NAIROBI, Kenya, Jul 14 – At least 300 clinical trials are currently being conducted in the country, yet chances of Kenyans benefiting from them are close to nil, according to the Kenya Medical Research Institute Ethics Committee.
The committee attributed this scenario to poor negotiations by concerned government officials.
“This is a policy issue which is handled at governmental level,” said the committee’s Chairman Ambrose Rachier who added that Kenyans ought to benefit from such studies done on their soil.
If vaccine studies are done in Kenya, for instance, the country should get the final vaccines at an affordable price after successful research.
“What happens most often is that when the product comes into the country it is unaffordable and therefore those who had participated (in the study) do not get the benefit despite taking the risk,” Mr Rachier told Capital News.
“And the ethics committee and participants are powerless at that time; we have no bargaining power,” he added.
In 2009, Public Health Minister Beth Mugo was embroiled in a bitter tussle with a vaccine manufacturer who had refused to subsidise the cost of a pneumonia vaccine despite the research having been done on Kenyan children.
In February this year, Kenya became the first African country to roll out the pneumococcal vaccine as part of routine immunisation for children under 12 months after the manufacturer accepted to subsidise the cost.
Mr Rachier is of the opinion that to avoid such confrontations, negotiations should be done immediately after a research is concluded and some of the findings are disseminated or published.
“But often this is the time nobody does anything unfortunately,” he says.
There have been emerging ethical concerns amongst some scientists across the globe about clinical trials done in third world countries with some saying there are numerous violations.
The Kenya Medical Research Institute Ethics Committee reviews at least 30 new applications for studies every month out of which 25 are clinical.
“The committee is very vigilant to ensure that researchers are not escaping from the north to try and exploit an area which is thought to have easier prey,” Mr Rachier assured.
For a research proposal to be approved in Kenya, it has to go through scientific clearance, peer review, the researchers must be competent and there must be consent from participants without inducement.
“We look at any compensation that is supposed to be given (to the participants) because when it is very attractive then we are dealing with the principle of inducement- that the people may not be acting in a voluntary manner; they may be coming in for money,” he states.
It is a requirement that participants in a study be compensated for their travel and meals.
Most participants in clinical trials are recruited through field workers.
“These are what we call fishers of men- people you send out to look for the specifications that you have because there is an inclusion and exclusion criteria depending on the nature of the research,” Mr Rachier explains.
The studies also have to get an annual approval which gives the committee an opportunity to audit the progress.
Scientists attending a recent conference of Science Journalists in Doha, Qatar had also expressed concern that most of the clinical trials are done in developing countries because of the low fee and less bureaucracy.
For example, a researcher requires USD 1,000 to apply to undertake clinical trials in Kenya while it may cost up to USD5, 000 to apply for the same in the United States.
Mr Rachier however assures that trials done in Kenya are up to standard adding that certain types of research can only be conveniently carried out in the third world.
“If you take for example malaria, if it doesn’t exist in your country, it’s not easy to study it. As a tropical disease you will only study it in the tropics where you find the mosquitoes,” he explained.
“But one cannot escape thinking that the rigidity of the rules for example in the west and the difficulty to get people to consent is real,” he adds.
The Ethics Committee Chair acknowledges that one of the weakest areas of research in the country is monitoring and evaluation of research after approval.
“After you approve a research, nothing stops a dishonest researcher from designing a different consent form and administering to participants. We usually do random checks on researchers to curb this,” he says.
He anticipates that based on the complaints they get, at least 10 percent of researchers could be sidestepping some of the procedures.
“When we get such researchers, we close the study completely,” he informs.
Some of the most popular research areas in Kenya are Kilifi, Kisumu, Busia and areas near Rusinga Island.