Informed years old above and competent to make

consent is the part of the research, especially in human subjects.
Classification  of “Consent”  must be an adult subject, capable to give
permission to involve in research, 18 years old above and competent to make any
decision either to involve or to withdraw from the research project (Nijhawan,
Janodia, Muddukrishna, Bhat, Bairy, Udupa, & Musmade, 2013). It is a legal
documents whereby participants agree to take part in research with three
conditions, include, voluntaries; comprehension; and disclosure off all the
information (Field-Springer, 2017). It is a process between participant and
researcher communicated about the topic of the research that will done. It is
also a communication process asking for permission for provide psychological
and physical health care services (Brodbeck, 2011). A three components must be
met before it considered to be valid including understanding all the
information been given by the researcher; voluntary; and competent to give
consent (Salkind, 2012). Informed consent considered as a ethical code and
regulations for human as a subject in research (Shahnazarian, Hagemann, Aburto,
& Rose, N.D.; Nijhawan, et al. 2013).
This element should be include in informed consent (Shahnazarian et al, N. D.) including purpose of the
research procedures involved, alternatives to participant, all foreseeable
risks and discomforts to the subject, benefits of the research, length of time
expected to participate, person to contact, statement indicating “Voluntary”,
and statements indicating “Right to confidentiality and right to withdraw”.
However, Joffe, Cook, Cleary, Clark, & Weeks (2001), indicate an extra
element which is identification of any procedures that are experimental


clinical research involving human subjects, it always difficult due to decision
when the research in quality-improvement because it will give effects to
subjects or participants routine care (Miller & Emanuel, 2008). Although
informed consent is compulsory in any human subjects research, standardized
method for assessing the adequacy of informed consent to research are lacking
(Joffe, et al. 2001). In certain
issues related to informed consent, certain participants will give “risk” to
self or to others. Even though, all the information in disclosed from public,
in any circumstances all this information will be revealed due to this three
type of risk: physical, including pain, injury, or/and impairment;
psychological risk are mental health illnesses include depression, anxiety,
and/or emotional turmoil, and social risk include breach of confidentially
among participant’s personal information (Field-Springer, 2017). In any time
needed, a legal or any authorities department will be assigned when a
participant has long-lasting cognitive impairment, such as dementia, severe
brain damage,  or moderate profound
mental retardation (Salkind, 2011).

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consent is a legal document to keep participants information as a secret. It
also a process minimizes an unethical actions (Allen, 2017). Particularly care
should be taken appropriate and preserve in safe place. Besides that, informed
consent is often neglected in evaluation. Sometimes participants did not
noticed that they be assigned to any or different services (Fitzpatrick, 2011).
This requirement stated in informed consent, and met to clinical research
wherever it is practiced, is ethical (Emanuel, Wendler, & Grady, 2000),
especially research on human subjects.


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