Research ethics
Authors: Kerasidou Angeliki , Binik Ariella 
Published: March 2023

Health research contributes to the development of life-saving vaccines, innovative medical devices, new drugs, improved options for reproductive health, and to the better understanding and treatment of a wide range of diseases and disorders. Yet, pursuing these advancements often requires the participation of human subjects in studies, which involve interventions and procedures (e.g. randomization, blinding, fixed treatment schedules) that may not be in their direct interests and may involve risks to their wellbeing. This raises an ethical question for health research: when and why is it ethically justifiable to expose individuals to risks in the interests of advancing science and/or for the benefit of future populations? Research ethics in the context of health research with human subjects focuses on identifying and examining this question, and on reconciling our moral obligations to individuals with the goals and requirements of the scientific enterprise. The solution to this ethical tension and the ethical justification for research participation is perhaps best understood as depending on a broad range of considerations, including risks, benefits, informed consent, privacy, study design and location, and fair subject selection.

Philosophical work in research ethics takes a number of different approaches. These include the application of moral theories to ethical questions (e.g. developing utilitarian arguments to defend germline gene modification in humans), efforts to derive ethical guidance from the examination of case studies (e.g. using a case study to analyse the requirement for informed consent), and approaches that draw both from theory and practice to answer ethical questions (e.g. duty of confidentiality in genetic counselling). One combined approach appeals to broad ethical principles to inform the analysis of human subjects research. We draw on this approach and examine four prominent ethical principles frequently invoked in philosophical debates in research ethics – social value, respect for persons, beneficence, and justice.

The principle of social value requires that human subject research should have both scientific and social merit. Otherwise, exposing individual subjects to the risks and harms of research that is not able to produce useful knowledge nor provide direct benefit to research subjects will be unjustifiable. Furthermore, the requirement for social value promotes the responsible use of limited resources and helps reduce waste across the research enterprise.

The requirement for respect for persons necessitates that research subjects should not be treated merely as means to an end (e.g. knowledge production) but as autonomous agents with their own preferences and values. One way of ensuring that research subjects are treated with respect is to obtain their informed consent before enrolling them in a study. In order for consent to be considered valid, certain conditions need to apply: first the consenting person should have access to appropriate information that will allow her to make an informed choice; second, the decision to participate in research should be voluntary, and third, the person should have capacity to consent.

The principle of beneficence in the context of human subject research includes a negative obligation to avoid harm and a positive obligation to ensure that the risks of research stand in a reasonable relation to the knowledge to be gained. Finally, the principle of justice in human subject research focuses on the fair distribution of research harms and benefits. Initially, the principle of justice served to protect certain populations from the risks and harms of research, including children, pregnant women and marginalized populations. In recent decades, justice has also been conceptualized as an inclusionary principle, arguing for the inclusion of these populations previously excluded from research. The justification for this shift appeals to the right of these populations to the fair access of research benefits, including proven therapeutics.