Informed Consent Form Clinical Trials – Everybody should be able to make educated decisions about their medical care. Treatments for medical conditions can be risky, therefore patients should be able decide, based on known risks of their body, how it will be treated. Thus, before medical personnel are allowed to be able to treat their patients, they need to receive the process of informed consent.
Informed consent is a legal condition under which a patient is provided with detailed information about the physical condition and the treatment suggested by the doctor in charge. Once this information is received the patient must provide the physician with consent to treat prior to any form or treatment can be delivered. Without the patient’s informed consent health care professional cannot offer treatment.
Decision Making Capacity
In certain situations patients may not have the skills to comprehend their options in terms of treatment and the potential risks and benefits associated with each. In other situations, patients may not be able communicate their decision to health workers. In such situations the patient is considered not to possess the proper capacity to make decisions. A family member or court-appointed representative then, is allowed to perform informed consent instead.
Patients who are strongly affected by their emotions, like anxiety or fear, for example they could be judged as not having the capacity to make decisions. The ones who are asleep clearly can’t make decisions on alone, and external parties must provide consent for treatment instead.
Items in an Informed Consent Form Clinical Trials
Certain elements are generally included in informed consent forms:
The patient’s medical diagnosis/condition
The procedure recommended by the doctor in charge
The risks and benefits that come with this procedure
Alternative treatments are offered, as are their benefits and risks
The dangers and advantages with refusing any treatment whatsoever
These items must not only be documented in a written document, but they must also communicated with the person receiving the treatment. So, he can be fully aware of the particulars of the case and will be able to get immediate answers to any concerns that might have arisen.
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