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Corlia van Vuuren February 2011

Research ethics. Corlia van Vuuren February 2011. Introduction. Research ethics are based on: ethical principles human rights medical law. Introduction (cont’d). Research is governed on national and international level by amongst others: government ethics committees

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Corlia van Vuuren February 2011

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  1. Research ethics Corlia van Vuuren February 2011

  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 • “Ethics in Health Research: Principles, structures and processes (2004)” • NHREC(www.nhrec.org.za) SA GCP.pdf • “Guidelines for good practice in clinical trails with human participants in SA (2006 2nd edition)” • MRC (http://www.sahealthinfo.org/ethics/index.htm) 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.pdfHPCSA Booklet 6.pdfHPCSA Booklet 9.pdf

  5. International documents • Declaration of HelsinkiDeclaration of Helsinki.pdf(http://www.history.nih.gov/research/downloads/helsinki.pdf) • Best known document related to medical ethics • Established in 1964 and revised 8 times (latest version 2008) • WMA Research manualWMA Research Ethics Manual.pdf(http://www.wma.net/en/30publications/30ethicsmanual/pdf/ethics_manual_en.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 Value of the study/ Introduction/ Motivation for the study

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

  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 Methodology/ Ethical aspects

  11. Questions

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