A participant in a research such as that for vaccine or medicine use in humans does not obtain a financial or material reward, either direct or indirect, according to the bill under a vote at the Chamber of Deputies.
Members of Parliament on Wednesday, May 18, voted for Article 11 of the draft law relating to research on a human participant.
The article provides that a research participant does not obtain a financial or material consideration, either direct or indirect.
It comes at a time when there is an increase in diseases whose treatment or vaccination requires the recruitment of human participants or other living things in compliance with research ethical standards, according to the Ministry of Health which tabled it before Parliament.
The country also continues to position itself as one of the pharmaceutical hubs in Africa, including in areas of vaccine manufacturing.
According to the Ministry of Health, granting rewards to research participants could compromise the study findings as some researchers would influence outcomes by paying money to participants.
The ministry also adds that some people could be influenced to participate in the trials just because they are driven by financial gains rather than for purpose of helping solve problems affecting communities.
MP Odette Uwamariya, Chairperson of the Committee on Social Affairs, which scrutinised the bill said that it is a principle not to give a reward to research participants.
"A person should not take part in a research because of the personal gains they expect from it or reward as in such cases, we might face a risk that some trials might be influenced because their participants are not in line with the intended objectives,” she said.
However, the bill provides that a researcher may reimburse the research participant for expenses related to participation in the trial or compensation for time spent for this purpose.
It indicates that the internal rules and regulations of the National Ethic Committee (NEC) determine the mode of reimbursement to the research participant for the expenses incurred by the research.
This Committee serves the purpose of overseeing and ensuring that research on human subjects is conducted according to ethical standards, hence protecting human participants from unethical or illegal research conducts.
MP Veneranda Nyirahirwa said that the principle not to provide reward to research participants should be explicit, pointing out that there was no need to include things like transport facilitation in the law.
"Even though the search participant does not get a reward, they are facilitated to reach the trial site … What would happen if you tell them you would refund them, yet they lack a ticket, wouldn’t that research be hindered,” she wondered.
However, MP Uwamariya indicated that the participant might have spent money on transport, or stayed in a paid for accommodation for say two days during the time of their participation in the research.
"We are setting a principle that when it requires a participant to pay some expenses depending on how the research will be conducted, it is signed in the research protocol that the participant will get reimbursed for the expenses incurred,” she said.
"A participant who is volunteering to take part in a trial for public interest, should not be subjected to incurring expenses for that purpose. They should be facilitated,” she remarked.
Meanwhile, concerning damages, the bill provides that a person who has suffered from unjustified harm arising from scientific research is entitled to fair compensation in accordance with relevant laws.
The voting on the bill will continue, on a date that is not yet specified, as there are some articles that have not yet been debated on by lawmakers.
It is to note that prior to commencement of research, a research participant provides his or her informed consent.
The is a consent of the research participant after being prior informed and understanding the aims and nature of the research, his or her obligations, the potential risks and advantages linked to the research.