Guidelines for Researchers Requesting Permission in District Yusuf Moosa
Roles and responsibilities of the District Research Committee (DRC) in the Johannesburg Health District, including reviewing research proposals, granting permission for studies, and ensuring ethical and regulatory compliance. Researchers must provide HREC and SAHPRA approvals, research protocol, study details, list of facilities, and risk assessments. The DRC aims to facilitate and support research activities while considering the impact on the district's health system.
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JHB DRC Requirements from Researchers requesting permission to conduct studies in the District Yusuf Moosa
Roles and responsibilities of DRC The role of the DRC is to co-ordinate and manage all health related and non-health related research undertaken in the Johannesburg Health District s health facilities. 1) Review research proposals and grant permission to conduct the research in our health facilities. 1) Consider the impact and risks of the study on the district health system. 2) Provide advice / expert opinion, where necessary or on request from the District Office 2) Support the development and appropriate use of the NHRD as a research co-ordination tool 3) To facilitate research activities in the District 1) Mobilize resources and build research capacity amongst health workers within the district 2) Identify district specific research priorities and research agenda 3) Lobby the research community in the District and potential research funders to undertake such research 4) To promote the use of health research outcomes and to advise and communicate with researchers, research institutions and policy makers
Review research proposals and grant permission to conduct the research in our health facilities. REQUIREMENTS FROM RESEARCHERS 1) Copy of HREC approval: (Add Ethics Approval Number, if still awaiting enter PENDING). Although we look at the ethics of the study, we are not an Ethics committee and we rely on them having attended to all ethical issues 2) Copy of SAHPRA approval (if applicable): There must be SAHPRA approval for any new medications or investigations to be done 3) Copy of the full research protocol
Review research proposals and grant permission to conduct the research in our health facilities. REQUIREMENTS FROM RESEARCHERS 4) Summary of the research study Research question Need for the study Aims and objectives Methodology : recruitment; sampling; inclusion and exclusion; procedures Anticipated benefits to the district 5) List of facilities: (district offices and exact facilities in that district where you want to collect data. Jhb. DRC only deals with clinics in Johannesburg NOT hospitals!) 6) Project time frame: Start date .End date
7) Assessment of Risks to Facilities (both participants and health systems) Risks to Facilities (both participants and health systems): Indicate Yes/No in the table below. (If yes, what are these implications and how does your project plan to mitigate the impact) No Yes Comments 1. Additional load on district staff e.g. To Recruit patients for study To Conduct clinical assessments To Conduct special investigations To be Involved in administrative tasks 2. Use of facilities resources e.g. Consumables (swabs, gloves etc.) Equipment e.g. BP cuffs etc. Office space/counselling cubicle etc. Laboratory and special investigations services. Use of facilities usual lab courier 3. Impact on Patients Is there a need for additional OPD visits by patients Is there a need for admission of patients Does the study involve disabled or vulnerable persons 4. Other Does the study require access to specific people or positions - from HOD to clerk Does the study require communications in the facilities e.g. announcements, handing out leaflets Does the study require any specific data / information from the department of health
Category Definition L0 No risk Nil/ No impact on health system No contact with patients / staff No use of staff, space or consumables Involves Lab work, information in the public domain or secondary analysis with broader ethics approval Low / minimal impact on health system Minimal use of staff, space or consumables Research about everyday lives. Some potentially sensitive questions that may create temporary emotional stress (incl. HIV status) no greater than daily life or routine clinical testing Minor discomfort e.g. taking blood samples No vulnerable participants e.g. children or mentally ill Significant impact on health system Significant use of staff, space or consumables, and equipment Risk of some harm, but steps are taken to mitigate or fair impact on health service resources. Sensitive questions, Drug trial (pre-general release) Vulnerable participants e.g. children or mentally ill High impact on health system Substantial cost to the health service Real risks of harm and serious consequences. Added patient numbers to the health system Highly sensitive questions e.g. inter-partner violence, rape, abuse Participants with multiple vulnerabilities Clinical trials L1 Low risk L2 - Medium Risk L3 High Risk
Support the development and appropriate use of the NHRD as a research co-ordination tool REQUIREMENTS FROM RESEARCHERS NHRD Application Reference Number: PS: Without this number this application will be rejected immediately!
To facilitate research activities in the District DRC OBJECTIVES Mobilise resources and build research capacity amongst health workers within the district Identify district specific research priorities and research agenda Lobby the research community in the District and potential research funders to undertake such research REQUIREMENTS FROM RESEARCHERS Health Category of the research: Blood / Cancer and Neoplasms / Cardiovascular / Congenital Disorders / Ear / Eye / Infection / HIV-AIDS / Inflammatory and Immune System / Injuries and Accidents / Mental Health / Metabolic and Endocrine / Musculoskeletal / Neurological / Oral and gastro-intestinal / Renal and Urogenital / Reproductive health and child birth / Respiratory / Skin / Stroke / Generic Health relevance / Disputed aetiology/ COVID-19 related / and other Area of Research: (Underpinning research / Aetiology / Prevention of disease / Prevention of Disease and Conditions, and Promotion of Well-Being / Detection, Screening and Diagnosis / Development of Treatments and Therapeutic Interventions / Evaluation of Treatments and Therapeutic Interventions / Management of Diseases and Conditions / Health and Social Care Services Research) Source of Funding
To promote the use of health research outcomes and to advise and communicate with researchers, research institutions and policy makers REQUIREMENTS FROM RESEARCHERS Progress reports Completed reports Publications Participation in webinars
