The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Latvia

Transcription

1 The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Latvia Question 1: What laws or regulations apply to an application for conducting a clinical trial in Latvia? The Pharmaceutical Law of 24 April 1997, amended on 19 March 1998, 17 December 1998, 1 June 2000, 14 June 2001, 16 April 2003, 9 September 2003 and 15 June 2004, which established the State Agency of Medicines (Sections 8 to 10) and the requirement that clinical trials may not occur if the permission of a clinical medicinal product investigation ethics committee has not been received (Section 26.1). The 2004 amendment implemented the Directive 2001/20/EC. An English translation of this law is available at The regulations for the conduct of clinical trials were adopted in September 2000 and amended in February 2006: Regulation of the Cabinet of Ministers Regulations Regarding the Conduct of Clinical Trials and Non-interventional Trials, the Procedures for the Labelling of Investigational Medicinal Products and the Procedures for Inspection of Conformity with the Requirements of Good Clinical Practice. The law on Human Genome Research: Regulation of the Cabinet of Ministers Procedures for Genetic Research came into force August Question 2: Which government, legal or authoritative body or bodies is or are responsible for the establishment and/or accreditation of (research) ethics committees for IMPs, and for their supervision and quality? Are there different (research) ethics committees reviewing other projects? There are 5 ethics committees, one central and four other independent committees. Members of those committees are proposed by the chairperson of committee and accepted by the Ministry of Health. For the Central Medical Ethics Committee (CMEC) (responsible for the review of ethical questions related to biomedical progress) members are proposed by the Ministry of Health and accepted by the Cabinet of Ministers. Latvia - 1

2 Question 3: What is the process for achieving clinical trial authorisation from the competent authority in Latvia? Question 4: What is the process for obtaining ethical review of a clinical trial protocol by a competent (research) ethics committee in Latvia? NB: It is appropriate for Latvia that Questions 3 and 4 should be answered together. The sponsor should submit an application both to the ethics committee and to competent authority (State Agency of Medicines). A clinical trial cannot be started without a positive decision from an ethics committee and without authorization from the State Agency of Medicines. The website for the State Agency of Medicines is at Question 5: Is there a single organisation to which to apply for ethical review of a clinical trial for an investigational medicinal product, regardless of whether this is for a single site or multiple sites? Question 6: What is the website for the organisation that issues guidelines on the ethical review of a clinical trial for an investigational medicinal product? Responsibility for issuing guidelines on all aspects of clinical research involving investigational medicinal produces rests with the State Agency of Medicines, whose website is at Question 7: Is there a procedural interaction between the national or local competent authority and the (research) ethics committee during the approval process? A copy of the decision issued by ethics committee should be submitted to the State Agency of Medicines. Once a year (in February) the ethics committee shall submit to the State Agency of Medicines a list of all clinical trial submissions examined and decisions taken during the preceding year. Question 8: Does the application to the REC and to the competent authority have to be submitted in parallel, or, if not, in which order? The applications may be made either sequentially (in either order) or in parallel. Latvia - 2

3 Question 9: How many (research) ethics committees are there in Latvia? Four, other than the Central Medical Ethics Committee (CMEC). They are the Ethics Committees of the Latvian Institute of Organic Synthesis Clinical Research Unit, of the Latvian Institute of Cardiology, of the Centre for Infectious Diseases, and currently one other. There is no upper limit specified. Question 10: How are RECs funded in Latvia? Do they charge fees? If yes, what is their scale of fees? CMEC is funded from the state budget. The other four committees charge fees ( EUR for review of application; 200 EUR for review of amendments). Question 11: Who is responsible for submitting the request for ethical review to the competent (research) ethics committee for single-site and for multi-site clinical trials? The sponsor or his legal representative submits the request. Question 12: How is a single opinion achieved for multi-site studies? There are no special provisions for the procedure, but in practice any one of the ethics committees acts as the provider of a single opinion. Question 13: How many members serve on a REC? Between nine and twelve. Question 14: How many members constitute a quorum? A majority of appointed members (i.e. 50% + 1). Question 15: How are REC members appointed? Members of ethics committees are proposed by the chairperson of the committee and accepted by the Ministry of Health. For the Central Medical Ethics Committee (CMEC) (responsible for the review of ethical questions related to biomedical progress) members are proposed by the Ministry of Health and accepted by the Cabinet of Ministers. Question 16: How is the independence of members ensured? Standard operating procedures include provisions on participation in meetings and rights to vote. Latvia - 3

4 Question 17: How are conflicts of interest of REC members avoided? Only the members of the Committee independent from the investigator and the sponsor concerned shall vote or express an opinion regarding the issues related to a particular clinical trial. Question 18: What backgrounds and/or qualifications of members are actively sought? Only the CMEC has requirements for qualification of members written in legislation. The CMEC must include doctors, nurses, scientists, lawyers, pharmacists, a religious representative, a representative of the disabled and a representative of the retired. Other ECs only have the requirement to include both medical and non-medical members. However, the Ethics Committee of the Latvian Institute of Organic Synthesis Clinical Research Unit includes physicians, a journalist, a pharmacist, a lawyer and a computer expert; the EC of the Latvian Institute of Cardiology includes 6 physicians, a biologist, a biochemist and a laboratory assistant; and the EC of the Centre for Infectious Diseases includes physicians, economists, pharmacologists, lawyers, a psychologist and lay persons. Question 19: How do RECs obtain specialist expertise? Ethics committees may consult any specialist they prefer. Question 20: What are the training requirements for members of RECs? None are laid down. Question 21: What training programmes are available for REC members in Latvia? Only on GCP and on local legislation. Question 22: What are the timelines for the assessment of single- and multi-site studies? 30 days for ethics committees and 60 days for the State Agency for Medicines (SAM). Question 23: How are substantial amendments submitted during the review process dealt with? They are submitted to the ethics committee and to the SAM. The Ethics Committee shall provide an opinion and the State Agency of Medicine shall take a decision not later than 30 days after receipt of an amendment. Latvia - 4

5 Question 24: How does a REC assess the suitability of investigators and of sites? Only certified health care institutions can be trial sites. The procedure for the assessment of investigators and sites is not specified. Question 25: How are the requirements for (research) ethics committees to review the contractual or financial arrangements in clinical trials for both investigators and hospitals handled? Question 26: How are the requirements for (research) ethics committees to review the compensation arrangements for study subjects handled? Question 27: Is there an ongoing quality assurance process (e.g. audits, inspections, internal SOP) for (research) ethics committees in Latvia? No, but the Agency has the right to inspect all aspects of a clinical trial as well as the performance of the Ethics Committees. Updated information about the requirements and contact addresses is available on the website of State Agency of Medicines at Question 28: Is there an appeal mechanism? Decisions of the four ethics committees that deal with clinical trial applications can be appealed to the Central Medical Ethics Committee. A decision of the CMEC can be appealed to the court. Question 29: How do RECs deal with SUSAR reports and Annual Safety Reports? Question 30: How are substantial amendments defined? Amendments are those that may have a substantial impact on the safety of the trial subject, the physical or mental integrity of the subject, the scientific value of the trial, the process or management of the trial, the quality or safety of investigational medicinal product. Latvia - 5

6 Question 31: What are the indemnity insurance requirements for research projects? The sponsor is responsible for the insurance that covers any injury to trial subjects caused by a trial, including insurance that covers liability of the investigator and sponsor. Question 32: What are the indemnity insurance requirements for (research) ethics committee members themselves? Question 33: How is informed consent obtained from vulnerable subjects who are potentially to be involved in a clinical trial? Detailed procedure on how to obtain informed consent is not specified. Requirements for inclusion of minors and persons not able to give consent are included in the legislation as well as requirements for obtaining consent if the person is not capable to give the consent and there is no legal representative, or the representative is not available (this issue should be included in the protocol and agreed by EC and SAM). Question 34: How do RECs assess the progress and outcome of research projects that they have approved? Question 35: How does the REC ensure reception of the Annual Safety Report and the Summary of the Final Report of a research project that it has approved? Submission of the Reports to the EC and SAM is required by legislation. Question 36: Do national regulations in Latvia allow research on healthy volunteer children (subjects under 16)? No Question 37: Do national regulations in Latvia allow payment, (other than expenses), to children taking part in research? Question 38: Do RECs invite or allow a) applicants or b) observers to attend committee meetings? The applicants may be invited, but no observers. Latvia - 6

7 Question 39: Are the minutes of (research) ethics committee meetings made public? Question 40: Is there any scope for Chairman s actions in between meetings? The Chairman may assess responses to queries raised by the Committee but these must be ratified at the next meeting of the Committee Question 41: Do (research) ethics committees ever appoint subcommittees for any specific purpose? Question 42: Is there a national policy on the registration of clinical trials before they start? Question 43: If the answer to Question 42 is yes, do (research) ethics committees have any role to play in reviewing such registration? N/A Question 44: If the answer to Question 42 is yes, is this register of clinical trials made available to the public? N/A EFGCP May 2011 Latvia - 7