The Pan American Bioethics Initiative (PABI) was the name of the UM Ethics Programs grant from the Fogarty International Center of the U.S. National Institutes of Health (grant number 1R25TW008186). The project began in 2008 and concluded in 2014. Principal Investigators were Drs. Kenneth W. Goodman and Paul Braunschweiger; Dr. Sergio Litewka was the Project Director. The grant was one of a suite of Fogarty International Research Ethics Education And Curriculum Development Awards.

The PABI name was established in 1993 as a mechanism to coordinate UM Ethics Programs’ efforts in Latin America and the Caribbean. In the two decades since, the Ethics Programs have collaborated with institutions in Latin American and the Caribbean on projects in human research subjects’ protection, the responsible conduct of research (RCR) and issues in health policy and human rights. PABI is a component of the Ethics Programs’ International Program.

The PABI grant aimed to challenge and enable Fellows from Latin American and Caribbean research organizations to foster clinical research integrity and responsible conduct of research at their institutions. Fellows were decision makers and policy architects who have practical responsibilities for the development and/or oversight of research ethics programs at their respective institutions.

The PABI approach was to build research integrity and research ethics capacity in Latin America and the Caribbean. It emphasized a “top-down” approach in which decision makers involved in research ethics regulations and policy development are challenged to develop a robust ethics program. The expectation was that by agreeing to participate in PABI, the Fellows would use the collective expertise and resources of the University of Miami and its partners to develop robust research ethic programs.

A collegial relationship between PABI Developers and Faculty maximized networking and mentoring opportunities for Fellows. In addition to seminars and in-country capacity building workshops, the CITI Program was provided as a tool for bioethics education for faculty, staff and students at participating organizations. The CITI Program offers Web-based education in human subject protection, good clinical practice (GCP), lab animal welfare and research integrity to more than 825 institutions in the U.S. and around the world.

The CITI Program has been implemented around the Hemisphere. It has Spanish and Portuguese libraries of nearly 60 modules.

Mission Statement

The overarching goal of this project is to stimulate institutional efforts to foster human subjects protection, research integrity and the responsible conduct of research by challenging and working with decision leaders and policy architects who have practical responsibility for the development and/or oversight of research ethics programs in Latin American and the Caribbean.

Activities by Country

Argentina
Brazil
Chile
Colombia
Costa Rica
Honduras
Jamaica
Mexico
Peru

Faculty

PABI Faculty provided expert presentations at annual meetings and workshops. In addition, non-U.S. Faculty provided their perspectives on their respective countries’ needs and their experiences regarding the implementation of bioethics programs at their institutions. Faculty members help PABI leadership assess the success of the Fellows as they progress to meet the challenge of implementing or enhancing their programs.  Faculty members also were intended to provide practical guidance as mentors to Fellows.

Fellows

The PABI Fellows design and implement bioethics programs for investigators conducting biomedical and behavioral research at their organizations. With the support of the PABI faculty, the Fellows and colleagues at their institution will develop local content modules describing country-specific regulations for conducting human subjects research, privacy and confidentiality and genetics research. Together with PABI program directors and faculty, the Fellows organize on-site PABI workshops. The Fellows attend the PABI meetings, provide progress reports and evaluate the new bioethics programs created under their leadership.

External Advisory Board

The External Advisory Board (EAB) assessed the program and advised PABI leadership regarding the strategies and approaches used to meet the specific aims of the project. The EAB was consulted for advice and counsel when difficult problems arised during the project. For example, a Fellow may fail to make significant progress toward the implementation of a bioethics program or to enhance an existing program. The EAB could intervene either to help the Fellow make progress or by finding another person to fill the Fellow’s role. Another way in which the EAB could help is by critiquing new, untested strategies before they are implemented. Thus, important decisions regarding the conduct of the project could be made with advice gleaned from the EAB. Dr.Fernando Lolas of the University of Chile chaired the EAB.

Related Activities
Following is a list of UM Ethics Programs’ activities not sponsored by the PABI.

November 21, 2014, Cali, Colombia | Dr Sergio Litewka was invited by CIDEIM, a WHO collaborative center for the study of Leishmaniasis, to give a talk about the institutional risk of research misconduct.
The lecture took place at the San Buenaventura University in Cali, Colombia. Link to Program.

August 18-20, 2014, Costa Rica | IV Congreso Ibersoamericano de Derecho Sanitario Y II Seminario Internacional de Derecho Sanitario “El Derecho a la salud desde una perspectiva de salud pública” Presentation, Dr. Sergio Litewka, La investigación biomédica en seres humanos. Link to Program.

August 14-15, 2014, Rio de Janerio, Brazil I 4th World Conference on Research Integrity “Research Reward and Integrity: Improving Systems to Promote Responsible Research”. Presentation, Dr. Sergio Litewka, Strategy Meeting – Research Integrity Initiatives in Latin America and the 4th WCRI Link to Program.

June 18-19, 2014, Tegucigalpa, Honduras |  Taller de Buenas Prácticas Clinicas Dirigido a Miembros de Comités de Êtica de Investigación e Investigadores en Honduras. Presentation, Dr. Sergio Litewka, Ética y Regulaciones en Investigatióne Clínica Hisoria, escáandalos y tragedias: Beecher, Tuskegee, Willowbrrok, otras. Link to Program, Media Article

May 14-15, 2014, Guatemala City, Guatemala | Congreso Nacional de Investigación Clínica: “Investigación Clínica: Actualidad y Futuro” Link to program

March 14, 2014, San Juan, Puerto Rico | Research and Development: The Ethical Dimension. Drs. Paul Branschweiger, Kenneth Goodman, and Sergio Litewka were keynote speakers. Video of the day’s presentations and speaker slides….Link to program..... For poster click here.

February 25-26, 2014, Porto Alegre, Brazil | III Encontro Internacional do Instituto de Bioética da PUCRS: Integridade na Pesquisa. Link to program.

December 2013, Mexico | Gaceta Conbiética, México 2014: Sede Mundial de la Bioética. Simposio internacional de aperura, Año III Núm. 10 Diciembre de 2013. Link to newsletter.

December 5-6, 2013 , Mexico City, Mexico | Seminario Sobre Divulgacón de la Bioética. Link to program.

December 5, 2013 , Tegucigalpa, Honduras | Bioética en el siglo XXI: retos y oportunidades. For more information click here.

December 4 - 5, 2013, Mexico | Dr. Sergio Litewka was a keynote speaker in a seminar on divulgation for bioethics activities, organized by the Mexican National Bioethics Commission. The seminar addressed several topics related to healthcare technology, media, genetics research and ethics. On page 70 of the publication linked here there is more information about Dr Litewka ’s involvement in this activity.

November 5-6, 2013, Guatemala City, Guatemala | Curso-Taller: Actualización en Ética en la Investigación con Sujetos Humanos. Link to program.

October 18, 2013, Cali, Colombia | 1er Taller Programa de Protección de Humanos en Investigación Conference, Presentation, Dr. Sergio Litewka, “Ética de la Investigación Científica: Puentes entre la Teoría y la Práctica.” Link to program...link to agenda.

August 3, 2013, Lima, Peru | Dr. Sergio Litewka hosted studies on Human Research Protection and Responsible Conduct of Research with Universidad del Valle Guatemala Ministry of Health and in conjunction with Pan-American Health Organization. Link to Program

April 3-5, 2013, Miami, Florida | Association for the Accreditation of Human Research Protection Programs (AAHRPP) Conference, Presentation, Dr. Sergio Litewka, “AAHRPP: Human protections programs have made great strides.” Link to article.

February 25, 2013, San Salvador, El Salvador | Primer Congreso Iberoamericano de Ética de la Investigación en Salud, Presentation, Dr. Sergio Litewka, “Los Comités de Ética de la investigación y sus Problemas en los Países Desarrollados y en Vías de Desarrollo.” Link to program.

February 19, 2013, Kingston, Jamaica | Health Information Use & Protection: NBCJ 1st Consultation Meeting, National Bioethics Committee of Jamaica, Jamaica National Commission for UNESCO, PAHO/WHO Ministry of Health, Presentation, Dr. Kenneth W. Goodman, “HIPAA or not? The US experience.” Link to program.

February 18, 2013, Kingston, Jamaica | Beyond the Common Law Protection of Confidences in Health Care: A Seminar, National Bioethics Committee of Jamaica, University of the West Indies and Jamaica National Commission for UNESCO, Presentation, Dr. Kenneth W. Goodman, “Medical informatics and confidentiality.” Link to program.

January 25, 2013, México DF | Universidad Nacional Autónoma de México, Instituto de Investigaciones Biomédicas, Presentation, Dr. Sergio Litewka, “Perspectivas Internacionales en Integridad Cientifica: De los principios a la practica.” Link to program …. Link to Gaceta Bioméedicas....Dr. Litewka with UNAM students

August 17, 2012, México DF | Universidad Nacional Autónoma de México, Keynote Speaker, Dr. Sergio Litewka, “Ética en Investigación: Retos y Fortalezas.” Link to program.... Link to publication.

June 4, 2012, Toluca, México |  “International Congress of Bioethics,” Universidad Nacional Autónoma de México, Presentation, Dr. Kenneth W. Goodman, “Bioética, Technología de la Información y Salud.” Link to program.

October 10, 2012, Cali, Colombia |  II Taller Internacional de Etica en Investigacion:  Integridad Cientifica, Presentations, Drs. Sergio Litewka and Paul Braunschweiger.  Guest Speakers, Link to Program, Media

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