Book 1: General Principles including research on children, vulnerable groups, international collaboration and epidemiology

Contributors to this book
Prof SR Benatar
Prof KD Bhoola
Prof PE Cleaton-Jones
Dr WA de Klerk
Prof D du Toit
Prof A Herman
Ms A Labuschagne
Dr M Leibowitz
Prof DJ Louw
Dr N Matsiliza
Dr AD MBewu
Dr W Orr
Prof M Poggenpoel
Ms C Roberts
Prof AA van Niekerk
Prof FFW van Oosten
Prof CW van Wyk.

Series Editorial Committee
Prof KD Bhoola
Prof PE Cleaton-Jones
Dr WA de Klerk
Prof D du Toit
Prof A Herman
Ms A Labuschagne
Prof DJ Louw
Dr N Matsiliza
Dr AD MBewu
Dr W Orr
Prof M Poggenpoel
Ms C Roberts
Prof AA van Niekerk
Prof FFW van Oosten
Prof CW van Wyk.

We extend our grateful thanks to the members of the current Editorial Committee and to colleagues who contributed to the third edition, on which the current edition is based. In the order that they appeared in the previous edition they are:

Editorial Committee
Prof OW Prozesky
Prof SR Benatar
Prof G Dall
Dr WA de Klerk
Prof PI Folb
Prof MP Keet
Prof J de V Lochner
Prof DJ Louw
Prof HJ Odendaal
Prof AP Rose-Innes
Prof SA Strauss.

Additional contributors
Prof AA van Niekerk
Dr Paul van Helden
Prof J Alexander
Dr R I Stewart
Prof PE Cleaton-Jones

Book 1: General Principles including research on children, vulnerable groups, international collaboration and epidemiology

Complete book available in pdf format (272 kb)

	Preface
	Foreword to the fourth edition
1	What is the South African Medical Research Council's ethics policy?
1.1	General policy
1.2	For whom are these Guidelines intended?
1.3	Ethics principles
1.4	Conclusion
2	What is research?
2.1	What constitutes research on humans?
3	What is meant by research ethics?
3.1	General philosophical concerns and human or anthropological perspectives on ethics in mrdical research
4	The medical justification for research
4.1	Healthy volunteers
4.2	Patients
5	The legal and moral justification for research
5.1	Consent is essential
5.2	Form of consent
5.3	Requisites of consent
5.4	Participant's friend
6	Conduct of research
6.1	Responsibility for overall care of patients
6.2	Responsibility in the conduct of multicentre studies
6.3	Delegation and research conducted by non-medical healthworkers
6.4	Responsibility for the welfare of research workers and laboratory personnel
6.5	Adequacy of facilities to carry out research
6.6	Participant privacy and confidentiality
7	Research principles
7.1	Research on healthy volunteers
7.2	Research on patients
8	Ethics issues in qualitative research
8.1	Introduction
8.2	Practical ethics issues in qualitative research
9	Assessment of the ethics of research
9.1	Independent ethical review
9.2	Knowledge of involvement
9.3	Clinician-patient relationship
9.4	Role and competence of the investigator
9.5	Research Ethics Committees
9.6	Objectives
9.7	Scientific misconduct
9.8	Function of Research Ethics Committees
9.9	Membership of the Committee
9.10	Method of working
9.11	Suggested format for applications to Research Ethics Committees
9.12	Assessing the value and risks of research
9.13	Financial transactions and inducements
10	Monitoring the conduct of research
10.1	National ethics body
10.2	Particular role of the Research Ethics Committee
10.3	Research in progress
10.4	Ownership of results of research
10.5	Research results
10.6	Legal implications and arrangements for compensation
10.7	Publication and authorship
10.8	Liaison with the public media
11	International collaborative research
11.1	Concerns
11.2	Ethics principles
11.3	Collaborators
11.4	Principles
12	Ethics guidelines for epidemiology
12.1	'Public' versus 'health'
13	References
	Recommended websites for more information
14	Appendices
	Appendix I: MRC checklist: quantitative research
	Appendix II: MRC checklist: qualitative research
	Appendix III: Sample information sheet
	Appendix IV: Clinical trial compensation guidelines
	Appendix V: The Belmont Report
	Appendix VI: Declaration of Helsinki
	Appendix VII: The Nuremberg Code

Last updated:
09-Feb-2006

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