Legal and Regulatory Frameworks Governing Science Laboratory Practice: A Global and Nigerian Perspective
DOI:
https://doi.org/10.60787/ijrti.vol3no1.81Keywords:
Legal, Regulatory framework, Laboratory practice, Safety, Ethics, NigeriaAbstract
Science laboratories are central to research, healthcare, industrial innovation, and education. Their operations must adhere to robust legal and regulatory frameworks to ensure safety, environmental protection, ethical compliance, and data integrity. This paper presents a narrative review of the global and Nigerian legal and regulatory environments governing science laboratory practice. It examines international standards such as those developed by the International Organization for Standardization (ISO), World Health Organization (WHO), and Organization for Economic Co-operation and Development (OECD), alongside Nigerian regulatory agencies including the National Institute of Science Laboratory Technology (NISLT), the Medical Laboratory Science Council of Nigeria (MLSCN), the National Agency for Food and Drug Administration and Control (NAFDAC), the National Environmental Standards and Regulations Enforcement Agency (NESREA), and the Standards Organization of Nigeria (SON). The review finds that while a relatively comprehensive regulatory architecture exists in Nigeria, persistent challenges—including inadequate infrastructure, poor enforcement, limited awareness, and corruption—undermine effective compliance. The paper underscores these challenges and proposes policy recommendations to bridge regulatory gaps and foster improved laboratory governance in Nigeria.Downloads
References
Abiola, T., & Khaleel, A. A. (2020). Legal requirements for health and safety in laboratory practice. Iman Medical Journal, 1(6). https://www.nigerian journalsonline.com/index.php/IMAN/article/view/4601/0
Agbo, F. O., Adedokun, I. A., & Edwinkenn, O. E. (2024). An analysis of the legal and ethical issues of medical laboratory science practice in Nigeria. Journal of Public and Human Rights Law, 1(2). https://jphrl.org.ng/index. php/jphrl/article/view/33
International Organization for Standardization (ISO). (2022). ISO 15189:2022 — Medical laboratories: Requirements for quality and competence. https://www.iso.org /standard/76677.html
Halatoko, W. A., Tchankoni, M. K., Komlan, F. A., & Kpangban, E. (2024). Knowledge, attitudes, and practices regarding biosafety in public laboratories in Togo. Applied Biosafety, 29(1), 12–22. https://doi.org/10.1177/15356760231204879
Etsuyankpa, M. B., Augustine, A. U., Musa, S. T., Mathew, J. T., Ismail, H., Salihu, A. M., & Mamman, A. (2024). An overview of wastewater characteristics, treatment and disposal. Journal of Applied Sciences & Environmental Management, 28(5), 1553–1572.
Smith, B., Lee, C., & Kim, D. (2020). The impact of international standards on laboratory safety. International Journal of Laboratory Research, 8(2), 123–135.
Johnson, A. (2019). Challenges in implementing regulatory frameworks for science laboratories in developing countries. Journal of Science Policy, 12(3), 45–56.
Ifeadike, C. O., Ironkwe, O. C., Adogu, P. O. U., Nnebue, C. C., Emelumadu, O. F., Nwabueze, A. S., & Omoruyi, I. (2022). Laboratory safety practices among Nigerian health workers. Nigerian Medical Journal, 63(1), 1–9.
Okeke, C. I., & Hassan, A. T. (2023). Professional ethics and accountability in Nigerian biomedical laboratories. African Journal of Biomedical Research, 26(2), 89–97.
Adebayo, A., & Musa, J. O. (2024). Institutional safety culture and compliance in Nigerian research laboratories. African Journal of Laboratory Science and Regulation, 18(2), 110–119.
World Health Organization (WHO). (2023). Good clinical laboratory practice (GCLP). Geneva: WHO Press.
Zhou, Y., Adeola, R. M., & Okeke, E. (2024). Artificial intelligence applications in laboratory safety benchmarking: Emerging risks and solutions. International Journal of Laboratory Technology, 22(1), 33–45. https://doi.org/10.1016/j.ijlt.2024.02.005
World Health Organization (WHO). (2024). Laboratory biosafety manual (4th ed., updated). https://www.who. int/publications/i/item/9789240011311
Organisation for Economic Co-operation and Development (OECD). (2021). OECD principles of good laboratory practice (GLP). https://www.oecd.org/chemicalsafety/testing/good-laboratory-practice-glp.htm
International Organization for Standardization (ISO). (2017). ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories. https://www.iso.org/standard/66912.html
World Health Organization (WHO) (2020). Laboratory biosafety manual (4th ed.). https://www.who.int/publications/i/item/9789240011311
National Institute of Science Laboratory Technology (NISLT) (2021). Laboratory practice guidelines and safety framework. https://www.nislt.gov.ng/guidelines2021
Ibekwe, F. N., Ofori, J. A., & Aina, B. A. (2023). Enhancing biosafety and biosecurity compliance in Nigerian laboratories: The role of regulatory frameworks. Journal of Applied Laboratory Management, 15(4), 212–225.
Medical Laboratory Science Council of Nigeria (MLSCN) (2025). MLSCN mandate. Retrieved from https://web.mlscn.gov.ng/index.php/mlscn-mandate/
News Agency of Nigeria. (2024, May 28). MLSCN inspected 103 new laboratories, sealed 23 in 1 year — Registrar. https://nannews.ng/2024/05/28/mlscn-inspected-103-new-laboratories-sealed-23-in-1-year-registrar/
Ekong, P. S., Ducheyne, E., Carpenter, T. E., Trostle, J., & Gibbs, E. P. J. (2020). Biosafety and biosecurity policies in Nigerian laboratories: Implications for the Cartagena Protocol. Biosafety and Health, 2(1), 12–18.
Standards Organisation of Nigeria (SON). (2015). Standards development and certification procedures. Abuja: SON.
National Health Research Ethics Committee (NHREC) (2019). National code of health research ethics (2nd ed.). Abuja: Federal Ministry of Health.
National Agency for Food and Drug Administration and Control (NAFDAC) (2022). Good laboratory practice guidelines. Abuja: NAFDAC.
National Environmental Standards and Regulations Enforcement Agency (NESREA) (2020). Guidelines for environmental compliance in industrial facilities. Abuja: NESREA.
Osinibi, O. M., & Adewumi, T. A. (2023). The imperative of a regulatory framework for the establishment of a national crime DNA database in Nigeria. UCC Law Journal, 3(1), 182–210. https://doi.org/10.47963/ucclj.v3i1.1255
Ogundiran, T. O. (2004). Enhancing the ethics review process for health research in Africa. Journal of Medical Ethics, 30(6), 571–572.
Ogunleye, O. O., Basu, D., Mueller, D., Sneddon, J., Seaton, R. A., Yinka-Ogunleye, A. & Godman, B. (2024). Response to the novel coronavirus (COVID-19) pandemic across Africa: successes, challenges and future prospects. Frontiers in Pharmacology, 11, 1205. https://doi.org/10.3389/fphar.2020.01205
Antimicrobial Resistance & Infection Control (ARIC) Journal (2025). Implementation of external quality assessment in Sub-Saharan Africa. ARIC, 14(1). https://aricjournal.biomedcentral.com/articles/10.1186/s13756-025-01530-9
Allison, F. I., Ojule, A. A., & Allison, I. (2024a). Medical laboratories in Nigeria (Part 1): Assessment of quality management practices and accreditation status. European Journal of Medical and Health Sciences, 6(2), 21–29.
Vanguard (2023, March 14). Experts seek establishment of regulatory body for clinical laboratories in Nigeria. Vanguard Newspaper. https://www.vanguardngr.com
Allison, F. I., Ojule, A. A., & Allison, I. (2024b). The status of laboratory equipment and reagents in Nigeria. European Journal of Medical and Health Sciences, 6(1). https://www.ej-med.org/index.php/ejmed/article/view/1988
Lab Manager. (2022). The long road to safe food and drug standards in Nigeria. https://www.labmanager.com/the-long-road-to-safe-food-and-drug-standards-in-nigeria-3313
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