Voluntary informed consent
Any biomedical research involving human subjects must be designed with respect to the basic ethical principles stated in:
- the Belmont Report, as well as in international legal acts;
- the World Medical Association (WMA) Helsinki Declaration on Ethical Principles for Medical Research Involving Human Subjects (2013);
- the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects (2016), as well as national laws consistent with these principles;
- a model law adopted by the Inter-Parliamentary Assembly of the Commonwealth of Independent States.
Vulnerable populations:
biomedical research involving women of reproductive age
Voluntary informed consent must be obtained from women of childbearing potential. Women who are capable of childbearing should be informed in advance of the potential risks to the fetus if they become pregnant while participating in the research. The permission of another person shall never supersede the requirement for individual informed consent of the pregnant woman or lactating mother.
Vulnerable populations:
Clinical Research Involving Minors
In the Decision of the Council of the Eurasian Economic Commission of November 3, 2016, No. 79, “On Approval of the Rules of Good Clinical Practice of the Eurasian Economic Union”, minors are also included in the group of vulnerable research subjects and may participate in research only with the consent of their legal representatives.
Vulnerable populations:
clinical research involving the elderly
Decision No. 79 of November 3, 2016, of the Council of the Eurasian Economic Commission “On Approval of the Rules of Good Clinical Practice of the Eurasian Economic Union” mentions “elderly persons” in the context of assigning them to a special group of patients―potentially vulnerable―to whom special attention should be paid when studying the safety of a drug. In the context of the COVID-19 pandemic, elderly patients may also be referred to vulnerable categories as they are more susceptible to the disease and the severe course of coronavirus infection.
For elderly patients, including those with cognitive impairment, the research protocol may provide for the participation of a “caregiver.” The person acting as a caregiver must sign and date a specific, separate informed consent form before the elderly patient may be included in the study.
Vulnerable populations:
research involving human subjects with mental, cognitive, and sensory disorders
When conducting research involving people with sensory disorders, informed consent must be obtained. However, if the patient cannot read the text of the informed consent form himself, the researcher must read it in full in the presence of a disinterested witness, who shall also sign a special form of informed consent. If patients with severe forms of mental disorders―who have been declared incompetent by a court―are included in the study, the consent of their legal representative (a guardian) shall be required.
Vulnerable populations:
research involving patients who are in an emergency, are terminally ill, or unable to give informed consent
Ethical standards may permit an exemption from obtaining a patient’s informed consent only if the research entails minimal risk, or if the patient’s life is in danger and no alternative proven or generally recognized treatment is available that could be equally or more likely to save the subject’s life. In such cases, informed consent must be obtained from the legal representative.
Vulnerable populations:
research involving minority ethnic groups
The following principles of biomedical ethics shall be implemented in research involving members of minority ethnic groups - voluntary informed consent.
Biomedical research involving obtaining information on the genetic data of a research participant
When conducting any biomedical research involving obtaining information on the genetic data of a research participant, it shall be necessary to obtain separate informed consent.
Research involving gene and cell therapy
For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, the physicians shall seek informed consent for their collection, storage, and/or reuse. The patients shall be provided with all the relevant research information and their informed consent must be obtained.
Research involving stem cells, germ cells, or human embryos
The Authors must confirm that informed consent was obtained from all the donors.
Research involving medical devices
According to the Guidelines for Clinical Trials of Medical Devices, the rights, safety, and health of clinical research subjects should be protected in accordance with the ethical principles established in the Declaration of Helsinki. Voluntary informed consent must be obtained from study participants.