An “Institutional Review Board” is an auditory committee set up to ensure that the human trials comply with the scientific and ethical standards. It consists of medical personnel, legal experts, social justice, representatives of local organizations, non-governmental group representatives and non-medical professionals to help research staff understand the condition of subjects and to ensure their rights and interests. Subjects with questions concerning their rights and interests for participating in the research can consult the Institutional Review Board at the hospital directly. In addition, there are also “Joint Institutional Review Boards” that operate independently from the hospitals to ensure subjects’ rights and interests.

Participation in a trial is not obligatory. You must know the followings before participating in a trial:

1.What is the objective of this trial?
The objective of a research is to increase knowledge. Therefore you should know what kind of information this trial is exploring. Research personnel should use a narrative and simple language to explain the objective of this trial and whether your participation is obligatory. If you are not willing to participate, what other treatment options are available.

2.What will happen during the trial?
You need to know what will be performed on you during the trial, how you should cooperate (such as: What is the frequency of return visits? How much blood will be drawn each time? What kind of tests will be performed?), and what kind of inconvenience it will cause (such as: no driving and needs to use birth control).

3.What are the potential adverse reactions?
All trials come with risks; therefore, you need to know the extent of risks involved in participating in this trial. Make sure to ask from the existing information what the potential side effects and their incidence rates are, preferably the exact figure of incidence rate. In the event of dangerous or emergence conditions, make sure you know what to do, who to contact, how to contact them, who will provide subsequent medical treatments and who will be responsible for the costs. You should be clarified all the details before participating in the trial.

4.What are the benefits and anticipated effects for me?
Participation in the trial is not obligatory; therefore, you should think about it carefully before you participate. You should understand that the “research” might not be beneficial to you. A “treatment” is a proven procedure that is beneficial to patients whereas a “trial” has unknown effects. Therefore a trial will not necessarily help the participants. The result of the trial might, however, help people with similar health problems. Overall, you should take a moment to think about whether you would like to participate in the trial and also be aware of the anticipated effect that you should expect without holding an over-optimistic expectation.

5.Are there any other treatment options available besides participating in the research?

• The doctor in charge of the human trial has the obligation to be familiar and comply with the relevant ethical and legal principles for obtaining informed consent:
  
• Patient’s consent must be a decision made under a pressure-free environment and with decision-making capabilities.
  
• Unless under an emergency condition or otherwise stipulated by the law, the doctor must obtain the patient’s consent before conducting examinations, treatments or any other medical interventions. The consent for human trial must be in the form of a written informed consent form signed by the subjects.
  
• Doctors should take proper steps and approaches to provide the following information to the subjects in order to allow the subjects understand their own condition as well as the information concerning the treatment in the human tria

  1.	Trial objective, method and relevant tests.
  2.	Subject responsibilities including restrictions, limitations and instructions during the trial.
  3.	Foreseeable risks and inconveniences for subjects, fetuses, infants, or breastfed babies.
  4.	Reasonable clinical benefits that can be expected. If the trial does not involve any clinical benefit, the subjects should also be informed.
  5.	Other treatment methods or procedures as well as their potential benefits and risks.
  6.	Indemnification and/or treatments entitled to the subjects in the event of trial-related injuries.
  7.	Participation from the subject is of voluntary nature. Subjects reserve the right to refuse to participate or withdraw from the trial at any time without being penalized or compromising the entitled interests.
  8.	Subject identification records should be kept confidential and remain undisclosed under the relevant laws and regulations. Subjects will also remain anonymous when the trial results are published.
  9.	If the new information might affect subject’s willingness to participate in the trial, he/she or his/her legal representative should be informed of such information immediately.
  10.	Acquire information relevant to the trial and find out who the subject’s contact person is and his/her contact method for subject’s interests and rights and the contact person and his/her contact method in the event of injuries incurred during the trial.
  11.	Foreseeable situations and reasons for subjects to terminate their participation in the trial.
  12.	Estimated duration of subject’s participation in the human trial.
  13.	Approximate number of subjects participating in the trial.

• Subjects with decision-making capabilities reserve the right to refuse to participate in the trial.
• For subjects rendered incompetent or declared interdicted, the doctor should obtain their signatures on the written consent form according to the Medical Care Act. The legal representative is authorized to give the consent on behave of the incompetent subject. In the event that the subject is declared interdicted, his/her consent should be validated by the legal representative.