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Transcript On Health Care Ethics - Finals
Transcript On Health Care Ethics - Finals
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1ST SEMESTER – FINALS REVIEWER
HEALTH CARE ETHICS (BIOETHICS)
TRANS BY: MARK GREGORY M. ADDATU
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1ST SEMESTER – FINALS REVIEWER
HEALTH CARE ETHICS (BIOETHICS)
TRANS BY: MARK GREGORY M. ADDATU
• Second trial referred to as the “Doctors’ where the experimental physicians also
Trial” or the “Medical Case.” Four serve as subjects.
judges presided over the eight-month
case, hearing 85 witnesses, and viewing 5. The degree of risk to be taken should never
1,471 documents and 11,538 pages of exceed that determined by the
transcript. humanitarian importance of the problem
• Twenty out of 23 defendants were to be solved by the experiment.
physicians. All had been singled out as
being responsible for the execution of 6. Proper preparations should be made and
humans they deemed “unworthy of adequate facilities provided to protect the
life” and for experiments conducted on experimental subject against even remote
concentra2on camp prisoners. possibilities of injury disability or death.
• The Nuremberg Military Tribunal’s
decision in the case of the United States 7. The experiment should be conducted only
v Karl Brandt et al. by scientifically qualified persons. The
• A ten-point statement delimiting highest degree of skill and care should be
permissible medical experimentation required through all stages of the
on human subjects. experiment of those who conduct or
• Humane experimentation is justified engage in the experiment.
only if its results benefit society and it is
carried out in accord with basic 8. During the course of the experiment the
principles that “satisfy moral, ethical, human subject should be at liberty to bring
and legal concepts.” the experiment to an end if he has reached
• Permissible Medical Experiments.” Trials the physical or mental state where
of War Criminals before the Nuremberg continuation of the experiment seems to
Military Tribunals under Control Council him to be impossible.
Law No. 10. Nuremberg October 1946 –
April 1949, Washington. U.S. 9. During the course of the experiment the
Government Printing Office. scientist in charge must be prepared to
terminate the experiment at any stage, if
Principles of Nuremberg Code he has probable cause to believe, in the
1. The experiment should be such as to yield exercise of the good faith, superior skill and
fruitful results for the good of society, careful judgement required by him that a
unprocurable by other methods or means continuation of the experiment is likely to
of study, and not random and unnecessary result in injury, disability, or death to the
in nature. experimental subject.
DECLARATION OF HELSINKI
2. The experiment should be so designed and Adopted by the 18th WMA General Assembly,
based on the results of animal Helsinki, Finland, June 1964 and amended by the:
experimentation and a knowledge of the • 29th WMA General Assembly, Tokyo,
natural history of the disease or other Japan, October 1975
problem under study that the anticipated • 35th WMA General Assembly, Venice, Italy,
results will justify the performance of the October 1983
experiment. • 41st WMA General Assembly, Hong Kong,
September 1989
3. The experiment should be so conducted as • 48th WMA General Assembly, Somerset
to avoid all unnecessary physical and West, Republic of South Africa, October
mental suffering and injury. 1996
• 52nd WMA General Assembly, Edinburgh,
4. No experiment should be conducted Scotland, October 2000
where there is an a priori reason to believe • 53rd WMA General Assembly, Washington
that death or disabling injury will occur; DC, USA, October 2002 (Note of
except, perhaps, in those experiments Clarification added)
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1ST SEMESTER – FINALS REVIEWER
HEALTH CARE ETHICS (BIOETHICS)
TRANS BY: MARK GREGORY M. ADDATU
❖ Came to supersede the Nuremberg Code 6. While the primary purpose of medical
as the normative ethical guidance for research is to generate new knowledge,
medical researchers. this goal can never take precedence over
❖ The Declaration of Helsinki represents an the rights and interests of individual
improvement over the Nuremberg Code in research subjects.
the sense that it balances the concerns of
individuals against the benefits to the 7. It is the duty of physicians who are involved
society. in medical research to protect the life,
❖ Developed by World Medical Association health, dignity, integrity, right to self-
(WMA), determination, privacy, and confidentiality
❖ Statement of ethical principles for medical of personal information of research
research involving human subjects, subjects. The responsibility for the
including research on identifiable human protection of research subjects must
material and data always rest with the physician or other
health care professionals and never with
Note: Both the Nuremberg Code and the the research subjects, even though they
Declaration of Helsinki indicate that animal-based have given consent.
research should be conducted before human
experimentation, the former more unequivocally 8. Physicians must consider the ethical, legal
than the latter. and regulatory norms and standards for
research involving human subjects in their
General Principle
own countries as well as applicable
1. “The health of my patient will be my first
international norms and standards. No
consideration,” and the International Code
national or international ethical, legal or
of Medical Ethics declares that, “A
regulatory requirement should reduce or
physician shall act in the patient’s best
eliminate any of the protections for
interest when providing medical care.”
research subjects set forth in this
2. It is the duty of the physician to promote Declaration.
and safeguard the health, well-being and
9. Medical research should be conducted in
rights of patients, including those who are
a manner that minimizes possible harm to
involved in medical research. The
the environment.
physician’s knowledge and conscience
are dedicated to the fulfilment of this duty.
10. Medical research involving human subjects
must be conducted only by individuals with
3. Medical progress is based on research that
the appropriate ethics and scientific
ultimately must include studies involving
education, training and qualifications.
human subjects.
Research on patients or healthy volunteers
4. The primary purpose of medical research requires the supervision of a competent
involving human subjects is to understand and appropriately qualified physician or
the causes, development and effects of other health care professional.
diseases and improve preventive,
11. Groups that are underrepresented in
diagnostic and therapeutic interventions
medical research should be provided
(methods, procedures and treatments).
appropriate access to participation in
Even the best proven interventions must be
research.
evaluated continually through research for
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1ST SEMESTER – FINALS REVIEWER
HEALTH CARE ETHICS (BIOETHICS)
TRANS BY: MARK GREGORY M. ADDATU
12. Physicians who combine medical research • Some groups and individuals are
with medical care should involve their particularly vulnerable and may have an
patients in research only to the extent that increased likelihood of being wronged or of
this is justified by its potential preventive, incurring additional harm.
diagnostic or therapeutic value and if the • All vulnerable groups and individuals should
physician has good reason to believe that receive specifically considered protection.
participation in the research study will not • Medical research with a vulnerable group
adversely affect the health of the patients is only justified if the research is responsive
who serve as research subjects. to the health needs or priorities of this group
and the research cannot be carried out in
13. Appropriate compensation and treatment a non- vulnerable group. In addition, this
for subjects who are harmed as a result of group should stand to benefit from the
participating in research must be ensured. knowledge, practices or interventions that
result from the research.
Risks, Burdens and Benefits
1. In medical practice and in medical Scientific Requirements and Research Protocols
research, most interventions involve risks • Medical research involving human subjects
and burdens. must conform to generally accepted
scientific principles, be based on a
2. Medical research involving human subjects thorough knowledge of the scientific
may only be conducted if the importance literature, other relevant sources of
of the objective outweighs the risks and information, and adequate laboratory
burdens to the research subjects. and, as appropriate, animal
experimentation. The welfare of animals
3. All medical research involving human used for research must be respected.
subjects must be preceded by careful • The design and performance of each
assessment of predictable risks and research study involving human subjects
burdens to the individuals and groups must be clearly described and justified in a
involved in the research in comparison with research protocol.
foreseeable benefits to them and to other • The protocol should contain a statement of
individuals or groups affected by the
the ethical considerations involved and
condition under investigation. should indicate how the principles in this
Declaration have been addressed. The
4. All medical research involving human
protocol should include information
subjects must be preceded by careful
regarding funding, sponsors, institutional
assessment of predictable risks and
affiliations, potential conflicts of interest,
burdens to the individuals and groups
incentives for subjects and information
involved in the research in comparison with
regarding provisions for treating and/or
foreseeable benefits to them and to other
compensating subjects who are harmed as
individuals or groups affected by the
a consequence of participation in the
condition under investigation.
research study.
5. Physicians may not be involved in a In clinical trials, the protocol must also describe
research study involving human subjects appropriate arrangements for post-trial
unless they are confident that the risks have provisions.
been adequately assessed and can be
satisfactorily managed. Research Ethics Committees
• This committee must be transparent in
When the risks are found to outweigh the its functioning, must be independent of
potential benefits or when there is conclusive the researcher, the sponsor and any
proof of definitive outcomes, physicians must other undue influence and must be
assess whether to continue, modify or
duly qualified. It must take into
immediately stop the study.
consideration the laws and regulations
Vulnerable Groups and Individuals of the country or countries in which the
research is to be performed as well as
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1ST SEMESTER – FINALS REVIEWER
HEALTH CARE ETHICS (BIOETHICS)
TRANS BY: MARK GREGORY M. ADDATU
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1ST SEMESTER – FINALS REVIEWER
HEALTH CARE ETHICS (BIOETHICS)
TRANS BY: MARK GREGORY M. ADDATU
and/or reuse. There may be exceptional conflicts of interest must be declared in the
situations where consent would be publication. Reports of research not in
impossible or impracticable to obtain for accordance with the principles of this
such research. Declaration should not be accepted for
publication.
Use of Placebo
The benefits, risks, burdens and effectiveness of a Unproven Interventions in Clinical Practice
new intervention must be tested against those of ➢ In the treatment of an individual patient,
the best proven intervention(s), except in the where proven interventions do not exist or
following circumstances: other known interventions have been
a) Where no proven intervention exists, the ineffective, the physician, after seeking
use of placebo, or no intervention, is expert advice, with informed consent from
acceptable; or the patient or a legally authorized
b) Where for compelling and scientifically representative, may use an unproven
sound methodological reasons the use of intervention if in the physician’s judgement
any intervention less effective than the best it offers hope of saving life, re-establishing
proven one, the use of placebo, or no health or alleviating suffering. This
intervention is necessary to determine the intervention should subsequently be made
efficacy or safety of an intervention. the object of research, designed to
c) and the patients who receive any evaluate its safety and efficacy. In all
intervention less effective than the best cases, new information must be recorded
proven one, placebo, or no intervention will and, where appropriate, made publicly
not be subject to additional risks of serious available.
or irreversible harm as a result of not
receiving the best proven intervention. CONTINIUNG EDUCATION OF ETHICO-MORAL
Post-Trial Provisions
➢ In advance of a clinical trial, sponsors, Advocacy
researchers and host country governments • Is acting in behalf of others.
should make provisions for post-trial access
Case Advocacy
for all participants who still need an
• aimed at specific patients. it is a tradition in
intervention identified as beneficial in the
the profession and upholds ongoing
trial. This information must also be disclosed
professional values (Cary, 1992; Gadow
to participants during the informed consent
and Schroeder, 1995; Nelson, 1988; Kohnke,
process.
1982; Winslow, 1984; Marks, 1985).
Research Registration and Publication and • Nurses are used to speaking up for specific
Dissemination of Results patients and their families to obtain the
➢ Every research study involving human services they need and find solutions to
subjects must be registered in a publicly issues unique to the case.
accessible database before recruitment of • Modern case advocate roles place a
the first subject. strong emphasis on client autonomy. They
➢ Researchers, authors, sponsors, editors and place a high value on educating and
publishers all have ethical obligations with assisting clients so they may decide what is
regard to the publication and in their best interests and act accordingly
dissemination of the results of research. (Kohnke, 1982)
Researchers have a duty to make publicly • The skills and goals of case advocacy
available the results of their research on frequently place an emphasis on better
human subjects and are accountable for coping mechanisms, negotiation, and
the completeness and accuracy of their facilitating access to already-existing
reports. All parties should adhere to resources in order to address health issues
accepted guidelines for ethical reporting. without requiring significant systemic.
Negative and inconclusive as well as
positive results must be published or "class advocacy" aimed at changing legislation
and social situations.
otherwise made publicly available. Sources
of funding, institutional affiliations and
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1ST SEMESTER – FINALS REVIEWER
HEALTH CARE ETHICS (BIOETHICS)
TRANS BY: MARK GREGORY M. ADDATU
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1ST SEMESTER – FINALS REVIEWER
HEALTH CARE ETHICS (BIOETHICS)
TRANS BY: MARK GREGORY M. ADDATU
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1ST SEMESTER – FINALS REVIEWER
HEALTH CARE ETHICS (BIOETHICS)
TRANS BY: MARK GREGORY M. ADDATU
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1ST SEMESTER – FINALS REVIEWER
HEALTH CARE ETHICS (BIOETHICS)
TRANS BY: MARK GREGORY M. ADDATU
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