Site Loader
Rock Street, San Francisco

The purpose of clinical research is to develop and establish knowledge to improve health which valuable to society. Clinical research ethics is about norms, values, right and wrong, good and bad, and what should and should not be done in the context of clinical research. Investigators are responsible for research ethics to ensure that there is no potential for exploitation and /or abuse of human research subjects. Two significant events that have contributed to the development of research ethics; a. Nazi experiments and Nuremberg Trial 1946, b. Tuskegee Syphilis study. The Belmont Report 1979 has introduced 3 fundamental ethical principles that is now widely accepted. They are 1. Respect for person 2. Beneficence and non-malfeasance 3. Justice. 1. Respect for personTrial subjects must continue to be treated with respect from the time they are enrolled, throughout their participation and after their participation ends. Respecting trial subjects means; the subjects will be informed of all aspects of the research that are relevant to the subject’s decision to participate (informed consent);  to protect their confidentiality and privacy; provide opportunity of early withdrawal without penalty; monitor subject’s well-being during and after trails; inform subject of new information and re-consent if necessary; inform subject of study results; compensate subject for research injury; all clinical trial information should be properly recorded, handled and stored; medical records and study data of subjects must confidentially protected.  2. Beneficence and non-malfeasanceExperiments need to be started and continued only if the benefits are expected to justify the risk. The assessment of risks and benefits of the research lies on the responsibility of International Review Board (IRB) Independent Ethics Committee (IEC) and investigator before embarking on a research. In order to gain interest of science and society, they must important things are to consider on the rights, safety and well – being of the trial subject. Medical physicians or qualified medical personnel should hold the responsibilities in giving medical care and medical decisions made on behalf on the trial subjects. All trials must have scientifically protocols to ensure research outcomes are accurate and reproducible, there must be adequate preclinical and clinical information, research conducted following and IRB approved protocols and the investigational product must be manufactured and used according to Good Manufacturing Practice (GMP). 3. JusticeTrial subjects should be fairly selected. The selection of subject must be consider of inclusion and exclusion criteria, target group as well as how to approach them. Furthermore, the selection requires a clear scientific objectives of the study and not vulnerability, privilege, efficiency or other factors unrelated to research purposes. Groups of trial subjects must be targeted especially for risky research or research without benefits, just because they are convenient or vulnerable.  Conclusion These three major ethical principles are the great tool use on the best ethical practices that involved in research and to bring ethical awareness to their thinking and decision – making.  

Post Author: admin

x

Hi!
I'm Glenda!

Would you like to get a custom essay? How about receiving a customized one?

Check it out