The accredited MREC

As defined by the Dutch Medical Research Involving Human Subjects Act (WMO), the following criteria must be fulfilled in order for the CCMO to grant accreditation to an MREC:

Members. The MREC will contain at least one physician, one ethics expert, one lawyer or legal expert, one clinical statistician, and one lay member.

To review research involving subjects under the age of 16, the MREC must also include a pediatrician (this pediatrician can be the same physician listed above). To review clinical studies using investigational medical products, the MREC must include a clinical pharmacologist and a hospital pharmacist; if qualified, one member can serve both roles. The MREC must include a medical device expert to be qualified for the review of clinical studies with medical devices.

In addition, the CCMO has established criteria that are used to assess both the quality and impartiality of potential MREC members, who must be approved by the CCMO. At the MREC’s discretion, they can also include members who represent additional disciplines such as medical physiology, immunology, genetics, medical physics, etc.; these additional members must also be approved by the CCMO.

Rules of procedures. The MREC must define and implement proper rules of procedure for their activities (Dutch: reglement), including a rules defining the region and/or institutes for which they operate.

Number of reviews. To maintain their accreditation status, the MREC must review an average of ten or more research files each year, calculated over a period of two consecutive calendar years.

In addition to these three requirements, the CCMO requires that the MREC establish a quality assurance system using standard operating procedures (SOPs) that describe in more detail the practicalities and procedures of their various working activities.

Upon successful accreditation, an MREC obtains the official status of an independent administrative agency (in Dutch: zelfstandig bestuursorgaan), and each assessment by the MREC represents a legally binding decision. If the applicant does not agree with the MREC's decision, he or she can file an appeal with the CCMO.

Any accredited MREC that does not comply fully with Dutch law and the requirements listed above will lose their accreditation along with their status as an independent administrative agency and the ability to issue legally binding decisions. In 2010, the CCMO revoked an MREC’s accreditation. The CCMO’s decision to revoke this MREC’s accreditation is described in the paper below.