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

Study design, laboratory and animal experimentation and ethic evaluation done mostly in developed countries

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 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 SUBJECTS

NOWADAYS FACTS

Lesser bioethical development at national, regional and local levels in developing countries

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 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 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.NAZIS EXP.

(1939-1945)(1939-1945)Informed Informed ConsentConsent

NUREMBERG NUREMBERG CODECODE

(1947)(1947)

TALIDOMIDETALIDOMIDE

DISASTERDISASTER

(1962)(1962)

Informed Informed Consent from Consent from Legal Legal RepresentationRepresentation

HELSINKI HELSINKI DECLARATIONDECLARATION

(1964)(1964)

HISTORICAL FACTS

ETHICAL ISSUES INCORPORATED

ETHICAL GUIDELINES

BEECHER & BEECHER & PAPWORTH PAPWORTH REPORTSREPORTS

(1966-1967)(1966-1967)

Ethics Ethics Research Research Committees Committees

HELSINKI HELSINKI DECLARATIONDECLARATION

(1975)(1975)

TUSKEGEETUSKEGEE

(1932-1972)(1932-1972)Ethical Ethical PrinciplesPrinciples

BELMONT BELMONT REPORTREPORT

(1978)(1978)

RESEARCH IN RESEARCH IN DEVELOPING DEVELOPING WORLDWORLD

Ethics Ethics Research Research UniversalityUniversality

CIOMSCIOMS

(1982)(1982)

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

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

• Do not harm

• Always look for subject benefit

• Act with justice

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 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

INTERRELATION SCHEME

Political freedom

Economic facilities

ETHICAL BEHAVIOR IN RESEARCH

PRINCIPLES-PRACTICES

Transparence guarantee

Protection and security

Social Opportunities

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

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

SPECIAL POPULATIONS IN

MEDICAL RESEARCH

SPECIAL POPULATIONS IN

MEDICAL RESEARCH

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

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

ETHICAL CHALLENGES IN INTERNATIONAL RESEARCH

ETHICAL CHALLENGES IN INTERNATIONAL RESEARCH

TO STIMULATE DIALOGUE

TO PROPOSE AND PROMOTE NEW PATHWAYS FOR INSTITUTIONAL IMPROVEMENT

TO AVOID IMPROVISATION

AGENTS FOR THE CHALLENGES: BUILDING

CAPACITY LATINAMERICAN RESEARCHERS

GRADE STUDENTS

ACADEMIC INSTITUTIONS AUTHORITIES

ETHICS COMMITTEE MEMBERS

CONGRESS MEMBERS

POLITICIANS

CITIZENS

CHALLENGE GOALS

ETHICAL

ECONOMICAL

CULTURAL

TO REACH:

ALL INHABITANTS OF NATIONS

RICHPOOR

DEVELOPED

DEVELOPING

“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

“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)

MENDOZA, ARGENTINA