Informed consent is an authorization verbally or written
agreement to participate in research. Basically, participant involves are
voluntarily without compulsion and there are rational decision to participate.
There is a common procedure to go through before starting any study or
research. Informed consent document must be clearly written and must be
understandable by the participant. The consent must use the easy language and
should be define or explained in lay terms if the words are scientific or there
is medical terms. The informed consent is an important agreement before
register a participant.
Indeed, the informed consent is described an ethical codes
and legal for human subjects research. The aim of informed consent process is
to provide sufficient detailed information on the study. The participants are
entitled to ask question and researcher must answer those question.
Furthermore, allowing sufficient time for participant to make their decision.
Therefore, the participant will make decision whether they are enroll or not to
continue in the study. However, the participants have the right to refuse to
participate in this study without penalty if they wish.
However, there are some issues relating research on human
1. Potential risk to subject
Potential risk can be widely categorized in human research.
Researcher need to take precaution to minimize potential of risk. The potential
risk in human research included;
a) Risk of
physical includes injury, physical discomfort, illness or disease cause by
research method and procedure.
risks include the level of muscle tension such as depression, anxiety and loss
c) Risks of
legal happened when the method of research violate the law rules designated. It
happen either by exposing the subject or other person engaging in an activity
where the subject can be a criminal.
d) Social or
economic risk occur due to changes in the relationship between subjects and
others people who are disadvantage such as shame, loss of respect of others and
labeling the subject in a way that bring negative. While economically including
payment by subject to unnecessary procedures, loss of salary and any financial
costs such as damage to the subject’s marketability as a result of
participation in research.
2. Deceptive practice
Deceptive happen when a researcher gives false information
to the subject or deliberately misleads them about some of the key aspect of
research. This may include feedback on the subject involving creating false
beliefs about relationship or the manipulation of self-concept.
Confidentially needs to be maintained in order not to leak
information. The subjects have the right to be protected from injury or unauthorized
intrusions into their privacy and the preservation of their personal dignity.
Benefits of maintaining confidentially will help to establish trust between the
participant and researcher and participant feels more respected.
Research Ethics is essential to adhering to ethical
principles and protecting the safety and wellness rights of research
participants. Then, all human-involved research should be reviewed by ethical
committees to ensure that appropriate ethical standards are maintained.
The existing research ethics source is the Belmont Report
published in 1979. It is a major work on ethics in healthcare research. Its
main purpose is to protect subjects and participants in clinical trials or
research studies. The Belmont Report is written by a panel of experts and
proposes three ethical research principles involving human subjects. The three
key ethical principles quoted from Belmont’s report are autonomy, beneficence,
In general, autonomy can be defined as an individual’s right
to determine the activities they want or not participate. In particular,
autonomy requires an individual to understand what they are asking to do,
making a reasonable decision about their entry and effect, and making the
choice to freely participate in force. The principle of protecting autonomy is
known as the consent process, in which a researcher provides potential research
participants with complete disclosure of the types of research, risks, benefits
and alternatives, and gives a chance to ask before deciding to take any part.
Participants are considered as reduced autonomy, based on decreased cognitions
such as children, cognitive disabilities or mental illness. Other conditions
such as prisoners or people with severe illnesses are considered vulnerable
populations. In some cases, children and inmates have certain protections to
protect their autonomy as required by law.
Beneficence can be clearly defined is the benefit of
research participants. Profitable principles are behind research efforts to
minimize risk to participants and maximize benefits to participants and
Justice requires careful selection of participants, preventing
participants from being unfair participants to participate, such as prisoners
and organized children. The principle of justice requires those who carry out
the burden of inquiry to benefit from the investigation, and principles that
are often violated by the export of clinical trials to less developed