Research Ethics Committees in Latvia: Problems and Perspectives Central Medical Ethics Committee (CMEC) – reviews different types of research, including.

Slides:



Advertisements
Similar presentations
1 Conflicts of interest Different types, different contexts.
Advertisements

Ethical standards in biomedical research: the acquis and projects of the Council of Europe Laurence Lwoff Bioethics Division Council of Europe
Group 1.3 Relationships between RECs in multi-centre, international studies –problems and solutions.
STUDENTS PERSPECTIVE ON TRAINING PROGRAMS Joanna Rozynska GSSR, Institute of Philosophy and Sociology Polish Academy of Science 8th Global Forum of Bioethics,
E. GefenasGlobal Forum 8, June, 2007, Vilnius Regional Perspective to Keynote Challenges - Europe.
1 st Training Seminar on Planning and Preparing for EHES at the National Level Legal and ethical issues Susanna Conti Istituto Superiore di Sanità (ISS)
National and External Control of Public Procurement Main Issues.
1 Large research and medical databases in clinical and research multi-centres trials A Swiss Perspective June 19, 2012 European Commission International.
Setting internal Quality Assurance systems
Adapted from ISEF webpage Society for Science and the Public “Roles and Responsibilities of students and adults” Roles and Responsibilities of students.
SOP Melody Lin, Ph.D. Deputy Director, Office for Human Research Protections Director, International Activities Santiago, Chile August.
Joint degrees in Europe Dr. Andrejs Rauhvargers Secretary General, Latvian Rectors’ Conference.
The Corporate Laws Amendment Bill, B6/2006. © 2006 Deloitte Touche Tohmatsu Corporate Laws Amendment Bill, B6/2006 – 29 May 2006 Introduction Presenting.
Sustainable Energy Systems Overview of contractual obligations, procedures and practical matters KICK-OFF MEETING.
PUBLIC SECTOR INTERNAL AUDIT IN THE REPUBLIC OF LITHUANIA Mr. Jonas Vaitkevičius Head of Internal Audit and Financial Control Methodology and Monitoring.
Obtaining Informed Consent: 1. Elements Of Informed Consent 2. Essential Information For Prospective Participants 3. Obligation for investigators.
EU: Bilateral Agreements of Member States
EU: Bilateral Agreements of Member States. Formerly concluded international agreements of Member States with third countries Article 351 TFEU The rights.
RATIFICATION OF FINAL ACTS AND DECISIONS OF THE 1999 BEIJING CONGRESS – UNIVERSAL POSTAL UNION.
Ph.d. Nguyen Thi Kim Thoa Ministry of Justice 1. Drafting progress: – time consuming, – Drafts are changed many times Quality of legal documents – Contents.
An introduction to the EU and its legislation. Member States currently 15 –Austria- Ireland –Belgium- Luxembourg –Denmark- Netherlands –Finland- Portugal.
3rd Baltic Conference on Medicines Economic Evaluation, Reimbursement and Rational Use of Pharmaceuticals Pricing and Reimbursement of Pharmaceuticals.
Clinical Research Conference 2012 Legal, Ethical, and Social Dimensions of Clinical Research Takis Vidalis, Ph. D., Hellenic National Bioethics Commission.
PREDICTIVE TESTING AND INSURANCE LAW. Summary: ① Predictive Tests ② Insured Perspective ③ Insurers perspective ④ Legislation.
A Common Immigration Policy for Europe Principles, actions and tools June 2008.
Whilst the pharmaceutical industry plays a key role in developing and producing medicines, there is a tension between industry’s need to expand product.
Oviedo Convention and Its Protocols – Impact on Polish Law International Bioethics Conference Oviedo Convention in Central and Eastern European Countries.
Retha Britz Copyright 2013 All rights reserved for this presentation 1 Establishment and functioning of a REC Retha Britz.
Clinical Research in South Africa - Ethical and Regulatory Processes NATIONAL HEALTH RESEARCH ETHICS COUNCIL Professor A Dhai Deputy Chair National Health.
Private sector : The 2nd industry of drugs in the African continent; 32 manufacturing units in conformity with the international standards; 70% of the.
Discussion “International Cooperation: Service of Documents, Taking of Evidence” – Practical Implementation of Regulations No 1393/2007 and No 1206/2001.
Teaching of Medical Ethics in Postgraduate Medical Education Jozef Glasa Slovak Health University - Dpt. of Clinical Pharmacology; Institute of Medical.
Results of audit “Quality of public services in the information society” Markko Kard Alo Lääne The 9th Annual Meeting of the Representatives of the Baltic,
Documents as quality manual, Annual quality report and product descriptions, Compensation for harm to health Prof. Juozas Galdikas State health care accreditation.
+ National and Institutional Guidelines on Conflict of Interest in Physician-Industry Relationships.
Policy track summary ICIUM 2011 – 18 Nov Policy track topics 1.The pharmaceutical policy process 2.Quality and safety of medicines in LMIC 3.Policy.
Policy level The policy and legislation development process in practice (politicians and scientists are involved) differs from the ideal model (politicians,
© OECD A joint initiative of the OECD and the European Union, principally financed by the EU Introducing a New Concessions System – Latvian Experience.
Dr. Igor Codreanu Center of Dialysis and Renal Transplant Republican Clinical Hospital, Chisinau THE IMPACT OF THE OVIEDO CONVENTION ON LEGISLATION IN.
Enforcement of Shareholders’ Rights: The Case of Bulgaria First South East Europe Corporate Governance Roundtable Bucharest, September 2001 Enforcement.
Ivowen Ltd1 Ivowen Limited Preparation and Submission of a Traditional Herbal Medicinal Product Application.
The ELSI Implications of Gene Therapy under the UNESCO Declaration -a Taiwan’s Perspective Panelist : Lin, Jui-Chu & Wang, Triumph.
SUPPORTED BY THE EUROPEAN UNION’S OBNOVA AND PHARE PROGRAMMES Public Involvement EIA TRAINING RESOURCE MANUAL FOR SOUTH EASTERN EUROPE.
ACCREDITATION AGENCY IN HEALTH AND SOCIAL SCIENCES Wednesday, 24 September, 2014 Vice Dean ship For Development & Quality Quality & Academic Accreditation.
Evaluation of Ethics Review Procedures for Research in Egypt Hany Sleem 1 Henry Silverman 2 1 National Hepatology and Tropical Medicine Research Institute,
Medical law and its place in the system of law and legislation in Ukraine. Legislative provision in healthcare in Ukraine.  The concept, object, method.
Portfolio Committee for Health Medicines and Related Substances Amendment Bill (06/08/08) IMSA represents Research Based Pharmaceutical Companies.
Do Statutes Enable Genetic Discrimination? Asya Yanchinova and Dr. Cheryl Arflin College of Business, Florida Atlantic University Issue Does the advancement.
MEMORANDUM OF AGREEMENT TEMPLATE Svilena Simeonova, Director of Internal Control Directorate, Ministry of Finance, Bulgaria.
INTERNATIONAL SCIENCE AND ENGINEERING FAIR Rules and Guidelines 2016.
HA Central Register of Clinical Research 1 Dec 04 HA REC.
M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Working Group for Chapter 32 – Financial Control Bilateral screening:
Documentation Requirements for Hospital Accreditation -By Global Manager Group.
THE AIM OF PRESENTATION TO PRESENT FRAMEWORK OF TRAINING AND REGULATION OF HEALTH CARE PROFESSIONALS TO PRESENT FRAMEWORK OF TRAINING AND REGULATION OF.
Improving Process and Outcomes of Ethics Review at Faculty of Nursing, Chiang Mai University Anusra Thaprom, MBA Chawapornpan Chanprasit, PhD Suthisa Lamchang,
A strategy to promote the ILO Declaration on Fundamental Principles and Rights at Work.
Quality Metrics of Performance of Research Ethics Committees Cristina E. Torres, PhD FERCAP Coordinator.
4–6 September 2013, Vilnius, Lithuania High-Level Seminar for Eastern Europe, Caucasus and Central Asia Countries QUALITY FRAMEWORK AT.
Enforcement of Shareholders’ Rights: The Case of Bulgaria First South East Europe Corporate Governance Roundtable Bucharest, September 2001 Enforcement.
GCP (GOOD CLINICAL PRACTISE)
TAIEX-REGIO Workshop on Applying the Partnership Principle in the European Structural and Investment Funds Bratislava, 20/05/2016 Involvement of Partners.
Convention on Human Rights and Biomedicine
Eimantas Peicius Kaunas regional REC, Lithuania
Reconsidering requirements for research ethics in Lithuania
Regulation EU 536/2014 on clinical trials
REGULATORY PROBLEMS IN CARING OUT PRE- AND POST- AUTHORISATION CLINICAL TRIALS Dr Penka Decheva GCP Inspector, BDA.
Ilze Danga Chief Economist of the Budget Division
AGREEMENT FOR TRANSPARENCY The Case of Mexico
PRESENTATION OF MONTENEGRO
Introduction to Basic Research Methods
Presentation transcript:

Research Ethics Committees in Latvia: Problems and Perspectives 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. RECs SYSTEM IN LATVIA 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. 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. Signe Mežinska, PhD Student, lecturer Advanced Certificate Program in Research Ethics in Central and Eastern Europe Vents Sīlis, PhD Student, lecturer Riga Stradins University (LATVIA) Union Graduate College (USA) Vilnius University (LITHUANIA) 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. 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.