Requirements for the evaluation of research projects

All research projects that involve the collection of patient data or samples from our centre, as well as carrying out questionnaires aimed at patients or staff at the centre, must be evaluated by our Clinical Research Ethics Committee (CEIm) before implementing them at the centre. Additionally, sample transfers must also be approved by the CEIm.

A request must be presented with the documentation corresponding to a research project for all studies that:

Do not involve drugs (they can include technique comparisons, nutritional products, etc.)
Are for medical devices with CE marking that are used under the conditions for which they have been authorised.

NOTE. Should a research project collect information on drugs and, upon evaluation, the CEIm considers it meets the criteria for an Observational Drug Study, the project will be evaluated as such. However, the usual process may be delayed since it has not been presented as per the requirements of the aforementioned study type. If it is detected that a study fits this definition, an evaluation of the project as an Observational Drug Study will be initiated, and a resolution will be issued within 30 calendar days.

See FAQs

New research projects: required documentation

The documents that need to be handed in for a new research project are the following:

Research project report/Protocol. This is the standardised model for our centre, though it is not mandatory to present the report or protocol in this format; if you already have a report or protocol in another format, you may present your own, though you will have to fill out and present the CEIm evaluation request form. In all cases, it is mandatory to include the version number and date of the document in the footer of the document.
Commitment of the principal investigator and collaborators / Acceptance from the departments involved. You must include the Principal Investigator's department head.
In the event that it is a supervised centre (without prior approval from an REC or CEIm), it is necessary to present the express authorisation of the supervised centre.
Patient information leaflet and informed consent (PIL-IC) - (Appendix) this is the standardised model for our centre, but if you already have another PIL-IC model, you can present your own, or attach a PIL-IC waiver request (including reasons and justification). It must be presented in Spanish and, if applicable, in Catalan (it must be in a language the patient can understand), and the version and date of the document must be included at the foot of it.
Temporary waiver of CEIm evaluation fees: only in the case of grants that have not yet been resolved or awarded.

NOTE. Once the grant is approved, the CEIm must be informed if funding is available to pay the fees and apply for the invoice (by sending an email with the billing information to facturacion@vhir.org).

Otherwise, if funding is not available to pay CEIm fees, you must request an exemption of fees from the CEIm (the justification for such a petition must be provided in the Reasons paragraph in the document). To do so, email ceic@vhir.org.

For a research project with biological samples

In the case of research projects with biological samples, it is necessary to present additional information.

For a project approved by another REC/ CEIm in Spain

Certificate of approval of the research project by another REC/CEIm accredited in Spain, in the case of multicentre studies, for a rapid review of the study.
Documents approved by the REC/CEIm (version that appears in the resolution).
You do not have to use our report model, only the report or protocol approved by the REC/CEIm.
PIL-IC, without modifying the version: It is necessary to provide the version approved by the REC/CEIm, but adapted with the contact information for our centre:
- Information on the principal investigator at our centre, including their contact data.
- Data protection officer at our centre.
CEIm evaluation request form
Commitment of the principal investigator and collaborators / Acceptance from the departments involved.

Presenting the documentation

The requirements for presenting the documentation are:

Deadline: The documentation can be presented until the 5th of the month of evaluation. The deadline is the 5th, anything submitted from the next day onward will be included in of the following month's evaluation. The documentation must be received in full within the term; in the event that it is incomplete, its evaluation will not be carried out.
Format: The documentation must be presented in a digital format that allows copying (except signatures that have only been scanned).
Where should the documentation be sent? You need to send it via email to: ceic@vhir.org.
Language: All the documentation presented to the CEIm may be written in Catalan, Spanish, or English, with the exception of the following documentation, which must be presented in Spanish:
- Study summary
- Patient information leaflet and informed consent
Fees
- Payment of fees: If the CEIm requests the payment of fees, the invoice must be requested via email, including the presentation and billing information, at facturacion@vhir.org.
- Fee exemption: You must request it in the corresponding section of our report model, or the CEIm evaluation request form, when our report model is not presented.
- Temporary waiver of CEIm evaluation fees: Present the corresponding document only in the case of grants pending resolution.

Transfer of samples: Documentation to be presented

Documentation

Transfer of sample documents.
Approval resolution from the REC/CEIm that evaluated the project from which the samples are transferred.
Approval from those responsible for the transfer.

Presenting the documentation

The requirements for presenting the documentation are:

Timeframe: The documentation can be presented at any time.
Format: The documentation must be presented in a digital format that allows copying (except signatures that have only been scanned) by email: ceic@vhir.org.
Language: All the documentation presented to the CEIm may be written in Catalan, Spanish, or English.

Supervised centres

Supervised centres are those that do not have their own CEIm and have accredited the Vall d'Hebron Research Institute (VHIR) CEIm in order to evaluate their investigations.

Presentation of a project previously approved by an REC/CEIm in Spain at a centre supervised by the VHIR. In this case, the documentation related to the project does not need to be presented at the VHIR. The resolution of a REC/CEIm will be valid for the supervised centre and they will have to formalise their contract or approval from the corresponding centre.
Presentation of a project previously approved by an REC/CEIm in Spain, when it stops evaluating during the project and, in addition, you want to present an amendment for centres supervised by the VHIR. In this case, the full documentation must be submitted, since our CEIm has not carried out the initial evaluation of the project. Consequently, the initial assessment fee will need to be paid.

Answers to clarifications

If the CEIm requests clarifications to previously presented documents, it is necessary to:

Submit a response document for the requested clarifications.
Present the modified documents with the changes highlighted.
For each clarification presented, the version and date of the modified documents must be updated. Example: "VERSION: Version 2. Date 11/02/2022".

The requirements for presenting the documentation are:

Timeframe for presentation: At any time.
Timeframe to receive a response from the CEIm: A maximum of 21 days, unless in addition to the changes requested, substantial changes are presented, a circumstance in which this period will be extended.
Format: A digital format that allows copying (except signatures that have only been scanned) via email to ceic@vhir.org.
Language: All the documentation presented to the CEIm may be written in Catalan, Spanish, or English.

Relevant amendments to a project already approved by another CEIm in Spain

To present a modification to an already approved project, it is necessary to present:

A letter of request for amendment evaluation where the changes made are justified summarily.
The modified documents, with a new version number and the date updated, at the foot of the document. It is necessary to present the modified documents with the changes highlighted.
In the event that there is a favourable resolution from another REC/CEIm accredited in Spain, it is necessary to attach this.

Presenting the documentation

Timeframe: Until the 10th day of the evaluation month. The deadline is the 10th, documentation submitted from the next day onward will be included in the following month's evaluation.
Format: The documentation must be presented in a digital format that allows copying (except signatures that have only been scanned), by email: ceic@vhir.org.
Language: All the documentation presented to the CEIm may be in Catalan, Spanish, or English, with the exception of the following documentation, which must be presented in Spanish:
- Study summary
- Patient information leaflet and informed consent
Fees: If the CEIm asks you for the payment of the evaluation fees, you need to request the invoice, sending an email with the presentation and invoicing information to facturacion@vhir.org.
- Fee Exemption: If you applied for this prior to the initial request and have not been informed of non-acceptance, it is not necessary to apply for the amendment. Should you need to request the amendment, you must provide the Request for fee exemption.

Relevant amendment for a change of principal investigator

You must present:

The document Change in principal investigator, signed by all the following:
- The new principal investigator
- The previous principal investigator
- Their department head
All the documents where the principal investigator appears, with the changes marked/tracked.

Presenting the documentation

Timeframe: Until the 10th day of the evaluation month. The deadline is the 10th, anything submitted from the next day onward will be included in the following month's evaluation.
Format: The documentation, which should be in a digital format and have scanned signatures, must be presented via email: ceic@vhir.org
Language: All the documentation presented to the CEIm may be written in Catalan, Spanish, or English.
Fees: If fee payment is requested, the invoice must be requested by sending an email with the presentation and billing information to facturacion@vhir.org.
- Fee exemption: If you applied for this prior to the initial request and have not been informed of non-acceptance, it is not necessary to apply for the amendment. Should you need to request the amendment, you must provide the Request for Fee Exemption.