An informed consent form is an important document to confirm that the doctor has fulfilled his/her obligation to inform and to ensure the interests and rights of the subjects, and therefore should be approved by the Institutional Review Board. Signing the informed consent form will not compromise the subject’s interests. The subject must read the informed consent form carefully and make sure that he/she understands every aspect of the human trial.

An informed consent form begins with a simple background introduction on the importance and objective of the trial. If the trial is a new drug clinical trial, the introduction will also include the global market condition.

This section explains the procedure of the study. It explains how many groups the subjects will be divided into, the chance of receiving the effective treatment, duration of human trial, approximate number of subjects, how to cooperate with the trial (such as birth control and no driving), and what kind of inconvenience the trial will cause (such as how often are the return visits, how many c.c. of blood will be drawn, what kind of tests will be performed etc.). In principle, no information that might reduce the subject’s willingness to participate in the trial can be omitted. If invasive tests are to be performed, it must be stated clearly. If the subject cannot obtain sufficient information from the informed consent form, make sure to ask the research personnel.

Should there be any specialized terms incomprehensible, the subject must ask the personnel to clarify the terms. Take a commonly conducted “randomized and double-blinded” trial for example:

This trial is a randomized and double-blinded research. The purpose of which is to ensure that the results cannot be distorted by human factors. Half of the subjects will be administered with study drugs while the other half with “placebo drug”. The so-called “placebo drug” is an active drug with an identical appearance to the study drug. The decision of who will receive the study drug and who will receive the “placebo drug” will be determined by the ratio similar to flipping a coin. Neither you nor your study doctor will know which medication you receive.

The emphasis of this section is to explain the degree of risks involved in participating in the trial. Therefore it should include detail description of the incidence rate of side effects based on previous data, preferably in figures, without concealing any information. Side effects of low incidence rates can be stated as “side effects with less than 1% incident rate in prior cases”. Subjects should be aware of whether the trial involves major risks of death or infertility as well as the incidence rate. Of course they should also be aware of the contact method and procedure in the event of dangerous or emergency condition, possible treatment methods the doctor may adopt as well as the foreseeable circumstances and reasons that might lead to the termination of their participation in the trial.

The emphasis of this paragraph is to explain the benefit for participating in this trial, thus must provide detail information regarding the anticipated effects based on existing data. The content must be thorough and comprehensive, preferably with actual figures. For example: describe the percentage of patients that will be cured; the percentage of condition that can be controlled and etc. The statements must base on concrete evidence and should not exaggerate.

The section explains the restrictions and limitations that the subjects should cooperate with during the trial such as what type of food or medications are not allowed, adopt birth control methods, no driving and etc.

Even though the trail will strive to protect the subject’s privacy, the following statement will be included to explain the responsibility for breach of confidentiality:

We will keep your trial results and diagnosis confidential by replacing your name with a research code. Apart from complying with the regulatory investigation by the authorities, we will protect your privacy carefully. The subject will remain anonymous even when the trial results are published.

• Losses caused by the adverse reactions arising from the human trial project stipulated in this research will be compensated by the OOO Company (or co-compensated with the OOO Hospital). Anticipated adverse reactions listed in the informed consent form will not, however, be compensated.
• The hospital will provide professional medical care and consultation in the event of adverse reactions or losses arising from the human trial project stipulated in this research. You will not be responsible for the medical charges accrued from the treatment.
• In addition to the above indemnification and medical care, the study will not provide any additional compensation in any other form. If you are not willing to take the risk, please do not participate.
• You will not waive any legal rights by signing this informed consent form.
• (This research is insured against liability. This research is not insured against liability.)

During the trial, the subject’s rights and obligations are usually explained by the following statements:

• The trial institution will defend the rights and interests entitled to the subject during the trial.
• The subject reserves the right to withdraw his/her consent or terminate his/her participation during the trial at any time without causing any unpleasantness or affecting the medical care that he/she might receive in the future.
• When discovering any new information that might affect the subject’s willingness to continue his/her participation in the trial, the subject or his/her legal representative must be informed immediately.
• No additional costs are required to participate in this trial.
• There are two copies to this informed consent form. The doctor has returned the duplicate copy to you and has explained in detail the nature and the objective of this research. Dr. OOO has answered all of your questions related to the drug and research.
  

Finally the contact information for the Institutional Review Board (IRB) will be provided. The IRB is an auditory committee set up to protect the rights and interests of the subjects. Subjects can verify the relevant information with the IRB directly. The following statement might be included in the informed consent form:

Your decision to participate in this project is of voluntary nature. You reserve the right to refuse to participate. If you have any questions regarding your rights and interests for participating in the trial, you can contact Mr. /Ms. OOO at the Institutional Review Board through the following methods:

TEL: ****-**** FAX: ****-**** E-mail:

The informed consent form might conclude with a statement to let the subject know to what trial he/she has given consent. It is preferable that a witness be present at the time of signing to verify that the content of the informed consent form as well as any other written documentation has been provided and explained to the subject or his/her legal representative. The subject or his/her legal representative has understood the content and given the consent voluntarily. The following statement might be included in the informed consent form:

Subject statement:
The above information has been explained to me. I have had the opportunity to ask questions concerning the project. I have also understood and consented to participate in this trial project. If I have questions in the future, I can contact Dr. OOO at the OOO Hospital.

Subject name:
Subject/Legal representative signature:
Date: ______year ______month ______date
Legal representative name (when signed by the legal representative):