Inform informed consent to be involved in a

Inform consent is a
principal means for ensuring the rights of research subject or participants in
studies are protected. It means that subjects agree to participate in studies
about which they have complete understanding of the study before the study begins.

Informed consent
reflects the practical, ethical and legal conceptions (Adams, et.al.,2007). Therefore,
the it is a must for a researcher to document that informed consent was
obtained. Informed consent may be obtained in written or oral form. As for oral
permission informed consent, it must be witnessed by a third person (Nieswiadomy, 2014). If self-report
questionaires are used, a statement like “RETURN OF THIS QUESTIONAIRE WILL
INDICATE YOUR CONSENT TO PARTICIPATE IN THIS STUDY” should be included on the
questionaire. Subjects are well informed and free to make decision whereby they
are allowed to withdraw at any time. Victorian Charter of Human Rights (2006) states that
informed consent:

“must be voluntary and the person concerned must have been
given sufficient information for an informed decision to be made.”

According to Neff (2008), the importance and integrity of informed consent is
based on partnership agreement between researchers and subjects in sharing
their understanding of a study. It is not merely to have a signature on a form
but it is a process that involves exchange of information and communication
between reseacher and subjects in the decision- making process (U.S. Food and
Drug Administration, 2014).

To the general community, informed
consent is an important issue which in many ways defines the commitment of the
health system to genuine consumer engagement beyond diagnostic services while
at a broader level, consent processes help deliver services that are more
closely aligned with the priorities and concerns of the community (Consumers
Health Forum of Australia, 2013).

The concept of informed
consent is embedded in the principles of Nuremberg Code, The Declaration of
Helsinki and The Belmont Report (Nijhawan,
2013). The Belmont
Report indentified three basic principles to be followed by all researchers.
One of it is all human participants are to “be treated as autonomous agents
capable of self-determination”. This implies that all participants must give
informed consent to be involved in a research project, after given adequate
information, understand the researchs protocol, and they are allowed to
withdraw from the project at any point.

Few studies support the position that
improved communication between clinicians and consumers overall contributes to
both increased adherence to treatment regimes (Bull,  Hu & Hunkeler, 2002), improved long-term
health outcomes, increased patient satisfaction, faster recovery, reduced
emotional distress, a lower level of pain relief used and in some cases a
reduced length of stay in hospital (Consumers Health Forum of
Australia, 2013).

However, there are still many covert
barriers to understanding the informed consent process that lead to ineffective
communication between the participants and researchers (Escobedo et. al 2007) involving
language barriers and cultural and religious influences.

Language
barriers

Many
individuals sign the consent form without being full understanding, which
results in withdrawal of subject at later stages of ongoing clinical studies (Nijhawan, 2013). Although  the responsibility of researcher enlarges
when a study is performed in multilingual subjects, it is still very difficult
to evaluate participant’s viewpoint about trial since there is no established
method to measure the level of understanding that a participant has. Appelbaum et al. (2002) reports
that 69% of the participants in their study “research subjects systematically
misrepresent the risk/benefits ratio of participating in research.” failed to
understand the meaning of randomization.

Cultural
and Religious influences

Beyond
language, cultural and religious issues will also affect a patient’s
understanding of the consent process and content. In some cases, for example, a
patient’s community or self-identified group may have a relative lack of
background knowledge about a certain disease or risk factor (Fleisher et.al.,
2018). In other cases, the patient may share a set of core beliefs that
essentially rule out a proposed procedure or test for example Jehovah’s
Witnesses believers refuse blood transfusions, including autologous
transfusions in which a person has their own blood stored to be used later in a
medical procedure (British Broadcasting Corporation,
2009).

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