WHAT voluntary action to say ‘yes’ that has

WHAT IS A CONSENT?Consent is a consistency voluntary actionto say ‘yes’ that has been proposed by another person.

If a person was giving aconsent, that person must have an adequate level in their own mental capacity. Theperson who is a mentally incompetent, or under an influence of drugs, he or shewas not in mentally stable for being consented as written in Miller-KeaneEncyclopedia and Dictionary of MedicineWHATIS AN INFORMED CONSENT?An informed consent is a consent of aclient where the principles of autonomy and privacy are followed. This hasbecome the requirement in decision making for health care and research Centre. There are 7 criteria in defining aninformed consent:1.   Competencein deciding and understanding. 2.

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   Voluntaryin making the decision 3.   Disclosureof material information. 4.   Recommendationof a plan. 5.   Comprehensionof terms (3) and (4). 6.   Decisionin favor of a plan.

7.   Authorizedthe plan. The person who give an informedconsent must follow all of the criteria and if the person rejects the plan,that person must have an informed refusal. ISSUESTHAT RELATE TO THE INFORMED CONSENT ON HUMAN SUBJECT RESEARCH.Informed consent defined a permissionwho given by client to a person who want to do any procedure that involved theclient itself. Client will be explained the purpose of the procedure,indication, contraindication, side effect and the risk of the procedure.Informed consent will be obtained once the client has understood and two-waycommunication (questioning and answering) was achieved.

Informed consent is a medico legal procedurewhich if it is not performed correctly, it may affect the client’sunderstanding. Some client may sign the consent blindly without aware of theconsequences, as all procedure have its benefit and risk. Misunderstanding maysometimes happen among the informer and receiver when language barrier is one ofthe issue. Language barrier among them might lead to a different outcome.

The clientswill also have their rights to accepts, refuse and argue about the decision thathas been made by them, but it is also the in-charge’s responsibility toexplained about the details.  ETHICAL PRINCIPLES FOR CONDUCTINGRESEARCH WITH HUMAN PARTICIPANTS.Medical research involving human beingshave created a lot of potential pitfalls that led to tragedies in the lastcentury.In 1963 in Brooklyn; Jewish ChronicDiseases Hospital, a cancer cells were injected into debilitated elderlypatients just to see if they would immunologically reject the cells and in1972, Willow Brook State Hospital in New York; a retarded child was deliberatelyinfected with viral hepatitis to study its natural history. So, it is clearthat various cultures such as Persia, Ancient and Greece have attempted toregulate medicine and protect patient rights. Due to all of these cases, theywere trying to avoid mistakes made in the past and to provide guidance for thefuture. These are the resulted in aseries of International Declarations and Conventions which underpin allresearch 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 whichspecifically addresses human rights and biomedicine was produced in 1997 in thelight of new advances in research. According to The US BelmontReport, they have the most concise summary of rights and obligations in termsof research and, as such, provide the foundation for research ethics guidancein several places around the globe. The Belmont Report includes three ‘basic ethical principles’ forjudging the ethical treatment of human participants: 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) Beneficence: Researchers have an obligation to protect persons from harm by maximizing the anticipated benefits and minimizing the risk of harm Justice: The benefits and burdens of research must be distributed fairly.TheBelmont Report also includes that to ensure informed consent to be ethically valid; it must includecomponents such as:     I.

       Disclosure: Theinformed consent must be clear.   II.       Understanding: Theparticipant understood about the explanations and they were given chance toquestion any doubt.

  III.       Voluntariness: Theparticipant joined the research voluntarily without any outside event.  IV.       Competence: Participantis fully competent to involve in the research.   V.

       Consent: Participantmust authorize their participation in the research study


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