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OVERVIEW

The Institutional Research Ethics Committee (IREC) has the responsibility of evaluating, approving and monitoring research involving humans, animals and the environment. It does so by following accepted research ethical guidelines as laid out by the Department of Health of South Africa and the Declaration of Helsinki. It aims to protect the rights and welfare of research participants, animals and the environment by adhering to the principles of beneficence, justice and respect for persons, especially vulnerable populations, animals and the environment. In so doing it must ensure that the research methodology and relevant literature is based on sound principles derived from appropriate studies with the aim to provide an answer to the research question posed.

The committee membership is composed as required by the National Health Research Council of South Africa, which is the accrediting body. All members are required to have initial and ongoing training in Research ethics.

Application Procedure
Informed Consent
Review Process
Appeals Procedure
Amendments to Research Protocol
Adverse Events Reporting
Continual Review, Annual Recertification and Safety Monitoring
Suspension and Discontinuation of Research Proposal
Research Requiring Additional Attention
Use of Animals in Research and Training
Completion of Study
Handling of Complaints
Conflict of Interest for Researchers
Fees for External Proposals

PG4a Research proposal and ratification of research rroposal by the Higher Degrees Committee
Appendix: Ethics Checklist for Research Approval
Appendix A – Letter of Information and Consent
Appendix B – Conflict of Interest Form
Appendix C – Application for Approval of Amendment
Appendix D - Adverse Event Reporting Form
Appendix E - Safety Monitoring and Annual Recertification Report
Appendix F - Completion and/or Termination of Study
Appendix G – Confidentiality Agreement
Appendix H - Application for Utilising Animals in Teaching
Appendix I - Application for Utilising Animals in Field Research

LINKS

National Research Ethics Guidance

• Ethics in Health Research: Principles, Structures and Processes - SA DoH, 2004
• Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa - Second Edition, 2006. Department of Health, Pretoria, South Africa
• Ethics Guidelines - Medical Research Council
• South African National Environmental Management Act

International Research Ethics Guidance

• Belmont Report - created by the National Commisssion for the Protection of Human subjects of research, published in 1979.
• Declaration of Helsinki 2008 – developed by the The World Medical Association (WMA) as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.
• International Ethical Guidelines for Biomedical Research Involving Human Subjects - Council for International Organizations of Medical Sciences (CIOMS)
• ICC/ESOMAR International Code on Market & Social Research
• ESOMAR Word Research Codes & Guidelines for Customer Satisfaction Studies
• ESOMAR Word Research Codes & Guidelines for Interviewing Children & Young People
• ESOMAR Word Research Codes & Guidelines for Conducting Survey Research Via Mobile Phone
• ESOMAR Word Research Codes & Guidelines on Social Media Research

Registration of Clinical Trials Undertaken in South Africa

• How to register
• Further information about the South African National Clinical Trial Register

Participants' Rights in Human Research

• 'What you should know when deciding to take part in a clinical trial as a research participant' - a booklet for researchers to give to potential participants in clinical trials, South African Department of Health.
• Participant's Bill of Rights - produced by the South African AIDS Initiative (SAAVI) for preventive HIV Vaccine Trials

Registration of Clinical Trials Undertaken in South Africa

• How to register
• Further information about the South African National Clinical Trial Register

Participants' Rights in Human Research

• Participant's Bill of Rights - produced by the South African AIDS Initiative (SAAVI) for preventive HIV Vaccine Trials

Ethics Training

• NIH Office of Extramural Research. Protecting Human Research Participants