1. What is the timeframe for submitting documentation to the Clinical Research Ethics Committee (CEIm) so that it evaluates a research project? 

From the 1st to the 5th of the evaluation month. The deadline is the 5th, anything submitted from the next day onward will be included in the following month's evaluation.

Documentation must be received in full within that term. Should it not be received in full, your evaluation will not be carried out.

2. When do the committee meetings that evaluate research projects take place?

Meetings take place on the last Friday of the month.

3. Does your CEIm perform evaluations in August? 

No. Not for research projects.

4. Does the CEIm stop the clock during the Christmas holidays? 

Yes, from 23 December to 7 January the clock stops for all applicable terms.

5. How long does it take from the relevant initial evaluation or amendment of a research project to receive the committee's resolution? 

A month and a half. 

6. How long does the CEIm take to evaluate an answer to the clarifications of a research project? 

Approximately 21 days from the moment we receive the answer, unless, in addition to the changes requested, other substantial changes are presented, a circumstance in which this period will be extended. 

7. Can I present an initial project without having all the signatures? 

Yes, the documentation can be presented between the 1st and the 5th of each month, and the signatures can be sent until the 10th of the evaluation month. 

8. I want to submit my research project for a scholarship that requires a CEIm certificate. How can I obtain this? 

You have to write to ceic@vhir.org to request it. We can issue two types of certificates:

• If you submit all the documentation according to the requirements of our CEIm (as indicated on the web), we can issue a certificate stating that we are in the process of evaluating the project.
• If you are not able to submit the documentation, we can issue a certificate stating that the project will be evaluated when we receive the required documentation. 

You will receive a certificate signed by the CEIm Technical Secretariat by email. 

9. What are the version and date of the document and what is their purpose? 

The version refers to the number of the document being written. The date refers to the final date of creation of the document in question. For example, if today is 15 January, 2022, the version of the document would be 1 and the date would be 15 January, 2022.

It is very important that this be modified when you present a modified version to the CEIm. For example, if we asked for clarifications and you present the new version of the document, and today it is 18 January, 2022, the new version will be 2 and the date will be 18 January, 2022.

The Generalitat of Catalonia requires that all resolutions list the documents approved, stating the version number and date. For this reason, it is important that each document submitted to the CEIm include the version and the date. If not, it will not be possible to issue the resolution.

It is also important to maintain the traceability of the document and to know at all times what the current version is.

10. Should the CEIm evaluate a study containing patient data collected from my practice? 

Yes, the CEIm must evaluate any study in which information or samples from patients from the centre are collected, even if they have been collected at a clinical practice, since these samples or information will be used for research purposes, not healthcare.

11. Should the CEIm evaluate a questionnaire study aimed at hospital staff? 

Yes, since data will be collected from the workers at the centre. It will have to be presented as a research project in accordance with the requirements specified on our website.

12. Should the CEIm evaluate a clinical case that I want to publish? 

In principle, the CEIm need not evaluate clinical cases and, legally, it is not necessary to do so. However, should a journal explicitly request our approval, we would evaluate the case that you want to publish and issue a certificate stating that the study is ethically acceptable. 

13. I want to carry out a study with food products or food supplements. How do I present it for evaluation by your CEIm? 

You need to submit it according to the requirements you will find in the Research project evaluation requirements section on our website.

14. I want to conduct a study with a CE-marked medical device that is used under authorised and common conditions of use. How do I present it for evaluation by your CEIm?

You need to submit it according to the requirements you will find in the Research project evaluation requirements section on our webiste.

15. I want to carry out a trial with a comparison of techniques that does not include any medical devices nor will it collect drug information. How do I present it for evaluation by your CEIm? 

You need to submit it according to the requirements you will find in the Research project evaluation requirements section on our website.

16. I have been asked to send samples to another centre that is carrying out a research project. Do I need to consult with the CEIm? 

Yes, you must submit the transfer of samples paperwork according to the requirements you will find on our website, specifically, in the Requirements for evaluating research projects section, Transfer of samples subsection.

17. I have a study without drugs/ones using CE-marked medical devices and under authorised and common conditions of use approved by another REC/CEIm. Does it need to be evaluated by your CEIm? 

Yes, you will find the presentation requirements in the Research project evaluation requirements section of our website.

18. I have to make a modification to a project already approved by the CEIm. Do we need to present anything to the CEIm? 

Yes, you will find the requirements for presentation on our website, specifically, in the Requirements for evaluating research projects section, Relevant amendment subsection. 

19. We want to change the principal investigator on a project already approved by the CEIm. Do we need to present anything to the CEIm? 

Yes, you will find the presentation requirements on our website, specifically, in the Requirements for evaluating research projects section, Relevant amendment to change the principal investigator subsection.

20. We have a research project where the principal investigator is a student and/or has no contractual link with the centre. Can they be the principal investigator? 

Yes, but there must be a person in charge linked to the centre by contract, who will be the director of the project. In addition, you will have to sign the local Commitment of the principal Investigator, collaborators and heads of service document, which you will find in the section called Research project evaluation requirements on our website.

21. We want to collect samples from patients that will then be used in different research projects. What should we do? 

There are 2 options:

• They can be stored under the biobank regime. You can contact the Biobank of the Vall d'Hebron University Hospital (HUVH) (biobanc@vhir.org) and manage and coordinate with them regarding the creation of a collection of samples, which will have to be presented to our CEIm.
• A collection of samples can be created, and the researcher responsible for the project will have to do the following:
  • Register the collection with the National Registry of Biobanks.
  • Communicate the registry reference to the HUVH Biobank (biobanc@vhir.org).

22. We want to prepare a single Patient Information Leaflet/Informed Consent (PIL-IC) to then use it in several research projects. How should we proceed with the CEIm? 

The PIL-IC must be presented to be evaluated with the relevant documentation according to the requirements on our website. Once approved, it may be used for other research projects, when the same projects are presented or through relevant amendments to other already approved projects; it will be necessary to point out that this PIL-IC is used (including data such as its CEIm code) in the project report.

23. We want to store samples from patients in a foreign storage facility that will then be used in future research. What information should we send to the CEIm when presenting the research project? 

You must send the information related to the policy of the storage facility, which will need to reflect compliance with the rules regarding collections/storage facilities/biobanks for biological samples, according to the "Recommendation CM/Rec (2016)6 of the Committee of Ministers to member states on research on biological materials of human origin" to the CEIm. In particular, the CEIm must be informed of the following:

• That the biobank/storage facility has independent oversight that guarantees the protection of data and the interests of the patients. 
• That there is an independent review (ethical and scientific) of the different studies that you want to carry out with the samples, and that there will be no transfer of the samples to third parties.

24. Should the CEIm evaluate a validation study of reagents or devices with biological samples from healthcare surplus? 

Our CEIm has agreed that there are two possible scenarios with respect to the transfer of samples for the validation of reagents or devices: 

• Transfer of surplus biological samples for the validation of reagents or devices within the framework of a research project. This scenario requires the presentation of the research project report to justify this assignment and an application for approval from an internal or external clinical research ethics committee (CREC). 
• Transfer of biological samples from health care surplus for the validation of reagents or devices under a specific agreement validated by the person in charge of the clinical service, the management of the Vall d'Hebron University Hospital (HUVH) and the management of the Vall d'Hebron Research Institute (VHIR), which does not require the CREC’s approval request since it is not a research project in of itself. In this scenario, the following conditions must be met:
  • The scope of this proposal is the use of surplus health care samples for the validation of a device or reagent.
  • Being health care surplus, the informed consent of patients for non-healthcare uses has not been previously obtained, and obtaining it would entail unreasonable effort. 
  • The use of these samples for such purposes is performed anonymously, and there is no possibility of identifying the patient again.
  • The understanding and/or agreement between the parties must specify:
    • That surplus samples from the healthcare process will be used, so that they do not entail any risk/inconvenience for the patient.
    • That it is necessary to ensure that extraction/taking of samples from patients will not be carried out solely in order to have the necessary samples for the validation.
    • That the samples and data will be anonymised so that it is not possible to establish a link between the samples and the patient's identity.
    • That the samples will be used for the validations described in the present understanding/agreement, and not for other purposes.
    • That the samples may not be transferable to third parties, and will not have any commercial value.

25. Do I have to pay CEIm evaluation fees for a research project? Can I request an exemption from these fees? In which cases? 

• For a research project with a commercial sponsor, evaluation fees must be paid. You must request them by sending the billing information via email to facturacion@vhir.org.
• In the event that you have requested a grant during the presentation of the project, you must submit the Temporary waiver of fees, document, also available in the Requirements for evaluating research projects section on our website.
  • Funding entities are aware of the mechanisms for paying evaluation fees, and therefore should be part of the economic report of the application for the scholarship in question.
  • Once the scholarship has been granted, you must inform the CEIm of whether you have funding to pay the fees and request the invoice (sending an email with the billing information to facturacion@vhir.org). Otherwise, if CEIm fee payment has not been granted, an e-mail must be sent to ceic@vhir.org requesting fee exemption (justification for such a request must be provided in the document's Reasons section).
• If there is no funding, you can request the exemption from payment of fees when presenting the project. It will be necessary to include this information in our Research project report model (section "CEIm Evaluation Fees/Fee exemption requested") or, if you present the protocol using a different model than ours, you must include it within the CEIm report request.

26. I need to draw up a contract, collaboration agreement or materials transfer agreement (MTA). Who should I contact? 

You must contact the Legal Department of the Foundation: legal@vhir.org.

27. I need to include a collaborator on an approved project. How should I proceed? 

• In the case of clinical trials, observational drug studies (ODS)/former post-authorisation studies (PAS) and NON-COMPETITIVE projects: contact the Foundation's Department of Document Management via email at gestio.documental@vhir.org.
• In the case of competitive projects, contact the Foundation's Department of Projects via email at gestio.projectes@vhir.org.

28. I need to apply for a career certificate. How should I proceed?

You must request it through the VHIR intranet: 

If you have any problems, contact the Foundation's Department of Document Management via email at gestio.documental@vhir.org.

29. I have questions about the Vall d'Hebron University Hospital's economic report model.

Request the local model or ask any questions regarding the economic report via the following email: memoriaeco.ac@vhir.org.

30. What are the contact details for your centre's data protection officer?

Data protection officer: dpd@ticsalutsocial.cat.

The Legal Unit at the Fundació Institut de Recerca Hospital Universitari Vall d'Hebron can resolve all your questions, complaints, clarifications, suggestions and will address the exercise of duties via email lopd@vhir.org, or by post: Passeig Vall d’Hebron 119-129, Edifici Mediterrània, 2a Planta, 08035 Barcelona.

For the Vall d’Hebron Institut d’Oncologia (VHIO): dpo.cliente@conversia.es.

31. A principal investigator is on medical leave. What should I do? 

There are 2 options:

• If, from the standpoint of a sponsor, you consider that during the medical leave, tasks can be delegated to a sub-researcher, it would not require a substantial modification to change the principal investigator. Only an email notification to the CEIm is required, to: ceic@vhir.org. The CEIm or the Technical Secretariat will not send any form of approval to the sponsor. It will be processed as a notification, and thus requires no evaluation.
• If, from the standpoint of a sponsor, you consider the trial will not be able to continue during the medical leave, it is recommended to make a substantial modification to change the principal investigator and present it to the CEIm for their evaluation.