Research Roadmap

Reviewing committees

WMO-involving human subjects

Anyone who wants to carry out scientific research involving the active participation of human subjects is obliged to get the advice of a recognised Medical Research Ethics Committee (MREC). The MREC reviews all research subject to the Medical Scientific Research (Human Subjects) Act (WMO). The goal of the review is, among other things, to safeguard the rights, safety and welfare of the human participants. She weighs scientific interest up against the burden and risks for participants.

Research is subject to the WMO if the following criteria are met:

1. It concerns medical scientific research and

2. Participants are subject to procedures or are required to follow rules of behaviour.

If you're not sure you can find more details and support on the website of the CCMO

To facilitate the review, you are required to compile a standard research file with a number of basic documents. You can find all the necessary information via the links below:

• MREC Amsterdam UMC 
• Information about standard research files CCMO

The investigator/submitter is responsible for carrying out a check to verify if all submitted documents comply with various requirements per study type. MREC Amsterdam UMC set up a checklist WMO-submissions and a list of mandatory documents.

In the case of multicenter research, additional documents must be included in the research file. This includes a list of participating centers, Research Declerations or VGOs, the resume of the principal investigator per participating center and a (draft) Clinical Trial Agreement.

There are costs involved with assessing a research file. For more information, see the websites of the MREC Amsterdam UMC.

Submitting your research file to the MREC Amsterdam UMC is done digitally through an online portal : Research Manager

You can find the complete procedure and instructons for submitting a research file on the webpage of the MREC.

WMO-Medicinal products

For clinical trials involving medicinal products, the European Clinical Trial Regulation (ECTR) is applicable.

The ECTR aims to simplify and accelerate clinical investigations involving medicinal products within the European Union. The regulation ensures that the medical ethical review process is regulated with uniform procedures and established timelines and deadlines, for both the sponsor and the reviewing ethical committee(s).

Sponsors submit the application for the medical ethical review via an EU web portal called Clinical Trial Information System (CTIS). Fore more details see CTIS sponsor handbook and CTIS- online modular training programme .

The ECTR applies to clinical trials involving medicines conducted in Europe. A clinical study falls under the scope of the ECTR if:

1. The clinical, pharmacological or pharmacodynamic effects of a medicinal product are investigated;

2. The study meets one or more of the following conditions:

• Patients or subjects are randomized to a treatment.
• The medicine is prescribed as part of the research and not as part of standard care.
• More or different procedures are performed on the subject than in the context of standard care.

Medicinal research without intervention, such as observational studies into the long-term effects of a medicine, does not meet the standards of the ECTR and is not assessed through CTIS.

See the Clinical Trial Tool (CCMO) to determine if your research falls under the scope of the ECTR.

A low-intervention trial is considered to be a study which is conducted with a registered drug and the subject is minimally burdened and at a minimal risk compared to the standard of care. In this type of research, the ECTR sets less strict requirements for the insurance obligation, Subject Information Letter and the collection of safety information, such as AEs and SAEs.

On this CCMO site you can find a Q&A about the ECTR in the Netherlands.

For further details see the CCMO Site and for local procedures see the CMC Site.

If you have any questions about the submitting procedure within the framework of the CTR, please contact our Clinical Monitoring Center via ctis@amsterdamumc.nl.

WMO-Medical devices

Specific rules for the submission, assessment and conduct of clinical investigations with medical devices are set out in the EU Medical Device Regulation (EU no 2017/745, MDR). These rules are described in Chapter 6 of the MDR.

Clinical investigations with medical devices must be assessed in advance by an authorised review committee, as stipulated in the EU Medical Device Regulation (MDR) and/or the Medical Research Involving Human Subjects Act [Wet medisch-wetenschappelijk onderzoek met mensen, WMO].

Investigations should be registered with the CCMO using ToetsingOnline (in 2022 via Eudamed), after which the CCMO will validate the article under which the clinical research falls.

For clinical research in the context of conformity purposes (MDR article 62/74.2) the research file is first validated by CCMO.After a positive decision on the validation, CCMO will transfer your file to the review committee (accredited MREC or CCMO) for assessment. Clinical research with medical devices that are invasive in nature (risk classification II a) and b) or III) fall under article 62 or 74.2 and can only be reviewed by an accredited MREC or the CCMO.

For other clinical investigations (MDR article 82) or post-market clinical follow-up investigations (MDR article 74.1), you may submit a file directly to the MREC. 

For further details see the CCMO Site and for local procedures see the website of the MREC Amsterdam UMC.

The CCMO is the authorised agency for registering clinical research using a medical device. This applies to both medical devices without a CE mark as well as medical devices with a CE mark that will be investigated outside the intended usage.

Non-WMO

If your research does not fall under the scope of the WMO then it does not have to be reviewed by an accredited MREC or the CCMO. Nonetheless Amsterdam UMC in principle assesses all nWMO research according to certain predefined ethical and legal criteria. This is performed by a dedicated review board under the responsibility of the MREC.

Submission procedure

nWMO proposals can be submitted to the non-WMO review committee of the MREC Amsterdam UMC. You can find the whole procedure for submitting a research dossier on the MREC webpage. You will also find a checklist with additional information about which documents you have to submit and how to prepare these.

To set-up a biobank or to conduct research with material from a biobank, approval from the biobank review committee (Commissie Toetsing Biobanken; CTB) is needed.

Biobank

The Biobank Assessment Committee of Amsterdam UMC (CTB) assesses requests to set up biobanks and issues of human tissue from existing biobanks based on the Biobank Assessment Regulations . The CTB falls under the responsibility of the MRECs and focusses on evaluation of the legal and ethical aspects of the research. More information can be found here.

Submission procedure

For more information and the new Biobank assesment Regulation, visit this page. You'll find a checklist with additional information about which documents you have to submit and how to prepare these. 

Non-WMO databases

A database is a collection of data from patients or research participants that is kept for future (medical) scientific research. Researchers can set-up a database or may use data from a database under certain conditions to answer a specific research question (an 'issuance').

Setting up a database:

For a review application for setting up a database, the protocol 'setting up a database' must be used instead of the regular research protocol. Furthermore, the same documents must be submitted as for a regular non-WMO application. You can find the protocol 'setting up a database' and further instructions at the website of the METC.

Request for assessment of a database 'uitgifte':

If researchers want to use data from a database for a specific research question, this can be done without prior assessment by the Non-WMO Review Committee, provided that specific conditions are met and it concerns a non-risk issue. For registration puposes the 'data uitgifte' needs to be registered in Research Manager under the tab 'Rapportages' of the database. High-risk issues are always submitted to the Non-WMO Review Committee for assessment.

The 'protocol uitgiste databank' can be found on the website of the MREC.

Research with Animals

Research involving laboratory animals is regulated by the Experiments on Animals Act (WOD). In compliance with the WOD, both Amsterdam UMC locations have an institutional license to perform experiments on animals. Moreover, for each project responsible researchers have to apply for a project license at the Central Authority for Scientific Procedures on Animals (CCD). Project permission is based on ethical assessment by an independent local committee of experts known as the Animal Ethics Committee (DEC).