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Fogarty International Center - Workshop

Dear Colleagues:

The workshop's Organizing Committee (ITREOH and Bioethics program directors working with CEE and NIS, and myself) had a conference call yesterday. It was agreed to move the workshop dates to June 4-6, 2003, and to conduct the technical "optional" session on IRBs BEFORE the meeting, on June 3.

In order to begin the planning process and get an initial head count, the Organizing Committee seeks your input re: your interest in participating as well as suggested names of foreign trainees and partners (and possibly others whom you would recommend). As we hope to be able to include relevant former FIC trainees/alumni as well, please provide those names/affiliations as well. At the moment, we have not set a limit of participants for each FIC program, but are using an initial estimate of 2 per program per country (+/-), with an upper limit of 150-200. However, some programs may be interested in sending more people.

Finally, let us know if any of you would like to participate on the Organizing Committee. Currently, the Committee includes program directors specializing in environmental/occupational health, infectious diseases, and naturally bioethics, and it would be ideal to be able to include someone who could provide programmatic leadership for the non-communicable diseases/mental health/ population health/track. And again, if any of you have conducted similar workshops in the region and have educational resources to share, please let us know -- we welcome your input. 

We would appreciate if you would begin to think about whom you could recommend (either as trainee or faculty), and forward that information to me, along with affiliations and contact info by Oct. 21 (with cc to Dr. Dan Hryhorczuk at dhryhorc@uic.edu).

Thanks and best regards,
Natalie
Natalie Tomitch, MPH, MBA
Program Officer for Russia and the New Independent States (NIS)
and Central and Eastern Europe (CEE)
Division of International Relations
Fogarty International Center
National Institutes of Health
31 Center Drive, Rm. B2C11 (MSC 2220)
Bethesda, MD 20892 USA
tel: (301) 496-4784
fax: (301) 480-3414
E-mail: tomitch@nih.gov
http://www.nih.gov/fic/.

Dear Folks:

During discussions at the last network meeting of FIC's International Training and Research Program in Environmental and Occupational Health (ITREOH) in January, an idea emerged among the program directors working with Central and Eastern Europe (CEE) and the New Independent States (NIS) to organize a regional meeting which would involve the ITREOH grantees and their foreign partners from that region.

The concept was expanded to include program directors and their CEE/NIS partners from other FIC programs, and the topic of bioethics in public health research was proposed as a cross-cutting and timely issue of interest and relevance to most of the FIC programs. As you are aware, progress towards adopting and implementing internationally-accepted ethical principles in research, IRBs, etc. has been variable in the CEE/NIS region and this topic is under great scrutiny. 

Based on some of the feedback and discussions in the other FIC network meetings, it appears that there is a great interest in more interaction and integration among the different FIC programs, and one of the most obvious ways to start is by networking regionally, which could lead to greater inter-program collaboration.

The outcome is that Dr. Dan Hryhorczuk, ITREOH program director at University of Illinois/Chicago, has taken the initiative to put together a proposal for a FIC supplement seeking core support to hold a regional bioethics workshop in Sofia, Bulgaria in early June 2003 (tentatively June 3-6). Plenary sessions will cover general bioethics issues as well as provide an overview of the current status of biomedical research ethics in CEE and NIS. Break-out discussion sessions on FIC program-specific topics would focus on ethical research issues in environmental health, infectious diseases, and non-communicable diseases/mental health/drug abuse. The draft agenda is included below -- the details will be worked out by an organizing committee that would include FIC representatives, PIs from other programs, and in-country partners. 

On behalf of Dr. Hryhorczuk and ITREOH Program Director Dr. Aron Primack, I would like to inform you about this opportunity for you and your CEE/NIS partners to consider participating in this unique workshop. In reviewing the inventory of FIC programs working with CEE and NIS, we are pleased to report that there are currently 17 PIs working with a total of 16 countries in this region in the following FIC programs: ITREOH, AITRP, ITREID/TB, ICOHRTA, Pop Health, Bioethics. Even if two foreign partners from each country per program participated in the workshop, the number of CEE/NIS participants would be close to 90! -- a critical mass indeed! The organizers would also want to include in the meeting bioethics leaders from these countries.

The FIC supplement is still under consideration, and is envisioned to cover core expenses in-country and some travel of non-FIC grantees/trainees (e.g., bioethics experts). We would expect that those program directors with FIC grants currently involved with CEE and NIS would be able to assume responsibility for their and their CEE/NIS partners' travel expenses under their FIC awards. If there are any difficulties, please contact your respective FIC program officer or Dr. Ken Bridbord. 

Please let us know of your or your trainees' interest in participating in this workshop. Also, if any of you have conducted similar workshops in the region and have educational resources to share, or would like to participate on the organizing committee or as faculty, please let us know -- we welcome your input. Finally, we welcome any suggestions for contact names in CEE/NIS, especially those involved in the bioethics issue, who may be interested in participating is this discussion.

Draft Program: June 3-6, 2003 Workshops

Note: this agenda is preliminary and awaits the input of the Fogarty Bioethics, AITRP, ICOHRTA, ITREID/TB, and ITRP in Population & Health Programs as well as input from our regional Fogarty partners

June 2, 2003
Orientation session in hotel
Arrival of participants
Registration and evening welcoming reception
Optional Day (June 3, 2002)
Elective IRB workshop

Elective Workshop on Formation and Operation of Institutional Review Boards

Suggested topics: IRB Registration Issues, Mock IRB and Protocol Review, Documentation/Registration Exercise and discussion/feedback, Structure and Responsibilities of Institutional Review Boards (IRBs), U.S. PHS/NIH Regulations and Required Elements, Ethical Issues Related to Animals in Medical Research, International Guidelines Regarding Protection of Animals as Research Subjects, etc.

Day 1 (June 4)

9:00 - 9:30 a.m.
Welcome and Opening Remarks from Organizing Committee

9:30 - 10:00 a.m.
Origins of Biomedical Research Ethics within the Context of Human Subjects
Research
Prof. Irina Dardynskaia, University of Illinois, Chicago

10:00 - 11:00 a.m.
Comparison of European, North American and Eurasian Laws in the area of
protection of the privacy rights of research subjects (Suggested speaker
Julie Cote, Canada)? 

11:00-11.15 a.m. 
Coffee break

11:15 - 12:00 p.m.
The human genome and human control of natural evolution: scientific and ethical issues (speaker TBN)

12:00-1:15 Lunch

1:15-2:00 p.m.
Biomedical Research Ethics in NIS: Current Status and Future Needs  Academician Yuri Lopukhin, Director, Research Institute of Physical-Chemical Medicine, Ministry of Health (MOH), Chairman of the Ethics Committee at MOH and the Russian Academy of Medical Sciences (RAMS)?

2:00-2:45 p.m.
Biomedical Research Ethics in Central and Eastern European Countries: Current Status and Future Needs (TBN)

2:45-3:00 p.m.
Coffee break

3:00-3:45 p.m.
Biomedical Research Ethics in the United States: Current Status and Future
Needs (TBN)

3:45-4:30 p.m.
Global Harmonization in Protection of Human Subjects in Public Health
Research (WHO: TBN)

Day 2 (June 5)

9:00 - 3:00 p.m.
Break-Out Sessions on Fogarty-Specific Program Areas (number and title to be agreed upon by Organizing Committee)

  • Environmental Health
  • Infectious Diseases (AITRP, TB, ITREID)
  • non-communicable diseases/mental health/substance abuse 
Regional Break-Out Sessions?
 

Day 3 (June 6)

9:00 - noon 
Special Issues and Case Studies
Case Studies on bioethical dilemmas in public health research in central and eastern Europe and NIS.
Examples of topics include special populations, clinical trials conducted by global corporations, environmental health and occupational health vs economic development, region-specific issues in HIV, TB-topics and speakers to be selected by organizing committee. Other issues may include confidentiality, compensation, access to treatment post-trials, standards of care.

Noon-1:15 p.m. Lunch 

1:15-4:30
Plenary Session

Reports from Day 2 presentations and discussions
Panel and Open Discussion: Future Directions in Promotion of Human
Subjects Protection in Public Health Research in Central Europe, Eastern
Europe, and NIS
 

Ostatnia modyfikacja: 9 października 2002 roku



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