Ключевые слова
Аннотация
The review article examines the main ethical and legal aspects of biomedical research. It covers historical background and international regulations, principles of research ethics involving humans and animals, requirements for informed consent, protection of vulnerable groups, regulation of clinical trials and biobanking, as well as issues of confidentiality, conflict of interest, and researchers' responsibility. The article provides recommendations for compliance with ethical standards and legal regulation.
Библиографические ссылки
Beauchamp TL, Childress JF Principles of Biomedical Ethics Oxford University Press
Declaration of Helsinki World Medical Association
Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Emanuel EJ, Wendler D, Grady C What makes clinical research ethical JAMA
ICH Harmonised Guideline Good Clinical Practice (GCP)
Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Health-related Research Involving Humans
GDPR Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data
Russell WMS, Burch RL The Principles of Humane Experimental Technique (3R principles)
Kaye J et al Dynamic consent A patient interface for twenty-first century research
National and regional legislation on clinical trials and animal research (examples may include US FDA regulations, EU Clinical Trials Regulation, national laws)