1. Corlia van Vuuren February 2011 Research ethics

2. Introduction Research ethics are based on: ethical principles human rights medical law

3. Introduction (cont’d) Research is governed on national and international level by amongst others: government ethics committees associations/councils/etc. e.g. WHO, DoH(SA), MCC, MRC, NHREC, HPCSA

4. Government legislation DoH (http://www.doh.gov.za/nhrec/norms/ethics.pdf) DoH Ethics in health research - Principles, structures and processes (2004).pdf DoH Ethics in health research - Principles, structures and processes (2004).pdf “Ethics in Health Research: Principles, structures and processes (2004)” NHREC (www.nhrec.org.za) SA GCP.pdf SA GCP.pdf “Guidelines for good practice in clinical trails with human participants in SA (2006 2 nd edition)” MRC (http://www.sahealthinfo.org/ethics/index.htm) MRC.pdf MRC.pdf “Ethics in Health Research. General principles including research on children, vulnerable groups, international collaboration and epidemiology” HPCSA (http://www.hpcsa.co.za/conduct_generic_ethical_rules.php) Book 2, 6 and 9 HPCSA Booklet 2.pdf HPCSA Booklet 6.pdf HPCSA Booklet 9.pdf HPCSA Booklet 2.pdfHPCSA Booklet 6.pdfHPCSA Booklet 9.pdf

5. International documents Declaration of Helsinki Declaration of Helsinki.pdf (http://www.history.nih.gov/research/downloads/helsinki.pdf) Declaration of Helsinki.pdf Best known document related to medical ethics Established in 1964 and revised 8 times (latest version 2008) WMA Research manual WMA Research Ethics Manual.pdf (http://www.wma.net/en/30publications/30ethicsmanual/pdf/ ethics_manual_en.pdf) WMA Research Ethics Manual.pdf “WMA Medical Ethics Manual”

6. Institutional documents

7. Research obligations Researchers also have an obligation to the: society/profession funders/employers colleagues participants

8. Obligation to society/ profession Widen the scope of research Benefit the community

9. Obligation to other researchers/colleagues Maintain confidence in research Expose and review the research methods Communicate ethical principles

10. Obligation to study participants Avoid undue intrusion Obtain informed consent Protect the interest of participants Enable participation Maintain confidentiality of all records Prevent disclosure of identities

11. Questions