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- 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

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- 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)

(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

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Ethics (ethos + ethica) an academic discipline that provides a set of intellectual instrument for the analysis of moralitymorality

Original: Ethics “inner being” or person’s character focus on the attitude & habits that render the person good or bad

Morality (mos-moris) person’s behavior that is open to judgements of right and wrong

Social ethics Social order and specifically with what’s right and good in the organization of human communities

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Ulla: I think it’s OK to use animals.

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.

Wang: It’s OK but be careful.

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.

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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.

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AgreeScience

- 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

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- 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)

- study the first stage of HIV pathogenesis (Chimpanzees)

- evaluate the protective effect of vaccine on AIDS-like disease (rhesus macaque monkey)

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- 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 ?

“It involves a consideration of the moral status ofnon-human animals and the idea that animalshave the right to live as well as not to be used byhumans in anyway because that animals haveequal rights to humans”

Ethical Problem IEthical Problem I

“Animal Rights”

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Dislocation of neck bone

Guillotine

General anesthesia

- 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.

Ethical Problem IIEthical Problem II: : Unreliable dataUnreliable data

5-25% correlation between 5-25% correlation between harmful effectsharmful effects in people and the in people and the results obtained from animal experimentsresults obtained from animal experiments

Half of all drugs released by the FDA are later reportedHalf of all drugs released by the FDA are later reported to have the to have the serious side effectsserious side effects in humansin humans

Yes. The scientists know animaltests are too unreliable to work.

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Rhesus macaques often show fear & defenseresponse, reflected in significant changes innormal physiology when personnel is aroundor tries to remove it from its cage.

So, can we confidence in the results obtained from it?

(cont)

Refine- handling- housing- feeding- caring

etc

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 “SUCCESSSUCCESS”.

Ethical Problem IIEthical Problem II: : Religion ethicsReligion ethics

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The Animal Welfare Institute “Alternative (3R)”

1) Refine

2) Replace

3) Reduce

: any technique that makes them feel more comfortable & less painful

: the changes of experimental animals species or way of uses e.g genetic engineering, human cell culture

: lowering the need or number of animals in the experiment e.g. using computer simulator, statistic team

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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

The demand for animal experiments can be limits if humansaccept and enforce the following 3 principles:

3) If doing without harmful animal experiment involves only a slightly risk or loss to humans. We should without it.

2) If there is organs or tissues from dead human, aborted human fetuses, or the like.

1) If there are humans volunteers to join the experiment that will cause only limited pain & convenience.

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CONCLUSION(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.

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Human/ 1

In vitro

In vivo

Humans testing (Clinical trials: I, II, III)

Alternatives: Cell culture, Computer model etc.

Human/ 2

EthicalEthicalproblemsproblems

Social’s right

Individual’s right

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

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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/ 4

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”

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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”

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Mr. A: I am not so sure about the efficacy although it already tested in animals and animal is not a human like us.

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.

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?

Unconfident, Not understand, No information

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“Normal subjects”- no high risk group- high risk group

“Infected group”- HIV infected subjects- AIDS patient

HUMAN’S RIGHTHUMAN’S RIGHT

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Ethical requirement of human subject’s researchEthical requirement of human subject’s research

““INFORMED CONSENT”INFORMED CONSENT”

A statement about liability

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Ethical problem I (Phase I trial): False HIV-seropositive

Vaccine develop Ab to HIV

“HIV-seropositive”

occupation, insurance, travel, job application

TAVEG-SIRIRAJ :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”EVIDENCE FORM”

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Ethical problem II (Phase I trial): Insurance

(cont)

Vaccine may develop side effect(s)

How can those volunteers do?

TAVEG-SIRIRAJ :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

FREEFREE

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Ethical problem III (Phase II & III trial): Human’s right

(cont)

HIV-infected subjects PLACEBOPLACEBOrandomization

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)

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PLACEBOPLACEBO

(cont)

“Standard therapyStandard therapy must not make the people worse than before”

Standard therapy make sense by mean of “ethics”?

“Unethical” to use because it obviously deny of effective therapy that the subject can be made with the maximum benefit

Standard therapyStandard therapy

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(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 infectionHIV infection”

Determine the protective effect of the candidate vaccine

Violent ethical problemViolent ethical problem

Human/ 14

(cont)

Ethical problem IV : Social’s right

Injection candidate vaccine into the high risk group

“Absolutely no HIV infectionHIV infection”

In Thailand

Morally, educate to reduce the high riskbehavior, condom support to decreasethe risk of infection

Individual’s right is more important than social’s right

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The consultation on Criteria for International Testing ofCandidate 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”

The protection concerning with the ethical problems in using human model

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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.

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HCP/ 1

1) Patient-to-health care professional transmission

2) Health care professional-to-patient transmission

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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

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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

Patient-to-health care professional transmissionHCP/ 4

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?

Patient-to-health care professional transmission

Ask the patient for “HIV testing”

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Patient-to-health care professional transmission

Patient Right to accept the HIV testing

Right to refuse the HIV testing

HCPs Right to know the patient’s HIV status

HIV testing without informed consent (anonymous testing)

Right to refuse the HIV 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

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Ethical problems II:

-What do the HCPs do after they contaminate with blood or other secretions from the HIV/AIDS patient?

Patient-to-health care professional transmission

Article 12 of Technical Rule, 1988Article 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

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Ethical problems III:

-What do the HCPs receive if they are work-related HIV infection?

Patient-to-health care professional transmission

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”

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Health care professional-to-patient transmission

In Florida, 1990: Ms. Kimberly Bergalis (23-year-old college student)

rapidly developed AIDS with no any risks

In 1987, she extracted 2 molar teethes

DNA sequencing test

“DentistDentist” 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-seropositiveHIV-seropositive

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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 aregoing to get AIDS. But they will not if the doctor strictly follows the guideline.

HCP/ 10

Health care professional-to-patient transmissionEthical problems II:

- Can the HCP retire by their supervisors if they claimed thatit 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.”

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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.

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- 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 ?