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.

In principle you will make a profit. Subjects might be taking certain amount of risks by participating in a trial but their disease might be cured. In principle they are not paid to participate; however, they might be compensated for the inconvenience caused by the trial.

In general, the participation in the treatment of human trial is free of charge. Since human trials have not become conventional medicine, they are different from other treatments. Therefore, in principle, it is free to enroll.

No, the informed consent form is the most important tool to confirm that the research personnel have fulfilled their obligation to inform and to ensure subjects’ rights and interests. An informed consent form is not a binding contract but an evidence to prove that research personnel have obtained the inform consent from the subject prior to the commencement of research.
The subject’s name will not show up anywhere in the trial except for the informed consent form, which might be the only place with the patient’s name. Therefore the research personnel are responsible for properly maintaining these forms. In the case of leakage from research personnel, the person will be legally responsible for such breach of confidentiality.

If you still cannot decide whether to participate in this human trial after listening to the instructions given by the research personnel and asked all questions, please double check first if the trial has been approved by the Department of Health, Executive Yuan and the Institutional Review Board. Once you’ve confirmed that, please try to answer the questions in chapter 5 of this handbook (How do I know for sure that I have understood this trial well enough to make a decision?) to see if you have understand this experiment well enough.

Of course there are risks involved. Human trials are researches. The purpose of conducting a research is to explore the unknown. Since it’s about exploring the unknown, there are unknown risks involved. “Researches” are different from “treatments”. A “treatment” has undergone complete researches and has a known potential treatment effect, side effects and incidence rates. A “research”, on the other hand, involves unknown procedures and results.

No. Insured human trials are not necessarily safer. For those insured trials, you receive compensation from the insurance company instead of the hospital in the event of unpredicted serious adverse reactions. Therefore whether a human trial has been insured or not does not concern the subject. It doesn’t matter whether the compensation comes from the hospital or the insurance company, the subject will always be entitled to their rights.

No, an informed consent form is the evidence to prove that research personnel have obtained the subject’s informed consent form before conducting the research. When the subject’s illiterate, senile or has mental disorders that might result in the questioning of his/her decision-making capacities, in addition to the evidence of the written informed consent form, a witness should also be present to verify that the informed consent was obtained properly. Therefore the witness must ensure that the subject has fully understood the content of the all information and that his/her consent is of voluntary nature before signing and dating the informed consent form.

They might be able to. Every subject must go through a screening process before participating in a human trial to evaluate his/her health condition. Only those qualified will be able to participate. If a terminal illness is one of the screening criteria, patients with such illness might be able to participate in such human trial. If such illness is not one of the criteria, those patients should not become study subjects.

No, the informed consent form is the most important tool to confirm that the research personnel have fulfilled their obligation to inform and to ensure subjects’ rights and interests. An informed consent form is not a binding contract but an evidence to prove that research personnel have obtained the inform consent from the subject prior to the commencement of research.
In the event that the subject’s illiterate or incapable of signing the informed consent form, a witness should be present. A witness should sign and date the informed consent form after confirming that the subject has understood the content of all information fully and ensuring that the consent from the subject is voluntary.

You might be able to. The regulation stipulated that the informed consent form must be signed and dated by the subject him/herself. Under the condition that the subject is declared interdicted, the legal representative is authorized to sign on behave of the subject. In the event that the subject is rendered unconscious or mentally disordered to sign on his/her own, his/her spouse or family member residing with the subject is authorized to sign on behave of the subject.