Guide to Clinical Trials

What should I know before joining a clinical trial?

It is an important decision for you to participate in a clinical trial. What you should do before enrolling in a clinical trial is trying your utmost to learn about the trial and consult the investigators including doctors and nurses to empty your questions and concerns.

What is informed consent?

Informed consent is the learning process for a clinical trial before deciding whether or not to participate it. In the process, investigators including the doctors and nurses have the responsibility to explain the details of the trial to someone who have not made a decision to involve in the study yet.

There also provides a written document called the “informed consent form (ICF)”, in which the purpose, risks and potential benefits, duration, required procedures, and important contact information of a trial are detailed.

The doctors and nurses involved in a trial can help you to make decision about participating in this trial or not by answering your questions. And your family, friends, or personal doctor can provide you with help as well.

About deciding whether or not to sign the form and participate in the trial, you should know that no one have rights to pressure or interfere with you in any way. It is for parents or guardians to sign the form and decide whether or not children can participate in a trial.

The subjects may withdraw from the trial at any time and for any reason without any restriction from informed consent, since which is not a contract.

Do clinical trial participants have specific rights and responsibilities?

Of course, all people who participate in clinical trials have specific rights and responsibilities. And the doctors and nurses involved in this trial have the responsibility to keep them knowing about these rights and responsibilities before deciding whether or not to take part in a trial.

The rights of participation include:

  • Clearly understanding the risks, possible benefits, tests that will be done, and other information of the trial detailed in the consent form;
  • Receiving the informed consent form that has been signed and dated;
  • Consulting the doctors and nurses for any questions about the trial at any time;
  • Withdrawing from the trial at any time for any reason; and
  • Asking for the results of the trial after it is completed.

The responsibilities of participation include:

  • Providing truthful answers to the questions that the doctors and nurses ask; and
  • Abiding by the clinical trial provisions detailed in the informed consent.

What are the benefits and risks of participating in a clinical trial?

The potential benefits of participation may include:

  • Taking care of oneself;
  • Having the chance to get new research treatments that are not widely available yet; and
  • Helping the patients suffering from the same disease in the future by your contribution to the medical research.

The potential risks of participation may include:

  • The probability of exerting unpleasant, serious, or even life-threatening exerting side effects;
  • The treatment failing to achieve the expected efficacy; and
  • The possibility of spending a lot of spare time and energy to trip to study site, be in hospital, or require complex dosages.

Before enrolling in a clinical trial, be sure that all of your questions about the potential benefits and risks of the trial have been discussed with the investigators.