An ICF (informed consent form) is one of the imperative medical documents. Medical translation has become evident to cater to the medical needs of people all over the world. This practice involves the translation of several documents such as training material, medical bulletins, drug details, and data sheets. It also includes the translation of the handouts of the medical devices and equipment such as clinical and regulatory content. Almost all countries demand that medical companies submit the literature content and labels for medical devices and pharmaceutical content in their respective language. Professional medical document translation services require a lot more from translators and translation agencies. They have to put extra effort into their content as there is no room for errors in the medical content. Medical text and content include a variety of documents. This includes content that has anything to do with the patient by any means or reference.
Certified medical document translation services also include the translation of the informed consent. It is an important and significant medical document that is important to sign for the safety and protection of the patient as well as the healthcare center. It is important that patients sign this document for ethical and moral reasons. One of the primary reasons that authorities report, in medical and malpractice suits is the lack of signed informed consent by the patient. As they are of the belief that the patients don’t really understand the risks of the ongoing treatments or undergoing serious surgery and alternative options. That is true to a certain extent, as per the reports despite the well-educated patients, the patients barely understand the risks and problems that the treatment may involve.
Seven basic features of informed consent
Informed consent is a medical document that patients sign formally. However, it is not simply content. It rather holds serious responsibilities and consequences in case of not using these. There are seven elements of informed consent which are the basics of this document. Moreover, informed consent is legally not a document if it does not meet the needs of patients or legal guardian representatives.
- The patient must understand the content of the informed consent. and they should be mindful of the fact about the presentation of the content.
- There should be no pressure or burden on the patient and he should sign the document of free will voluntarily.
- The material information that the healthcare staff is going to use for the surgery or any procedure should be open for the awareness of the patient.
- The plan and procedure for carrying out the treatment should be clear and open for the patient’s convenience.
- The patient must be able to understand the treatment, the way they plan to execute it, the material information, and plan for the whole treatment
- The patient should be able to make a decision of proceeding with the treatment plan without pressure.
- Last but not the least, the treatment plan should have the authorization of the patients with signatures.
Usually, the patients refuse to sign the informed consent when the medical people do not make these abovementioned elements points clear to the patients. However, eventually patient has all the right to not accept the plan and back out.
Process of the informed consent form
Medical and pharmaceutical translations are a complex process. Each and every document requires approval to carry out and execute to protect the patients.
The process of informed consent forms should be treated as a cultural norm for all practices including a dental practice. The physician or the dentist should educate his patient about his diagnosis and about treatment. They should share the condition, they are going through and physicians should also motivate the patient to get better treatment. Also, they should try to not scare or bewilder him with unnecessary details and outcomes. Educating a patient can make him feel more comfortable and relaxed and he can sign the informed consent more voluntarily.
Importance of translating ICF
The procedure and its sensitivity which requires the patient to sign an informed consent may vary with the laws of each state. However, a good rule of thumb is whoever is getting the treatment should be the one to sign the informed consent. Also, the whole healthcare staff and physicians should be vigilant with it and should play their role. The healthcare center should make sure they have the backup for the informed consent translation for dental clinics too for the patients who are coming to get dental treatment.
The staff can help in educating the patients by making them read the brochures and handouts, and watch videos. However, all content should be in their native language. They can also show them some signed consent forms and can serve as a witness during the whole process. They should ask the patient for any concerns and questions before signing the document. The patients should not hesitate to share their concerns and reservations if any before signing the document. They should be familiar with the alternate methods and mediums to verify if they are getting the right treatment. They should feel free to acquire pharmaceutical translation services if they face any difficulty reading about pharmaceutical content.
This is a significant aspect of the informed consent process. Hence, with all these details translation of these documents is mandatory to cater to the needs of the patients. These patients with limited proficiency in the main language have all the rights to get the content in their mother tongue. Translation services in the pharmaceutical industry play a vital role to make people understand their rights as patients.
Medical practices are tough and complicated, and so is medical translation considering the complexities it involves. The medical documents are apparently simple documents that the healthcare staff deals with on daily basis. However, each of these is important and informed consent is one of the most important documents which the patient has to sign to give his consent for the proposed treatment. Similarly, the translation of the informed consent is also significant to deal with patients who speak different languages and come from different backgrounds.