The Government of Rwanda on Monday, October 25, tabled before Parliament’s Chamber of Deputies a "draft law relating to research on a human participant” in a move meant to help the country meet international medicine and vaccine trial standards.
The development comes as the country continues to position itself as one of the pharmaceutical hubs in Africa, including in areas of vaccine manufacturing.
While explaining the relevance of the bill to lawmakers on Monday, Dr. Tharcisse Mpunga, Minister of State in the Ministry of Health in charge of Primary Healthcare said that the new legislation will address the issue of lack of a robust legal framework that recognises ethical standards and protecting the rights of participants in health research activities conducted on humans.
The draft law – whose relevance was adopted by the legislators - also establishes the National Ethics Committee (NEC) that reviews and approves the ethical component of such researches before they are conducted.
The committee will oversee and ensure that research on human subjects is conducted in accordance with ethical standards hence protecting human participants from unethical or illegal research activities.
Timely legislation
Mpunga said that this draft law comes at a time when there is an increase in diseases whose treatment or vaccination requires the recruitment of human participants or other living organisms in compliance with research ethical standards.
One of such diseases is the Covid-19 pandemic that has ravaged the entire world by causing disruption in the global health system and claiming the lives of many, stifling the economy as well as depleting [some] people’s livelihoods.
This draft law will also enable the country to fulfill the prerequisite for the Rwanda Food and Drugs Authority (FDA) to attain the World Health Organisation regulatory system classification of medical products: "Maturity level 3", which implies having a legal instrument regulating research in a way that is recognised worldwide.
Needs for review
Currently, research conducted on a human is regulated by Ministerial Instructions N°003/2010 of 09/12/2010 regulating research activities in Rwanda by the Ministry of Education and a Rwanda National Ethics Committee with the mandate to examine all related research projects as well through the Ministry of Health’s Ministerial Instructions N°20/37 of 3/10/2008.
However, Mpunga told lawmakers that the two Ministerial instructions, much as they are considered as legal tools, cannot serve as sources of enabling law that recognise or regulate research and protect the rights of human participants as well as establishing a Committee that is required to be multidisciplinary and autonomous in nature, to enforce the research ethical standards.
Mpunga said that the country was receiving about 120 research protocols per year, adding that no severe effects have been reported in humans thus far for them to be given compensations.
"The reason for this is that the researches that have been done in Rwanda so far are not radical because they involve pharmaceuticals that were already approved [elsewhere] so that they can start being used [in the country],” he said, commenting on the situation.
Talking about trial effects on humans, MP Winifrida Niyitegeka said that great caution should be exercised to ensure the rights of the participants are fully protected.
"Sometimes, the adverse effects on the participant in a trial might be lenient in the first days but become severe later on,” she said.
MP Albert Ruhakana wanted to know what kind of research will be done on humans especially because they might fear to take part in some depending on their nature as they might put their lives at risk.
"Even developed countries use human bodies or animals such as mice in trials. ... I think, not all kinds of research should be done on humans,” he said.
On trial type, Mpunga replied that the research to involve human participant is for the pharmaceuticals or vaccines that passed the pre-clinical trial involving animals as they were cleared after being considered effective and safe [in animals] to go to the clinical trial involving humans in order to see whether they can cure or protect them.
Non-granting of reward to a research participant
A research participant does not obtain a financial or material consideration, either direct or indirect. However, the researcher may reimburse the research participant for expenses related to participation in the research or compensation for time spent by participation in the research.
The internal rules and regulations of the Committee determine the mode of reimbursement to the research participant the expenses incurred because of the research in question.
Consent of the person subject to research
The bill provides that a research participant, prior to commencement of research, provides his or her consent. Before expressing his or her consent, the researcher informs him or her about its objectives, methodology, duration, expected outcomes, possible consequences, and the risks that he or she may incur as a result.
The consent of a research participant must be informed and free, without coercion. The informed consent process is performed in the language that the research participant understands.
Compensation for unjustified harm
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.