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Fundamental Principles of Research Ethics in Healthcare

This document outlines the foundational principles of research ethics within the healthcare context, emphasizing human rights and relevant medical laws. It discusses the governing frameworks established at national and international levels, including oversight by government bodies, ethics committees, and professional associations such as the WHO, DoH (SA), and MRC. Furthermore, it highlights the obligations researchers have to society, participants, and colleagues, detailing the ethical responsibilities such as informed consent, participant confidentiality, and accountability in research practices.

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Fundamental Principles of Research Ethics in Healthcare

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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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