Report: Research Ethics Workshop for PAHO staff Washington DC, November 1-3 2010
Description With the support from WHO-ERC and the WHO Center in Ethics and Global Health Policy, and in coordination with HRM/CW, the Secretariat of PAHOERC organized a research ethics workshop for PAHO staff. The workshop took place in the Hilton Washington DC Rockville in November 1-3 2010. Its objectives were to strengthen the capacity of relevant PAHO staff to identify, understand and analyze ethical issues in research involving humans, and to promote ethical research that adheres to international guidelines and takes into account local contexts. Additionally, the workshop aimed at providing participants with the skills, tools and support necessary to replicate learning experiences in research ethics in their countries. The workshop followed a dialogic and case-based approach. The cases that were used had been developed on the basis of proposals that had been reviewed by PAHOERC. The workshop covered the fundamentals of ethics in research with human participants. Based on the weaknesses in the region as identified by PAHOERC Secretariat when reviewing research proposals, the following topics were be given special attention: social value of research, scientific validity (including study design issues such as use of placebo), responsibilities of researchers towards research participants, and voluntariness and role of communities in the process of informed consent. The workshop included small group discussions and practical activities (such an informed consent clinic and a simulated ERC review) that actively involved participants in the learning process and allowed for a multidirectional learning experience in which researchers, PAHOERC members and focal points benefit from the discussion. Faculty included David Wendler (PhD) and Nicola Barsdorf (MHS, PhD candidate) from the Department of Bioethics at the Clinical Center of the National Institutes of Health; Kenneth Goodman (PhD) from the University of Miami / Ethics Programs; Sergio Litewka (MD, MPH) from the University of Miami / CITI Program – Pan American Bioethics Initiative; Abha Saxena (MD) from WHO Ethics Review Committee Secretariat; and Carla Saenz (PhD) from PAHO Ethics Review Committee Secretariat. Relevant PAHO staff members, such as research focal points, technical officers processing research proposals, and members of PAHOERC, were invited to participate in the workshop, which had originally aimed at 20 participants. Excluding faculty, 36 participants had registered
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for the workshop prior to its start date. Registered participants included 7 research focal points from representative countries and 1 external PAHOERC member based in Chile. Actual attendees included 6 faculty, 9 PAHOERC members, 12 PAHO WDC staff, 6 PAHO staff from representative countries, and 1 WHO-ERC consultant (total: 34). Participants were provided with relevant materials (such as cases for discussions) in advance.
Agenda November 1 9:00-9:15 9:15-9:45
9:45-10:40 10:40-11:00 11:00-11:45 11:45-12:30 12:30-13:30 13:30-14:00 14:00-15:10 15:10-15:30 16:00-16:45 16:45-17:00
November 2 9:00-10:00 10:00-10:40 10:40-11:00 11:00-11:50 11:50-12:30 12:30-13:30 13:30-15:10 15:10-15:30 15:30-17:00 November 3 9:00-9:40 9:40-10:40 10:40-11:00 11:00-12:15
12:15-12:30 12:30-1:30
Introduction What is research? Case 1: Congenital syphilis and Chagas disease in a Central American country What makes research with human subjects ethical? Coffee break Social value of research (small group discussion) Case 2: Diagnostic test for visceral leishmaniasis Scientific validity (small group discussion) Case 3: Participative strategy for helminthiasis control Lunch Assessment of small group discussions Guidelines for the use of placebo Coffee break Risk-benefit ratio Case 4: Protection against cutaneous leishmaniasis What do researchers owe to participants? Case 5: Gender dimensions of alcohol
The elements of Informed Consent Voluntariness and Informed Consent Case 7: HIV/AIDS and leishmaniasis coinfection Coffee break The role of communities in research: Case 6: Research in an Amazonian indigenous community Inclusion and exclusion criteria Lunch Informed consent clinic Coffee break Simulated ERC review
Review and assessment of simulated ERC Building capacity in research ethics: Experiences and challenges Coffee break How can we work together towards the successful implementation of PAHOERC SOP’s? How can we promote research in the region? (Panel discussion) Closing remarks and evaluation Lunch
Cuervo, Saenz Wendler
Wendler Barsdorf, Saenz Barsdorf, Saenz Saenz Saenz Goodman Saenz
Goodman Goodman
Saenz Saenz Saxena Saenz
Saenz Litewka
Lutter, Cuervo, Saenz Cuervo
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Workshop Attendees Faculty Nicola Barsdorf Dave Wendler Ken Goodman Sergio Litewka Abha Saxena Carla Saenz
Title NIH - Department of Bioethics NIH - Department of Bioethics University of Miami Ethics Program University of Miami Ethics Program & CITI program WHOERC Secretary PAHOERC Secretariat Ethicist
Attended
PAHOERC members Luis Gabriel Cuervo Marie Claude Lavoie Alessandra Guedes Kira Fortune Paulo Lyra Oscar Mujica Maria Paz Ade Roberto Samayoa Chessa Lutter Maria de los Angeles Cortes Javier Vasquez Sergio Muñoz
Status Attended Attended Attended Attended Attended Attended
PAHOERC Secretary - Research Promotion and Development PAHOERC Member - Workers’ Health Program PAHOERC Member - Intra-Family Violence PAHOERC Member - Environmental Health PAHOERC Vice President - HIV-AIDS-STI PAHOERC Member - Epidemiologist PAHOERC Member - Specialist, HSD/CD/Malaria PAHOERC Observer - Procurement PAHOERC President - Family and Community Health PAHOERC Member - Vaccines and Immunization PAHOERC Observer - Human Rights PAHOERC External Member - CHILE
Attended Absent Attended Attended Absent Attended Attended Attended Attended Attended Absent Attended
PAHOERC WDC staff
Cristina Leria Floriza Gennari
PAHO Staff - Research, Promotion and Development PAHO Staff - Research, Promotion and Development PAHO Staff - Research, Promotion and Development PAHO Staff - Research, Promotion and Development PAHO Staff - New Vaccines PAHO Staff - Procurement PAHO Staff - Health Development PAHO Staff - Family and Community Health PAHO Staff - Oral Health PAHO Staff - ProVac Initiative PAHO Staff - Gender, Diversity and Human Rights PAHO Staff - Gender, Diversity and Human Rights PAHO Staff - Gender and Ethnicity Mainstreaming PAHO Staff - Human Rights Law for Health Services PAHO Staff - Gender, Diversity and Human Rights
PAHO other countries: Giovanni Escalante Gabriel Vivas Guillermo Troya Adriana Mendoza Lourdes Ramírez Zaida Yadón Christophe Rerat
Research Focal Point - PERU Research Focal Point - BARBADOS Research Focal Point - TRINIDAD AND TOBAGO Research Focal Point - COLOMBIA Research Focal Point - HONDURAS Focal Point PANAFTOSA - BRAZIL Research Focal Point - BRAZIL
Attended Attended Attended Attended Attended Attended Attended Cancel
Others Reva Gutnick Gustavo Cruz
WHOERC Team PAHO Guest - Fellow NYU/HSS
Attended Absent
Eleana Villanueva Evelina Chapman Ludovic Reveiz Kei Alegría Lucia Helena de Oliveira Leonardo Acosta Jose Francisco García Freddy Perez Saskia Estupinan Barbara Jauregui Bethany McCurley Marijke Velzeboer-Salcedo Esmeralda Burbano
Attended Attended Attended Attended Attended Attended Attended Attended Absent Attended Attended Attended Attended Attended Absent
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Participants’ Evaluation of the Workshop Participants were given the opportunity to evaluate the workshop. 16 participants filled in and returned the evaluation forms. All their answers are included below. Overall, the participants’ assessment of the workshop is very positive. It indicates that the workshop’s goals have been achieved. The participant’s suggestions for future training activities are useful, and will be taken into account for future training initiatives.
Previous training received: Yes No Online In-person
7 9 3 4
Enhanced capacity to understand Strongly agree Agree Neutral
56% 25% 19%
Clear objectives Strengthen skills to analyze Strongly agree Agree Neutral
47% 47% 6%
Strongly agree Agree Neutral
19% 44% 37%
Appropriate length Strengthen ability to apply ethical principles Strongly agree Agree Neutral Slightly disagree
31% 38% 19% 12%
44% 19% 31% 6%
Strongly agree Agree Neutral Slightly disagree
13% 40% 34% 13%
Will use acquired knowledge and skills
Strengthen capacity to identify Strongly agree Agree Neutral
25% 56% 19%
Provided tools to replicate experience
Enough time for interactive learning Strongly agree Agree Neutral Slightly disagree
Strongly agree Agree Neutral
69% 25% 6%
Strongly agree Agree Neutral
67% 20% 13%
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Suggestions: •
Feedback with countries (focal points) to share experiences and learned lessons.
•
Speaking of participants was not always an orderly process. Raising a hand to speak was acknowledged but as the discussion proceeded whoever raised his/her hand first was forgotten.
•
2 ½ days is too short of a time to achieve all that was mentioned in the evaluation. At best, the workshop will allow participants to understand why ethical principles are important and how to identify them.
•
The first day of the workshop should be to study PAHOERC’s SOPs
•
Give more time to extend discussions
•
More openness to hear some of the comments and suggestions. There was a feeling of not being heard or paid attention to. Would like many short examples of what constitutes research with human subjects and what doesn’t.
•
More different speakers.
•
Future workshops should have the option to be conducted in Spanish.
•
Last day was not as interesting.
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Perhaps 2 days are enough.
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Control excessive participation of some participants because they are distracting.
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Would have liked to see a greater Diversity of faculty on various issues.
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The PABI CITI presentation was too long and didn’t learn much from it.
Other activities proposed: •
Short sessions / elluminate conferences for internal PAHO team (consultants in the countries)
•
Develop a plan, not just activities.
•
Link to online training and promote a network to share experiences.
•
In house PAHO training.
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Dissemination of PAHOERC SOPs
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Online course on research ethics.
•
More workshops and online information
•
Give some background milestone articles to read before the workshop.
•
Offer links to key sites.
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Require participants to read the Belmont Report.
•
Build capacities with more learning activities
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Liked most: •
Possibility of meeting the team at a regional level and colleagues from other countries, as well as sharing expectations and solve doubts.
•
Lots of discussion.
•
Participants from different areas (investigators, committee, members, focal points from countries).
•
Different speakers who were very good.
•
Interactive nature.
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Case studies and possibility of meeting the PAHOERC team and learning about their work.
•
Discussion time.
•
Different points of view.
•
Openness to discussion.
•
Interactive.
•
Multiple speakers.
•
Could understand better how to improve projects in ethical points.
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The opportunity to listen to speakers involved in the cases, colleagues that submit projects to the committee and the experiences from the other countries.
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Case study basis for discussions.
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Variety of participants.
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The whole: Theme, method of delivery, the group.
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Speakers.
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Issues on real or not so real cases.
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Interactive.
PAHOERC’s Assessment of the Workshop The workshop constituted a successful learning experience. Besides achieving the anticipated objectives, it has accomplished some additional valuable goals. First, it has well-positioned PAHOERC’s work in the institution and strengthened the understanding of the ethics review requirement. Second, it has fostered a collaborative relationship between PAHOERC and the focal points and/or investigators. Third, it has strengthened ties among PAHOERC members, and reinforced their commitment to participate in ethics review regularly. The organization of the workshop involved several challenges, such as those regarding the transfer of funds form Geneva and its implications, which we had not anticipated. Useful lessons were learned in the process. Some organizational aspects, such as having the workshop somewhere other than the office and giving participants the opportunity to share lunch together, had a very positive impact in the experience, as participants could genuinely
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focus on the topics being discussed, and continue the discussions and share relevant experiences in a more informal setting. The workshop has resulted in an ongoing dialogue about research ethics issues (from training activities to specific proposals) between the Secretariat of PAHOERC and many of the participants. After the workshop, the power point presentations and handouts were translated to Spanish, and offered in both English and Spanish to attendees. Per their immediate request, 12 attendees were sent these learning materials. A mere five weeks after its completion, there is evidence that the workshop is having the multiplying effect we aimed at. Overall, most research focal points have been since then actively promoting research ethics in their countries. A series of relevant activities are either taking place or in the works. First, a research ethics workshop in Honduras scheduled for the beginning of February. We are organizing it in collaboration with CITI, local government, the representation, and a local university. With a view to maximizing the benefits from this training activity and facilitating the dialogue among parties facing similar challenges, PAHOERC aims at funding the participation of PAHO research focal points from the other countries in Central America. Next, we are collaborating with Sergio Mu単oz (external PAHOERC member who participated in the workshop and is based in the Universidad de la Frontera in Temuco, Chile) in the organization of a workshop on informed consent in mid-January, which we will lead via elluminate. He has requested for this event some materials that were used in the DC workshop. We are also providing ad-hoc consultation on research ethics problems in Colombia, per request of the PAHO research focal point that participated in the workshop. The consultation has involved other PAHO-Colombia staff and representatives of other organizations conducting research in Colombia. Additionally, there are discussions in progress with a team in Peru, led by the PAHO research focal point that participated in the workshop and a government representative, and involving other PAHO-Peru staff about the development of research ethics training activities in Peru, including workshops and internships. The PAHO research focal point from Peru has further shared about the DC research ethics workshop with its counterparts in Ecuador and Bolivia, and involved them in conversations with PAHOERC about research ethics issues. These conversations are at an early stage, as are the exchanges with PAHO research focal points from other countries that have after the workshop expressed interest in organizing research ethics training initiatives, such as Trinidad and Tobago. ---End---
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