Proposed Introduction of Clinical Trials Regulations

The National Health Research Authority is a regulatory body that was established under the National Health Research Act No. 2 of 2013. The mandate of the Authority derived from the Act is to provide a regulatory framework for the development, regulation, financing and coordination of health research and ensure the development of consistent health research standards and guidelines for ethically sound health research. The National Health Research Authority is governed by the National Health Research Authority Council (NHRAC), appointed by the Minister of Health. The functions of the Research Authority may be summarized into six thematic areas:

• Research promotion
• Research regulation
• Research coordination
• Research capacity building
• Research dissemination and knowledge management
• Research Advisory

Apart from the NHRA, the National Health Research Act also provides for the National Health Research Ethics Board, responsible for regulating the Ethical Conduct of Researchers, Research Institutions, Research Ethic Committees (RECs) and Institutional Review Boards (IRBs).

The Vision of the NHRA is to promote a healthy research environment where all research is ethically conducted and all research products translate into improving the health status of the people of Zambia. The Mission is to promote, regulate and coordinate ethical conduct of quality health research and facilitate translation of all research products into evidence-based policies and programs that improve the health of the people of Zambia and beyond. The NHRA work is governed by the following Core Values: Integrity; Professionalism; Transparency; Efficiency; Confidentiality; Effectiveness and Accountability.

Problem Statement

Research evidence on misconduct in clinical trials in Africa in general and Zambia in particular is scarce because of weak regulatory oversight and as such failure to adequately document. However, a study from Nigeria showed that 69% of researchers admitted to committing at least one of the eight forms of misconduct. The eight forms of misconduct are: falsifying data, plagiarism, intentional protocol violations related to subject enrollments, intentional protocol violations related to procedures, selective dropping of data from outliers, disagreement about authorship, and pressure from study sponsors.

Zambia has had its own share of misconduct in clinical trials resulting in adverse effects on human participants and animal subjects. These adverse effects have had both direct and indirect harm. The direct harm is injury to the study participants and animal subjects that may result in death or a disability while indirect harm may include loss of benefits for research participants from the commercialization of a product and denied access from the product. Other forms of clinical trial misconduct related to the researcher may include exclusion of some research team members from publication rights, denied research ownership, denied access to data and loss of royalties in collaborative research.

According to the National Health Research Policy of 2010 situational analysis, health research in Zambia is not fully regulated. Anecdotal evidence reveals that not all health research in Zambia has been ethically approved in the last ten years. This is so because, before the operationalization of NHRA and NHREB there was no regulatory framework for ethical conduct of research. Although some research ethics committees existed, they had no legal mandate to regulate research This led to heavy reliance on individual researcher to comply with international research guidelines. Further, there was some oversight role provided by the Ministry of Health.

For clinical trials there was partial regulation by PRA now ZAMRA whose main focus was and still is on Medicines and Allied substances. While studies that do not involve medicines and allied substances was left unregulated.

The lack of effective regulation of health research becomes a breeding ground for abuse of research participants. Available literature shows that an effective regulatory system would prevent abuse of research participants and if abuse occurs, the culprits would be discovered and prosecuted. For example, in Zimbabwe, during the early 1990s, Dr Richard Gladwell McGown, a British anesthetist working in Zimbabwe, was charged with conducting dangerous human experiments. He was arrested on allegations of having carried out medical experiments on 500 patients, of whom the majority were black. Having been charged with murder, Dr McGown was found by the courts to have conducted interventional studies, using new drugs and anesthetics, without the approval of the National Drugs Authority, and without the knowledge of his patients. Allegedly, up to six of the patients died as a result of the experiments. [3, 4] A Harare court found him guilty of professional negligence. Another example is a case in Nigeria in 2001 where 30 families sued the Pfizer pharmaceutical company over trials of trovafloxacin (Trovan), an antibiotic that was intended to treat meningitis. The issue was that in 1996, Pfizer flew a team of doctors from the USA into Kano, Nigeria, to test Trovan, an experimental drug against bacterial meningitis. The new drug was tested on nearly 200 children during a meningitis outbreak. The trial compared Trovan with the recommended drug Ceftriaxone. Unfortunately children in the control arm allegedly received Ceftriaxone at an inadequate dose. Eleven children died, while some survivors suffered permanent brain damage and paralysis. During investigations, it was found that the clinical trial had not been approved by a local research ethics committee, and that the families concerned were not adequately informed that their children were research participants in a study employing the use of Trovan. [5] The families sued Pfizer through the US courts, resulting in an out of court settlement, but with Pfizer having to pay substantial compensation to them. 

The Authority intends to introduce Clinical Trial Regulations and invites comments from stakeholders and the research community. The draft regulations have been uploaded on this portal.