Transcript Slide 1

Research Ethics Committees in Latvia: Problems and Perspectives
Signe Mežinska, PhD Student, lecturer
Vents Sīlis, PhD Student, lecturer
Riga Stradins University (LATVIA)
Advanced Certificate Program in Research Ethics in Central and Eastern Europe
Union Graduate College (USA)
Vilnius University (LITHUANIA)
RECs SYSTEM IN LATVIA
Introduction:
This research is part of the larger comparative study of RECs in Central and
Eastern European countries. It focuses on main aspects of the REC systems: the
structure, legal provisions and accountability, composition, workload, procedure
of issuing approvals, sources of financing and other relevant aspects of their
functioning.
Aims:
1. To gather thorough and up-to-date information about the system of ethical
regulation in biomedical research in Latvia.
2. To indicate main problems in the functioning of RECs system and to
propose appropriate solutions.
Methods:
• analysis of legal documents and regulations;
• review of publicly available information – publications, statutes and annual
statistics;
• distribution of specifically developed questionnaire addressing the functioning
of RECs and analysis of the obtained data.
Main results:
• Latvian legislation does not clarify why ethical
review of RECs is required for drug and genome
research and why it is not required for other types
of biomedical research.
• Separate group of RECs dealing only with drug
trials indicates that the system to a great extent is
build to serve the interests of pharmaceutical
companies.
• Vagueness and incompleteness of legislation
results from two reasons:
1) Convention on Human Rights and
Biomedicine is not ratified in Latvia;
2) responsible institutions (including CMEC) are
disinterested and passive.
Central Medical Ethics Committee (CMEC)
– reviews different types of research, including human genome research, but excluding
clinical trials of drugs;
– does not collect fees per review and members are not paid;
– activities of CMEC are regulated by Medical Treatment Law.
4 RECs for clinical trials of drugs
• review clinical trials of drugs; only one of
these committees reviews also other types
of research;
• collect fees per review and members
receive payment from fees;
• are accountable to both State Agency of
Medicines and CMEC (annual reports must
be submitted);
• activities of these RECs are regulated by
Pharmaceutical Law.
Main problems:
 Asymmetry between rather strict regulations of
clinical trials of drugs and genome research and
relatively weak regulations of other types of
biomedical research.
 Lack of transparency – it proved to be very
difficult to find even the most general information
about RECs. Several of RECs refused to reveal any
information about themselves thus raising
suspicions about their practices.
 Flawed system of financing – RECs for drug and
pharmaceutical products trials collect fees per
review and members receive payment from
collected fees, while members of other RECs work
for free.
4 institutional RECs:
• review different types of biomedical;
research, except of clinical trials of drugs
• review students’ research projects;
• do not collect fees per review and
members are not paid;
• in reality are not accountable to CMEC;
• 1 REC of hospital is weakly regulated by
Medical Treatment Law;
• 3 RECs at universities are not regulated
by law.
Proposed solutions:
Asymmetry can be diminished by:
• clearly defining the types of biomedical research
that need ethical review in Law on Scientific Activity;
• ratification of Convention on Human Rights and
Biomedicine.
Transparency can be increased by:
• introducing the requirement for accreditation and
annual audit of RECs;
• facilitating communication with general public (f.e.
creating web pages).
System of financing can be amended by:
• changing the system of financing from direct to
redistributive model in order to avoid conflicts of
interests ;
• assigning payment to members of all RECs to
ensure fairness and reinforce quality of work.