Informed consent in clinical trials: not just a form


It is not an exaggeration to say that patients determine the outcome of the clinical trial since they are the subjects of the research – meaning that their reactions to the tested drug or therapy decide whether or not the regimen can appear on the market.

Therefore, guidelines have been put forward in the Good Clinical Practices (GCP) by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in order to protect participating patients by making sure that they totally understand what will happen through a process called informed consent.

Normally, we only perceive informed consent as a piece of paper in which details about the trials are laid out for the patients to sign. However, ICH affirms that it is not that simple. Informed consent is a process in which investigators and researchers get voluntary agreement from the patients who are capable of making the decision to take part in the trials by providing them with adequate information.

Information disclosure

There hasn’t been a rigid template of an informed consent form, yet ICH has proposed some key information that must be present on the form including the purpose and duration of the study, expected benefits and risks that the patients may receive, research procedures, availability of alternative treatments, rights to withdraw anytime without being denied of benefits, and any other information that a patient needs to make an educated decision.

Note that these details must be written in language that patients can fully comprehend. This may not seem like a big deal at first, but considering the density of jargons in the pharmaceutical industry, this becomes not an easy task. Patients have the right to ask any question relating to the trials, and here investigators can explain verbally any misunderstanding that exists.

Voluntary agreement

Both study conductors and patients must be aware that a decision to join the trial is completely voluntary. In other words, patients’ choices to become research subjects are to be free from coercion, persuasion and any kind of influence.

As much as a patient is willing to participate in the trial at first, he or she can choose to opt out at any time during the research if he or she feels uncomfortable or that he or she is exposed to harmful impacts. Forcing the patients to take steps that they don’t want to do or complete the trials against their will is against the law.

Decision-making capability

Though less obvious than the two categories mentioned above, the capability to make a rational and informed decision must be taken into account. There are a lot of cases where some health problems prevent patients from being conscious of the situations; for example, a schizophrenic patient who does not believe that he is ill, or a person too sick to think clearly. It is important that the Institutional Review Board (IRB) or Institutional Ethics Committee (IEC) pay careful attention to special cases before admitting them to the trials.

This aspect should not be confused with competency. For instance, a 16-year-old patient is capable of making a decision but is not competent enough by law to make the decision on his or her own. Children under 18 need consent from their legal guardian.

The ICH regulates that the patients should be given enough time to think through before they give an answer on whether or not they would like to join the clinical trial as research subjects. This further emphasizes that informed consent is neither a paper form nor a contract, but a long process to help patients get the whole picture of the trials before they decide. As long as this step is carried out carefully and properly, the trial will stand more chance of success.