CIDRZ RESEARCH AND REGULATORY SUPPORT
Based on Zambia National Health Research priority agenda, CIDRZ aims to identify locally-relevant, culturally-acceptable, resource-appropriate, evidence-based interventions that will influence evidence-based policy formulation. Therefore, in pursuit of evidence based policy decisions informed by available systemic evidence that produce better outcomes, CIDRZ conducts research studies ranging from clinical trials, surveys,behavioral and implementation science studies. Most studies are conducted within public clinical care facilities in Lusaka. All are endorsed by the Ministry of Health (MOH) and undergo continuing ethical review.
As an organisation that focuses on health research, CIDRZ recognizes the fact that all research involving human participants must be conducted in accordance with the ethical principles governed by International Conference on Harmonization (ICH) and other current guidelines such as the Code of Federal Regulation 45 part 46 (CFR), Council for International Organizations of Medical Sciences (CIOMS), and national laws and regulations. In this regard CIDRZ has a designated Research Operations department responsible for meeting each applicable regulatory requirement for both in country and internationally. For more than 10 years, this department has demonstrated the capability to assure compliance with all international and national regulatory bodies.
All CIDRZ trial applications or notification to any ethical bodies and relevant authorities, amendments to the trial protocol, reporting of all adverse events, and notifications are thoroughly reviewed by this department before submission to ensure that they are within the confines of the applicable laws and regulations. The department maintains a current knowledge base of existing or emerging regulations and guidance documents from all regulatory authorities and ethical bodies. Further, the department is current with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guidelines and the US Code of Federal Regulations regarding Human Subject Protection (CFR Title 45 Part 46). The research department ensures that all parties involved in clinical trials fully comply with the existing national and international regulations and requirements.
Review of Regulatory Submissions and Tracking
The Research department ensures the trial application process, subsequent submissions and approvals or acknowledgements are smoothly done without omitting ethical and any regulatory authority body and in a timely manner.
Other Main duties
- Gives support to all CIDRZ Research activities
- Quality Assurance and Quality control of all research data
- Training of research personnel, Good Clinical Practice, Human Subject Protection, Source Documentation etc.
- Research study submissions to Ethics committees and regulatory authorities for
- Facilitating submissions of progress reports to Ethics committee and regulatory authorities and other partners.
- Ensures compliance of research studies to both national and international guidelines – ICH-GCP 2.8, 4.2.4 , , ICH GCP4.8, 21 CFR PART 50.27, Nuremberg Code, Belmont Report etc.
International Guidelines to our Research:
- The Nuremburg Code of Human Rights (1947)
- The World Medical Association’s Declaration of Helsinki (1964-2008)
- The Belmont Report (1979),
- The World Health Organisation (WHO) and International Committee on Harmonization Guidelines for Good Clinical Practice (ICH GCP, 1995), and
- The Council for International Organizations of Medical Sciences (CIOMS) International Guidelines for Biomedical Research involving Human Subjects (2001).
These Guidelines (listed above) emphasize the three basic principles of the ethics of health research, namely, respect for persons (autonomy), beneficence (benefit to the research participant), and justice (equitable distribution of risks and benefits). This is to ensure that the rights, dignity, safety and wellbeing of research participants are protected.
National guidelines to our Research:
Zambia medicine Regulatory Authority (ZAMRA)
National Health Research Authority (NHRA)
- NHRA – www.nhra.org.zm
- UNZBREC – www.unza.zm
- ZAMRA – WWW.zamra.co.zm
- NBSA – www.nbsazambia.org.zm
