ADVOKS GLOBAL · KENYA
Charter for Kenya Medical Research Institute, 2026
47. Biobanks
Edition: 2025-07-21 · In force
47. Biobanks
(1)The Institute shall establish biobanks for the collection, storage and management of biological materials.(2)Despite subparagraph (1), the Institute may, by notice in the Gazette, designate any research institution, site or health establishment as a biobank.(3)A biobank may—(a)receive biological materials for storage purposes;(b)store aliquots of biological materials for such period as may be prescribed; and(c)dispose of biological materials in accordance with the prescribed Regulations.(4)The Institute shall, in establishing the biobanks —(a)put in place processes and procedures for the operation of biobanks;(b)ensure adherence to ethical, regulatory and quality standards for responsible management and use of biological materials and associated data for research, healthcare and public health;(c)develop and implement guidelines or procedures for all aspects of biological materials management including—(i)collection procedures including informed consent processes and documentation;(ii)processing techniques to ensure sample integrity and quality control;(iii)storage conditions including temperature monitoring and security measures; and(iv)distribution protocols for access to biological materials and associated data by authorized users;(d)restrict access to biological materials to authorized users; and(e)implement data management systems to ensure secure storage, retrieval and sharing of clinical and metadata.(5)The Institute may establish and manage bio-banks in a manner as may be provided for in the Statutes.