the meaning of informed consent, and identify issues relating to it in research
on human subjects.
Informed consent is a fundamental
ethical requirements for research with human subjects. It is when a subject voluntarily agrees to participate in a research
study in which he or she has full understanding of the study before the study
begins (Nieswiadomy, 2014).
The informed consent process is where the
participant is informed regarding all aspects of the trial, which are important
for the participant to make a decision and after studying all aspects of the
trial, the participant voluntarily confirms his or her willingness to
participate in a particular clinical trial and significance of the research for
advancement of medical knowledge and social welfare (Nijhawan et al., 2013)
The informed consent process might
create or result several ethical issues if it is not being done properly.
Misunderstandings between the researchers and the participants will result due to
communication barriers such as language differences and religious dogma. The
individual who signed the informed consent is assumed to have fully understand
the information that is stated in the consent form but it is difficult to
evaluate the level of understanding in the individual’s point of view.
Therefore, there might some degree of misunderstanding that might occur.
Besides that, other issue is the
participants may have a false expectation regarding the research. Moreover, the participants might get involved
in research projects that they did not approve of due to misunderstandings or
misinterpretation concerning the experimental procedures (Escobedo et al., 2007).
In addition the participant’s perception regarding the research might
affect the process of obtaining the informed consent because they afraid of the
consequences of the research on them. In this case, disclosing information to
them might scare them away.
In order to prevent issues related to
informed consent to occur when doing research, the researcher need to identified
and credentials presented
selection process is described;
of study is described;
procedures are discussed;
risks are described;
benefits are described;
if any, is discussed;
procedures are disclosed, if any;
or confidentiality is assured;
to refuse to participate or to withdraw from study without penalty is assured;
to answer all question is made;
of obtaining study results is presented.
Discuss the major ethical principles that guide researchers in their works.
of research ethics
Respect for persons (autonomy) – entails
two requirements: firstly, individuals should be treated as autonomous agents,
capable of deciding for themselves about important personal matters.
Accordingly, subjects should only be involved in research if they have given
their voluntary consent and been fully informed about the nature, purpose and
consequences of the study. Secondly, individuals whose autonomy is diminished
as a result of external circumstances, or their physical or mental condition,
require special protection. With regard to a research project, this protection
needs to be adapted to individual circumstances, ensuring that the persons
concerned are not involved in research which could be harmful for them.
– To ensure the welfare of the persons concerned. This means an obligation
firstly to avoid harm and secondly to maximize possible benefits. But here a dilemma
arises: to avoid risks, one needs to know what is harmful. This knowledge, in
turn, depends on evidence obtained from studies. In order to discover what is
actually beneficial for patients, it may be necessary to expose them to risks. The
ethical principle of beneficence refers to the Hippocratic “be of benefit,
do not harm. “. Beauchamp and
Childress, suggest that
“the principle of beneficence includes the professional mandate to do
effective and significant research so as to better serve and promote the
welfare of our constituents”( Beauchamp & Childres, 2001).
Justice – is concerned with the
distribution of burdens, risks, chances and benefits to different persons and
groups, and with the question of what exactly is “owed” to an individual. The
first element raises the question, for example, who should receive the benefits
of research and who should bear its burdens. The second asks, for example, to
what extent people whose condition may differ markedly should be recognized as
equals and treated accordingly. Justice which is deals with the concept of
fairness that is the distribution of burdens, risks, chances and benefits. Participants
need to be treated with equal respect and concern where the benefits of the
research will be shared, where feasible with all of those affected by its
Other than the three previously mentioned
fundamental principles of research ethics, there are also five basic ethical
principal (Laerd, 2012) which are minimising the risk of harm, obtaining
informed consent, protecting anonymity and confidentiality, avoiding deceptive
practices and providing the right to withdraw.
researcher must avoid deceptive practices. This occur when the researcher
provide false or incomplete information to the participants for the purpose of
misleading research subjects. Dissertation research should avoid any kinds of
deceptive practice while in the covert research, deception is sometimes a
necessary components. Coverts research reflects research where the identity of
the observer and/or the purpose of the research is not known to participants.
have right to withdraw from the research study and they also should have the
right to withdraw themselves from the research study anytime. They should not
be pressured or coerced in any way to try and stop them from withdrawing
Respect for privacy – According to Levine (1976) “privacy is
the freedom an individual has to determine the time, extent, and general
circumstances under which private information will be shared with or withheld
from others “. Information such
as beliefs, attitudes, opinions and records, is shared with others, without the
patients’ consent. A researcher cannot
decide on behalf of the participants on those delicate issues. All aims,
instruments and methodology must be discussed with the prospective subject. Even
apply to report of age, income, marital status, and other details that the
subject may regard intimate.
The elements of informed consent plays
an important role in the informed consent process.