WHAT IS A CONSENT?Consent is an agreement with a voluntaryaction proposed by another person. If a person was giving a consent, thatperson must be sufficient in their own mental capacity. The person who is a mentallyincompetent, or is under an influence of drugs, he or she is not in mentallystable for being consented as written in Miller-Keane Encyclopedia andDictionary of MedicineWHATIS AN INFORMED CONSENT?An informed consent is 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: i. Competenceto understand and to decide.
ii. Voluntarydecision making. iii. Disclosureof material information. iv. Recommendationof a plan. v.
Comprehensionof terms (3) and (4). vi. Decisionin favor of a plan.
vii. Authorizationof the plan. A person who give an informedconsent must follow all of the criteria but 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 patient to a doctor or other medical team regarding any procedure involvingsurgical or non-surgical procedure. Patient will be explained the purpose ofthe procedure, indication, contraindication, side effect and the risk of theprocedure. Informed consent will be obtained once the patient has understoodand two-way communication (questioning and answering) was achieved.
Informed consent is a medico legal subjectwhich if it is not performed correctly, it may affect the patient’sunderstanding and health. Some patient may sign the consent blindly withoutaware of the consequences, as all procedure have its benefit and risk.Misunderstanding may sometimes happen among the informer and receiver when languagebarrier is one of the issue. Misinterpretation of language among them mightlead to different outcome. Patients also have their rights to accepts, refuseand argue about the decision that has been made by them, but it is also theinformer’s responsibility to explained 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 which specifically addresses human rights and biomedicine was produced in 1997 in the light 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