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ETHICAL ISSUES IN CLINICAL RESEARCH CHALLENGES TO ETHICS OVERSIGHT IN INTERNATIONAL RESEARCH Rio de Janeiro, Brasil 2008 Prof. Enrique Guntsche GLOBAL SCENERY IN INTERNATIONAL RESEARCH INVOLVING HUMAN SUBJECTS NOWADAYS FACTS Increasing number of collaboratives and multicenter studies

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slide1

ETHICAL ISSUES IN CLINICAL RESEARCH

CHALLENGES TO ETHICS OVERSIGHT IN INTERNATIONAL RESEARCH

Rio de Janeiro, Brasil

2008

Prof. Enrique Guntsche

global scenery in international research involving human subjects
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
global scenery in international research involving human subjects3
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
global scenery in international research involving human subjects4
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
global scenery in international research involving human subjects5
GLOBAL SCENERY IN INTERNATIONAL RESEARCH INVOLVING HUMAN SUBJECTS

NOWADAYS FACTS

  • Lesser bioethical development at national, regional and local levels in developing countries
global scenery in international research involving human subjects6
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?
global scenery in international research involving human subjects7
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
global scenery in international research involving human subjects8
GLOBAL SCENERY IN INTERNATIONAL RESEARCH INVOLVING HUMAN SUBJECTS

QUESTION

  • Can Unethical Clinical Research be prevented?
slide12

Subject autonomy

  • Researcher freedom
  • No legislate
  • Moral autoregulation

NUREMBERG CODE

  • 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

HELSINKI DECLARATION OF WMA

slide13

1964: HELSINKI DECLARATION

1975: TOKYO

1983: VENICE

1989: HONG KONG

1996: SOUTH AFRICA

2000: EDIMBURGH

slide14

1979: BELMONT REPORT

Respect for Persons

Informed Consent

Justice

Subjects selection

Beneficense

Risk/Benefit

slide15

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
slide17

THE CULTURE OF ETHICAL CONDUCT

Values and Practice

Human environment

Political environment

Development context:

Degree of delivery and protection of fundamental freedoms by society and how they contribute to political and human environment development

J.V. Lavery “A culture of ethical conductt in research: The proper goal of capacity building in International Research Ethics” 2002

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INTERRELATION SCHEME

Transparence guarantee

Political freedom

ETHICAL BEHAVIOR IN RESEARCH

PRINCIPLES-PRACTICES

Protection and security

Economic facilities

Social Opportunities

slide19

MULTICENTRIC RESEARCH

Results comparison

Consent request

To guarant respect of bioethics principles and norms

DIFFICULTIES

Equity in sample selection

Standards of care application

Harm reimbursement

Monitoring

slide20

SPECIAL POPULATIONS IN

MEDICAL RESEARCH

  • Vulnerability
  • Dependency level
  • Competence and capacity
  • Risk/benefit ratio
  • Children
  • Women
  • Elderly persons
slide21

SPECIAL POPULATIONS IN

MEDICAL RESEARCH

  • Persons with congnitive disability
  • Subordinated personnel
  • Coma or critically ill patients
  • Terminal diseases
  • HIV/AIDS
  • Healthy volunteers
  • Minorities
slide22

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

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ETHICAL CHALLENGES IN INTERNATIONAL RESEARCH

  • TO STIMULATE DIALOGUE
  • TO PROPOSE AND PROMOTE NEW PATHWAYS FOR INSTITUTIONAL IMPROVEMENT
  • TO AVOID IMPROVISATION
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AGENTS FOR THE CHALLENGES: BUILDING CAPACITY

  • LATINAMERICAN RESEARCHERS
  • GRADE STUDENTS
  • ACADEMIC INSTITUTIONS AUTHORITIES
  • ETHICS COMMITTEE MEMBERS
  • CONGRESS MEMBERS
  • POLITICIANS
  • CITIZENS
slide26

CHALLENGE GOALS

  • ETHICAL
  • ECONOMICAL
  • CULTURAL
  • TO REACH:
  • ALL INHABITANTS OF NATIONS

RICH

DEVELOPED

POOR

DEVELOPING

slide27

“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

slide28

“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)