Meeting schedule & fees
Meeting schedule & fees
The MREC Utrecht does not have a deadline for mail submission, except for new research files and response letters concerning ‘important changes’ as these need to be discussed by the whole MREC chamber (see further below). Mail is processed in the order in which it was received and put on the agenda as soon as possible, depending on how busy the MREC’s schedule is. For new files submitted, you will receive notification of the date of first discussion.
Meeting schedule & timelines uitklapper, klik om te openen
The MREC consists of two chambers which each have two meetings per month:
- Chamber D (Tuesdays in even weeks)
- Chamber M (Tuesdays in odd weeks)
Both chambers review research with adults as well as research with minors.
Once a research file has been assigned to a chamber, this chamber will also review the response to questions, etc.
Files to be discussed will be put on the agendas of the chambers in the order in which they were received. Before a research file is put on the agenda, it is checked for completeness. Incomplete files will not be discussed. The investigator will be informed via e-mail if a file is incomplete.
The chairpersons of the two chambers together make up the MREC’s Executive Committee; they meet up every Tuesday.
The Executive Committee is authorised on behalf of the MREC to take decisions which have been delegated to the Executive Committee. If a chamber has decided that a few minor changes are required in a protocol, the study will be reviewed during a meeting of the Executive Committee (possibly after consultation with a number of committee members).
Response to MREC questions, amendments, SAE and SUSAR reports and other correspondence will be discussed during an Executive Committee meeting, unless discussion during a chamber meeting is considered necessary.
When will I hear about the result? uitklapper, klik om te openen
It is only after the first submission of a new research file that the applicant will receive confirmation of receipt, including information on:
- the chamber to which the research has been assigned
- the date of first discussion
- any fees associated with the review
Within 7-14 days after the meeting, you will receive the MREC’s decision or a request for changes/additions to the research file. This period also applies to documents discussed by the Executive Committee.
The term within which the MREC must decide on your application will be stated in the ToetsingOnline portal. Via ToetsingOnline you can also keep track of the remaining decision period.
Is there a deadline for submissions? uitklapper, klik om te openen
All mail is processed in the order in which it was received and put on the agenda as soon as possible, depending on how busy the MREC’s schedule is. Any new files and response letters concerning ‘important changes’ must be received by the MREC no later than 8 working days before the meeting, so that they can be processed by the secretariat and the committee can prepare for the discussion properly.
Fees for review uitklapper, klik om te openen
The fees for the review of research will change per 01-01-2022. New studies or amendments received before 31-12-2021 will receive an invoice with the 2021 review fees (even though the review took place in 2022).
In the download below the fees for 2022 can be found for research directly submitted to the MREC. For information on the rates for the reviewing of clinical research with a medicinal product (CTR) and research with a medical device (article 62/74.2 MDR), from 31 January 2022, please visit the website of the CCMO. Website CCMO - rates
N.B.1: Investigator initiated onderzoek dat bij de METC wordt ingediend vanuit het NKI/AVL, het Prinses Máxima Centrum of het UMC Utrecht krijgt geen factuur, maar het bedrag wordt aan het eind van het jaar verrekend met de inzet van leden van die instelling of divisie. Als deze dossiers via de CCMO lopen volgt er vanaf 01-02-2022 vanuit de CCMO wel een factuur, maar ook dan wordt dit meegenomen in de verrekening aan het eind van het jaar.
N.B.2: Ten aanzien van MDR dossiers art. 62 en 74.2, die ook nu al ingediend moeten worden via de CCMO: Start facturering CCMO voor deze MDR dossiers is vermoedelijk met ingang van datum indiening bij CCMO 31-01-2022. Tot die datum geldt voor deze MDR dossiers, al worden zij bij de CCMO ingediend, hetzelfde tarief als voor onderzoek dat direct bij de METC wordt ingediend.
The fees for the review of research will change per 01-01-2022.
If research is funded or co-funded by UMC Utrecht through a fourth flow of funds (company), the fees for review will be charged to the applicant at UMC Utrecht according to the applicable rates. As an internal applicant you must state the cost centre for payment of the review fees in your cover letter. You will not receive an internal invoice, but the Accounting Department of the Information Provision & Finance Division (DIF) will deduct the amount and transfer it to the MREC cost centre.
For the review of non-sponsored UMC Utrecht research (i.e. investigator-initiated research), no invoice will be sent. In the month of January following submission of the research file, the division concerned will receive an invoice for the total amount for the preceding year, according to the applicable rates.
If UMC Utrecht does not participate in the research (neither as a sponsor nor as an investigator), other rates will apply. The Information Provision & Finance Division (DIF) will send the invoice to the external applicant. Please state an invoice reference number in your application.
For the review of a substantial amendment (including the addition of participating centres), 500 euro will be charged if the sponsor is a company. The invoicing procedure will be the same as for primary submissions.
No costs are associated with the review of amendments to investigator-initiated research.
Subscription fees for continued review
Research sponsored by a company: in addition to the above-mentioned review fees, 250 euro will be charged per year as a subscription fee for continued review (review of SAE/SUSAR reports, progress reports).
An amount of 250 euro will be charged every February as of the year following the positive decision until the February following the 31st of December of the year in which the inclusion ended.
No subscription fees apply in case of investigator-initiated research.
For an assessment of whether research is or is not subject to the CCMO, 500 euro will be charged if it concerns research sponsored by a company. In all other cases these charges do not apply.
UMC Utrecht as a local participating centre
If UMC Utrecht is a participating centre, and the research has been reviewed by a different MREC, the CCMO External Review Directive (RET) will apply. Invoicing will still be done via the MREC secretariat. In case of sponsored research (fourth flow of funds), administration charges of 500 euro will apply.
In your request for permission from the Executive Board, you must state the cost centre for payment of the fees. You will not receive an internal invoice, but the Accounting Department will deduct the amount.
Participating institutions: UMC Utrecht and Prinses Máxima Center for pediatric oncology