RESPONSIBLE CONDUCT OF RESEARCH- LATIN AMERICA
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RESPONSIBLE CONDUCT OF RESEARCH- LATIN AMERICA Sergio G. Litewka M.D. M.P.H. University of Miami Ethics Programs Collaborative Institutional Training Initiative CITI PROGRAM Seattle, October 2007
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RESPONSIBLE CONDUCT OF RESEARCH- LATIN AMERICA. Sergio G. Litewka M.D. M.P.H. University of Miami Ethics Programs Collaborative Institutional Training Initiative CITI PROGRAM Seattle, October 2007. Research Misconduct Without Borders. - PowerPoint PPT Presentation
Transcript of RESPONSIBLE CONDUCT OF RESEARCH- LATIN AMERICA
RESPONSIBLE CONDUCT OF RESEARCH- LATIN AMERICA
Sergio G. Litewka M.D. M.P.H.University of Miami Ethics Programs
Collaborative Institutional Training Initiative CITI PROGRAM
Seattle, October 2007
Research Misconduct Without Borders
In 2006 Seoul National University concluded that Hwang Woo-suk, a pioneer in stem cell research and a national hero in Korea, had fabricated much of his research.
William Summerlin from the Sloan-Kettering Institute in New York, one of the world’s leading biomedical research centers, claimed to have transplanted human corneas into rabbits. He also faked transplantation experiments in white mice by blackening patches of their skin with a pen.
Research in the Latin American region
.
Latin America
• Clinical research mainly funded by the pharmaceutical industry.
• Less than 0.5 % of National GDP of investment in Science and Technology..
• Lack of guidelines for managing research misconduct.
Latin America puzzle
Research Misconduct
• According to the Federal Government of the United States, research misconduct is defined as fabrication, falsification or plagiarism in proposing, performing or reviewing research, or in reporting research results.
• Must be a “ significant departure from accepted practices of the relevant research community.
• The misconduct must be committed intentionally, or knowingly or recklessly.
• The allegations must be proved by “ a preponderancy of evidence”.
Research misconduct according to Norway and the UK
• … “All serious deviations from accepted ethical research practice in proposing, performing and reporting research”.– ( Norwegian Committee on Scientific Dishonesty)
• “Behavior by a researcher, intentionally or not, that falls short of good ethical or scientific standards”.– Joint Consensus on Misconduct in Biomedical
Research. Consensus Statement 28 and 29 October 1999.
Research Integrity in Latin America
• Research ethics committees and independence.
• Coercion?
• Authorship.
• Duplication
• Research instead of health Interventions
CLINICAL TRIALS ACCORDING RESEARCH PHASE- Argentina- (1994-2006)
55%
20%
5% 3%17%
PHASE I PHASE II PHASE III PHASE IV BIOAVAIL.
1894 TRIALS
Source : ANMAT
Clinical Trials in Latin America
Salud frena nuevas investigaciones médicas
Por un mes, el ministro Oscar González no autorizará el inicio de estudios de
fármacos en seres humanos en la provincia.
Marcela FernándezDe nuestra Redacción
Publications and Research Integrity in Latin America and the Caribbean
• IRB approval – Research sponsored by the industry- 46% – Research not sponsored by industry – 27%
• Disclosure of conflict of interest.• More compliance with international ethical
guidelines in industry sponsored studies phase I and II.
MANCINI RUEDA, Roberto y LOLAS STEPKE, Fernando. EVALUACIÓN BIOÉTICA DE TRABAJOS DE INVESTIGACIÓN EN SERES HUMANOS PUBLICADOS EN AMÉRICA LATINA Y EL CARIBE. Acta bioeth., 2001, vol.7, no.1, p.159-169. ISSN 1726-569X.
Fabrication
Dr. Juan Carlos Vidal develops a compound from snake poison: “ Crotoxine” ( During the 80’s)
The only ethical principle which has made science possible is that the truth shall be told all the time. If we don’t penalize false statements made an error, we open up the way, don’t you see, for false statements by intention. And of course a false statement of fact made deliberately, is the most serious crime a scientist can commit.Charles.Percy. Snow, The Search. Charles Scribner’s Sons, New York, Revised Edition 1959
Why research misconduct…In Latin America ?
• Why not?
• Lack of codes or regulations for handling research misconduct.
• Not many research institutions have clear policies for managing research misconduct.
• Conflicts of Interest.
Scientific misconduct in Latin America
– A recent survey in Mexico found that 40% of scientists affirmed that scientific misconduct happens “often” and 10%, very “often”- Fraud, plagiarism and lack of scientific rigor are the most cited causes.Citation by Eduardo Rodriguez Yunta, Center of Intersdisciplinary Studies in Ethics- CIEB- Chile.
CITI- Latin America and Research Integrity
• Raising awareness among researchers.– Procedures for informed consent
management, authorship, confidentiality, conflicts of interest,.
– There are not “ text book” answers but there are ways for ethical reasoning.
– “ Everybody does it” behavior.
• Collaborating in building up a critical mass for improving standards on research integrity.
Research Integrity in Latin America
• Research integrity is more than mere regulations.
• Research integrity does not implies inquisitorial tribunals.
• In any society, individual honesty should matter.
Collaborative Institutional Training Initiative Collaborative Institutional Training Initiative CITI PROGRAMCITI PROGRAMSeattle, October 2007Seattle, October 2007
