Research Involving Human Beings

Basic principles

The authority of the HREC (Human Research Ethics Committee) is subsidiary to that of the cantonal ethics committees on human research (“Commission cantonale d’éthique de la recherche sur l’être humain”).

The Federal Act on Research involving Human Beings (Human Research Act, HRA) entered into force in early 2014 with four Ordinances: Ordinance on Clinical Trials in Human Research (Clinical Trials Ordinance, ClinO), Ordinance on Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO), Ordinance on Organisational Aspects of the Human Research Act (HRA Organisation Ordinance, OrgO-HRA) and the Ordonnance sur les dispositifs médicaux (ODim). Legislation on research involving humans intends to protect every human being and ensure respectful treatment of personal data related to health.

The Human Research Act governs research involving:

• living or deceased persons,
• in vivo human embryos and foetuses,
• human biological material (i.e. bodily substances derived from living persons),
• collection of health-related personal data (but also research concerning the structure and function of the human body and studies on human diseases in the field of the humanities and social science).

Under the framework of the HRA, when such research is conducted in order to gain a better understanding of human diseases or the structure and function of the human body, it must be authorised in advance by the relevant cantonal ethics committee on human research (“Commission cantonale d’éthique de la recherche sur l’être humain”). Research conducted on anonymised biological material or data collected anonymously or irreversibly anonymised with the donor’s general consent is not subject to such authorisation.

Outside of the scope of the HRA, the EPFL Human Research Ethics Committee (HREC) has the authority to approve or refuse any project for non-invasive human research or research involving in particular the collection of personal data, on the basis of conformity to ethical standards. The HREC reserves the right, in addition to stating its opinion regarding the ethical conformity of a project, to comment on ethics in relation to the project in a broader sense, beyond the project’s conformity.

Trial subjects must be informed and state their consent for the use of the data or material. For the processing of personal data, the laws applicable to data protection also apply and must be respected (namely the Federal Act on Data Protection, and even the General Data Protection Regulation (GDPR), if applicable). For more information, see the chapter on “Data Protection”. Furthermore, the directives applicable for the publication of results and the insurances necessary may apply. For all questions on insurance relating to clinical trials/human research projects, contact the Internal Control and Risk Management Department (see “Contact” section).

Advice for day-to-day business 

Complete the available online trainings related to research involving human subjects, including: the TRREE training (open access and available in multiple languages), the CITI trainings accessible to EPFL staff (see the fastguide), and the EPFL trainings on data protection and scientific integrity (available via Les Essentiels ‒ Internal Trainings ‒ EPFL).

Look up the booklet “Research with human subjects – A manual for “practitioners” which answers many questions regarding the legal or ethical compliance of a proposed project.

Allow enough time in your research plan to obtain approval from a cantonal ethics committee or the EPFL Human Research Ethics Committee (HREC): the processing time for an application for approval is at least three to four weeks.

Make sure that any biological material or personal data purchased from institutional or commercial suppliers have been collected in compliance with statutory regulations under Swiss law and EPFL directives in force.

For suppliers abroad, contractually ensure that local laws comply with Swiss law and EPFL directives.

Responsibilities

Heads of Unit are responsible for compliance with laws and internal regulations governing ethics and research involving human beings.

Legal basis

• “Federal Act on Research involving Human Beings (Human Research Act, HRA)”
• “Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA)”
• “Ordinance on Human Research with the Exception of Clinical Trials (Human Research Ordinance, HRO)”
• “Ordinance on Clinical Trials in with Medical Devices (ClinO-MD)”
• “Ordinance on Organisational Aspects of the Human Research Act (HRA Organisation Ordinance, OrgO-HRA)”
• “Medical Devices Ordinance (MedDO)”
• LEX 3.3.2 “Directive concerning research integrity and good scientific practice at EPFL”
• “Loi fédérale sur la protection des données”
• “Ordinance to the Federal Act on Data Protection (DPO)”
• “General Data Protection Regulation (GDPR)”

Further informations 

• “Research with human subjects – A manual for practitioners (2nd edition, revised in 2015)”
• Commission cantonale d’éthique de la recherche sur l’être humain CER-VD (Vaud, Fribourg, Neuchâtel, Valais)
• Commission cantonale d’éthique de la recherche CCER (Geneva)
• EPFL Human Research Ethics Committee (HREC)