Reconsidering requirements for research ethics in Lithuania V. Lukaševičienė, E. Gefenas, A. Čekanauskaitė

Overview of research legislation 1 National: No specific requirements for biomedical research until 1997; 1995 Lithuanian bioethics committee was established; 1997 Health Care Ministry decree on the temporary procedure to issue approvals to conduct biomedical research was adopted; 2000 Law on Ethics of Biomedical Research, came into force. Ministerial orders, regulating procedural issues;

Overview of research legislation 2 International: Convention on Human Rights and Biomedicine, ratified in 2002; Law on Ethics of Biomedical Research amended according to the EU directive 2001/20/EC, Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research, signed in 2005;

Law on Ethics of Biomedical Research Stricter provisions provided by the Law on Ethics of Biomedical Research to compare with international documents; It was justifiable in the context of postcominist society, where basic practices of respecting human/patient rights were just started to be implemented; Should those requirements remain the same?

Requirements of the Law on Ethics of Biomedical Research Two perspectives: “Protective”: lawyers, specialists of human rights declare that higher standards should be stated in the laws especially in postsoviet countries. “Permissive”: scientists, investigators, conducting medical research, argue that some of the requirements are too restrictive and/or not flexible

Main points of the presentation Informed consent: Research on persons not able to consent Studies of minimal risk: - Anonymous questionnaires -Anonymous questionnaires for minors -Research on medical documents

Research on persons not able to consent According to the Law on ethics of biomedical research, written informed consent is essential requirement to include patient into the research (article 4); Case 1: Two methods of enteral feeding were planed to be investigated at the Department of Intensive Care. Both methods are used in everyday practice, but there is no data which of them is more safe and effective. Research involves only routine treatment procedures. According to the principal investigator: “results of the research would help to evaluate the safety and efficacy of both methods and to prepare recomendations for treatment”.

Convention on Human Rights and Biomedicine It is stated in the article 6 (Protection of persons not able to consent): “<...> where, according to law, an adult does not have the capacity to consent to an intervention because of a mental disability, a disease or for similar reasons, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or body provided for by law. The individual concerned shall as far as possible take part in the authorisation procedure”. Article 17 (Protection of persons not able to consent to research) specifies the requirements for research on persons not able to consent.

Requirement of written consent for anonymous questionnaires: International requirements: “No research on a person may be carried out, subject to the provisions of both Chapter V and Article 19, without the informed, free, express, specific and documented consent of the person” (Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, article 14). “This article requires consent to be informed, free, express, specific and documented. Express consent may be either verbal or written as long as it is documented” (Explanatory report to the additional protocol to the convention on human rights and biomedicine concerning biomedical research) National: “Informed consent  (hereinafter consent) means an express written agreement given with full consciousness of the consequences by the research subject to participate in the research”(Law on ethics of biomedical research, article 2).

Specific requirements for minors: “ If the subject is a minor, consent to undertake a biomedical research shall be given by both parents or legally acceptable representatives of the minor, and the children’s rights protection agency of a district or a city. If the parents of a minor  are separated, consent of one of the parents or of the legally acceptable representative and  of the district or city children’s rights protection agency must be obtained” (Law on Ethics of Biomedical research, article 7) Case 2: Anonymous questionnaire on sexual abuse of the children is conducted in Lithuanian schools. Doesn’t the requirement of written consent infringe the anonymity of research subject ? How can the requirement of written consent and consent of both parents be fulfilled?

Waiver of the informed consent requirement 1 Case 3: A retrospective study, based on analysis of 200 case-records of patients treated with radiotherapy in Oncology Institute in 1999-2003. The principal investigator approached the EC explicitly asking to waive the requirement to obtain IC, arguing that it was impossible and too expensive to get IC, because the patients whose documents were going to be analysed lived in different (and distant) parts of the country and were not visiting the Institute any more, some of them were dead.

Waiver of the informed consent requirement 2 Obtaining informed consent is obligatory according to the Law of Ethics of Biomedical Research, however, Ethics Committee has a right to waive this requirement in case of research on medical documents, biological material, etc. What should the criteria be to decide whether the situation can be regarded as “impossible or involving unnecessary difficulties owing to a large number of data recipients, the outdated character of the data and excessively large expenses” (The Law on Legal Protection of Personal Data)? Should the prior checking be carried out by EC of Data Protection Authority?

Insurance 1 “The sponsor and the principal investigator of biomedical research shall be liable for damage resulting from injury  to the health of a research subject or his death as well as for research-related non-pecuniary (moral) damage, if they fail to prove that damage has resulted from causes unrelated to biomedical research or from deliberate acts of the research subject”. (Article No. 11) This requirement shall be applicable only where biomedical research is carried out on human subjects.

Insurance 2 Isn’t it a redundant requirement for “minimal risk studies” e.g.: questionnaires, research which involves only routine diagnostic / treatment procedures, research on ‘residual’ biological material?

Law on Ethics of Biomedical Research provides stricter requirements than international regulations Everyday practice rises a lot of questions on legal interpretation and practical implementation of the provisions of the law Need for broader discussion We would very much appreciate your comments ...