Question 2: What regulations are in place to oversee the professional and ethical management of these

trials?

Both developed countries or not, restrictions are in place either to directly prevent trials or, at the very
least, to ensure the professional and ethical management of those trials:

• Many developing countries have laws against “first in person” trials to prevent the treatment of their
citizens as guinea pigs in highly experimental drug trials.

• Russia and China have both limited the export of blood and patient tissue samples in recent years,
partly out of concern over illegal trafficking in human organs.

• The FDA recently set up an office in China to increase inspections of the rapidly growing number of
clinical trials.

• The World Medical Association’s 2004 Helsinki declaration called for stringent ethical practices in drug
trials, but these remain voluntary practices

Reference: https://www.latestlaws.com/articles/clinical-trials-in-india-and-role-of-a-legal-expert-in-the-
ethics-committee-by-mrityunjoy-seal/