Schools Training

Issues Surrounding Clinical Research Testing on Humans

9 OCT 2012
Career Path : Healthcare

“Man is the measure of all things.” Spoken by the ancient Greek philosopher Protagoras almost 2500 years ago, these words still form the basis of much human activity and many of our opinions. While the philosophical truth of this is constantly in debate, it is nonetheless meaningful regarding other aspects of our day-to-day existence. When it comes to inventing and developing new things for mankind, whether to entertain us, educate us, or give us happier and healthier lives, the best basis to determine the efficacy of these new inventions and developments is to test them on ourselves—in other words, to use our experience and reaction as the measure.

This is nowhere truer or more significant than it is regarding new medicine and pharmaceutical drugs. If treating human disease and illness is the intended goal of new developments in pharmaceuticals, than it goes without saying that the only way to know if they work, and if they are safe, is by testing the drugs on human subjects. But there are many issues surrounding this. For example, if a new drug is being tested then there is a chance it can be harmful to the human subject. Secondly, the drive to further testing and new development might disregard the human’s subjectivity in terms not only of their immediate health, but privacy and personal integrity as well.

Clinical research therefore has certain ethical standards that must be followed when using human subjects for clinical testing. They may differ from country to country, but there are some internationally recognized standards, for example the Nuremberg Code of 1948 and the Declaration of Helsinki on 1964. Here are some generally agreed-upon ethics for human testing:

– Preliminary testing should be done first with animals where possible to eliminate any immediate unforeseen dangers.

– The procedures of the test should be clear and revealed to an overseeing committee beforehand, and if possible, to the subject.

– Every human subject should participate in the testing on their own free will, and to obtain formal documentation attesting to their voluntary participation.

– The human subject must be allowed to change their mind at any time during the testing, and even before testing has begun.

– The test should not place the human subject in any serious danger or cause any extra, unnecessary physical or psychological harm.

– The risks involved in being tested must not be greater than the benefits being anticipated from the results.

– The clinical research must have as its goal something beneficial to the healthcare industry and society as a whole, and not be done for pure commercial or superficial reasons.

– The human subject must be respected in his or her capacity as a human being, in terms of personal integrity and privacy.

These are some of the most important ethical guidelines surrounding clinical research and human testing. Across the country, many students are learning the finer details of such standards in clinical research training. Improving our national health should be a main goal of our society, but only with a responsible system of clinical testing.

Visit the Academy of Applied Pharmaceutical Sciences to find out about taking clinical research courses.