Drug Research Ethical Committee
The Drug Research Ethical Committee (CEIm) of Parc de Salut Mar was created and accredited on November 11, 1993 by the General Management of Health Resources of the Autonomous Government of Catalonia, in accordance with the “Ordinance dated October 26, 1992”.
Subsequently we were reaccredited on 19 December 2008 via the Order dated 24 October, 2006; and again on 27 October 2014. Accredited as a CEIm on February 7, 2018.
The principal duties of CEIm-Parc de Salut Mar, which are regulated by current legislation and approved by the Administrative Council of Parc de Salut Mar, are as follows:
• To evaluate the suitability of study protocols with regard to the objectives of studies, their scientific efficiency and the justification of the foreseeable risks weighed against the expected benefits for research subjects and society (riskbenefit ratio).
• To evaluate the suitability of the research team with regards to its experience and capacity to carry out the study.
• Clinical care requirements and commitments previously made to other research protocols are taken into consideration.
• To evaluate written study information to be given to participating research subjects (or to their legal representatives).
• To evaluate the procedure by which such information will be given and the type of consent to be obtained.
• To check the compensation and treatment being offered to research subjects in case of injury or death resulting from the study and to verify liability insurance to cover the funding agency, researchers, collaborators and the individual responsible at the center where the research is to be carried out.
• To be aware of and to evaluate the compensation to the study researchers and compensation to the subjects for their participation in the study.
• To monitor studies from the time of their inception and to follow them up until completion of the final report.
List of studies evaluated in 2018, classified by type
Committee for Research Integrity and Good Scientific Practice
The Committee for Research Integrity (CRI) of the IMIM was constituted by the Scientific Management of the institutions to act at the complete service of researchers and the scientific community, with the interest of giving support to the quality of research and contributing to its integrity.
Its specific functions are:
• To provide information and raise awareness with regard to events, necessities and orientations related to research integrity and good scientific practices in biomedical research.
• To promote and ensure that IMIM researchers and research support personnel receive appropriate training in best scientific practices to guarantee good scientific practices and integrity in the research developed at the IMIM.
• To implement procedures and investigate potential cases of research integrity misconduct.
In relation to the functions mentioned above, the Committee will guarantee, by all means, its own managerial diligence, independence of action, anonymity, and confidentiality in the processing of personal data, solvency of the information generated, impartiality in the deliberation process and equity of resolutions as well as possible allegations.
This Committee will form part and will work in alignment with the CRI of the Barcelona Biomedical Research Park (PRBB). The functions of the CRI of the PRBB are:
• To supervise the general, constant, and complete fulfilment of the guidelines of the Code of Good Scientific Practice at the PRBB’s centers.
• To act as an arbitration body for doubts or disputes that may arise in relation to research integrity matters. Its decisions are binding for those researchers submitting their disputes to the CIR.
• To provide information and continuously raise awareness with regard to events, necessities and orientations related to the ethical and deontological aspects of biomedical research. The Committee has the commitment to request from the Governing Bodies of the Centers those resources and measures that will contribute to the development of this function.
• To be receptive to new problems related to research integrity, to propose their discussion to our institutions and, consequently, to update the Code of Good Scientific Practice as needed.
Ethical Committee for Animal Research
The PRBB has an Ethical Committee for Animal Research (CEEA-PRBB) which evaluates project procedures using experimental animals. It takes into account the appropriateness of the procedure in relation to the objectives of the study, the possibility of reaching valid conclusions with the fewest animals, the effect on the animals not being disproportionate to the potential benefits of the research, and, in short, the avoidance of unnecessary suffering, as well as considering the possibility of alternative methods to the use of animals. That is the internationally accepted 3R rule (Reduction, Refinement and Replacement).
The Ethical Committee for Animal Research (in USA, IACUC- Institutional Animal Care and Use Committee) conducted 9 meetings where 44 projects were evaluated. These projects include 92 experimental procedures.
During the meetings scientific articles and new ways of controlling and improving animal welfare to adapt to the new legislation on animal experimentation have been discussed.
Also comments, recommendations or amendments done by the Government of Catalonia’s Animal Experimentation Ethics Committee (CEEA) were included in each meeting.
The CEEA also carried out their traditional inspection of the animal facility, which is a quality requirement recommended both by the AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International) and current legislation.
PRBB Animal Facility Users’ Committee
The Animal Facility Users’ Committee at the Barcelona Biomedical Research Park (CUA-PRBB) is an advisory committee external to the animal facility that reports directly to the PRBB management. The committee’s main objective is as a forum to provide information and debate the most important issues affecting the animal facility.
Its functions are:
• To remain informed and be aware of the content of animal facility’s annual report.
• To raise any problems identified in the overall functioning of the animal facility as well as to discuss and propose new solutions.
• To discuss processes and operating procedures at the animal facility and make suggestions as to how to improve them.
• To propose functional or procedural solutions for extraordinary action within the animal facility that may involve modifications from the normal routine, such as building work, repairs, supply cuts, reviews, extraordinary maintenance, etc.
• To make suggestions for improving the facilities, including the purchase or replacement of equipment, and to prioritize these purchases.
• To take part, when appropriate, in the preparation of applications for equipment grants or funds for provisioning the animal facility.
• To participate in the development of satisfaction surveys.
• To collaborate in the evaluation and assessment of these surveys.
The Animal Facility Users’ Committee (CUA-PRBB) conducted two meetings during 2018 in order to address the various issues affecting the functioning of the animal facility, to solve problems and consider proposals from researchers in the field of animal experimentation.
Barcelona Biomedical Research Park Biosafety Committee
The Barcelona Biomedical Research Park Biosafety Committee (CBS-PRBB) was set up with the aim of regulating and supervising the activities using GMOs (Genetically Modified Organisms) that take place around the PRBB, as set out in Law 9/2003 of 25 April, establishing the legal regime for the confined use, voluntary release and commercialization of genetically modified organisms, and considering the general norms for their development and implementation (Royal Decree 178 / 5004, 30 January).
The main objective of the CBS-PRBB is the biosafety evaluation of scientific projects using GMO, biological and chemical agents with a complex or important biological effect according to current biosafety legislation.
The Biosafety Committee (CBS-PRBB) evaluated 7 projects during 2018. Among other activities, it collaborated with the Inter-institutional Commission on Prevention of Occupational Risks (CIPRL) in reviewing a document on the transport of biological samples in order to implement this throughout the PRBB.
Inter-institutional Commission on Prevention of Occupational Risks at the Barcelona Biomedical Research Park (CIPRL-PRBB)
The Inter-institutional Commission on Prevention of Occupational Risks at the Barcelona Biomedical Research Park (CIPRL-PRBB) was created in application of Article 24 of Law 31/1995 of 8 November, on the Prevention of Occupational Risks, in matters of the coordination of business activities to channel the exchange of preventive information between the companies involved and the joint establishment of preventive measures, procedures and action protocols at the Barcelona Biomedical Research Park.
Its purpose is to give support to the management by the health and safety of the personnel existing at the building.
This Commission is the legacy of the Inter-institutional Prevention Group for the Coordination of Preventive Activity at the Barcelona Biomedical Research Park (GPIPRBB) which was created on 8 January 2008 by specialists in prevention.
The tasks performed are diverse, and include:
• Information campaigns featuring the “Previ” mascot as a joint image for the Prevention of Occupational Risks in the building.
• Joint publications in different Journals, participations with oral presentations and posters at Congresses in the prevention sphere, publication of Manuals on preventive information in the sphere of biomedical research, participation in the PRBB Open Doors Day with a range of Workshops, etc.
• Awards: The Ignasi Fina Occupational Health Award 2010 (April 2010), Occupational Health Advisory Council of Barcelona City Council, and runner-up at the 6th Atlante awards, in the modality of large company and the category of initiatives for awareness-raising, information and/or training (November 2012), Foment del Treball Nacional.
During 2018, the CIPRL-PRBB held six coordination meetings, with the aim of promoting coordination between all the institutions resident in the building, that participate in biomedical research activity.
The most prominent questions were: the review of the Procedure for the Transfer of Biological Samples, the coordination of business activities with the Animal Supply Facility and the Awareness-Raising Campaign for 2018-2019 with the redesigning of our mascot (PREVI version 2.0.) and the preparation of the ORP 2019 international congress on Occupational Risk Prevention.
Each meeting also includes comments and recommendations to be taken into account, and the sharing of everyday issues: emergencies, accidents, incidents, etc.
The Commission also coordinates with the Biosafety Committee of the PRBB (CBS) in order to develop a joint approach to different issues.