As it is not perform correctly. It may

As written in Miller-Keane Encyclopedia and Dictionary of Medicine, consent is a voluntary agreement with an action proposed by another. If a person is giving consent, he must be sufficient in their mental capacity. A person who is a baby, which is mentally incompetent, or is under influence of drugs, is not in mentally stable for giving consent.What is an informed consent?An informed consent is consent of a client where the principles of autonomy and privacy are followed. This has become the requirement in decision making for health care and research Centre.There are 7 criteria in defining an informed consent: i. Competence to understand and to decide.ii. Voluntary decision making.iii. Disclosure of material information.iiii. Recommendation of a plan.v. Comprehension of terms (3) and (4).vi. Decision in favor of a plan.vii. Authorization of the plan. A person who gives an informed consent must meet all of these criteria but if the person rejects the plan, that person must have an informed refusal.Informed consent is defined by permission given by patient to doctor or other medical team regarding any procedure regardless involving surgical or non-surgical. Patient explained the purpose, indication, contraindication, side effect and benefit. Informed consent will be obtain once patient is understood and two way communication (questioning and answering) done. Informed consent is a medico legal issue if it is not perform correctly. It may affect the patient’s understanding and health if not well delivered. Some patient may sign the consent blindly without aware the consequences, as all procedure have its benefit and risk. Misunderstanding may sometimes happen as language barrier among the informer and receiver might become the issue. Misinterpretation of language among them might lead to different outcome. Patients have their rights to accepts, refuse and argue about the decision they are making, but it is the informer’s responsibility to explained.  Ethical principles for conducting research with human participants.Medical research involving human beings have created a lot of potential pitfalls that led to tragedies in the last century.In 1963 in Brooklyn; Jewish Chronic Diseases Hospital, a cancer cells were injected into debilitated elderly patients just to see if they would immunologically reject the cells and in 1972, Willow Brook State Hospital in New York; a retarded children were deliberately infected with viral hepatitis to study its natural history. So, it is clear that various cultures such as Persia, Ancient and Greece have attempted to regulate medicine and protect patient rights. Due to all of these cases, they were trying to avoid mistakes made in the past and to provide guidance for the future. These are the resulted in a series of International Declarations and Conventions which underpin all research involving human participants:• The Nuremberg Code (1947) set out ten key points for responsible research with human participants, including the need to obtain informed consent, the importance of proper planning and conduct, and the need for beneficence towards participants.• The Council of Europe (CoE) was created in 1949 and established the European Convention on Human Rights in 1953, which is now also embedded in Member States’ legislation.• The Declaration of Helsinki (1964) developed these ethical principles further by looking at issues such as informed consent in more detail.• A further Convention which specifically addresses human rights and biomedicine was produced in 1997 in the light of new advances in research.According to The US Belmont Report, they have the most concise summary of rights and obligations in terms of research and, as such, provide the foundation for research ethics guidance in several places around the globe. The Belmont Report includes three ‘basic ethical principles’ for judging the ethical treatment of human participants:i. Respect for persons: The personal dignity and autonomy of individuals must be recognized and there must be special protections for persons with ‘diminished autonomy’ (e.g. children and prisoners)ii. Beneficence: Researchers have an obligation to protect persons from harm by maximizing the anticipated benefits and minimizing the risk of harmiii. Justice: The benefits and burdens of research must be distributed fairly.The Belmont Report also includes that to ensure informed consent to be ethically valid; it must include components such as:I. Disclosure: The informed consent must be clear. II. Understanding: The participant understood about the explanations and they were given chance to question any doubt.  III. Voluntariness: The participant joint the research voluntarily without any outside event. IIII. Competence: Participant is fully competent to involve in the research. V. Consent: Participant must authorize their participation in the research study 


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