Verification of need for ethical approval

Projects that must be submitted to a cantonal research ethics commission are those that fall within the scope of the Federal Law on Research Involving Human Subjects (LRH)  Loi fédérale relative à la recherche sur l’être humain (LRH) .

The scope of application of the HRA covers all research activities relating to human diseases and to the structure and function of the human body which are carried out with natural persons, legal persons or legal entities;es avec des personnes physiques, des personnes dédées, embryons et fœtus, avec du matériel biologique ou avec donnonnetacute;es personnelles liéesées à la santé.

Research into human diseases encompasses research into the causes, prevention, diagnosis, treatment and epidemiology of physical and mental health disorders. Research into the structure and function of the human body means basic research relating in particular to the anatomy, physiology and genetics of the human body, including research into interventions and effects on the human body unrelated to disease.

Caution: The scope of the law does not cover research on in vitro embryos or research on anonymised biological material or on anonymised or anonymously collected health-related data.

To help you decide whether or not your project should be submitted to a cantonal ethics commission, we recommend that you ask yourself the following questions:

• Does my project étude the disease, structure and/or functioning of the human body?
• Does my project involve the use or reuse of personal data relating to health, without it being completely anonymised?
• Does my project include the use of human biological material (embryos, foetuses, foetal tissue, human reproductive material or human stem cells from living or deceased persons)?

If the answer to any of these questions is yes, it is likely that your project will have to be submitted to a cantonal research ethics committee.

We also invite you to consult the Catalyst's Assistant for Human Research Projects  made available by the Coordinating Body for Human Research (Kofam).

The list of projects that have been approved by a cantonal ethics commission since 2016 is available on the Swissethics website .

The HRA gives the following definitions (Art. 3 ):

• Research : methodological research aimed at obtaining generalizable knowledge;
• Research into diseases : research into the causes, prevention, diagnosis, treatment and epidemiology of physical and mental health disorders;
• Research into the structure and function of the human body : fundamental research, particularly in the fields of anatomy, physiology and genetics of the human body as well as non-disease-oriented research relating to interventions on the human body;
• Biological material : substances in the body originating from living persons;
• Health-related personal data : information about a specified or determinable person that is related to his or her state of health or illness, including genetic data;

The University Research Ethics Committee is involved in research projects conducted at the University of Lausanne (UNIL) for which a certificate of institutional ethical compliance is required. It is called upon when the research project involves human subjects and does not fall within the scope of the Loi fédérale relative à la recherche sur l'être humain .

To help you decide whether or not your project should be submitted to the CER-UNIL, we recommend that you ask yourself the following questions:

• Do the institutions that are funding me, the publishing houses I plan to publish with and/or the land I plan to study require a certificate of ethical compliance?
• Does my research project involve the recruitment of participants directly (interviews, questionnaires, etc.) or indirectly (consultation of private databases or archives, observation of human behaviour)?
• Does my project involve working with populations that may be considered vulnerable?
• Does my project involve the use of personal and/or sensitive data (not health-related) collected via the internet, forums or any other virtual space where access is protected?
• Can my research project pose any risk (physical, psychological, family, professional, social, economic, political, symbolic, religious or other) to the individuals, groups or communities participating in the research?
• Do I see myself resorting to à deception (in English deception)?

If the answer to any of these questions is yes, you can contact the CER-UNIL. The process is, that said, completely voluntary and should only be carried out in cases of real need.

• Personal data: any information relating to à an identified or identifiable individual (définition tirée de la LPrD , Art. 4)
• Sensitive data: any personal data relating to religious, philosophical, political or trade union opinions or activities, as well as an ethnic origin; the intimate sphere of the person, in particular; his or her psychological, mental or physical state; to individual measures and assistance arising from social legislation; to criminal or administrative proceedings or sanctions (a conclusion drawn from the law);LPrD , Art. 4)