The ethicalaspects of a study take precedence over any other areas of the study (Nieswiadomy, 2014).Participants’ rights must be protected in all proposed research studies. Ethicson the other hand, concerned with rules and principle of human behaviour whichis known to be complex that makes it difficult to formulate rules to govern theactions of human being. The present ethical standards used in research arebased on guideline developed after the World War II where Nuremberg Code wasestablished in 1947, followed by Declaration of Helsinki in 1964. In 1978, theethical principal and guideline were reviewed. A draft was prepared andreported in The Belmont Report published in 1979 presenting three basicprinciples.
Principles ofresearch ethics v Respectfor persons (autonomy) – entails two requirements: firstly, individuals shouldbe treated as autonomous agents, capable of deciding for themselves aboutimportant personal matters. Accordingly, subjects should only be involved inresearch if they have given their voluntary consent and been fully informedabout the nature, purpose and consequences of the study. Secondly, individualswhose autonomy is diminished as a result of external circumstances, or theirphysical or mental condition, require special protection.
With regard to aresearch project, this protection needs to be adapted to individualcircumstances, ensuring that the persons concerned are not involved in researchwhich could be harmful for them. v Beneficence- is the duty to ensure the welfare of the persons concerned. This means anobligation firstly to avoid harm and secondly to maximise possible benefits (Beauchamp & Childres, 2001). Buthere a dilemma arises: to avoid risks, one needs to know what is harmful. Thisknowledge, in turn, depends on evidence obtained from studies. Thus, in orderto discover what is actually beneficial for patients, it may be necessary toexpose them to risks.
v Justice- is concerned with the distribution of burdens, risks, chances and benefits todifferent persons and groups, and with the question of what exactly is “owed”to an individual. The first element raises the question, for example, whoshould receive the benefits of research and who should bear its burdens. Thesecond question, for example, to what extent people whose condition may differmarkedly should be recognised as equals and treated accordingly.