Respect for human subjects

Introduction

In any type of scientific research, an absolute prerequisite is to respect the participants and their rights. In medical research, this prerequisite is fundamental. It is also enshrined in the law in various ways; for example the rights that research subjects have to protect their physical and mental integrity and their privacy are laid down in law. Lastly, respect for subjects involved in research is essential if the trust and cooperation of potential participants is to be secured for the future.

Respect for the persons or participants cannot be fully captured in rules or procedures. This means that respect for participants is not only a matter of obeying rules and following verification procedures: it is also a state of mind. Researchers need to be open to and feel responsible for those interests of participants that could be affected by the research, and to ensure that the participants are aware of this.

Medical Research in Human Subjects
Medical Research in Human Subjects

Medical research can be broadly divided into three types according to the degree of the subjects’ involvement (Figure above):

  1. Research on human subjects, that is, research in which patients are subjected to certain interventions or investigations, for example administration of a trial drug (medicinal product) in order to compare it with a well-known registered drug, or taking samples of body material for analysis;
  2. Research on body material (blood, tissue, urine, spinal fluid, DNA, etc.) that is already available for one reason or another (e.g. material that was taken in the course of diagnosis or treatment);
  3. Research on other data that are already available from patients’ medical records or elsewhere, or that is collected directly from the subjects.