The should and should not be done in the

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.

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1. Respect for person

Trial 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-malfeasance

 A trial should be initiated and continued only
if the anticipated benefits justify the risks. 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 addition, the rights, safety and well- being of the
trial subjects are the most important considerations and should prevail
interests of science and society. 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. Justice

Trial subjects should be fairly
selected. Fair subject selection for research involves; decisions about who
will be included through the development of specific inclusion and exclusion
criteria and strategy for recruiting subjects such as which communities and
individuals to be approached. 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. 

References: The Belmont
report  1979, International Conference on
Harmonization of Technical Requirements for Registration of Pharmaceuticals for
Human Use. 

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