currentethicsregulat ionsinrussia

Current Ethical Regulation of Biomedical Research in Russian Federation: 

Current Ethical Regulation of Biomedical Research in Russian Federation Prof. Igor Gorlinsky, SPbSU, Dean of Faculty of Biology and Soil Science Prof. Nadezhda Golik, SPbSU, Faculty of Philosophy Ivan Potekhin, BS, MA, SPbSU, Faculty of Biology and Soil Sciences Elizaveta Veikher, BS, MA, SPbSU, Faculty of Biology and Soil Sciences BSRUN Workshop on Research Ethics Turku 12-13 November 2004. © Saint-Petersburg State University

Main topics: 

Main topics Legislative basis of human rights protection in research practice in Russian Federation Ethical regulation of research involving human subjects in Russia Ethical Committees in Russia © Saint-Petersburg State University

Slide3: 

Constitution of Russian Federation Rights and freedoms of the human and citizen can be restricted by federal law only to the extent necessary for the protection of constitutional order, morals, health, rights and interests of other parties, for the defense of the country and safety of the State. (Chapter 2, article 55, section 3) Nobody can become a part of medical, scientific or other experiment without their voluntary consent. (Chapter 2, article 21, section 2) © Saint-Petersburg State University

Russian Federation Laws: 

Russian Federation Laws “Foundations of Russian Federation legislation on protection of people’s health", revised in 2000 Federal Law “On medical remedies", 1998 Federal Law “On prevention of HIV-infection spread in Russian Federation", revised in 1996 Federal Law “On immunoprophylactics of communicable diseases", 1998 Federal Law “On psychiatric help and warrantees of human rights", revised in 1998 Federal Law “On human organ and (or) tissue transplantation ", revised in 2000 Federal Law “On donation of blood and blood components", revised in 2001 Federal Law “On temporal ban on human cloning", revised in 2002 © Saint-Petersburg State University

“Foundations of Russian Federation legislation on protection of people’s health", 2000: 

“Foundations of Russian Federation legislation on protection of people’s health", 2000 Article 43. Usage of new methods of prophylactics, diagnostics, therapies, new drugs, immunobiological and disinfection remedies, and conduct of biomedical research. Every biomedical research study involving human subjects can be carried out only after obtaining a written consent of the participant. Person cannot be forced to participate in a biomedical research. In the consent process participant must be provided with the information about the goals, methods, side effects, possible risks, duration and expected results of the study. Participant can withdraw at any time. Conclusion: The principle of voluntary informed consent is legally established © Saint-Petersburg State University

Federal Law “On medical remedies", 1998: 

Federal Law “On medical remedies", 1998 Chapter IX. Development, pre-clinical, and clinical testing of medical remedies Article 40. Rights of the patients, participating in clinical trials. 1. Participation of patients in clinical trials is voluntary. 2. Patient gives written consent to participate in a clinical trial. 3. Patient must be informed: 1) About the medication under study and the nature of research conducted; 2) About expected effectiveness, safety of the medicine, extent of the risk for the patient; 3) What patient should do in case of unexpected effects of the medication on his/her health; 4. Patient have a right to withdraw at any stage of the trial. Conclusion: the list of provided information is formulated (is it sufficient?) © Saint-Petersburg State University

Protection of persons, unable to consent : 

Protection of persons, unable to consent Federal Law “On medical remedies", 1998 Article 40. Rights of the patients, participating in clinical trials 6. In clinical trials involving minors, written consent of the parents is required. © Saint-Petersburg State University

Protection of persons, unable to consent(2): 

Protection of persons, unable to consent(2) Federal Law “On psychiatric help and warrantees of human rights", revised in 1998, Art.5. Rights of persons with mental disorders. 2) All persons with mental disorders while been provided with psychiatric help have a right for: prior consent to and withdrawal at any time from being subject for testing of medical remedies and methods, scientific research or teaching process, from being photographed and video-recorded. Federal Law “On medical remedies", 1998 Article 40. Rights of the patients, participating in clinical trials 8. Clinical studies of medicines, designed for the treatment of mental disorders, can involve mentally ill people and incompetent … with a written consent of a legal representative. © Saint-Petersburg State University

Groups, which are excluded by law from any biomedical research in Russian Federation: 

Groups, which are excluded by law from any biomedical research in Russian Federation Federal Law “On medical remedies", 1998, Chapter IX, Art.40 It is prohibited to conduct clinical trials involving: 1) children who have no parents; 2) pregnant women, except the studies of medicines for pregnant women with the condition that there is no risk of harm for the pregnant woman and the fetus; 3) military personnel; 4) prisoners. “Foundations of Russian Federation legislation on protection of people’s health", 2000, Art.29 Prohibit testing of new methods of prophylactics, diagnostics, therapies, new drugs, and conduct of biomedical research on prisoners and arrested. (Why? - historical perspective) Limitation of the possibilities of researchers in the search for new methods, oriented towards the groups, mentioned above. © Saint-Petersburg State University

European Convention on Human Rights and Biomedicine, 1997: 

European Convention on Human Rights and Biomedicine, 1997 In comparison with Russian federal laws Convention gives the opportunity to participate in any kind of biomedical research to a broader variety of subject categories, at the same time providing more detailed guidance for the conduct of such research. Research involving human subjects unable to consent can be conducted only if the following conditions are met (Art.17): Research of comparable effectiveness cannot be carried out on individuals capable of giving consent; Specific written authorization of his or her representative or an authority or a person or body provided for by law is given; In exceptional cases it is allowed to conduct the research not aimed on direct improvement of the participant’s health, but potentially beneficial for the participant as well as for other people in the same condition; Expected results of the research have the potential to produce real and direct benefit to his or her health; Participation in the study is associated with minimal risk or discomfort for the participant; Person concerned does not object. © Saint-Petersburg State University

European Convention on Human Rights and Biomedicine, 1997(2): 

European Convention on Human Rights and Biomedicine, 1997(2) Has a special chapter 5 “Scientific Research”, containing main principles for all types of biomedical research involving human subjects (including requirements for the balance of risks/benefits, independent review, validity of the research, including ethical acceptability, etc.) Conclusion: it is expedient for Russia as a member-State of the Council of Europe to sign and ratify European Convention on Human Rights and Biomedicine; it would force the legislature to make appropriate amendments to current laws. One of the important steps towards the development of national legislation is to pass the general law on legal foundations of bioethics © Saint-Petersburg State University

Ethical regulation of human subjects research in Russia: 

Ethical regulation of human subjects research in Russia Professional standard “Conduct of Good Clinical Trials in Russian Federation» (ОСТ 42-511-99) - 1998; “Rules of Clinical Practice in Russian Federation” - 2003 What do they regulate? Similarities and differences? Accordance to international regulations? © Saint-Petersburg State University

What do they regulate?: 

What do they regulate? Main reason for the development of these regulations – concern of the Ministry of Health about the situation with clinical trials in new drugs development. Rules of Clinical Practice (2003) actually work only for the new drugs development clinical trials. Professional Standard (1998) besides drug clinical trials may also be applied to “other clinical studies, which cannot exclude undesirable effects on human health and safety”. © Saint-Petersburg State University

Similarities and differences?: 

Similarities and differences? Both documents are prepared by Ministry of Health of Russian Federation and enforced by the order of the Minister Professional Standard practically is a translation into Russian of the Good Clinical Practice (GCP) guidelines, developed by ICH in 1996. Professional Standard is a requirement for new drugs clinical trials, but also it’s principles may be applied to other clinical studies. Rules of Clinical Practice as a matter of fact are aimed only at the detailed regulation of new drugs development clinical trials. © Saint-Petersburg State University

Similarities and differences?(2): 

Similarities and differences?(2) Rules of Clinical Practice in comparison with the Professional Standard are much less detailed about information to be provided to the participants during the informed consent process. Rules of Clinical Practice (2003), in comparison with the Professional Standard (1998), are designed rather for legal, governmentally regulated decision-making than for ethical decision-making in planning and conducting clinical research in Russian Federation. © Saint-Petersburg State University

Similarities and differences?(3): 

Similarities and differences?(3) Professional Standard (1998), as well as Rules of Clinical Practice in RF (2003), emphasize that special attention should be given to the research involving vulnerable populations or people, who’s ability to give voluntary consent is questionable for various reasons. Professional Standard (1998) in accordance with the original text of GCP Guidelines, developed by ICH, lists vulnerable groups without prohibiting research involving any of these groups. Rules of Clinical Practice (2003), on the contrary, do not set any groups as vulnerable, but in the accordance with Federal Law “On medical remedies" (1998) prohibit the research on children who have no parents, military personnel and prisoners. Also they prohibit research involving pregnant women and minors if the comparable research can be carried out in less vulnerable group of people. © Saint-Petersburg State University

Ethical Principles.  Accordance to international regulations?: 

Ethical Principles. Accordance to international regulations? In the Professional Standard (1998) it is pointed that ethical principles underlying the guidelines origin from the Declaration of Helsinki. Rules of Clinical Practice (2003) not only have no list of basic ethical principles, but do not mention Declaration of Helsinki at all. Thus, Rules do not determine ethical principles, according to which biomedical research in RF should be conducted. What regulations to follow? Answer: Conducting clinical trials of new drugs in Russia, investigators are obliged to follow the Rules of Clinical Practice, which are the part of the approving system, working in accordance to the Law on medical remedies. In case of other clinical studies investigators can use Professional Standard. © Saint-Petersburg State University

General conclusion: 

General conclusion In Russia there are no special federal regulations (recommendations) for non-clinical research involving human subjects. For non-clinical studies involving human subjects possible way to solve the problem is to use international recommendations (Declaration of Helsinki, CIOMS Guidelines) © Saint-Petersburg State University

Legal basis for the establishment and work of ethical committees in RF: 

“Foundations of Russian Federation legislation on protection of people’s health“ (2000), Part III, Art. 16. Committees (Commissions) on Ethics in the field of health care “At the governmental agencies, state and municipal health care institutions, enterprises and organizations ethical committees (commissions) can be set up”. Purposes: Protection of human rights and rights of specific groups Participation in the development of the norms of medical ethics and in the decision-making regarding the violations of those norms Development of the recommendations on most important fields of practical and scientific activities (?!) Solving other problems in the field of health care. CONCLUSION: there are no preconditions for the creation of well-structured multiple-level system of ethical committees. Legal basis for the establishment and work of ethical committees in RF © Saint-Petersburg State University

Legal basis for the establishment and work of ethical committees in RF (2): 

Legal basis for the establishment and work of ethical committees in RF (2) “Foundations of Russian Federation legislation on protection of people’s health“ (2000), Part III, Art. 16. Members of the Committees on Ethics in the field of health care are persons, representing interests of public (community, society), including specialists in medical ethics, lawyers, scientists, religious leaders, representatives of professional medical associations, professional unions and other public organizations. Regulation (Statute) of the procedure of establishment and work of ethical committees (commissions) on ethics in the field of health care have to be approved by Russian Federation State Legislature (Duma). Comment: this Regulation is not approved yet (since 2000) © Saint-Petersburg State University

Federal Law "On medical remedies" 1998: 

Federal Law "On medical remedies" 1998 State system of control of quality, effectiveness, and safety of medical remedies includes ethical committees, working at the health care organizations in accordance to the Regulation (Statute) on Ethical Committees, which should be approved by the federal executive body in the field of health care (Chapt. III, art. 8, part 3, point 4) Clinical trials Positive decision of the Ethical Committee at the Federal agency for the control of the quality of medical remedies is required for conducting clinical trial testing specific drug or other medical remedy. (approving function) (Chapt. IX, art. 37, part 2, point 2) Program of clinical testing of a medical remedy should be designed with the participation of an institutional ethical committee of the health care organization conducting the trial (advisory function). (Chapt. IX, art. 39, art. 1) Today the Regulation on Federal Ethical Committee is approved and a project of Regulation on Local Committees is under discussion. © Saint-Petersburg State University

Status of Ethical Committees in Russia according to professional regulations: 

Status of Ethical Committees in Russia according to professional regulations Professional Standard (1998) defines ethical committee as “An independent committee, working at the level of a medical institution, region or country, consisting of medical and other specialists. It consider questions of rights protection, safety and health care of the participants, approve research protocols, evaluate the researchers qualification, and correctness of informed consent documents”. Rules of Clinical Practice (2003) do not provide a definition of ethical committee, and in chapter VI of the Rules (“Ethical Committee”) nothing is said about it’s independence. © Saint-Petersburg State University

Ethical Committees in RF: 

Ethical Committees in RF Ethical Committee at the Federal agency for the control of the quality of medical remedies (Ministry of Health), 2000 Committee on Bioethics at the Ministry of Health Ethical Committee at Russian Academy of Medical Sciences Russian National Committee on Bioethics at Russian Academy of Science, 1992 National ethical committee of the Russian Medical Association, 1997 Independent interdisciplinary committee for ethical review of clinical research (established by Russian Academy of Medical Sciences, “RosPharmInfo”, League for assistance to clinical trials and protection of pharmaceutical market participants, “Society of pharmacological Research”, “Universimed” – pharmaceutically oriented) © Saint-Petersburg State University

List of Russian IRB’s, registered at the Office for Human Research Protections: 

List of Russian IRB’s, registered at the Office for Human Research Protections Institutional Review Board City Biomedical Ctr IRB #1 ST. PETERSBURG Chapaevsk Med Assoc IRB #1 CHAPAEVSK City Hosp N2 IRB #1 ST. PETERSBURG City Municipal Hosp #30 IRB #1 ST. PETERSBURG Ethics Committee Yekaterinburg Regional Hosp No. 1 IRB #1 YEKATERINBURG Inst Sociology Russian Academy Sci IRB #1 MOSCOW Institution Rheumatology RAMS IRB #1 MOSCOW Moscow Municipal Psychological Pedagogical Inst IRB #1 MOSCOW Moscow State U IRB#1 MOSCOW Natl Ctr for Hematology IRB #1 MOSCOW Noncommercial Fdn - Ctr for Economic and Financial Rsch IRB # 1 MOSCOW Pavlov Ste Med U IRB #1 ST. PETERSBURG © Saint-Petersburg State University

List of Russian IRB’s, registered at the Office for Human Research Protections (2): 

List of Russian IRB’s, registered at the Office for Human Research Protections (2) Institutional Review Board City Republican Hosp Infectious Diseases IRB # 1 ST. PETERSBURG Rsch Inst Phthisiopulmonology IRB #1 MOSCOW So Ural Biophysics Inst IRB # 1 OZYORSK St.Petersburg Ste U IRB # 1 - Behavioral ST.PETERSBURG State Rsch Ctr Virology and Biotechnology "Vector" IRB#1 KOLTSOVO Students for Peace #153 IRB #1 ST. PETERSBURG Students for Peace, Sch # 212 IRB #1 ST. PETERSBURG Students for Peace, Sch # 205 IRB #1 ST. PETERSBURG Students for Peace, Sch # 325 IRB #1 ST. PETERSBURG Students for Peace, Sch # 359 IRB #1 ST. PETERSBURG Tyumen Cardiology Ctr IRB #1 TYUMEN Urals Rsch Ctr for Radiation Med IRB #1 CHELYABINSK © Saint-Petersburg State University

Slide26: 

Conclusions: At the current moment Russian Federation does not have any clear regulation of the system of ethical committees, which are supposed to review all research involving human subjects. In the area of clinical trials of medical remedies, where some regulation is present, system of local ethical committees is not developed and still does not have any legal basis for this. The Federal Ethical Committee is an authorization body of the state system of quality control. In Russia there is a present tendency to establish local ethical committees at various institutions and organizations in order to provide ethical review of research involving human subjects. These committees base there work on the international guidelines, but their status is not yet defined by law. © Saint-Petersburg State University

Thank you for your attention!: 

Thank you for your attention!