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

• Florencia Luna
• Ruth Macklin

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:

• Global Forum on Bioethics in Research, Carel IJsselmuiden, Sandra Realpe
• WHO, Marie-Charlotte Bouësseau
• European Commission DG Research, Rene Von Schomberg
• European Commission, EGE, Maurizio Salvi
• Council of Europe , Laurence Lwoff
• Wellcome Trust, Jacob Leveridge
• Fogarty International Center , Barbara Sina
• Medical Research Council, Catherine Elliott
• Nuffield Council on Bioethics, Hugh Whittall
• CIOMS, Gottfried Kreutz

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