Ani/ 1
Ani/ 2
Ani/ 3
- Ethics
- Ethics of using animals as model for HIV/AIDS research
: The opinions of our classmates about the animal experiment
: The reasons of agreement and disagreement in using animal
as a research model
: Ethical problems
: Alternative choices
: Conclusion
- Ethics of using human as a subject for HIV/AIDS research
: The opinions of our classmates if they were asked to be a subject
in HIV/AIDS clinical trials
: The reasons of volunteer subjects in HIV/AIDS clinical trials
: The reasons of people who are not want to be subjects in HIV/
AIDS clinical trials
Ani/ 4
(Cont)
- Ethics of using human as a subject for HIV/AIDS research
: Ethical problems
: The protection concerning with ethical problems in using
human model
: Conclusion
(Cont)
- Ethics about health care professionals and HIV/AIDS patients
: Patient-to-health care professional transmission
: Ethical problems
: Health care professional-to-patient transmission
: Ethical problems
: Conclusion
- Acknowledgement
Ani/ 5
Ethics (ethos + ethica)
an academic discipline that provides
a set of intellectual instrument for
the analysis of morality
Morality (mos-moris)
person’s behavior that is open to
judgements of right and wrong
Original: Ethics
“inner being” or person’s character
focus on the attitude & habits that
render the person good or bad
Social ethics
Social order and specifically with what’s
right and good in the organization
of human communities
Ani/ 7
Ulla: I think it’s OK to use animals. Wang: It’s OK but be careful.
Tan: The extrapolation of animal studies to human may not be
useful.in HIV case. The thoroughly understanding on how
virus work still have to rely on human study but it’s defficult
due to the ethical problems. Therefore, using animal model
should be the choice of no choice.
Juraporn: Animal experiments are important for the progress in
scientific & medical researches esp. for prevention or
cure some lethal disease. Now, we can not seek for any
in vitro methods that can mimic systemic organizations
like the human body.
Varaporn: I can not avoid the use of animals in the research esp. in
the study of toxicity of the new thing like anti-HIV drug.
But how can I manage them to obtain the maximum
reliable results as well as minimum the number of them.
Ani/ 8
Aung: There will be positive & negative effects on the use of animals.
Anyway, it’s good to do for our mankind but the limitation
must be concern.
Army: Animal can be used as a model.
Aktah: It’s OK. But every care must be undertaken to minimizing
the loss.
Ani/ 9
Agree
Science
- To search for new knowledge
- To diagnose disease
- To test new therapeutic technique & new medicine
- To detect & analyze drugs & others biological compounds
- To produce & test vaccines, sera, and others biological compounds
- To increase understanding of disease processes
- To test for toxicity, carcinogenicity, and teratogenicity of new & old
drugs and chemical compounds
Ani/ 10
- study the first stage of HIV pathogenesis (Chimpanzees)
- evaluate the ability of anti-retroviral drug and the efficacy of the
HIV candidate vaccine to prevent, limit, or cure HIV infection
before application to humans (Chimpanzees)
- evaluate the protective effect of vaccine on AIDS-like disease
(rhesus macaque monkey)
Ani/ 11
Ethical Problem I
- Animals are living and feeling.
So it’s morally wrong to inflict
pain on any living creature e.g.
for the cure of disease-affecting
humans
“Animal Rights”
Animal Rights ?
“It involves a consideration of the moral status of
non-human animals and the idea that animals
have the right to live as well as not to be used by
humans in anyway because that animals have
equal rights to humans”
Dislocation of neck bone
Guillotine
General anesthesia
Ani/ 14
Ethical Problem II: Unreliable data
- Animal is not human, any results obtained are not applicable to
human anyway and so the experiments are worthless.
- After drugs are developed and tested on animals, they are always
tested on humans.
Yes. The scientists know animal
tests are too unreliable to work.
5-25% correlation between harmful effects in people and the
results obtained from animal experiments
Half of all drugs released by the FDA are later reported
to have the serious side effects in humans
Rhesus macaques often show fear & defense
response, reflected in significant changes in
normal physiology when personnel is around
or tries to remove it from its cage.
So, can we confidence in the results
obtained from it?
(cont)
Refine
- handling
- housing
- feeding
- caring
etc
Ani/ 16
Ethical Problem II: Religion ethics
Five Percepts = Ten Commandments
- “No to hurt “living being”.
All beings tremble for danger and fear death.
- Killing animal can not be justified by the claim
that it will prolong our life.
- Humans are not superior to or more important
than other animals.”
Doing the righteous thing has a higher
priority over worldly “SUCCESS”.
Ani/ 17
The Animal Welfare Institute
“Alternative (3R)”
1) Refine : any technique that makes them feel more comfortable
& less painful
2) Replace : the changes of experimental animals species or way
of uses e.g genetic engineering, human cell culture
3) Reduce : lowering the need or number of animals in the
experiment e.g. using computer simulator, statistic team
Menache A: Reduction & replacement techniques can be reduced
use of animal experiments worldwide 30-50% in the
last 15 years.
(cont)
Refine
- handling
- housing
- feeding
- caring
etc
Ani/ 20
The demand for animal experiments can be limits if humans
accept and enforce the following 3 principles:
1) If there are humans volunteers to join the experiment that will
cause only limited pain & convenience.
2) If there is organs or tissues from dead human, aborted human
fetuses, or the like.
3) If doing without harmful animal experiment involves only a
slightly risk or loss to humans. We should without it.
CONCLUSION
Ani/ 21
(Animal experiments & HIV/AIDS research)
Animal experiments are still important in HIV/AIDS research.
Although, some populations are disagree in using them due
to they are “living beings”. Thus, ethical problem in
animal’s right must be concern. The use of 3R
methods is the best way to solve this problem.
Human/ 1
Human/ 2
In vitro
Alternatives: Cell culture, Computer model etc.
In vivo
Humans testing (Clinical trials: I, II, III)
Human/ 3
Important:
- no ideal animal model that similar to human
- no alternative methods can be use instate of human
- to determine the efficacy of anti-HIV/AIDS drug or vaccine
Social’s right
Ethical
problems
Individual’s right
Human/ 4
Ulla: If I was 100% sure that there is no risk to get infected and not
bad side effects. I could do it.
Tun: I will not do it, unless they provide sufficient proof that the
vaccine is safe or sufficient insurance if there is any infection
occurs.
Wang: If I believe that it’s safe. I want to.
Julaporn: I don’t want to be a volunteer even though it safes. Since
everything that still in trials may be harm or toxic.
Varaporn: Nothing in the world is absolutely safe. So, I will not be
a volunteer until I sure by myself that the vaccine causes
no risk or harm.
Human/ 5
Aung: It would be great if I have a chance to be volunteer. But !!! I
want to make sure that there are safe for me. So, I’ll not be
the first man to be testes.
Army: Definitely “NO”. Unless I get enough information on the
safety of that drug or vaccine.
7/7
“No”, “If”, “Safe”
“Insurance”
Human/ 6
Mr. A: I clearly understand what will they do now and future and I
certainly sure that it will not be the problem.
Miss. B: They told me everything that I want to know. I confident
that it will be safe.
Mr. C: I quite sure that the vaccine is rather safe because they said
it tested in the animals for many times and there are many
organizations join and responsible for this trial.
Confident about effect of vaccine “safe”
Human/ 7
Mr. A: I am not so sure about the efficacy although it already tested
in animals and animal is not a human like us.
Mr. B: I am not sure that the vaccine itself will not make me infected
with HIV. If it can, what will I do? Who will responsible?
Ms C: I think there is no clearly information about this vaccine. I
never find or read anywhere particular in Thai language.
But I have heard this project for a long time.
Unconfident, Not understand,
No information
Human/ 8
“Normal subjects”
- no high risk group
- high risk group
“Infected group”
- HIV infected subjects
- AIDS patient
HUMAN’S RIGHT
Human/ 9
Ethical requirement of human subject’s research
“INFORMED CONSENT”
A statement about liability
Human/ 10
Ethical problem I (Phase I trial): False HIV-seropositive
Vaccine
develop Ab to HIV
“HIV-seropositive”
occupation, insurance, travel, job application
TAVEG-SIRIRAJ :
- 1 year occurrence, HIV-seropositive from the vaccine, not real
HIV infection, which can detect by using Western Blot analysis.
- 100% not transmission to your lover(s)
“EVIDENCE FORM”
Human/ 11
(cont)
Ethical problem II (Phase I trial): Insurance
Vaccine
may develop side effect(s)
How can those volunteers do?
TAVEG-SIRIRAJ :
- care must be taken by the physician until the subjects feel
normal
- If you have seroconversion, the project will responsible for all of
the therapeutic cost for all of your life
FREE
Human/ 12
(cont)
Ethical problem III (Phase II & III trial): Human’s right
HIV-infected subjects
randomization
PLACEBO
In 1982; 19 cases died in placebo-treated group, only 1 case died in
AZT-treated AIDS or ARC patients
In 1996; only 8.3% of vertical HIV transmission can be found in
HIV-infected mothers when compared to the placebo
treated group (25.5% infection in newborn)
Human/ 13
(cont)
PLACEBO
Standard therapy
“Unethical” to use because it obviously
deny of effective therapy that the
subject can be made with the
maximum benefit
“Standard therapy must not make
the people worse than before”
Standard therapy make sense by mean of “ethics”?
Human/ 14
(cont)
Ethical problem IV : Social’s right
How can we determine the exactly efficacy of the candidate
vaccine in the prevention of HIV-infection?
Injection candidate vaccine into the high risk group
“HIV infection”
Determine the protective effect
of the candidate vaccine
Violent ethical problem
Human/ 15
(cont)
Ethical problem IV : Social’s right
In Thailand
Injection candidate vaccine into the high risk group
Morally, educate to reduce the high risk
behavior, condom support to decrease
the risk of infection
“Absolutely no HIV infection”
Individual’s right is more important than social’s right
Human/ 16
The protection concerning with the ethical
problems in using human model
The consultation on Criteria for International Testing of
Candidate HIV Vaccine (WHO’s Global Program on AIDS, 1989)
“AIDS vaccine (or even drug) trials should adhere to the 3 basics
ethical principles of biomedical research in humans including:
1) Beneficence: maximize possible individual benefit and minimize
possible individual risk
2) Distribute justice: risks and benefits must be equitable sharing
3) Respect: autonomous individuals should be treated with respect
for their capacities for self-determination (informed
consent”
Human/ 17
CONCLUSION
(Human subjects & HIV/AIDS research)
To determine the efficacy of anti-HIV/AIDS drug or vaccine, it
is necessary to study its efficacy in human. Ethical problems
must be carefully concern about benefits and risks.
All of the volunteers must be informed their
consent and they can terminate the test
all time if they want.
HCP/ 1
HCP/ 2
1) Patient-to-health care professional transmission
2) Health care professional-to-patient transmission
HCP/ 3
Patient-to-health care professional transmission
Health care professionals (HCPs)
- provide dedicated and equal treatment the patients
- care both physical and mental of the patients
- can not turn around or abandon the patients
High risk group?
- very close to the HIV/AIDS patients
- easily to contact blood or other discharges from
the HIV/AIDS patient
HCP/ 4
Patient-to-health care professional transmission
In 1992: The Center of Disease Control (CDC) and Prevention
surveillance for occupational acquired
HIV infection in U.S.A
“Health care teams had the possibility to be infected with
HIV during work only 0.3-0.5%”
No sig. of HIV infection comparing with other occupations
UNIVERSAL PRECAUTIONS
HCP/ 5
Patient-to-health care professional transmission
0.3-0.5%
Accidental exposure
- needle-stick
- cut wound
- contact mucous membrane
Ethical problems I:
- If the HCPs exposed to a patient’s blood by needle-stick injury,
can he or her right to know the HIV status of the patient?
Ask the patient for “HIV testing”
HCP/ 6
Patient-to-health care professional transmission
HCPs
Patient
Right to know the patient’s HIV status
Right to accept the HIV testing
Righttotorefuse
refusethe
theHIV
HIVtesting
testing
Right
HIV testing without informed consent
(anonymous testing)
- The results could be placed in the physician occupational
medicine file, not at the patient’s medical record
- The name of the patient must be a secret
- The employee health program must pay for the patient
HIV testing
HCP/ 7
Patient-to-health care professional transmission
Ethical problems II:
-What do the HCPs do after they contaminate with blood or other
secretions from the HIV/AIDS patient?
Article 12 of Technical Rule, 1988
“A test specific Ab should be carried out immediately after the accident
and repeated at intervals of 3, 6, and 12 months. Seroconversion
during this period shall be diagnosed as a case of
WORK-RELATED INFECTION.”
- During 1 year, the HCP can or can not receive the anti-retroviral
drugs, which recommend the use by the Provisional Public Health
Service (1996).
- Side effects must be checked
- Advise to control or change the behavior during waiting for result
- Accidental Report must be write within 24 hours
HCP/ 8
Patient-to-health care professional transmission
Ethical problems III:
-What do the HCPs receive if they are work-related HIV infection?
Same insurance benefits and health care coverage
Able to continue their work until the symptoms occur
Problem: Can they transmit the HIV to their patient?
“Health care professional-to-patient transmission”
Health care professional-to-patient transmission
HCP/ 9
In 1987, she extracted 2 molar teethes
In Florida, 1990: Ms. Kimberly Bergalis (23-year-old college student)
rapidly developed AIDS with no any risks
DNA sequencing test
“Dentist” was the source of infection
Her dentist contacted AIDS and the CDC suggested
“You must used gloves and musk during practice”
Four patients of this dentist also tested
HIV-seropositive
HCP/ 10
Health care professional-to-patient transmission
- The risk of transmission is low
- The CDC (1992): 360 surgeons, 1,200 dentists, 5,000 physicians
in U.S.A were HIV-seropositive
Ethical problems I:
- Is it important to tell the patients that their physician infected
with HIV?
Penny Strong (director of Public Information of Illinois, 1988) :
“We believed that by not telling the patient, you are protect the patient.
Telling patient gives them false impression that if their doctor has HIV, they are
going to get AIDS. But they will not if the doctor strictly follows the guideline.
HCP/ 11
Health care professional-to-patient transmission
Ethical problems II:
- Can the HCP retire by their supervisors if they claimed that
it is the best way to protect the patients?
The CDC recommendations, 1991:
“Seropositive HCPs would be restricted from performing
invasive procedures if they are violated infection control
procedures or had significant cognitive or neurological
impairment.”
“The termination of the employer-employee relationship can
only take place when development of the AIDS
symptomatology makes it impossible for the
workers to perform their work.”
HCP/ 12
CONCLUSION
(Health care professions & HIV/AIDS patients)
There are many sophisticate ethical problems between patient
-to-HCP transmission and HPC-to-patient transmission
especially “human’s right” that involved “right to
know”. The decision is not depend on “benefit
and risk” but it is depend on the way that
how to make equally maximum
benefits to both of them.
- Professor. John Essigmann (MIT)
- Dr. Maria Kartalou (MIT)
- Dr. Suvit Loprasert (CRI)
- Dr. Praphan Phanuphak (Thai Red Cross & Chulalongkorn U.)
- Mr.. Pornchai Sornsathapornkul ( TAVEG-SIRIRAJ)
- All of my ethic group members and my classmates
Question ?
Suggestion ?