Research Ethics Committees in Latvia: Problems and Perspectives

1. Research Ethics Committees in Latvia:Problems and Perspectives Signe Mežinska, PhD Student, lecturerAdvanced Certificate Program in Research Ethics in Central and Eastern Europe Vents Sīlis, PhD Student, lecturerRiga Stradins University (LATVIA)Union Graduate College (USA)Vilnius University (LITHUANIA) • Introduction: • This research is part of the larger comparative studyof 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 aspectsof their functioning. • Aims: • To gather thorough and up-to-date information about the system of ethical regulation in biomedical research in Latvia. • To indicate main problems in the functioning of RECs system and to propose appropriate solutions. RECs SYSTEM IN LATVIA • 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. • 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. • 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 theobtained 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: • Convention on Human Rights and Biomedicine is not ratified in Latvia; • responsible institutions (including CMEC) are disinterested and passive. • 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 – itproved to be very difficult to findeven 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. • 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.