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Roundtable proffers ways of respecting the rights of participants in......

The state of clinical trials in developing countries came under
scrutiny recently.And the crux of the matter was the right of
volunteers to leave any critical trial without any undue harrassment
or loss of priviledges.

Africa like most developing parts of the world has been the centre
of most clinical trials expecially by western drug
companies.Clinical trials are organised testing of a drug
compound,vaccines or medical device in humans to ensure that the
drug is efficacious and safe.

Volunteerism in clinical trials depicts freedom to leave without any
strings attached.Do clinical trials conducted in developing
countries actually allow such freedoms?

At a media roundtable organized by Journalists Against AIDS (JAAIDS) Nigeria in collaboration with the Nigeria HIV Vaccine & Microbicides Advocacy Group (NHVMAG),Dr. Morenike Ukpong, NHVMAG Coordinator,Ms. Marrie De Cernival of SIDACTION,France and Mr. Azubuike Nwagbogu of the Clinical Trial Unit the National Agency for Foods and Drugs Administration and Control (NAFDAC) bared their minds on various forms of unethical practices with regards to clinical trials.Some of these, according to the speakers, include the poor performance of regulatory bodies tasked with such responsibilities like NAFDAC and the seeming negligence of institutional review boards who are supposed to also monitor trials and other researches being conducted in tertiary institutions across the country. In her presentation, Dr. Ukpong said the freedom to participate in a trial or to opt out of should be part of the fundamental rights of trial participant. She added that participants must also be given full briefing on the trial processes and procedures and comprehension must be assessed before seeking for signing of consent forms.But she lamented that this is oftentimes not so. She tasked the media to be alert and help correct these anomalies. "Just like the media coverage of the court proceedings on the controversies surrounding the Pfizer trials, the media must play its role as an effective watchdog so that government agencies and companies can do what is right." Ms. De Cernival identified poverty in developing countries as a factor that forces participants to remain in trials because they can't afford to pay for such treatments themselves. `In developing countries like Nigeria, participants involved in a clinical trial don't often have the same reasons for participating as that of researchers as many participate primarily because of the free benefits that will accrue to them." This is not the case in developed countries where most trial participants are not interested in free medical care since they can easily access that as provided by the government health plans for citizens.

"In the western world, participants often volunteer for trials
because they are interested in the questions the research aims to
answer. Some also do it because of the benefits the results could
bring to humanity."

Mr. Nwagbogu of NAFDAC, said the agency is working to ensure that
all trials going on in the country are registered with it and are
appropriately approved. He said when applications for approval to
conduct clinical trials are submitted to NAFDAC, its clinical trial
unit first studies the research protocols being presented by the
proponents before making a final judgment on whether to approve or not. He agreed with the other speakers on the significance of informed consent of participants in any research effort, and their freedom to opt out anytime they choose without any backlash from the researchers.

`Overall, before approving any research whatsoever, we make sure the subject of research is something that is important to the nation, is for the greater good of the society and that the interests and
welfare of all trial participants are protected".

The NAFDAC officer admitted that some researches still go on in the
country without NAFDAC's approval.However, such efforts are illegal
while the research findings, no matter how laudable, also wear the
cloak of illegality. He warned that the unscrupulous masterminds
behind such illegalities are also liable to criminal prosecution.

O'Femi Kolawole
Email:ofemi@nigeria-aids.org

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