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[fousseyni]

Dear Dr Aceme,
1) If the Tenofovir has been already tested in animals (Preclinical studies) and the safety successfully attested there is a need of such study.
2) The political interferences
3)Ethical committee, Ministry of Health
4) Good communication skill at the begining of the study

[sithembile Ruzario]

1. Is there a need for such studies as the Tenofovir Trials in the first place?
Yes, there is need for such studies as the tenofovir trials to take place because vaginal microbicides empower women in the prevention of HIV/AIDS, and if found to be effective, they would be useful complement to other HIV prevention methods like safer sex education, condom use, voluntary testing and counselling, treating of sexually transmitted infections and other anti-HIV campaigns. HIV/AIDS is a public health problem and poses a threat to international growth and development, any research; as long as it is carried out in an ethical manner should be encouraged.
2. On one hand, activists alleged that there were ethical flaws in the study, while on the other hand the Ministry of Health investigated and concluded that the allegations were false. What could be the reason for such a discrepancy?
The reason for such a discrepancy might have been that the Ministry of Health is the one that reviewed the protocol for ethical and scientific fitness. There is no way they could have blamed themselves for a mistake they made. The activists might have been well informed by scientists that the study had ethical flaws and had all the right to have the study halted. If the Ministry of Health investigated and concluded that the allegations were false, why was the study stopped if they were really genuine about their findings? Lack of education on ethical and scientific issues on one of the two concerned parties could have caused the discrepancy. This shows that the country does not have written ethical guidelines because if they were there such a discrepancy could not have happened
3. If tenofovir antiretroviral drug was licensed and widely used in the USA only and was not widely used elsewhere in the world, who should have brought up issues of post-trial availability and affordability in the event that it was found to be effective as a pre-exposure prophylactic drug?
The issue of post-trial availability and affordability in the event that tenofovir was found to be effective as a pre-exposure prophylatic drug should have been brought up by the reviewing ethics committee, the country drug regulatory body and the researcher.
4 a) Insufficiency of the informed consent process in terms of the risks involved
It is a must in research that potential participants be provided with all the necessary information pertaining to the trial. The language used must be simple and is to be understood by the participants. Participants should be allowed time to digest the information on the informed consent, they should be allowed to consult other people before entering into a trial. In research like this some participants might think that they are being given a preventive gel and can as well indulge in unprotected sexual intercourse making the situation even worse.

b) Inadequate access to health care for participants who become HIV positive during the trial
A source of funding should have been identified before the study started to look after the women who sero-converted during the trial so that there is adequate care throughout their life. The issue here is whether the investigator or funder is obligated to provide HIV care to the infected women. If yes, what kind of HIV care and for how long?
c) Exploitation of trial participants
Poverty, limited health-care services, illiteracy, cultural and linguistic differences, and limited understanding of the nature of scientific research increase the possibility of exploitation. This is typical of research populations in developing countries like Cameroon where the study took place. Regulatory structures and research oversight processes can minimize risk of exploitation. A country should try by all means to have guidelines for ethical research to protect their people from exploitation.

d) Unethical experimental design

The ethics committee that reviewed and approved the study for ethical and scientific fitness should have not approved the study, instead, the protocol was supposed to be sent back to researcher to redesign the study. IRB members need continuing education.

e) Inadequacy of research staff members

This again should have been detected during protocol review before approval. The IRB should have looked at the anticipated workload versus the number of study health personnel.
.
_________________
Sithembile Ruzario
Medical Research Council of Zimbabwe
Research Training and Monitoring Officer
sithembileruzario@yahoo.co.uk

[Constance Agwang]

1. In my opinion, I don’t think such studies should even be carried out in the first place. This is because HIV is a disease that has no cure and the risks of getting infected in such a study are so high, nothing can compensate for the life that will eventually be lost in the event of HIV infection, especially due to the trial.
2. The ministry might have wanted to protect it name and image.
3. Issues of post-trial availability and affordability should have been brought up by the Ethics review board, because before the study is approved, its future implications should be put into consideration.
4. (i) The participants should be given the whole truth about the study, risks involved so that they consent into taking part in the study when they are fully aware of its implications. (ii) Sufficient health care should be available to subjects at all times, in the event they contract the virus. (iii) The experimental design should be reviewed and approved by an ethics committee. In a nut shell, research rules and guidelines on humans should adequately adhered to
_________________
Constance Agwang
Med Biotech Laaboraories
P.O Box 9364
Kampala, Uganda
Mobile: 256-77-257791