Why is informed consent important

It is also an important ethical consideration for doctors and healthcare providers. Informed consent means patients receive enough information to make an educated decision about their treatment. This may mean a physician explains the possible side effects, risks and benefits of a course of treatment or informs a patient of what other treatments may be available.

It can mean patients are given enough time, if possible, to consider their options and seek a second opinion, if appropriate. Informed consent can also mean patients are informed if treatment is recommended, as well as what might happen if they get no treatment. No one can guarantee positive outcomes in healthcare settings, but informed consent at least ensures patients understand the risks they undertake with treatment.

It is also the law. When patients agree to a treatment, they must sign paperwork indicating they understand the risks and agreeing doctors can take specific life-saving measures if needed. Informed consent creates trust between doctor and patient by ensuring good understanding. It also reduces the risk for both patient and doctor. With excellent communication about risks and options, patients can make choices which are best for them and physicians face less risk of legal action.

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Abstract Informed consent is an ethical and legal requirement for research involving human participants. Keywords: Human subjects, informed consent, institutional review board. Open in a separate window. Table 3 Informed consent and obligations. Table 2 Classification of informed consent. Figure 1. Religious Influence The informed consent process is designed to give every participant the liberty to decide whether to accept or refuse the recommended medical treatment.

False Expectations Even when there are no language barriers or religious impediments to hinder the communication relationship between researcher and participant, misunderstanding can still occur due to participants false expectations of the experiment outcome. Patient Perceptions Most patients believe that, trials will put extra burden on them. Vulnerable People and Groups Vulnerable groups include the person who is absolutely or relatively incapable of protecting their interests.

Indian Scenario In countries like India, the clinical investigations are based on regional values and practices, the concept of disease as perceived through social values and power hierarchies in family of villages based on cultural systems. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. Guideline for good clinical practice E6 R1 June. Berry IR. New York: Marcel Dekker; The Pharmaceutical Regulatory Process.

Clinical Trials of Drugs and Biopharmaceuticals. World Medical Association declaration of Helsinki. Ethical principles for medical research involving human subjects. The Belmont Report ethical principles and guidelines for the protection of human subjects of research. The National Commission for the protection of human subjects of biomedical and behavioral research; April International ethical guidelines for biomedical research.

Research involving children under the age of Short form written consent document. Investigator responsibilities-Protecting the rights safety, and welfare of study subjects October. Informed consent. Niazi SK. USA: Informa Healthcare; Handbook of Bioequivalence Testing. Guidelines for writing informed consent documents. Informed Consent Process Flow. Waiver of Informed Consent. Ethical Issues with Informed Consent. If they change their mind at any point before the procedure, they're entitled to withdraw their previous consent.

But someone with parental responsibility may need to give consent for a child up to the age of 16 to have treatment. Find out more about how the rules of consent apply to children and young people.

There are a few exceptions when treatment may be able to go ahead without the person's consent, even if they're capable of giving their permission. A person may be being kept alive with supportive treatments, such as lung ventilation, without having made an advance decision , which outlines the care they'd refuse to receive. In these cases, a decision about continuing or stopping treatment needs to be made based on what that person's best interests are believed to be.

To help reach a decision, healthcare professionals should discuss the issue with the relatives and friends of the person receiving the treatment. Treatment can be stopped if there's an agreement that continuing treatment is not in the person's best interests. It's important to note the difference between stopping a person's life support and taking a deliberate action to make them die.

Consent may be given orally , or it may be implied - as when a patient rolls up their sleeve and offers their arm so you can take their blood pressure. For more complicated procedures, you must obtain the patient's express consent, and this will usually be in writing, by signing a consent form.

It is vital that you give the patient all the information they need about the procedure and clearly document the information you have given the patient in their notes. To be valid, consent must be freely and voluntarily given by a patient with capacity who has been given all the information he or she needs to reach a decision. Patients should not be subjected to undue pressure or influence by medical staff or their family or friends.

Capacity is defined in the Mental Capacity Act , section 3 1. A person has capacity to make a decision for themselves if they can:. If any one of the four criteria is not met, the patient will be considered to lack capacity. If you have any doubt about the patient's capacity you should not proceed but instead seek the advice of your consultant or the MDU. You should consider consenting the patient as a 'process' rather than a single act.

You must ensure that you have given the patient all the information he or she requires to decide whether to undergo the treatment - otherwise the consent you have obtained will not be valid, even if the patient has signed the consent form. GMC guidance on consent sets out in detail the information you should provide.