Ethical dimention of hiv

Ethical Dimension of HIV/AIDS

Najibullah Safi, MD, MSc. HPM
PhD Candidates (Health Management)

Presentation outline
• Introduction (what is ethics, why is it
important)
• General principles
• Ethical dimensions of HIV/AIDS in clinical
practice and research
• Codes and policies for research ethics
• Conclusion

Monday, March 11, 2013 Ethical dimensions of HIV/AIDS 2

What is ethics?
• It comes from the Greek word “ethos”, which
mean character
• Dictionary meaning:
– The moral principles governing or influencing
conduct (OXFORD)
– – (Babylon)
– In Arabic


What is ethics? cont…
• Moral philosophy – defining or recommending
the concept of right and wrong
• Ethics has to do with:
– Feelings (e.g. right and wrong)
– Law requirement
– Standard of behavior society accepts
– Religious beliefs (character traits of the human
and virtuous physician are already embedded in
the Qur’an and Sunna)


What is ethics? cont…
• At a more fundamental level, ethics is the
method by which we categorize our values
and pursue them
– Do we pursue our own happiness, or do we
scarifies ourselves to a great cause
• Hippocratic Oath:
– … “first of all, do not harm”…


Ethics in epidemiology
• Ethics is a branch of philosophy that deals
with distinction between right and wrong –
the moral consequences of human action
• The ethical principles in epidemiological
practice and research includes:
– informed consent
– Confidentiality
– Respect for human rights and
– Scientific integrity


Why is ethics important?
• Required for human life
• Means of deciding on a course of action
• Without ethics – no way to work towards goal


General ethical principles
• Respect for person
– Autonomy
– Protection of persons with impaired or diminished
autonomy
• Beneficence
– Maximize benefits and minimize harms
• Nonmaleficence (do not harm)
• Justice (equitable distribution of both burden
and benefits)

1. Clinical Ethics


Confidentiality
• Protection of HIV related medical records
• Exceptions may exist (e.g. HIV/AIDS cases
should be reported to Public Health
Authorities in USA)
– Benefits to public health to outweigh the risk to
individuals
– Health care providers may also disclose a patient’s
HIV infection to person at risk of infection
• Prevent serious harm to an identifiable person
• No other effective means of achieving goal
• The breach of confidentiality is minimized

Informed consent for testing
• Blood test do not require extensive informed
consent discussion (minimal risk, only implied
consent)
• However, in early epidemics of HIV/AIDS
– Serious psychosocial risks (e.g. rejection by
family, discrimination in employment)
– Specific procedures (e.g. pretest
counseling, specific informed consent)


Exceptions to informed consent
• HIV test without consent
– Significant exposure to emergency response
workers or health workers
– Testing of prisoners
– Persons accused of sex crimes
– Mandatory HIV testing of newborns (indirectly
reveals maternal HIV status)


Exceptions to informed consent
• Prenatal HIV testing (all pregnant women be tested
for HIV as a routine part of prenatal care in US)
• May raise several concerns
– Acceptability
– Women may not realize that they have option to
decline testing
– Caregivers may forget the psychosocial risk of
testing
– Routine testing may undermine prevention efforts
– May affect adherence to the norms of pretest
counseling and informed consent in other contexts

End of life issues
• End-of-life care in HIV infection in US has
become less prominent – as the availability of
highly active antiretroviral therapy prolonged
survival
• In developing countries palliative care focuses
on relief from suffering (pain, psychosocial
issues)
– Ongoing efforts to reduce the price of
ARV, permitting production of generic
version, provisions of funds

2. Research Ethics


General principles
• Helsinki Declaration of1964 focuses on:
– Privacy and integrity of individuals protected
– Adequate informed consent
– Research for valid scientific benefits
– Accepted scientific principles
– Benefits outweigh risks
– Protect control group
– Individual wellbeing vs. needs of science and
society


Research design
• People accept risks and inconvenience to
advance knowledge and to benefits others
• Sufficiently rigorous that the results will be
valid and generalizable
• Meet ethical obligations
• Adequate sample size
• Appropriate end point (study outcome)
• RCTs – require preliminary lab and animal
research

Informed consent
• Informed consent might be affected by
– Personal expectation
– Individual benefits vs. generalizable knowledge
– Inadequate understanding of experiment vs. research
– Randomization
– Patients inclination to follow the advice of their health
care providers
– Patients trust in health care providers
– Over estimation of the benefits by health care
providers


Vulnerable participants
• Vulnerability is defined by categories, in US
includes:
– Children, prisoners, pregnant women, mentally
disabled person, economically and educationally
disadvantage persons, homosexuals, injecting
drug users, minorities
• Vulnerable groups require special protection
from research risks


Conflict of interest
• Some conflicting interest are inherent in research
such as:
– Gain prestige, grants, promotion, publication
– This interest may conflict sometimes with the best
interest of participants
– It is an accepted element of research and
acknowledged
• Some interest e.g. financial interest may create
ethical problems
– Overestimate the benefits, underestimate the risks


Special issues in vaccine research
• Good animal model does not exist
• HIV is highly variable and undergoes rapid
mutation
• Little information on protection against HIV
• Misbelieve of protection from the vaccine, may
increase high risk behavior
• Participants should have access to appropriate
risk reduction counseling
• Appropriate monitoring


Special issues in vaccine research
cont…
• Risk to participants
– May not participate in future trials, less effectiveness
of vaccine may produced in the future
– Positive reaction to HIV antibody tests (may limit
travels and eligibility for certain jobs)
• Early phase clinical trials should take place in
sponsor countries
• Placebo-controlled vaccine trials are ethically
acceptable


Codes and Policies for Research
Ethics


Codes and Policies for Research Ethics

• Honesty
• Objectivity
• Integrity
• Carefulness
• Openness
• Respect for Intellectual Property
• Confidentiality
• Human subject protection


Codes and Policies for Research Ethics cont…

• Responsible publication
• Responsible mentoring
• Respect for colleagues
• Social responsibility
• Non-discrimination
• Competence
• Legality
• Animal care


Conclusion
• Muslim Physician and the ethics of medicine:
the Muslim physician, guided by Qur’an and
Sunna (two primary sources of Islamic
Law), will possess the necessary character
traits of a good physician. This in turn, will
lead to a healthy physician-patient
relationship and will safeguard the profession
of medicine.


References Materials
1. International ethical guidelines for epidemiological studies
2. Responsible Conduct of Research, 2nd ed. (New York: Oxford
University Press) - Shamoo A and Resnik D. 2009.
3. Ethical dimension of HIV/AIDS, Leslie E. Wolf et all, University of
California San Francisco
4. Guidance on Ethics and Equitable access to HIV Treatment and
Care, WHO, UNAIDS 2004
5. The Muslim physician and Ethics of Medicine , Thalia A.
Arawai, PhD, JIMA: Volum 42, 2010, page 111-116
6. The Ethics of Muslim Physician and the Legacy of Mohammad
, Thalia A. Arawai, PhD, JIMA: Volum 43, 2011, page 35 - 38


Ethical dimention of hiv

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