Describe obtained in written or oral form. As for

Describe the meaning of
informed consent and identify issues relating to it in research on human
subject

 

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.

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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).

 

 

Major ethical issues in
conducting research

 

A.   
Informed
consent

Informed consent
is the major ethical issue in conducting research. According to Armiger:
“it means that a person knowingly, voluntarily and intelligently, and in a
clear and manifest way, gives his consent” (Armiger,1997)

Another major
ethical issue is obtaining an informed consent from groups with diminished
autonomy which will be further discussed later. From what has been discussed,
it becomes clear that disclosure, comprehension, competency and voluntariness
are the four essential parts of a consent. (Burns & Grove, 2005.)

The researcher
must inform the subjects about the methods which will be used to protect
anonymity and confidentiality and indicate a person with whom they can discuss
the study. He must also provide a “Non-coercive Disclaimer” which
states that participation is voluntary and no penalties are involved in refusal
to participate. The researcher must take into account that persons with
physical, cultural and emotional barriers may require a very simple language in
order to understand him (Fouka
& Mantzorou, 2011)

 

B.   
Beneficence-
Do not harm

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).

 

C.  
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 other persons 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.

 

D.  
Skills
of the researcher

Nurse researchers
should have the necessary skills and knowledge for the specific investigation
to be carried out and be aware of the limits of personal competence in
research. Any lack of knowledge in the area under research must be clearly
stated.

According to Hunt
G. (1992) inexperienced researchers should work under qualified supervision
which has to be reviewed by an ethics committee, careful choice of method for
data collection, to ensure validity and reliability, are two main requirements
that must be met in all kinds of research.

 

E.   
The
nature of Nursing

According to
Mckenna G (1993) the primary scope of nursing is to help persons to adapt in
different stages of illness which is a rather task-orientated and
behaviouralistic approach.  Nursing views
persons as a whole and health as a subjective and meaningful experience of
integrating with the environment and as interpersonal interactions which
involve practical actions

 

This is quite
indicative of the nurses’ role, but it does not reflect the values, experience
and passion of nursing. Swanson suggests that nursing has to do with
“science, concern for humanity and caring. (Swanson,1993)

 

 Describe the meaning of
informed consent and identify issues relating to it in research on human
subject

 

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).

 

 

Major ethical issues in
conducting research

 

A.   
Informed
consent

Informed consent
is the major ethical issue in conducting research. According to Armiger:
“it means that a person knowingly, voluntarily and intelligently, and in a
clear and manifest way, gives his consent” (Armiger,1997)

Another major
ethical issue is obtaining an informed consent from groups with diminished
autonomy which will be further discussed later. From what has been discussed,
it becomes clear that disclosure, comprehension, competency and voluntariness
are the four essential parts of a consent. (Burns & Grove, 2005.)

The researcher
must inform the subjects about the methods which will be used to protect
anonymity and confidentiality and indicate a person with whom they can discuss
the study. He must also provide a “Non-coercive Disclaimer” which
states that participation is voluntary and no penalties are involved in refusal
to participate. The researcher must take into account that persons with
physical, cultural and emotional barriers may require a very simple language in
order to understand him (Fouka
& Mantzorou, 2011)

 

B.   
Beneficence-
Do not harm

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).

 

C.  
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 other persons 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.

 

D.  
Skills
of the researcher

Nurse researchers
should have the necessary skills and knowledge for the specific investigation
to be carried out and be aware of the limits of personal competence in
research. Any lack of knowledge in the area under research must be clearly
stated.

According to Hunt
G. (1992) inexperienced researchers should work under qualified supervision
which has to be reviewed by an ethics committee, careful choice of method for
data collection, to ensure validity and reliability, are two main requirements
that must be met in all kinds of research.

 

E.   
The
nature of Nursing

According to
Mckenna G (1993) the primary scope of nursing is to help persons to adapt in
different stages of illness which is a rather task-orientated and
behaviouralistic approach.  Nursing views
persons as a whole and health as a subjective and meaningful experience of
integrating with the environment and as interpersonal interactions which
involve practical actions

 

This is quite
indicative of the nurses’ role, but it does not reflect the values, experience
and passion of nursing. Swanson suggests that nursing has to do with
“science, concern for humanity and caring. (Swanson,1993)

 

 

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