Human trials are a mandatory and critical step to transform scientific research results into practical clinical applications. They are referred to as human trials in the Medical Care Act and clinical trials in the Pharmaceutical Affairs Act. There has not been a consistent terminology. From the perspective of trial subjects, human trials are not obligatory treatments and the participation may lead to unknown consequences. Therefore the informed consent form for human trials might look similar to those of regular medical procedures, the nature of which are entirely different.

The implementation of human trial involves scientifically unknown risks and therefore may not be beneficial to the subjects. In addition, subject welfare is not the primary objective for researchers when conducting human trials. Hence, there tends to be a conflict of interests between researchers and subjects during human trials. As a result, a subject’s consent for human trial is more important than a patient’s consent for medical procedure. A subject’s consent is not simply a signature on the informed consent form. It is a demonstration of consent after understanding the trial objective, meaning, risks and values by the subject. An effective communication between researchers and subjects is the key to subject consent. The informed consent form itself is a record of such communication process.

Indemnification or insurance terms entitled to the subjects in the event of injuries during human trials must be stated in the informed consent form in accordance with article 79 of the Medical Care Act. The content of this article aims to clarify the responsibilities of hospitals, physicians and trial sponsors to compensate and indemnify and to provide a template for the content of informed consent form referring to the compensation and indemnification.

Provision 1 of article 79 of the Medical Care Act states: “When conducting human trials, medical care institutions shall pay proper attention to the medical procedure, and shall first obtain a written letter of consent from the trial subject.” Statutorily, the parties involved in a human trial include the medical institution and subject; therefore, the medical institution is the indemnification obligor in the case when injuries happen and compensation is to be paid to the subject. Even though several medical institutions request trial sponsors (such as pharmaceutical companies) to sign an affidavit which demands compensations to be paid by the sponsor on behalf of the hospital, according to article 268 of the Civil Law: “When one party of the contract had an agreement with a third party to pay to the other party and the third party refused to pay, the party is still held liable for the compensation.” From the perspective of the subject, the medical institution remains liable to compensate the injuries attributable to the human trial.

Some medical institutions request trial sponsors to sign an affidavit to transfer the liability to compensate the subject. However according to the “Good Clinical Practice”, such affidavit should exclude situations where the injuries are caused by medical malpractice. Article 47 of the Good Clinical Practice states: “The trial sponsor should be liable for the indemnification related to the trial caused by the trial investigator or trial institution or should be responsible for purchasing liability insurance. Indeminification attributed to medical malpractice are not included.” That is, the individual responsible for the medical malpractice (medical institution or trial personnel) is liable for providing indemnification for injuries resulted from such malpractice. Such liability cannot be transferred to the trial sponsor.
Some informed consent forms might have terms such as: exemption from liability to indemnify. According to article 18 of the Good Clinical Practice:” The informed consent form or any written documents relating to the subject shall not cause subjects, legal representatives, or authorized individuals to waive their legal rights or exempt trial investigator, trial institution, trial sponsor or any agents from any liabilities. Any provisions violating the above statement are rendered ineffective.” Therefore, in a human trial, indemnification for injuries (misdemeanor) shall not be waived by citing article 222 of the Civil Law. Indemnification for injuries not attributable to medical malpractice can be transferred to the trial sponsor. The medical institution or individual responsible are, however, liable for indemnification resulted from medical malpractice. In addition, the medical institution is jointly and severally liable for all indemnification.

Negligence refers to any action that should or could be prevented and yet is failed to be prevented by the individual. Regardless of human trials or conventional medical practices, individuals resulting in such negligence shall be solely liable. This is to follow out the principle of liability in order to govern the individuals in fulfilling their duties. As a result, article 47 of the Good Clinical Practice states: “Events attributable to medical malpractice by trial investigator or trial institution are not included.”

In conventional medical practice, if there is no negligence involved in the medical practice; then the known risks (side-effects) of the medication should be the responsibility of the pharmaceutical company. In Taiwan, it is decompensate by the Drug Relief Fund to protect patient and reduce legal action. It also conforms to the principle of consumer protection law. However, if the injury was caused due to an unknown risk or was beyond the expected risk level, given that it was unknown or unexpected by the trial sponsor, the sponsor shall not be the liable such injury.

The repartition of risk is different in human trial and conventional medical care. Provided that the treatment method, effectiveness and safety level are uncertain in a human trail, uncertainty of the result is higher than that in conventional medical care. For subjects, it is not obligatory to accept the risk. In human trials, given that there is no medical malpractice involved, the subjects are burdened with known risks, which demonstrates with the function of the informed consent system. Whereas if the unknown risk or injury was beyond the expected level, according the human trail ethic point of view, the trial sponsor is responsible. However, the trail sponsor could transfer the risk by purchasing human trail insurance. Therefore, in Taiwan, the insurance coverage for the human trail includes: “the insurer will be liable to indemnify, according to the terms of the informed consent form, in case of injuries caused by adverse drug reaction or death of subject during the human trail as insured by the medical insurance. The insurer should inform the insurance company during the trail period and request for compensation. The insurance company will be liable to compensate the insurer.” The exclusion clause states: “The term covers the compensation liability for the expected side-effects of the insured drug but not those beyond. This is based on the same principle.

Note: The medical care facility is jointly and severally liable for all injury indemnification.