Application of informed consent waiver for the involvement of persons with limited capacity in clinical research

Background. According to data, in psychiatric settings, the average proportion of patients with incapacity is 45% (Lepping et al. l, 2015). The number of patients who are limited in capacity taking decisions in respect to research should be likewise. Legal and ethical norms provide that if a potential research subject has limited capacity legally authorised representative can give informed consent on behalf of a person. However, a person may not have a representative, or there is bias when the representative makes the decision. There is a need to perform clinical trials that include all relevant patients with limited capacity. For example, trials for evaluation of the mental capacity of psychiatric patients or studying coercion in psychiatry.

Aim. The study aims to reveal ethical and legal approaches suitable for the involvement of patients with limited mental capacity in clinical trials without explicit consent.

Methods. The national and international legal and ethical regulations have been studied. The studies addressing legal and ethical issues in protecting patients with limited capacity in research have been analysed.  

Results. The research results provide that a waiver to the informed consent rule allowing the involvement of subjects who cannot consent in research should be sought. The research protocol proposing the application of a waiver must substantiate that the study: 1) would not be feasible without the particular group; 2) cannot instead be performed with persons capable of providing informed consent; 3) availability of representatives is limited, or there is bias when representatives are making decisions; 4) has significant social value and is intended to promote the health of the group represented by the potential subject; 5) poses minimal risk and burden to participants; 6) cannot be delayed; 7) dissent of a person is respected.  The proposed waiver must be evaluated by a research ethics committee who should have the authority to grant the exemption.

Conclusion. If ethically and legally provided conditions for a waiver of informed consent are met in a research proposal, the research ethics committee can grant exemption from the ordinary consent rule. Article 11 of the Patients’ Rights Law should be amended, providing that the ethics committee can grant the exemption of the informed consent rule.

Acknowledgements. This paper has been prepared within the research project “Towards a human rights approach for mental health patients with a limited capacity: A legal, ethical and clinical perspective”, No. lzp-2020/1-0397.