Have you recently used the phrase, “Well, in one study it was found…?” This statement is usually used in reference to a new tidbit that may improve your health. But have you ever wondered about the people participating in these studies? One day, perhaps even you might be asked to participate in clinical trials. Before you do, it is important to understand informed consent.

Sometimes, agreement is not enough. In instances where the person may not be aware of the details, it is not only necessary to take the time to enlighten them but is in fact a moral requirement. For example, say a person agrees to clinical trials on hair growth. They believe their participation is just for the examination, but are unaware that their results pictures from the tests may be distributed to outside parties. Would they still give full consent?

That is a minor example, although some patients are very particular about how their information is shared. Clinical study is an area that has at times drawn public ire due to some medical research studies that probed into patients’s psychological health. The Milgram Study is one famous study that examined the link between authority and violence. The study was manipulated so that the participant believed they might be causing physical harm to another person behind a glass while a scientist appeared in an authoritative overseer position. It is unlikely that clinical trials advertising psychological manipulation would have many volunteers. Due to the questionable nature of some proposed trials, the American Psychological Association’s Ethical Code 9th edition contains in section 8.02 specifics outlining informed consent. One such provision is that when anyone under 18 years of age is the subject of a study, the patient’s parents must give proper consent.

But what about clinical trials featuring new medicine, or new procedures? Informed consent is very important in Phase 1 clinical trials too. Clinical drug development is a long process. The testing in Phase 1 is so important, and yet it can be a little frightening for the participants. The small group of 20 to 80 people need to be confidant that their health is the highest priority. Also, when they know what is normal and what is not, it is easier for them to report any side effects.

People want to trust their doctors. For them to have complete faith in figures of medical authority, it is vital that the lines of communication are kept open. Keeping study participants in the dark about the possible side effects, or long-term effects, is simply negligent. Informed consent is the right way.