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ETHICAL ISSUES IN CLINICAL
RESEARCH
CHALLENGES TO ETHICS
OVERSIGHT IN
INTERNATIONAL
RESEARCH
Rio de Janeiro, Brasil
2008
P...
GLOBAL SCENERY IN
INTERNATIONAL RESEARCH
INVOLVING HUMAN SUBJECTS
NOWADAYS FACTS
 Increasing number of collaboratives and...
GLOBAL SCENERY IN INTERNATIONAL
RESEARCH INVOLVING HUMAN
SUBJECTS
NOWADAYS FACTS
 Important switch of research from publi...
GLOBAL SCENERY IN INTERNATIONAL
RESEARCH INVOLVING HUMAN SUBJECTS
NOWADAYS FACTS
 90% of global research funding invested...
GLOBAL SCENERY IN INTERNATIONAL
RESEARCH INVOLVING HUMAN SUBJECTS
NOWADAYS FACTS
 Lesser bioethical development at nation...
GLOBAL SCENERY IN INTERNATIONAL
RESEARCH INVOLVING HUMAN SUBJECTS
CONTROVERSIES
 Placebo: when is it ethically allowed it...
GLOBAL SCENERY IN INTERNATIONAL
RESEARCH INVOLVING HUMAN SUBJECTS
LANDMARKS IN BIOETHICS CONTRIBUTIONS
 Nüremberg Code
 ...
GLOBAL SCENERY IN INTERNATIONAL
RESEARCH INVOLVING HUMAN SUBJECTS
QUESTION
 Can Unethical Clinical Research be
prevented?
HISTORY OF INTERNATIONAL
RESEARCH ETHICS REVIEW
RELEVANT EVENTS AND ORIGIN OF
NORMS AND CODES
HISTORICAL
FACTS
ETHICAL ISSUES
INCORPORATED
ETHICAL
GUIDELINES
NAZIS EXP.NA...
HISTORICAL
FACTS
ETHICAL ISSUES
INCORPORATED
ETHICAL
GUIDELINES
BEECHER &BEECHER &
PAPWORTHPAPWORTH
REPORTSREPORTS
(1966-1...
NUREMBERG
CODE
Subject autonomy
Researcher freedom
No legislate
Moral autoregulation
HELSINKI
DECLARATION
OF WMA
 Phy...
1964: HELSINKI DECLARATION
1975: TOKYO
1983: VENICE
1989: HONG KONG
1996: SOUTH
AFRICA
2000: EDIMBURGH
Respect for
Persons
Informed
Consent
Beneficense
Risk/Benefit
Justice
Subjects selection
1979: BELMONT REPORT
GREAT CONTRIBUTIONS
NORMS - GUIDELINES- DECLARATIONS
 Respect for person subject of research:
AUTONOMY FREEDOM DIGNITY
• ...
How to move towards an ethical
conduct in international research?
THE CULTURE OF ETHICAL CONDUCT
Human
environment
Development context:
Degree of delivery and protection of
fundamental fre...
INTERRELATION SCHEME
Political
freedom
Economic
facilities
ETHICAL BEHAVIOR IN RESEARCH
PRINCIPLES-PRACTICES
Transparence
...
MULTICENTRIC
RESEARCH
Results comparison
Consent request
To guarant respect of bioethics
principles and norms
Equity in sa...
 Vulnerability
 Dependency level
 Competence and capacity
 Risk/benefit ratio
 Children
 Women
 Elderly persons
SPE...
SPECIAL POPULATIONS IN
MEDICAL RESEARCH
 Persons with congnitive disability
 Subordinated personnel
 Coma or critically...
SCIENTIFIC AND ETHICAL MISCONDUCT
DEFINITION:
Scientific error: unintended and unintentional
Misconduct: purposeful, knowi...
ETHICAL CHALLENGES IN
INTERNATIONAL RESEARCH
ETHICAL CHALLENGES IN
INTERNATIONAL RESEARCH
 TO STIMULATE DIALOGUE
 TO PROPOSE AND PROMOTE NEW
PATHWAYS FOR INSTITUTION...
AGENTS FOR THE
CHALLENGES: BUILDING
CAPACITY
 LATINAMERICAN RESEARCHERS
 GRADE STUDENTS
 ACADEMIC INSTITUTIONS AUTHORIT...
CHALLENGE GOALS
 ETHICAL
 ECONOMICAL
 CULTURAL
TO REACH:
ALL INHABITANTS OF NATIONS
RICH
POOR
DEVELOPED
DEVELOPING
“All written norms will not have a lasting value
as long as some interests, at times not
identified non concientious (scie...
“There is nothing more difficult to carry
out, nor more doubtful of success, nor
more dangerous to handle, than to
initiat...
MENDOZA, ARGENTINA
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LIBRO.INVESTIGACIÓN EN SALUD.DIMENSIÓN ÉTICA

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Transcript of "LIBRO.INVESTIGACIÓN EN SALUD.DIMENSIÓN ÉTICA"

  1. 1. ETHICAL ISSUES IN CLINICAL RESEARCH CHALLENGES TO ETHICS OVERSIGHT IN INTERNATIONAL RESEARCH Rio de Janeiro, Brasil 2008 Prof. Enrique Guntsche
  2. 2. GLOBAL SCENERY IN INTERNATIONAL RESEARCH INVOLVING HUMAN SUBJECTS NOWADAYS FACTS  Increasing number of collaboratives and multicenter studies  Study design, laboratory and animal experimentation and ethic evaluation done mostly in developed countries
  3. 3. GLOBAL SCENERY IN INTERNATIONAL RESEARCH INVOLVING HUMAN SUBJECTS NOWADAYS FACTS  Important switch of research from public to private incumbency  From altruism in science development research to investment for profit purposes  Research in developing countries: from poverty related diseases to less frequent but more profitable ones
  4. 4. GLOBAL SCENERY IN INTERNATIONAL RESEARCH INVOLVING HUMAN SUBJECTS NOWADAYS FACTS  90% of global research funding invested to solve problems affecting 10% of world population  Insufficient funding assignment for research generally in developing countries  Known differences in social, cultural and economic contexts between developed and developing countries
  5. 5. GLOBAL SCENERY IN INTERNATIONAL RESEARCH INVOLVING HUMAN SUBJECTS NOWADAYS FACTS  Lesser bioethical development at national, regional and local levels in developing countries
  6. 6. GLOBAL SCENERY IN INTERNATIONAL RESEARCH INVOLVING HUMAN SUBJECTS CONTROVERSIES  Placebo: when is it ethically allowed its use?  Standard of medical care: is there room for distributive and commutative justice?  Treatment resultant from research: whom should it be provided to? For how long?
  7. 7. GLOBAL SCENERY IN INTERNATIONAL RESEARCH INVOLVING HUMAN SUBJECTS LANDMARKS IN BIOETHICS CONTRIBUTIONS  Nüremberg Code  Helsinki Declaration  Belmont Report  CIOMS guidelines  Nuffield Council on Bioethics  UNESCO Universal Declaration on Bioethics and Human Rights
  8. 8. GLOBAL SCENERY IN INTERNATIONAL RESEARCH INVOLVING HUMAN SUBJECTS QUESTION  Can Unethical Clinical Research be prevented?
  9. 9. HISTORY OF INTERNATIONAL RESEARCH ETHICS REVIEW
  10. 10. RELEVANT EVENTS AND ORIGIN OF NORMS AND CODES HISTORICAL FACTS ETHICAL ISSUES INCORPORATED ETHICAL GUIDELINES NAZIS EXP.NAZIS EXP. (1939-1945)(1939-1945) InformedInformed ConsentConsent NUREMBERGNUREMBERG CODECODE (1947)(1947) TALIDOMIDETALIDOMIDE DISASTERDISASTER (1962)(1962) InformedInformed Consent fromConsent from LegalLegal RepresentationRepresentation HELSINKIHELSINKI DECLARATIONDECLARATION (1964)(1964)
  11. 11. HISTORICAL FACTS ETHICAL ISSUES INCORPORATED ETHICAL GUIDELINES BEECHER &BEECHER & PAPWORTHPAPWORTH REPORTSREPORTS (1966-1967)(1966-1967) EthicsEthics ResearchResearch CommitteesCommittees HELSINKIHELSINKI DECLARATIONDECLARATION (1975)(1975) TUSKEGEETUSKEGEE (1932-1972)(1932-1972) EthicalEthical PrinciplesPrinciples BELMONTBELMONT REPORTREPORT (1978)(1978) RESEARCH INRESEARCH IN DEVELOPINGDEVELOPING WORLDWORLD EthicsEthics ResearchResearch UniversalityUniversality CIOMSCIOMS (1982)(1982)
  12. 12. NUREMBERG CODE Subject autonomy Researcher freedom No legislate Moral autoregulation HELSINKI DECLARATION OF WMA  Physician duty is always to promote and protect people health. His/her knowledge and conciousness are subordinated to fulfil this duty.  In medical research with human beings, concern for their welfare must always have primacy over science and society interests
  13. 13. 1964: HELSINKI DECLARATION 1975: TOKYO 1983: VENICE 1989: HONG KONG 1996: SOUTH AFRICA 2000: EDIMBURGH
  14. 14. Respect for Persons Informed Consent Beneficense Risk/Benefit Justice Subjects selection 1979: BELMONT REPORT
  15. 15. GREAT CONTRIBUTIONS NORMS - GUIDELINES- DECLARATIONS  Respect for person subject of research: AUTONOMY FREEDOM DIGNITY • Do not harm • Always look for subject benefit • Act with justice
  16. 16. How to move towards an ethical conduct in international research?
  17. 17. THE CULTURE OF ETHICAL CONDUCT Human environment Development context: Degree of delivery and protection of fundamental freedoms by society and how they contribute to political and human environment development Values and Practice Political environment J.V. Lavery “A culture of ethical conductt in research: The proper goal of capacity building in International Research Ethics” 2002
  18. 18. INTERRELATION SCHEME Political freedom Economic facilities ETHICAL BEHAVIOR IN RESEARCH PRINCIPLES-PRACTICES Transparence guarantee Protection and security Social Opportunities
  19. 19. MULTICENTRIC RESEARCH Results comparison Consent request To guarant respect of bioethics principles and norms Equity in sample selection Standards of care application Harm reimbursement Monitoring DIFFICULTIES
  20. 20.  Vulnerability  Dependency level  Competence and capacity  Risk/benefit ratio  Children  Women  Elderly persons SPECIAL POPULATIONS IN MEDICAL RESEARCH
  21. 21. SPECIAL POPULATIONS IN MEDICAL RESEARCH  Persons with congnitive disability  Subordinated personnel  Coma or critically ill patients  Terminal diseases  HIV/AIDS  Healthy volunteers  Minorities
  22. 22. SCIENTIFIC AND ETHICAL MISCONDUCT DEFINITION: Scientific error: unintended and unintentional Misconduct: purposeful, knowing and reckless DEGREE OF MISCONDUCT: - fabrication, - falsification, - plagiarism RESPONSES TO MISCONDUCT: - External sanctions: criminalizing misconduct - Due process protection for the accused - Informant protection
  23. 23. ETHICAL CHALLENGES IN INTERNATIONAL RESEARCH
  24. 24. ETHICAL CHALLENGES IN INTERNATIONAL RESEARCH  TO STIMULATE DIALOGUE  TO PROPOSE AND PROMOTE NEW PATHWAYS FOR INSTITUTIONAL IMPROVEMENT  TO AVOID IMPROVISATION
  25. 25. AGENTS FOR THE CHALLENGES: BUILDING CAPACITY  LATINAMERICAN RESEARCHERS  GRADE STUDENTS  ACADEMIC INSTITUTIONS AUTHORITIES  ETHICS COMMITTEE MEMBERS  CONGRESS MEMBERS  POLITICIANS  CITIZENS
  26. 26. CHALLENGE GOALS  ETHICAL  ECONOMICAL  CULTURAL TO REACH: ALL INHABITANTS OF NATIONS RICH POOR DEVELOPED DEVELOPING
  27. 27. “All written norms will not have a lasting value as long as some interests, at times not identified non concientious (scientific promotion, economic incentives, competing for rewards), continue influencing researchers education. The conclusion to be imposed is that the ethical structure of the scientific work, has to be part of science body and neither a foreign nor extemporary addendum” Lolas, F. Quesada, A. “Pautas éticas de investigación en sujetos humanos: nuevas perspectivas” 2003
  28. 28. “There is nothing more difficult to carry out, nor more doubtful of success, nor more dangerous to handle, than to initiate a new order of things. For the reformer has enemies in all who profit by the older, and only lukewarm defenders in all those who would profit by the new order.” Nicolo Machiavelli (In Shamoo and Dunigan 2000)
  29. 29. MENDOZA, ARGENTINA
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