1. Ethical Issues: Specific focus on HIV/AIDS Research
Capacity Building Workshop on Ethics in HIV/AIDS Research
2nd Regional Workshop
Sep 13th-15th , 2011
NARI, Pune

2. GCP
Freely given informed consent should be obtained from every subject prior to HIV testing and research participation in accordance with national culture(s) and requirements.
When a subject is not capable of giving informed consent, the permission of a legally authorized representative should be obtained in accordance with applicable law

3. Confidentiality HIV test result must be kept confidential
Previously, the beds of HIV positive subjects in hospitals used to labeled as “HIV Positive” at the head end of the bed
Confidentiality if violated could have disastrous consequences

4. Breach of Confidentiality
Patient developed typhoid and admitted in rural setting
Health care workers informed others subject is HIV positive
Information spread in rural area
Subject dismissed from job
Wife committed suicide
Shunned by all when he went out of house
Social boycott of his house

5. Confidentiality
If husband/wife is HIV positive, should the HIV status of the spouse be revealed to the partner/ fiancee?
If the husband or relatives do not want to reveal the husband’s HIV status to the wife, what should be done?
Should a HIV seropositive child’s HIV status be told to school/teacher to ensure proper care of child?

6. Clinical Trials
How to ensure the study subject has understood the benefits and risks of the clinical trial during the counselling session?
How to ensure that the informed consent was not obtained under any coersion or by giving incentives?

7. GCP - Principle 8
Research involving humans should be continued only if the benefit-risk profile remains favorable

8. JAMA 2000 PMTCT in Resource-Poor Countries
Each year, an estimated 590,000 infants acquire human immunodeficiency virus type 1 (HIV) infection from their mothers, mostly in developing countries that are unable to implement interventions now standard in the industrialized world.
In resource-poor settings, the HIV pandemic has eroded hard-won gains in infant and child survival.
Recent clinical trial results from international settings suggest that short-course antiretroviral regimens could significantly reduce perinatal HIV transmission worldwide if research findings could be translated into practice.
JAMA. 2000;283(9): doi: /jama

9. PMTCT Studies
There was debate about the ethics of placebo-controlled trials of antiretroviral agents in perinatal transmission of HIV.
Lurie and Wolfe1 argued forcefully that such trials were unethical, in view of the knowledge that there is an effective regimen available (PACTG 076 study).
Their argument was that study participants were entitled to the highest standard of care available anywhere, not only in the host country.
THE LANCET • Vol 353 • May 29, 1999

10. PMTCT
Five ethical principles were endorsed; these included the idea that study participants should receive the highest standard of care “practically attainable in the host country”.
However, they concluded, “there is no obligation to provide study participants with the highest standard of care attainable elsewhere in the world”, this statement being in direct contrast to the Declaration of Helsinki (1964).

11. Research in Developing Countries
If the research is planned and financed by a sponsor from a developed country who cannot do it in their own country for ethical reasons, and especially when a developed sponsoring country is likely to benefit (albeit less than the host country) from successful results, then only the highest possible standards of care of the sponsoring country should be offered to consenting research volunteers.

12. Research in Developing Countries
All host country investigational patients should be given the benefit of the best care, for their participation in the study, to fulfill universal ethical standards of research trial design.

13. Issue Related to Placebo
Despite two randomised, placebo-controlled trials showing the effectiveness of zidovudine in reducing perinatal HIV transmission, In The Lancet of March 6th 2000, three placebo-controlled trials of short course zidovudine therapy in expectant mothers with HIV were reported.

14. PMTCT
Public debates about the HIV perinatal transmission trials had earlier not focused on whether the women in the trials should be provided HIV combination therapy as they would have been if they had been in a developed country

15. GCP - Principle 11
All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification

16. GCP - Principle 12
The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s)

17. Confidentiality Stigma is still a major issue in HIV
The contact details (addresses, phone numbers) and records of subjects in HIV research studies need to be kept safely so that their confidentiality is not compromised

18. When to start ART?
Recent guidelines indicate the there may be benefit even when the CD4 count is between 350 to 500.
When a patient comes with CD4 count between 350 to 500, then what should the clinician / counsellor inform the patient?
There could be benefits when starting ART even above 500 CD4 counts since safer ART medications are available now. What to tell patients who have CD4>500?

19. Research Benefits
Developing countries do take care of the patients after the study is over in a collaborative study with developed countries
In a collaborative study between developing and developed countries, the benefits of the research should reach the developing countries who take part in the research eg HIV vaccine related research