Research involving human subjects is a necessary undertaking in both biomedical and social settings. The knowledge generated by research, other than its value for its own sake, is primarily oriented to improving public health and providing scientific evidence for social and political decision making. However, in clinical research, and even in any research involving human subjects, participants may be exposed to some risk of harms. Those harms range from confidentiality breaches related to personal health or other sensitive data to adverse effects related to drugs or devices tested in clinical trials. As for clinical research, while the main purpose of clinical practice is health care for the benefit of patients, the main purpose of clinical research is to generate knowledge, not the benefit of the particular patient involved. Ethics of clinical research, and for that matter ethics of human research, raises the question of when it is acceptable to expose some individuals to risks of harm for the potential benefit of others (1).

It is essential that research involving human subjects should respect participants and not treat them as mere means to collect information to benefit others in the future (1), as persons subject to exploitation. Several codes and guidelines, like the Nuremberg Code (2), the Declaration of Helsinki (3) and the CIOMS (Council for International Organizations of Medical Sciences) guidelines (4), have set the ethical standards in health-related human research over the last 70 years to make the protection of human subjects and their human rights compatible with the development of research. Moreover, governments have enacted laws to regulate clinical research, especially that on clinical trials of pharmaceutical drugs and devices. The requirements of both an informed consent by participants and the previous review by an independent research ethics committee of all protocols constitute safeguards to guarantee research ethical standards.

Currently, research ethics faces new challenges. Big data has opened new avenues for research but also has created new threats and risks for data privacy. Electronic medical records and other records containing health data might be extremely useful for research and quality control, as is the case of learning healthcare systems. However, the more information is gathered in those databases the greater the risk for violations of confidentiality. For instance, processing of data concerning health might fall into the hands of third parties, such as employers or insurance or banking companies, or personal data concerning health may be sold to third parties for profiling. As a result, data subjects can be discriminated against.

Are the classical safeguards enough guarantees to address these threats for human rights in research? Informed consent may not be feasible when a research project intends to study many thousands of records with data concerning health whose original purpose was not research but health care. The alternative could be not to carry out the study at all if the consent was not given expressly for a research purpose. Nevertheless, other options less detrimental for research can also be considered. The CIOMS guidelines establish three joint conditions for research ethics committees to waive consent in special cases: if the research would not be viable without the waiver, has important social value, and poses no more than minimal risks to participants (4). There remain some controversial issues related to research ethics committees (their certification, composition, member training, decision-making methods, patient and layperson participation…) and participants (their right to opt-out in research they have not the chance to give their consent or their right to know what kind of research is being done with their data). A new climate of transparency and openness and a greater participant or patient involvement in research design is coming. The newly applied European General Data Protection Regulation sets out a legal framework that makes scientific research as we have known it compatible with the protection of human rights. But it still leaves many questions open, questions that research patients and participants, researchers and society at large will have to answer in the following years.