Lomic Services maintains and manages all institutional, government, and international ethics approvals associated with the research projects we support. We ensure that every study operates within the legal, ethical, and regulatory frameworks established by relevant national authorities and international bodies, and that approval conditions are met on a continuous basis.
Ethics application & submission
We coordinate the preparation and submission of ethics applications to relevant institutional review boards (IRBs), national health research ethics committees (such as the National Health Research Ethics Committee of Nigeria — NHREC), and international ethics bodies. Applications are prepared in compliance with applicable guidelines, including the ICH E6 Good Clinical Practice guidelines, the Declaration of Helsinki, and CIOMS international ethical guidelines for health-related research.
Regulatory authority liaison
Where studies require notification to or authorisation from national regulatory authorities — including the National Agency for Food and Drug Administration and Control (NAFDAC) — Lomic Services manages the submission process, tracks application status, and facilitates timely responses to regulatory queries.
Ongoing ethics maintenance
For active studies, we manage all post-approval obligations including annual ethics renewals, continuing review submissions, protocol amendment approvals, and serious adverse event reporting to ethics committees within required timeframes. We maintain a live compliance calendar to ensure no renewal or reporting deadline is missed.
Regulatory documentation archive
Lomic Services maintains a comprehensive and structured archive of all ethics approvals, regulatory correspondence, and compliance documentation for each project. This archive is maintained in a format suitable for regulatory inspection and is retained for the required period following study close-out in accordance with applicable guidelines.
Primary audience: International research sponsors, academic institutions, government health agencies, and NGOs requiring end-to-end regulatory compliance management for studies conducted in Nigeria.