Health Research and Knowledge Management

HRKM was established in 2007 and is part of the Health Services Planning, Monitoring and Evaluation Unit. It provides secretariat services to the Provincial Health and Research Ethics Committee (PHREC). The main aim of the sub-component is to co-ordinate the approval of health research in the Province. This is achieved by reviewing study proposals from researchers that wish to conduct research within public health institutions of the Province and keeping a repository of submitted research studies. Studies are reviewed in the presence of documents such as the study proposal, ethical approval from an accredited committee, institutional support, and informed consent forms. For clinical trial studies additional documents such as clinical trial application form, MCC approval, and insurance certificate are required for the review (Guidelines for Submitting a Research Proposal) Once the necessary documentation is present, studies are then recommended for approval to the PHREC.

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The functions of the unit involve the following responsibilities:

• Provision of Professional Secretarial services to the Provincial Health Research Committee.
• Formulate and maintain the Research Policy, Research Strategy and Research Protocols for the Provincial Department.
• Analyze, review and recommend on research proposals submitted to the Provincial Department in line with the Research Policy, Research Strategy and Research Protocols of the Provincial Department.
• Facilitate processes for the formal registration of health research initiatives within the Province including setting of conditions and ethical standards.
• Ensure that progress and final research reports are presented to the Provincial Health Research Committee and other stakeholders.
• Provide research oversight services including site visits to monitor progress of research activities.
• Determine the health research needs of the Provincial Department and liaise with research institutions to facilitate the alignment of research agenda.
• Coordinate research initiatives to determine the clinical outcomes of traditional and other practices.
• Project manage “in-house” research initiatives and report on the outcome thereof.
• Analyze health research reports with a view to identifying new developments that may impact on existing clinical procedures and advice the Departmental Managers accordingly.
• Facilitate processes to identify best practice in the Provincial Department and to share relevant lessons throughout the Provincial Department.
• Develop a knowledge and learning management framework in the Provincial Department of Health.

The research priority areas are in-line with the following documents:

• Department of Health: KwaZulu-Natal 12 point plan for the 2006/2007 financial year
• Priority Research Questions
• District Priority Questions
• Provincial Priority Questions

These guidelines include research proposals of observational study designs (Refer to Part A) and those that are clinical trials (Refer to Part B). (applicable for all studies)

NO FORMS ARE REQUIRED FOR OBSERVATIONAL STUDIES

The below documents are required for ALL CLINICAL TRIAL APPLICATIONS.

• KZN Clinical Trial Application Form (November 2022)
• KZN Checklist for Clinical Trial Applications (August 2017)
• Guidelines for submitting research proposals to the KwaZulu-Natal Department of Health for approval (applicable for all studies) (February 2024)

Umgungundlovu Health Ethics Review Board (UHERB)

• Application to conduct a clinical trial
• Synopsis study template
• Process for applying for permission to conduct research within the KwaZulu-Natal Department of Health
• SOP: Application process for gatekeeper permission to conduct research in KZN
• Knowledge management framework
• Process for applying to conduct research
• NHRD applicant user manual
• Research Ethics Guidelines - 2004. Ethics in Health Research : Principles, Structures and Processes
• Guidelines on ethics in Medical Research : General Principles
• Guidelines on ethics for medical research : reproductive biology and genetic research
• Guidelines on ethics for medical research : use of animals in research and training
• Guidelines on ethics for medical research: use of biohazards and radiation
• Guidelines on ethics for medical research: HIV preventative vaccine research
• Medicines Control Council : General Information
• Guidelines for good practice in the conduct of clinical trials in Human participants in South African. 1st Edition
• South African good clinical practice guidelines. 2nd edition

• Africa Centre for Health and Population Studies
• Caprisa - Centre for the AIDS Programme Research in South Africa
• HAVEG
• Health Systems Trust
• Human Science Research Council
• Maternal, Adolescent and Child Health
• Population Council
• South African AIDS Vaccine Initiative
• South African National Clinical Trials Register
• South African National Health Research Database
• The KwaZulu-Natal Department of Health GIS Webpage
• The Medicines Control Council (MCC)
• The Medical Research Council of South Africa
• The WHO
• University of KwaZulu-Natal Research

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