Biomedical research involving elderly subjects: ethical aspects

Abstract

Due to the aging of the population and growing proportion of the elderly, medicine requires a more active and purposeful approach not only to study theoretical aspects of gerontology, but also to search for new drugs designed specifically for this category of the population. Clinical trials in older people are more in demand than ever. However, researchers must ensure that they conduct their studies ethically. Key ethical issues include prevention of discrimination and violations of the autonomy of older people, as well as special requirements for informing and obtaining voluntary informed consent. When preparing voluntary informed consent for older people, especially for those with cognitive decline, special attention should be paid not only to the information itself, but also to the form of its presentation. The documents should be concise, clear and contain all the key information. In addition, the use of modern multimedia technologies can help the subjects make an informed decision about their participation in the study. For patients with cognitive impairment, it is important to adhere to the principle that the higher the risk for the study participants, the more the patient’s cognitive functions and decision-making ability should be preserved. Excluding patients from studies with potential benefit due to age or cognitive impairment is considered unethical and discriminatory. This is taken as an unfair restriction of their access to the achievements of scientific and technological progress in the field of medicine.