Regulatory framework
The interests of human subjects involved in medical research are protected by a number of (supplementary) laws, decrees, regulations, directives and codes of conduct. Applicable legislation depends on the specificities of the research (such as research using a medicinal product or medical device, trials with embryos, population screening, or research involving children or incapacitated subjects). A comprehensive list of all requirements for all types of research is presented on the website of the Central Committee on Research Involving Human Subjects (Centrale Commissie Mensgebonden Onderzoek; CCMO) or see the Appendix of the Netherlands Code of Conduct for Research Integrity, 2018, p28.
Currently, the main legislation governing clinical research conducted in the Netherlands is the Medical Research Involving Human Subjects Act (Wet Medisch-wetenschappelijk Onderzoek met mensen; WMO), which is based on the Nuremberg Code, the Declaration of Helsinki and the ICH Good Clinical Practice guideline (ICH-GCP). ‘Medical research that includes subjecting persons to interventions or imposing a particular course of conduct upon them’ is subject to the WMO. The main purpose of the WMO is to protect those who participate in medical scientific research while ensuring the integrity of research data.
- Research must be as safe as possible for human research subjects and impose the least possible burden on them.
- Proposed research that falls under the WMO must be reviewed and approved for its compliance with medical, scientific and ethical standards (see section 4.2).
- The research subject must be provided with written information about the research (see CCMO Template Subject Information).
- An independent expert must be available to inform the research subject.
- Written consent must be obtained by research subjects before they participate in the research.
- Liability and clinical trial insurance must be taken out or arranged to cover any damage endured by the research subject.
- The law imposes additional requirements on research involving subjects under the age of 16 years, women who are pregnant or breast-feeding, and people who are not capable of giving informed consent (e.g. those suffering from dementia). Those carrying out the study must ensure that the privacy of the research subject is adequately protected.
The ultimate responsibility for medical research involving human subjects carried out at Amsterdam UMC lies with the executive board, and entails the implementation of systems, mechanisms and procedures for quality assurance and control at all stages of the research process. Amsterdam UMC adheres to the guideline Guideline Quality assurance of research involving human subjects 2023, formulated by the Netherlands Federation of University Medical Centres (Nederlandse Federatie van Universitaire Medische Centra; NFU). This guideline defines the minimum requirements for WMO research in UMCs and focuses on the quality assurance of the research. In accordance with this guideline, Amsterdam UMC has described central policies and procedures on conducting scientific research involving human subjects in a Research policy. Dedicated Research Support teams are in place to help researchers comply with quality requirements.
Amsterdam UMC employees, interns and students are not allowed to participate as healthy volunteers or patients in clinical research executed by their own department, due to the dependent relationship between the subject and (more senior) colleagues and/or department head. Exceptions are conceivable, for example when an employee is a patient who would otherwise be denied potential therapeutic benefit. These specific cases must be submitted to the Dean of the executive board for review, to make sure sufficient measures are taken (e.g. involvement of an independent physician) to assure the independence and voluntary participation of the employee, intern or student.