Voluntary informed consent



Any biomedical research involving human subjects must be designed with respect to the basic ethical principles stated in: 

Voluntary informed consent must be obtained from all participants in clinical trials.

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. 


Learn on news, product access, webinars and events by "Eco-Vector"

logo
©

Eco-Vector, 1998-2024