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Research Governance Department

The Research Governance Department (RGD) oversees the research governance framework and systems at the Unit, closely working with the Research Governance and Integrity Office (RGIO). The department supports all research activities at the Unit and ensures compliance with regulatory requirements; ethical requirements; international standards of best practice such as Good Clinical Practice (GCP), Good Research Practice (GRP), Human Subject Protection (HSP), Good Clinical Laboratory Practice (GCLP), ISO15189, Declaration of Helsinki among others; and LSHTM/Unit Standard Operating Procedures (SOP) and Policies. The department has supported and continues to support investigators during; pre-grant award activities, protocol development, review and obtaining of ethical and regulatory approvals, study conduct as well as monitoring and audit activities.

The department also coordinates and supports external monitoring, auditing and regulatory inspections at the Unit and participates in investigating and managing research misconduct. Over the years, the department has participated in capacity building activities including training of Unit and collaborative institution staff in HSP, GCP and Quality Assurance.

The department continues to expand its involvement in the management, coordination and independent monitoring of studies as well as providing a link between the Unit and the ethical and regulatory bodies in the country, and has participated in the review of a number of national ethical and regulatory guidelines.

 

The department is fully integrated within the RGIO, undertakes sponsorship duties for LSHTM sponsored studies at the Unit and provides support to external sponsors of studies conducted at the Unit.