Table 4

Examples of rights and justice considerations when evaluating regulatory protections for clinical research

Rights considerationsApplication in the context of clinical research
Right to have one’s interests and well-being prevail over the sole interest of society or scienceRight to have the risks and burdens of research participation minimised and not to be deprived of medically necessary procedures
Right not to be exposed to risk and burdens that are disproportionate to the potential benefits of the research; if the research does not have the potential to benefit one’s health, it must entail no more than acceptable risk and acceptable burden
Right to be enrolled in research only when it is carried out under the supervision of a clinical professional who possesses the necessary qualifications and experience
For persons not able to provide consent: right to be enrolled in research only when it has the potential to produce real and direct health benefits, or when it entails minimal risk or burden, and the research has the aim of benefiting other persons in the same age or disease category
Right to be free from non-consensual experimentationRight to be enrolled in research only with one’s explicit free and informed consent to research
Right to withdraw from research freely at any time and for any reason without disadvantage or prejudice
For persons not able to provide consent: right to be enrolled in research only with the authorisation of a legal representative, to have one’s previously expressed wishes relating to research taken into account, and to be involved to the greatest extent possible in the decision-making process; research should be undertaken only if the person concerned does not object
Right to non-discrimination and non-stigmatisationRight to have one’s integrity, other rights and fundamental freedoms with regard to research respected without discrimination or stigmatisation on any grounds (eg, without distinction of race, religion, political belief, sexual orientation, economic or social condition)
Right to have any personal information collected treated confidentiallyRight to have any personal information collected during research considered as confidential and treated according to the rules relating to the protection of privacy
Right to know about any information collectedRight to know about any information collected about one’s health
Right to access other personal information collected
Right to have one’s wish not to be informed respected
Right to receive research resultsRight to receive the conclusions of the research on request
Right to receive information relevant to one’s current or future health or quality of life, within a framework of healthcare or counselling
Right to receive compensation for harmRight to fair compensation for harm suffered as a result of participation in research
Right to independent ethics reviewRight to be enrolled in research only after independent examination by an ethics committee has confirmed that the dignity, rights, safety and well-being of research participants are protected
Right to enjoy the benefits of scientific progressRight to access the benefits of science and its applications, including scientific knowledge
Right to have opportunities to contribute to the scientific enterprise and the freedom indispensable for scientific research (eg, freedom from political and other interference)
Right to participate in science-related decision-making
Justice considerationsApplication in the context of clinical research
Equal moral standingThe dignity and rights of all research participants are to be respected so that all participants are treated justly and fairly
Priority to the worst off*Special weight should be given to enhancing research benefits, and reducing research costs, to those who are least advantaged
  • The examples are derived from key international documents regarding human rights and health50–55 and relevant literature on health justice.49 Note that the referenced documents do not include a right to post-trial access, although this could potentially be derived from other rights listed in the table (eg, the right to receive research results and the right to enjoy the benefits of scientific progress).

  • *A ‘moderate prioritarian’ view—which gives substantial, but not absolute priority to the worst off—is widely endorsed because it can be justified drawing on egalitarian, prioritarian, sufficientarian and utilitarian theories of distributive justice.49