is a fundamental ethical requirement 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
understands 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
which in the end caused the participant to withdraw from the
ongoing studies (Nijhawan, 2013). Many
researchers come out with inform consent in multilingual form as solution, but
it is still difficult to evaluate individual’s viewpoint on a study as there are
no verified method established to measure the level of participant’s understanding.
For example, there was one study by Appelbaum et al. (2002), found that 69% of participants
misunderstood the meaning of the word ‘randomization’.
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. Therefore, it is recommended that researchers ensure all the elements of
informed consent is described clearly and identified then documented in the
consent form. For example, a statement like “RETURN OF THIS QUESTIONAIRE WILL
INDICATE YOUR CONSENT TO PARTICIPATE IN THIS STUDY” must be included in
self-report types of questionnaires.
The elements of
informed consent play an important role in the informed consent process (Nieswiadomy,
The major elements include presentation of researcher’s identification and
credential, description of the selection process of participants, description
of purpose, study procedure, potential risk, and potential benefits; discussion
of any compensation if applicable, disclosure of any alternative procedures,
anonymity and confidentiality assured and other right that participant hold
like right to refuse / withdraw without penalty.