Ethics Committee for Research with medicines (CEIm)
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The CEIm is an independent multidisciplinary body that ensures the protection of the rights, safety and well-being of individuals participating in a biomedical research project and provides public assurance in this regard through an opinion on the corresponding research project documentation, taking into account the views of persons without expertise, in particular patients, or patient organisations.
Its specific functions are:
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- Clinical trials and observational studies with medicinal products
- Clinical investigations with medical devices
- Studies evaluating surgical procedures or other non-pharmacological interventions, or those not involving medical devices.
- Studies involving invasive procedures or the use of health data and/or biological samples.
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To evaluate relevant amendments to projects approved by the CEIm
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To monitor clinical trials with medicines and clinical investigations with medical devices
Areas of activity
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Hospital de la Santa Creu i Sant Pau (healthcare centre)
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Clínica Creu Blanca (healthcare centre)
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Biobank of the IR Sant Pau (non-healthcare centre)
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President of the CEIMDr. Belvís
It is an honour for me to have been chosen as chair of the Ethics Committee
for Research with Medicines (CEIm). My appointment is not just a replacement due to the retirement of the previous chair and friend,
Dr. Antonio Lopez-Pousa, whom I thank for his work. I have been selected to modernise the CEIm and prepare it for the changes approaching the Hospital, immersed in the Strategic Plan.One of my objectives is to bring the CEIm closer to researchers, to the Hospital in general and to society. We need to make known who we are and what we do and add to our bioethics oversight function the role of advising and supporting researchers. This website is an example of our new direction.
The CEIm's primary function is to protect patients and this function, in turn, protects our researchers and our institution. The CEIm determines whether a research project meets bioethical requirements based on the documentation provided.
The format of this documentation to be submitted is a major bureaucratic effort for our researchers, but we do not set it. These are requirements of a Royal Decree and, therefore, we must demand them from everyone, no matter how simple the research project may be. Nevertheless, we must manage to streamline all working procedures.Maria Estela Moreno MartínezVice-president
Pharmacist - Hospital Pharmacy
Albert QuerolSecretary
Clàudia Erika Delgado EspinozaTechnical Secretary
Physician - Clinical Pharmacology
Marta PujolPatient representative member
Núria AlberichLegal member
Lawyer - Legal Department
Alba MonroyAdministrative staff
Cristina Galisteo SaezAdministrative staff
Philosophy
Marisol MogollónAdministrative staff
Robert CaballeroAdministrative staff
Ana Carolina Caballero GonzálezMembers
Physician - Haematology
Beatriz Fernandez Montells RamaMembers
Engineer
Caridad Pontes GarcíaMembers
Physician - Clinical Pharmacology
Cristina Trilla SolàMembers
Physician - Gynaecology
Enric Garre PizàMembers
IT Specialist
Ignasi Gisch SaladichMembers
Physician - Epidemiology
Indalecio Morán ChorroMembers
Physician - Intensive Care Medicine
Iria González ÁlvarezMembers
User Service Unit
Jordi Torralba OrtegaMembers
Nurse
Laia Matas PericasMembers
Physician - Internal Medicine
Laura Lozano PoloMembers
Physician - Internal Medicine
Lucía Vallez ValeroMembers
Pharmacist - Pharmacy
Manel Fa BinefaMembers
Physician - COT
Mª Teressa Ricart BassagañaMembers
Nurse - EUI
María Jesus Portella MollMembers
Psychologist IR
María Rosa Ballester VernedaMembers
Primary Care Pharmacy - External member
Marta Lestón VázquezMembers
Pharmacist - Pharmacy
Óscar Gallego RubioMembers
Physician - Oncology
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If you want to submit a research project, please contact us to receive the advice and information needed about the requirements and the process.
You can contact to the following email: ceiminicial@santpau.cat-
- Not all CEIm members belong to the healthcare field. We have lawyers, patients, members of the administrative body, from non-clinical services....
- Documents addressed to patients (information sheet and informed consent) must avoid technical jargon and must be expressed in a format that a layperson can understand.
- Check that the translation is correct if the study protocol does not come from a national institution. NEVER submit a cooperative project to the CEIm without having previously read the translation of the protocol.
- If you prepare a protocol for your own study using the protocol from a previous study, watch out for copy and paste.
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- Given that the recipients of the documents (researchers, CEIm members, patients and family members...) are addressed to men and women, the language must be inclusive from a gender perspective.
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- The study protocol can be in Catalan or Spanish. If it is in English, the summary must be in Catalan or Spanish.
- The informed consent and the patient information sheet must be in Catalan and Spanish.
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- The request for informed consent exemption must be justified. Each request will be evaluated individually, but there are research scenarios in which there is a greater possibility of obtaining the exemption.
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- It must be reflected in the protocol specifying the affiliation of the nursing staff involved and their funding.
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- We cannot yet require that studies designed at other institutions take into account the gender perspective in their design, but it will be required for studies designed at our Hospital.
Requirements by study type
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- Definition
- Check list documents
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- Definition
- Check list documents
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- Definition
- Check list documents
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- Definition
- Check list documents
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- Definition
- Check list documents
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- Definition
- Check list documents
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- Definition
- Check list documents
Other project submission procedures
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- Contact by email at: ceimsantpau@santpau.cat
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- Contact by email at: ceimcontractes@santpau.cat
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- Contact Dr. Claudia Erika Delgado Espinoza by email at: ceimsantpau@santpau.cat
For any other enquiry, please contact ceimsantpau@santpau.cat -
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Any research project must comply with the legal framework of its state, which must conform to the international framework. It should be noted that there are many internationally agreed documents that are not legally binding.
We highlight among them:International Guidelines and Good Practice GuidelinesThe International Guidelines for Biomedical Research Involving Human Subjects of the Council for International Organizations of Medical Sciences (CIOMS) and the Good Clinical Practice Guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.Global regulationsThe only binding provision, although addressed to a very specific scenario of biomedical research, is Article 7 of the International Covenant on Civil and Political Rights of the United Nations Convention on the Rights of Persons with Disabilities.European regulationsThere are three legally binding instruments:
- Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the
approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on human medicines.
- Convention on Human Rights and Biomedicine (Oviedo Convention) of the Council of Europe.
- Additional Protocol on Biomedical Research. Also from the Council of Europe.
No researcher should be able to conduct research in Spain without accrediting their knowledge of the following four laws.No researcher should be able to conduct research in Spain without accrediting their knowledge of the following four laws.Biomedical Research Law 14/2007.Although it is already some years old, it is the legal reference document on biomedical research in Spain, establishing definitions and criteria for research in human beings.Royal Decree 1090/2015.This royal decree is actually a document that addresses two quite different topics. On one hand, it establishes the rules for forming the CEIm and their functions, but at the same time, it has a second part that establishes how clinical trials in humans should be conducted.Royal Decree 1090/2015.This is a document that establishes the rules for conducting an Observational Study with Medicines (EOM). Its annex contains a guide on how to present this type of study, which is in fact applicable to any type of research project.Organic Law 3/2018 on the Protection of Personal Data and guarantee of digital rights (LOPD)The patient is the owner of their body and mind, their tissues and their samples; but also of their data. The LOPD is a general law, not a bio-health law, but the CEIm must apply its content to research projects.
- Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the
Meetings
14:00h - 16:30h