8th Forum – Vilnius, Lithuania, 27-29 July 2009

Fostering Research Ethics Infrastructure in the Developing World and Transition Societies

Themes of the Forum
Fostering Research Ethics Infrastructure in the Developing World and Transition Societies
Organisers

Vilnius University (Lithuania) and Union Graduate College Bioethics Program (USA)

Supported by:

  • Aga Khan University
  • Council on Health Research for Development (COHRED)
  • Facultad Latinoamericana de Ciencias Sociales (FLACSO)
  • Institut National de la Santé et de la Recherche Médicale (INSERM)
  • Medical Research Council-United Kingdom
  • National Institutes of Health-Fogarty International Center
  • The Wellcome Trust
  • World Health Organisation

Programme/Case Studies

Programme Details

 

FOSTERING RESEARCH ETHICS INFRASTRUCTURE IN
THE DEVELOPING WORLD/TRANSITION SOCIETIES,
27-29 JUNE, 2007, VILNIUS

Holiday Inn Vilnius hotel, Seimyniskiu 1, Vilnius

June 26 (Tuesday)

6:00-08:00 pm.

Registration

8:00 pm.

 Reception (hotel)

June 27 (Wednesday)

8:00-8:30 am.

Registration

8:30-9:00 am.

Welcome and Introductory Remarks

  • Representatives from the Lithuanian Parliament, Ministry of Health, Vilnius University , COHRED/Global Forum

9:00-9:45 am.

Keynote Speeches:  Challenges Facing Developing and Transition Countries in Establishing an Effective System of Research Ethics Infrastructure

9:45-10:30 am.

Panel Discussion: Regional Perspectives to Keynote Challenges –

Africa – Douglas Wassenaar,
Asia – Xiaomei Zhai,
Europe – Eugenijus Gefenas,
North America- Rosamond Rhodes,
Latin America – Rodrigo Salinas.

Session 1: Challenges in Operationalizing Research Ethics Review: Establishment, Composition and Organizational Aspects

10:30- 10:45 am. 

Introduction to breakout groups by panel discussants

10:45-11:15 am.

Coffee break

11:15 am – 12:30 pm. 

Sub-sessions:

 Break-out groups discussing issues and cases related to previously introduced challenges. Each group to appoint a rapporteur for feedback to the plenary session at 2:00pm.

Sub-session 1.1.
Registration

Establishing RECs , Moderator Marie-Charlotte Bouësseau

  • Should the state aim to establish Regional RECs or Institutional Review Boards?
  • Composition of RECs: Ratio of scientists/health care professionals/lawyers, profile of lay members.

Sub-session 1.2.
Registration

How to Enhance RECs’ Work? Moderator Carel IJsselmuiden

  • What national policy instruments can be used to expand REC review to include private and public research?
  • Are RECs over-regulating research and stifling rather than promoting ethical research?
  • Financing RECs and reimbursing secretariat and members: Should their service be voluntary, or should they be paid for their contributions?

Sub-session 1.3.
Registration

Relationships Between RECs in multi-center, International Studies – Problems and Solutions , Moderator Karen J.Hofman

  • One tier vs. two-tier model of ethical review for multi-center trials: Which is more preferable?
  • What are the relationship and linkage between RECs from developed and developing countries?

Sub-session 1.4.
Registration

Research Governance  – Where Does Ethics Review Fit? Moderator Rene Von Schomberg

  • What relationship should there be between RECs and other bodies responsible for regulating research, e.g., between RECs and so-called “competent authorities” (in Europe these are usually state drug agencies that issue approvals for clinical trials)?
  • Legal status of research protocol review by RECs: Should the approval be legally binding or should it rather serve as a recommendation?

12:30-2:00 pm.

Lunch

2:00-3:15pm.

Feedback and debate at the plenary from break-out groups
Session 2: Challenges in Operationalizing Research Ethics Review: Domain and Competencies

3:15-4:15pm.

Sub-sessions:

 Break-out groups continued. Each group to appoint a rapporteur for feedback to the plenary session at 4:30pm.

Sub-sessions:

Sub-session 2.1.
Registration

Scope of Research Requiring REC Approval , Moderator Jacob Leveridge

  • What sorts of studies should be considered by RECs?
  • How should “research” be defined for the purposes of REC review?
  • Where is the boundary between clinical research and clinical/managerial quality improvement projects?
  • How to review social science research (e.g., questionnaires)?
  • Should student research projects be reviewed by the same process and standards as non-student research?

Sub-session 2.2.
Registration

Challenges and Limitations to Oversight , Moderator Catherine Elliott

  • Supervision and oversight of research by RECs:
    • informed consent process
    • adverse events
    • violations of the protocol
  • Should the domain of RECs include the monitoring of ongoing research?

Sub-session 2.3.
Registration

How and Where to Obtain Specialized Technical Expertise? Moderator Eugenia Lamas

  • Should the scientific quality of protocols be part of the domain of a REC, or should this be assigned to another body?
  •  Are RECs competent enough to evaluate insurance and financial contracts of the projects, especially pharmaceutical ones?
  • How to prevent “rubberstamping” or “bullying” in those cases when RECs do not have much in-house capacity to judge complicated trial protocols?

Sub-session 2.4.
Registration

Minimizing Conflicts of Interest , Moderator Matthias Kaiser

  • How to resolve conflicts between patient care and research interests in cases of clinical trials sponsored by pharmaceutical companies?
  • How to resolve conflicts in evaluating protocols from sponsors who also contribute to salary?
  • How to resolve conflicts related to evaluating research projects of colleagues from the same institutions?

4:15-4:30 pm.

Coffee break

4:30-5:30 pm.

Feedback and debate at the plenary from break-out groups

5:30-6.00 pm.

Concluding remarks on Best Practices to Meet Challenges and Build Infrastructure, Robert Baker

6.30 pm. 

Dinner at Restaurant “Belmontas”

June 28 (Thursday)

Session 3: Models for Training in Research Ethics – includes plenary session, poster-sub-session, and concurrent break-out sub-session

9:00-10:00 am.

Sub-sessions:

 Plenary Session: Building an Infrastructure Through Training: Best Practices and Lessons Learned from Africa, Asia, Central/Eastern Europe, Latin America
Panelists:
Clement Adebamowo,
Ren-Zong Qiu,
Jiri Simek,
Mayra Achio

10:00-10:15 am.

Introduction to Best Practices in Training, Martin Strosberg

Sub-session 3.1. 10:15 am. – 1.00 pm. (including coffee break)

Best Practices in Training Poster (laptop) Sub-session (market-place format): Demonstrations in Pedagogy, Technology, Content, Resources, Distance Learning, and more

Sub-session 3.2. 10:15-11:15 am.

Student Perspectives on Training Programs

Panelists:
Elizabeth Kwagala,
Joanna Rozynska,
Dirce Guilhem

1:00-2:30 pm.

Lunch – WHO/UNAIDS report
Session 4: Ethics of Mental Health Research

2:30-2:40 pm.

Introduction to this session and introduction of plenary speaker, Douglas Wassenaar

2:40-3:00 pm.

Plenary speaker: Rodrigo Salinas

3:00-3:15 pm.

Questions from floor

3:15-4:30 pm.

Break-out groups (four). Moderators: Dafna Feinholz-Klip, Joseph Millum, Dinesh Singh, Athula Sumathipala. Each group to appoint a rapporteur for feedback to the plenary session at 5:00pm.

  • From the point of view of researchers and research ethics committees, what, if any, are the major ways in which mental illness itself differs from other health problems?
  • What, if any, are the main ethical implications for research, of the problems with capacity and competence that are likely to be associated with mental disorder?
  • Should there be special precautions and/or procedures for the ethical conduct of research with mentally disordered persons who have diminished capacity and competence? If so, what should these special precautions and procedures be?
  • Are there any special issues in research on mental disorder that arise in developing country/under-resourced settings? If so, what are these and what additional measures do they require?

4:30-5:00 pm.

Coffee break

5:00-5:45 pm.

Report back from breakaway groups
Group 1
Group 2
Group 3
Group 4

5:45-6:00 pm.

Discussion from floor & close

6:30 pm.-

Tour, concert and dinner at Vilnius University, http://www.vu.lt/lt/

June 29 (Friday)

Session 5: The Role of International Organizations in Establishing and Supporting Research Ethics Infrastructure and Networking

9:00-11 am.

Plenary Session.

Panelists representing organizations such as:

11:00-12:30 pm. (including coffee break)

Consultation Session

(At this session, individuals may interact directly with the representatives of the international organizations in small break-out groups)

12:30-1 pm.

Conference Wrap-up

 

Case Studies

Reports



Back to Past Meetings