Committees

2016

Clinical Research Ethical Committee

The Clinical Research Ethical Committee (CEIC) 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.

The principal duties of CEIC-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 2016, classified by type

*On 20 January 2016, the new Royal Decree 1090/2015 entered into force, and only clinical trials in which we are evaluators are considered and the concept of clinical trial with involvement is removed

Committee for Research Integrity

The Committee for Research Integrity (CIR) is a body constituted freely and voluntarily by the researchers of PRBB centers:

• Hospital del Mar Medical Research Institute (IMIM)

• Department of Health and Experimental Sciences of the Pompeu Fabra University (CEXS-UPF)

• Centre for Genomic Regulation (CRG)

• Centre for Research in Environmental Epidemiology (CREAL)

• Centre of Regenerative Medicine in Barcelona (CMRB)

Acts independently and at the complete service of researchers and the scientific community with the unique interest of giving support to the quality of research and contributing to its integrity.

Its functions are:

• To supervise the general, constant, and complete fulfilment of the guidelines of the Code of Good Scientific Practice at PRBB’s centers.

• To act as an arbitration body for uncertainties or conflicts that may arise in relation to research integrity matters. Its decisions are binding for those researchers submitting their conflicts to the CIR.

• To provide information and continuously raise awareness with regard to events, necessities and orientations related to ethical and deontological aspects of biomedical research. The Committee has the commitment to request from the Governing Bodies of the Centers the 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.

In relation to the functions mentioned above, the Committee will guarantee, by all means, its managerial diligence, independence of action, anonymity, and confidentiality in the treatment of personal data, solvency of the information generated, impartiality in the deliberation process and equity of resolutions as well as possible allegations.

We are currently working on setting up the IMIM Commission for Best Scientific Practices, with the aim of developing institutional strategies and procedures to

encourage the adherence of the research carried out at IMIM to the Code of Best Scientific Practices of the Barcelona Biomedical Research Park, ensure that IMIM researchers and research support personnel receive appropriate training in best scientific practices, and implement the procedures for carrying out research and for investigating potential cases of bad scientific practice

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 15 meetings where 32 new projects that include 101 experimental procedures were evaluated.

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) had two meetings during 2016 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) met three times in 2016. It evaluated 11 projects and responded to 2 consultations relating to biosafety. 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.

The protocol of "Basic rules for the transfer of biological samples" was approved at the CBS meeting on 3rd September 2016, in order to be implemented at the PRBB centers during 2017.