Aim

Ensuring that all prerequisites have been completed prior to starting an EMGO project.

Description

The project leader is responsible for organising a number of matters before the research study gets off the ground. For instance, there needs to be an agreement between the relevant professor or departmental head and the EMGO board. Other issues that need to be organised include:

A. Assessment by the EMGO Scientific Committee;
B. Registration with the Data Protection Board (College Bescherming Persoonsgegevens);
C. Review by the Medical Ethics Committee;
D. Study participants need to be informed about the study (including information about the central VU University Medical Center's insurance policy) and written consent needs to be obtained from participants;
E. The confidentiality regulations and agreement need to be signed;
F. Trials need to be registered;
G. Population Screening Act (Wet op het bevolkingsonderzoek).

These points are explained in further in the Details section.

For information: Penalties
According to the Medical Research (Human Subjects) Act of February 1998 (Wet Medisch Onderzoek met mensen, WMO), conducting scientific research without written consent of the participant is a serious offence, which is punishable with a prison sentence up to 1 year. Undertaking research without insurance cover or in the absence of a protocol that has been approved by a recognised medical ethics committee is an offence punishable with a prison sentence of up to 6 months.
According to the Data Protection Act, the Data Protection Board may impose fines for non-registration of projects. Not registering projects on time, or incomplete registrations, may incur a maximum fine of EUR 4500 per infringement. Serious cases may also face criminal sanctions.

Further questions?
If you still have some questions or something is not clear, then please contact Michel Paardekooper for questions about confidentiality aspects, and contact the EMGO Scientific Committee for questions regarding assessments.

A. EMGO Scientific Committee

Written approval must have been obtained from the EMGO Scientific Committee. The Scientific Committee assesses proposals for relevance to extramural healthcare, suitability within one of the EMGO research programmes, and methodological quality. For the EMGO Scientific Committee’s criteria and procedures refer to the relevant handbook page.

B. Data Protection Board

The use of personal or privacy sensitive information in scientific research need to be registered with the Data Protection Board. The registration need to be submitted to the EMGO+ data protection officer. Some pilot studies can be excepted from registration under the condition that: the study is finished within six months and  communicative details are destroyed within this period.  For information refer to the guideline Handling privacy sensitive data, and the website http://www.cbpweb.nl, , containing information about the Data Protection Board (CBP) and the Data Protection Act (WBP: Wet Bescherming Persoonsgegevens).

C. Medical Ethics Committee

The very first question is whether the study falls under the Medical Research (Human Subjects) Act. Not every study falls under the WMO’s remit, and therefore not every study needs to be assessed. The assessment criteria for whether a study falls under the WMO remit can be found here. If you believe that your study does not fall under the WMO’s remit, then you are advised to notify the Medical Ethics Committee of this (please consult Michel Paardekooper in the first instance if there is any doubt). You could notify the committee by sending them your research proposal (for instance, the version assessed by the Scientific Committee) in an e-mail explaining why you believe your proposal does not fall under the WMO remit. You should explicitly ask the Medical Ethics Committee to provide confirmation of this, which can be sent at a later date to any journals requesting this information. Journals will occasionally ask for this confirmation.

WMO research:
Protocols approved by the Scientific Committee should be worked out in detail, including any potential questionnaires, and should be accompanied by all the information leaflets and consent forms when sent for approval to the VU University Medical Center’s Medical Ethics Committee (Medisch-Ethische Toetsingscommissie, METc). The METc will consider the scientific significance of the study and weigh this against the burden on and risk to patients.

The research protocol sent to the METc of the VU University Medical Center will be screened for completion. Only once the proposal is complete, both formally and contents-wise, it should be submitted to the METc; the assessment period starts at this point. The committee aims to make a decision within 8 weeks. The study may not be started before the executive board has issued an approval. A copy of this approval letter should be sent to the EMGO manager for archiving. Refer to the METc website for information about the VU University Medical Center’s METc procedure (incl. an example of the insurance statement, information letter and consent form). Always review the checklist before submitting research protocols; this is also available on the website.

In addition to the comprehensive study protocol you should always submit:

1. A cover letter, signed by the project leader, the director (Hans Brug) and the Operations Manager (Michel Telkamp);
2. The General form for Assessment and Registration (Algemeen formulier voor Beoordeling en Registratie, ABR) that should be signed by any potential external researchers/sponsors. This online form must be completed online at https://toetsingonline.ccmo.nl/; A text version is also available for information;
3. All information brochures and consent forms (including the date and version);
4. Hard copies of questionnaires;
5. A budget statement signed by a Finance Manager;
6. In the event of a multiple site study (including studies involving multiple GP’s/nursing homes): At least 1 signed declaration of intent from a participating centre (template available on the intranet). Modifications to this declaration of intent are possible in consultation with the METc secretariat.

D. Participants (insurance and informed consent)

The Medical Research (Human Subjects) Act requires that participants are insured against any potential injury caused by the study. The VU University Medical Center has taken out a central insurance policy covering this eventuality. Study participants need to receive information about this in writing (VUmc Example Letter). You should contact the VU University Medical Center’s legal representative (O. van der Beek) and the Medical Affairs Office (W.E. van der Voet or Dr. P. de Haan) when a participant makes a claim.
Another aspect of the METc procedure is that participants need to receive written information about the study and should have provided written consent to participate in the research. For research involving participants who are unable to provide informed consent, written consent will be required from their parents or representatives.

E. Privacy

In respect of the statutory safeguards for confidentiality the VUmc privacy regulations need to be completed, signed and sent to Ms. A.F. van Manen (BIZA) prior to the data collection process starts. This form records the title, aim and nature of the personal details register, and will indicate precisely where the register is held, who has access to the register, whether links to other files are possible and how security has been safeguarded. In addition, the emgo+ confidentiality agreement needs to be signed by all project team members with access to the confidential (paper or digital) study details. The project leader is responsible for ensuring that information about the confidentiality agreement is provided, and that the document is signed and archived on time. Access to confidential research data should only be extended to employees of the EMGO+ Institute who are registered to the project. (See also the guideline: Handling privacy sensitive data).

  F. Trials registration

The board of the EMGO+ Institute requires that all RCT’s carried out in the Institute to be included in the trial register. All studies with interventions that are allocated by randomisation need to be considered for registration. This may involve registration at participants’ level, as well as cluster randomisation (e.g. randomisation of treatment providers or departments). Registration may also be important to the project, given that a number of journals require that a trial has been registered for publication. Refer to trial registration for information about how and why.

G. Population Screening Act (Wet Bevolkingsonderzoek)

The Public Screening Act (Wet Bevolkingsonderzoek, WBO) is intended to protect individuals against screening studies that may pose a danger to physical or mental health. Projects falling under the WMO’s scope need to obtain a licence from the Ministry of Health, Welfare and Sport (Volksgezondheid, Welzijn en Sport, VWS) prior to the study being carried out. This therefore does not fall under the METc auspices.
Projects satisfying the following criteria will need to assess whether they fall under the WBO’s scope.

1. Screening of population groups. The group size is irrelevant.
2. The study is initiated by the researcher and offered to participants. That is, for the majority of medical studies people will be present as a result of a medical problem. The offer to participate assumes that people are approached via an invitation to participate, an advert or (public) information bulletin, rather than participants taking the initiative themselves. The VWS committee is minded to view brochures originating from fundraising organisations or patient associations as constituting an “offer" to participate. “Criteria to be used in identifying 'recruitment brochures’ is that the text is intended for specific target groups, originates from a provider and includes an address or telephone number for further information…” In brief, the brochure needs to fulfil a number of real tests.
3. Another important criterion is that individuals have a personal interest, or attach significance to the results of the study in which they are involved.

The study also needs to satisfy one of the criteria below in order to fall under the WBO scope:

1. Use of ionising radiation (such as X-rays), e.g. study into osteoporosis with DEXA;
2. Screening for cancer or pre-cancerous cells;
3. Screening into severe disorders or abnormalities for which there are no treatments or prevention. For instance, pre-natal screening of Down’s, screening for Duchenne’s disease.

If your study satisfies criteria 1, 2 and 3, as well as A, B or C, then it probably falls under the WBO scope. The national hearing test does not fall under the WBO’s scope, as it does not satisfy A, B or C. Contact Michel Paardekooper if you have any doubts about this and/or consult the METc in order to determine whether the study falls under the WBO’s scope. A report from the Health Council of the Netherlands (Gezondheidsraad) about the WBO assessment and permit application procedure can be found here (Dutch).
Don’t forget that the WBO licensing procedure may take a long time. The procedure may take as long as 3 to 4 months. The process may even take up to a year if there are any objections, or if information is incomplete.

V 1.3 1-1-2009: Translation into English and update.
V 1.2  22-1-2009:  TIP non WMO project.
V 1.1, Sept 2006: Addition of trial registration and Population Screening Act (WBO).