The Informed Consent is the most important document to ensure the doctor has fulfilled the informing obligation and to protect the rights of the participant. This is also one of the most important audit items in the review of the protocol by the institutional review board. The rights of the participant will not be reduced by signing the Informed Consent, which should be written with care and should not be considered as the simplified protocol. The Informed Consent should be written with the spoken language and suitability in mind.
Using the Spoken Language
The reader of the Informed Consent is the patient or their legal representative. This is why the content should be written in the descriptive form with friendly and spoken language. The content should be prepared based on middle high school grade-3 (basic obligatory education level) language level and avoid mix of Chinese and English. It is advised that the informed consent form be proofread by a reader of middle high school grade-3 language level before finalizing the content. If the reader can comprehend the text without further explanation, the goal of narrative writing is achieved. Non-medical staff in the Institutional Review Board contributes significantly to whether the content of informed consent from is narrative.
Content Suitability
The Informed Consent should not be too long but those parts of the content which might negatively affect the willingness of the participant to take part in the trial must be included. The Informed Consent can be deemed as part of the participation contract of the clinical trial, but it should not contain the whole contract. The reason is the clinical trial is highly technical, and it will complicate the Informed Consent and hinder understanding if all the content is included. The professional details can be included in the protocol or the investigator's manual, and it will be equally legally binding. The participant will not know and it will not affect their rights. Not all items related to the clinical trial are necessary to be included in the Informed Consent, for example, the include and exclude conditions do not need to be added. However, those parts of the content
Which might negatively affect the willingness of the participant to take part in the trial must be included. Those parts which might positively affect the willingness of the participant to join do not have to be included. For example, the insurance for the trial is meant for the transfer of liabilities in case of compensation. This might increase the willingness of the participant to take part in the trial, therefore, it does not have to be included in the Informed Consent. The protocol and principle investigator’s manual are legally binding. Any breach on the part of the principle investigator will have to bear the responsibility. This is the reason why the protocol or principle investigator’s manual has to be signed by the principle investigator, as their commitment to follow the protocol.
As specified in Article 52 of the Enforcement Regulation of the Medical Act, the Informed Consent should include “purpose of the Research”, “potential side effects and risks”, “expected effects”, “alternative treatments” and “the right of withdrawal for the participant anytime”. For studies other than new medical techniques, drugs or equipment, such as questionnaires, the Informed Consent should describe “purpose and method of the Research”, “effects on the respondents” (e.g., the time involved), and the contact information of the researcher. The Informed Consent can also be designed into a form which can be completed by filling-in the fields. Due to the different backgrounds of the participant in a trial, the Informed Consents can varies according to individual hospital, but they have to be reviewed and approved by the individual institutional review board.
ICH-GCP recommended that the Informed Consent should include the following 20 items, which should be checked one by one and make sure they have all been explained before the Informed Consent is finalized.
- The clinical trial is a research
- The purpose of the Research
- The treatment in the trial and the randomized possibility of each treatment
- Procedures and all types of intervention that will be undertaken.
- The responsibility of the participant
- The trial in the Research
- The expected risk or inconvenience for participants, embryos, babies or breastfed infants
- Reasonably expected clinical benefits. The participant should be informed in case there is none.
- Alternative treatments and their potential main benefits and risks
- Compensation and / or treatment for the participant should trial-related damage occurred.
- The participant should be informed if there is any expected reward.
- The participant should be informed if there is any fee expected to be paid.
- The participant should join the trial in a voluntary basis. They can decline to participant or withdraw from the trial any time without any punishment or harm on their rights.
- By signing the Informed Consent, the participant is deemed to have agreed that his medical history can be reviewed directly by the supervisors, examiners, institutional review boards/ ethics committees and health authorities, in order to ensure the compliance of the trial procedures and / or data with related laws and regulations. The identity of the participant will be kept confidential in all cases.
- The identity information of the participant should be kept confidential and should not be made public according to related laws and regulations. Should the result of the trial be published, the identity of the participant will still be kept confidential.
- Should there be any new information which might affect the willingness of the participant to stay in the trial, the participant or their legal representatives should be informed immediately.
- Provide further information of the trial, the contact person on participants’ rights and the contact person for trial-related damages.
- The expected conditions and reasons for the participant to withdraw from the trial
- The expected duration of the trial for the participant
- The estimated number of participants
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