drastically in recent years, with more than 409 thousand globally registered studies as of March 2022. These studies are crucial for researching and developing novel drugs for treatment purposes.

In response to many past cases where patients were exploited, ethical guidelines and regulatory processes have been developed over the years to ensure that volunteers are protected and that the integrity of science is maintained.

Why are regulations and codes of ethics important in clinical research?

Regulatory and ethical principles have been put in place over the years due to unfortunate cases of unethical research that have occurred throughout history. One of the most well-known cases is the Tuskegee Syphilis Study. This unethical trial involved deceptively administering placebos to 400 African American males in Alabama with syphilis. These participants were led to believe that they were receiving treatment when researchers never intended to give any treatment but instead performed the trial to assess the progression of syphilis over time. Read more …