By Gatonye Gathura
Scientists at the Kenya Medical Research Institute report the dilemma of compensating research volunteers who are deliberately infected with disease causing organisms.
The researchers are investigating how some people manage to resist malaria; knowledge that can be used to create new vaccines and drugs against the disease.
To do so the researchers are screening 2,000 volunteers to pick 200 suitable candidates to be injected with the malaria parasite.
Successful volunteers are then injected with the malaria parasite and monitored as inpatients for 24 days.
For every overnight stay each participant is paid Sh2, 000 with a possible maximum 24 nights – totaling Sh48, 000.
Currently the study, which started in 2016, is ongoing in Kilifi at the Coast where some 105 volunteers have already gone through the process.
Other scheduled study areas are Ahero in western and Nairobi for central Kenya.
The four-year study to 2020 is being carried out by the Kemri-Wellcome Trust Research Programme, Kilifi, Oxford University, UK, University of Cambridge, UK, Pwani University and Sonaria Inc., a US biotechnology company.
But last year a second team of social scientists from the same institutions including the World Health Organization revisited the Kilifi volunteers.
They went to investigate the moral and ethical issues around infecting health individuals with a potentially harmful organism in exchange for money.
“There are a myriad of ethical issues that are likely to emerge with such studies especially in poor countries, and the need to ensure that communities are not exploited,” the latter team says in a report published in April.
This group of researchers had walked back to the Kilifi volunteers to find out what motivated them to participate in an activity which had some obvious medical risks.
The investigation was carried out in Kilifi between January and April 2017 and the results published on 11th April 2018 in the journal Wellcome Open Research.
The team says the biggest motivation for majority of volunteers was the promise of money.
“The greatest motivation for participation was the monetary compensation of 20 USD per overnight stay given as a lump-sum at the end of their residency stay,” says the report.
But for a volunteer to get the lump-sum, Sh 48,000 they have to resist malaria for at least 24 days.
“If I manage to stay for those 24 days, I will have gotten a lot more money than going to the market where on average I make Sh1, 000 per day,” said a 23-year-old female respondent.
But getting the whole amount is no walk in the park. In an earlier similar study by the same institutions, carried out among university medical students in Nairobi, of 28 volunteers only one managed to resist malaria all the way.
In the current study participants are monitored closely and those who develop malaria are identified, treated, paid for the nights spent and then released.
Possibly informed by the higher cost of life in Nairobi compared to Kilifi, the city volunteers had been Sh 4,000 for an overnight stay, Sh 1,000 for each scheduled clinic visit, and Sh 500 for each return journey to clinic.
The whiff of money, the study says has raised high expectations in the receiving community.
“I have already set a budget for the money; every coin is allocated,” a 25-year-old potential male participant told the researchers.
“Many participants indicated that they would use this income to develop their families, pay school fees, pay-off debts, buy livestock, go for vocational training, open businesses and build houses,” says the report.
For those screened out, the study reports anger: “From today I will never participate in any KEMRI study and neither will my children,” said a woman who was disqualified for too much smoking.
Most of the people, the research says while appreciating a vaccine, would not have volunteered without the promise of money.
Despite scary romours triggered by the study, especially because of the heavy blood collections involved, the report says the money factor had overcome such fears.
The windfall, the report says is not without some domestic conflicts.
One female participant, who had pullout her children from school to enable her attend the hospital stay, told of a bitter tongue lashing from her mother.
Others possibly not wanting to share the proceeds with their partners or families had spun convenient excuses to cover their 24 day absence.
While most said they were willing to dare malaria because it was a disease they knew well, including its treatment another disease such as HIV, may not be as welcome.
But what if the next researchers raise the cash offer? “Our research suggests particular care is needed in such studies to ensure that communities are not unduly exploited.”
Criteria for participating
- Healthy adults aged 18 to 45 years.
- Willing to comply with all study requirements
- Women should not be pregnant
- Females to verify they are on contraceptives
- No recent malaria infection
- No recent use of antibiotics
- No recent blood transfusion