Theaim of clinical research is to develop and establish knowledge to improvehealth which valuable to society. Ethics of clinical study in the contact ofclinical research are all about values, norms, correct and wrong, good and badand which is must be done and must not be done. Investigators are responsiblefor research ethics to ensure that there is no potential for exploitation and /orabuse of human research subjects. Two significant events that have contributedto the development of research ethics; a. Nazi experiments and Nuremberg Trial1946, b. Tuskegee Syphilis study.
TheBelmont Report (1979), had come out with three important ethical principlesthat had been accepted and used by worldwide. These 3 fundamental ethicalprinciples are; Respect for person, beneficence and non-malfeasance and lastlyis justice. 1.Respect for personStartingfrom the participation, in the middle of the participation and until theparticipation have ended, the person should be treated with respect andequally. Respect for person who involve in the research means; the researchershould inform the participants regarding all of the aspects related to thestudy and participant’s decision to participate which means taking consent fromthe participants. Other than that, researcher must protect participant’sconfidentiality and privacy and provide opportunity of early withdrawal withoutpenalty. Besides that, participants need to be monitored during and after thetrails, participants need to be informed regarding new information and detailsand to re-take the consent if necessary.
At the end of the study, the participantsshould be informed the result of the study, compensate participants to researchinjury, all of the information regarding clinical trial should be recorded,handled and keep properly. The researcher must make sure the medical recordsand data of subjects must be keep confidentially. 2.Beneficence and non-malfeasanceExperiments need to be started and only canbe continued if the benefits are expected to justify the risk.An assessment of risks and benefits of the research lies on the responsibilityof International Review Board (IRB) Independent Ethics Committee and before theresearcher embarking on that particular research. In order to gain interest of science andsociety, there are some important things to consider which are on the correct,safety and well-being of the participants.
Medical physicians or qualified medicalpersonnel should hold the responsibilities in giving medical care and medicaldecisions made on behalf on the trial subjects. All trials must havescientifically protocols to ensure research outcomes are accurate andreproducible, researcher should provide adequate information regarding pre –clinical and clinical, research conducted following and IRB approved protocolsand the products of investigational should be manufactured and used based onGood Manufacturing Practice (GMP). 3.JusticeTrialsubjects should be fairly selected. The selection of subject must be considerof inclusion and exclusion criteria, target group as well as how to approachthem. Furthermore, the selection requires a clear scientific objectivesregarding the study, and not vulnerability, privilege, efficiency or otherfactors unrelated to research purposes.
Groups of trial subjects should beaimed especially for risky study or study without advantages, which they areconvenient or vulnerable. Conclusion Thesethree major ethical principles are the great tool use on the best ethicalpractices that involved in research and to bring ethical awareness to theirthinking and decision – making.