Obtaining approval from the PHEG Science Committee
The PHEG Science Committee ensures the quality of the department’s research and evaluates research protocols based on their scientific quality, relevance and feasibility.
Submission requirements
For review, submit the following documents (in Word) to the PHEG Science Committee (email Wetenschapscommissie_PHEG@lumc.nl):
- Application Form for the Research Protocol
- Final protocol (C1)
- Non-WMO submission letter (A1 Niet-WMO aanbiedingsbrief, template only available in Dutch)
- Non-WMO questionnaire (B2 Niet-WMO vragenlijst, template only available in Dutch)
On behalf of the PHEG science committee, members of the ELAN-research team will review and provide their advice by filling in an ELAN-specific checklist. The Science Committee will then communicate their final decision to the researcher.
Next step (see flowchart) is to submit all documents (A1, B2, C1) and the letter of approval (K1) to the nWMO-committee of division 3: see www.metc-ldd.nl/indienen-niet-wmo-en-mdr. Once you have received the WMO exception letter from the nWMO-committee, upload this letter and the final protocol to your ticket at www.elanresearch.nl.
We are working on simplifying this evaluation process!
Background
Every department of the LUMC has its own Science Committee, and the designated medical ethics committee is the METC-Leiden Den Haag Delft (www.metc-ldd.nl).
A research project that (solely) uses retrospective patient data (like ELAN) is exempt from the Medical Research Involving Human Subjects Act (WMO). In that case, the METC-LDD will not review the protocol. Instead, the non-WMO-committee of your division (div-3) will provide a WMO exception letter. Be aware that sometimes, when multiple datasets are linked together, a research project may fall under the WMO, and it needs to be submitted to the METC-LDD. In all cases (WMO and non-WMO), you need to have letter of approval from the Science Committee.
To get your research published, many (medical) journals request a confirmation/letter of approval from a medical ethics committee. That is why we advise you to submit any research intended for publication for review by the Science Committee, including research with ELAN-data. Of note, a prerequisite for ELAN-research is to be of ‘public interest’, therefore publication of the results is necessary.