Health Research and Knowledge Management
Contact Details
Director : Dr Elizabeth Lutge
Tel: 033 395 2046
Fax: 033 394 3782
Email: elizabeth.lutge@kznhealth.gov.za
Alternative contact numbers:
Mrs R Desai : 033 395 3123
Dr GE Shezi : 033 395 3189
Mr X Xaba : 033 395 2805
Physical Address:
Health Research and Knowledge Management Secretariat
330 Langalibalele Street
Natalia Building
South Tower, 10-102
Pietermaritzburg, 3200
Postal Address:
Health Research and Knowledge Management Secretariat
Private Bag X9051
Pietermaritzburg
3201
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.
Submit your research application to the National Health Research Database | About the NHR Database
Responsibilities
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.
Research Responsibility Areas
The research priority areas are in-line with the following documents:
Priority Research Questions: KZN DoH Research prioritisation 2023
Guidelines for submitting a research proposal
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.
Notice All research being conducted on human subjects must comply with national and international ethical and regulatory practices.
Research should be in accordance to international guidelines such as the Declaration of Helsinki (2008) and Belmont Report (1979) and national guidelines of Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa (2006) and the Department of Health’s Ethics in Health Research: Principles, Structures and Processes (2004) as well as the Constitution of the Republic of South Africa (1996).
Participants of a research study also have rights. The South African AIDS Initiative (SAAVI) has produced a Participant’s Bill of Rights for preventive HIV Vaccine Trials. To be informed of your rights please visit: http://www.saavi.org.za/billofrights.htm or the South African National Clinical Trial Register http://www.sanctr.gov.za/YourbrnbspRights/tabid/185/Default.aspx
If you are a participant in a research study and you wish to express any concerns or lodge any complaints of grievances that may have arisen during the research process, please submit your concerns/complaint to the Chairperson of the Provincial Health Research and Ethics Committee, Dr Elizabeth Lutge. Your concern/complaint will be investigated, processed, and where possible, resolved.
Please note the principles of confidentiality and fairness shall be applied with the appropriate balance to all parties, complainant/s and respondent/s.
The written statement of concern/complaint can be submitted to the Provincial Health Research & Ethics Committee Chairperson at the following address:
Elizabeth.lutge@kznhealth.gov.za or Provincial Health Research & Ethics Committee Chairperson
Dr Elizabeth Lutge
Epidemiology and Research
Private Bag X9051
Natalia
South Tower, 10 – 120
Pietermaritzburg
3201
Alternatively Dr Lutge can be contacted on: 033 395 2046.
Other useful research guidelines
- 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
Knowledge and Information Links
- 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