Research that falls under the Medical Research Involving Human Subjects Act (WMO) is assessed by Medical Research Ethics Committees (METCs). In the Máxima, these kinds of studies are submitted to the METC Utrecht, which also assesses research by the UMC Utrecht. Increasingly higher quality requirements are imposed on METC assessments, and strict lead times apply.
European playing field
New European legislation on clinical studies will come into effect from February 1, 2022. The METC merger was motivated by this new European Clinical Trial Regulation. This law sets additional requirements in the field of quality, reporting and lead times when it comes to medicines research.
In order to prepare for a European playing field, the boards of directors of the Máxima, UMC Utrecht and AvL have given the green light to the two METCs that are now available for the three institutions, METC Utrecht and METC Stichting Nederlands Kanker Instituut-Antoni van Leeuwenhoek Hospital, to be merged into one METC.
For researchers, the biggest change will come when the new European legislation comes into force. It sets strict requirements for lead and response times. The merger of the METCs is specifically aimed at optimally supporting these lead times. Under the new European legislation, research on human subjects will primarily be submitted via the Central Committee on Research Involving Human Subjects (CCMO), with the CCMO appointing the METC to assess the protocol.
The collaboration between the Máxima, UMCU and AvL should lead to a growth in the expertise of the METC, especially in the field of cancer drug research. It will also the METC to further specialize in the assessment of (child) cancer research.
By joining forces, the three centers expect to achieve benefits that will enable them to further strengthen their position in the field of research and its assessment. A joint METC also helps to anticipate future (European) legislation and regulations.
In April 2021, a letter of intent was signed by the three Boards of Directors. The aim is to have one METC operational by 1 January 2022 that assesses investigations for the three affiliated institutions. Three different chambers will be created: a specialized oncology chamber, a medicines chamber and a general chamber. Committee members of the three institutions will participate in various chambers based on their expertise, thus guaranteeing the quality and independence of the assessment.
The merger will create an METC that will assess between 150 and 200 studies annually. Partly due to its size and due to the changes expected in the coming years, there will be a general chairman who will lead the METC and the chamber presidents. The secretariat that will support the METC will consist of 14-17 people and will be led by a manager.