Biomedical Research in Developing Countries - UNICRI

IRBs and local RECs to ensure scientific and ethical validity and community
involvement was established, by creating community advisory boards. Informed
consent was obtained in the language of choice and explained that trial participation
was not going to protect participants from HIV infection, Consent was, in some
cases, preceded by the administration of a comprehension test.
All participants were to receive risk-reduction counselling and other prevention
services (condoms and STD testing in sites where risk was related to sexual
behaviour; methadone treatment programmes and bleach to clean needles in the
case of injecting drug users). Participants infected during the trial received
confirmatory testing, post-test counselling and assistance in enrolling in local HIV
care programmes 41 . However, post-trial access to therapies was not clearly defined.
The reasons for the termination of the tenofovir studies are various. In each of the
sites, activists raised concerns over heavy violations of human rights and ethical
issues. In Thailand for example, the activists accused the sponsors of neglecting the
participants’ rights, for not providing clean syringes and for not following up in
post-trial treatment. Sponsors claimed that clean needles were not provided,
consistently with the drug national policy, in both the sponsoring and the hosting
country. The Thai government was heavily criticized for the total absence of harm
reduction policies in its policy that leads to widespread human rights abuses against IDUs.
In the Cambodia trial, activists groups forced the Ministry of health to stop the trial,
and the protest became dramatic at the 2004 AIDS Conference in Bangkok, where
activists attacked and closed the Gilead’s Booth, accusing the investigators of
providing inadequate prevention counseling, in order that participants would
understand the repercussion of their participation, especially that participation in
the trial would not protect them from getting infected by HIV or any other
infection. Also participants faced a lack of pre- and post-test HIV counseling, and
those who seroconverted or experienced adverse events were not provided with
adequate medical services and insurance.
The Cameroon trial was also terminated and an independent inquiry commissioned
by the Ministry of health was necessary to resume it, due to concerns raised about
the complete inadequacy of prevention counselling, with a ratio of 5 counsellors
for 400 participants and due to the absence of any agreement for provision of
treatment after completion of trial. In addition, suspicions were raised that
investigators were intentionally allowing participants in the placebo arm to become
infected with the HIV virus, in order to raise evidence of the efficacy of the tenofovir.
Along the same line, on March 11, 2005, the Nigerian study was also terminated
earlier, this time voluntarily by FHI due to the fact that local researchers failed to
reach “the necessary standard” previously established to comply with the study.
41 Botswana was one of the first countries in Africa to establish an antiretroviral therapy programme, beginning
in 2002 and expanding across the whole country. AIDS treatment is offered free of charge within the national
health system.
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