Types of research using human participants and applicable legislation
Types of research using human participants and applicable legislation
The way ethics approval procedures for research involving human participants are organised is highly dependent on the applicable legislation in the country where the research will be performed in combination with potential additional obligations sets by the host institution. Without going into detail, research with human participants can be broadly divided into research projects on medical-scientific and healthcare-related topics on the one hand, and non-medical research on the other hand.
Within Belgium there are a several legislations with regards to research using human participants to adhere to, both at the level of the European Union as local federal legislation.
Examples of EU legislation are:
- The Clinical Trial Regulation (CTR), regulation (EU) 536/2014
- The Medical Device Regulation (MDR), regulation (EU) 2017/745
Examples of Belgian legislation are:
- The human experiments act of 7 May 2004 on experiments on human beings.
- The human body material act on the acquisition and use of human bodily material for the purpose of medical application to man or scientific research)
- The implementation of the MDR and IVDR regulations
Some important definitions:
Experiment (as defined by the Human Experiments Act): any test, study or research carried out on a human person, for the development of the knowledge specific to the exercise of the health care professions.
Clinical study (as defined by the article 2 of the CTR): any investigation in relation to humans intended to:
- discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products.
- identify any adverse reactions to one or more medicinal products; or
- study the absorption, distribution, metabolism and excretion of one or more medicinal products.
- with the objective of ascertaining the safety and/or efficacy of those medicinal products.
Clinical trial (as defined by the article 2 of the CTR): a clinical study which fulfils any of the following conditions:
- the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned.
- the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or
- diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.
Medical device (as defined by the article 2 of the MDR): any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
In order to perform medical-scientific and healthcare-related research, it is also imperative that researchers become familiar with the universal principles of the Declaration of Helsinki and the Oviedo Bioethics Convention. Moreover, researchers are required to follow the principles of Good Clinical Practice (GCP).