The ABR-form and the CCMO National Register

The introduction of the WMO led, amongst others, to the establishment of the Central Committee Involving Human Subjects (Dutch abbr. CCMO).  The CCMO has many statutory tasks (see the infographics in first theme Explaining the Dutch Review System). It acts, amongst other,  as the Oversight Body of all accredited MRECs, can make legally binding directives on the operational activities of these reviewing committees and takes care of the national registry with basic information from all reviewed research proposals in the Netherlands.

Before 1999 there was a complete lack of overview on the actual number of MRECs and clinical trials in the Netherlands. There was little harmonization in the review of research files by the various MRECs. Most MRECs had produced their own review form that had to be filled in by the applicant to be included in the submitted research file.

Especially for investigators and companies that were planning a multicenter trial in the Netherlands, this created quite a substantial bureaucratic burden, which was further increased when in 1999 the CCMO introduced a national registration form to comply with their statutory task to build a national register with basic information on all medical research that was reviewed in the Netherlands.

In order to reduce the bureaucratic burden for investigators and companies, the CCMO and accredited MRECs worked together to produce new and single national form for both the review and the registration of medical research that would replace all individual MREC review forms. This national form was introduced in 2002 and is known as the ABR-form. Its name is derived from the Dutch abbreviation of the General Review and Registration form (Dutch: Algemeen Beoordelings- en Registratieformulier).

The data of all submitted ABR-forms are incorporated in CCMO´s national register on medical research in the Netherlands. The ABR-form can be found at the webportal ToetsingOnline (ReviewOnline). After the ABR form has been completed in ToetsingOnline, a pdf of this form will created and included  in section B of the research file that is submitted to a MREC or CCMO.

With the introduction of the ABR-form, the CCMO issued a directive which requires that the (staff of the) accredited MREC checks the data of ABR-form along with the review of the submitted research file. This guarantees the accuracy of the data in the CCMO National Register, which is important for its use.

Yearly the CCMO reports on medical research in the Netherlands in its public Annual Report that is published on its website and discussed in the Houses of Parliament. In this way, on behalf of the accredited MREC and the medical field, the CCMO provides insight into the data on medical research in the Netherlands. This transparency helps to keep the trust of the public in medical research. Without it, medical research with human subjects would not be possible.

The CCMO National Register is also consulted in case of incidents during medical research in the Netherlands or abroad. Although incidents in medical research are extremely rare,  the usefulness of the National Register became immediately clear a few years after it was established.

In March 2006, eight healthy volunteers  participated in a clinical trial at a Contract Research Organization (CRO) in London. Six volunteers were administered a monoclonal antibody with a novel mechanism of action (two volunteers got a placebo). Soon after the administration of the antibody, the trial went terribly wrong and the men suffered from life-threatening adverse reactions.

When the incident was reported by the media in the UK, the CCMO was able to consult the National Register within minutes and found that antibody was not tested in the Netherlands and thus no immediate actions had to be undertaken to safeguard the well-being of research subjects.

All six healthy volunteers that participated in the London trial survived, but unfortunately not all of them without permanent physical damage. Although these type events are extremely rare in medical research, the case illustrates the importance of an up to date national register on medical research with human subjects.

As a result of the incident the CCMO developed a structured risk analysis scheme and published it in the Lancet. The risk analysis was further improved and incorporated in CCMO’s template research protocol (paragraph 13). Investigators can used this template to develop a research protocol for their clinical trial. The research protocol is subsequently included in section C of the research file.