ORBEA-BIOPOLIS regulations

BIOPOLIS-CIBIO

Órgão Responsável pelo Bem-Estar dos Animais - ORBEA

The "Órgão Responsável pelo Bem-Estar dos Animais do BIOPOLIS-CIBIO” (Animal Welfare and Ethics Review Body of BIOPOLIS-CIBIO), hereafter referred to as ORBEA, is an independent body with deliberative, informative and pedagogic nature, with the mission of advising researchers of BIOPOLIS-CIBIO on issues related to animal welfare, according to applicable legislation, guaranteeing the good course of research projects and overseeing that animal welfare regulations are observed during research, with the competences of:

a) promoting animal welfare in general;

b) overseeing ethical conformity and observance of animal welfare regulations in the context of teaching and scientific research activities undertaken in BIOPOLIS-CIBIO, according with applicable legislation. ORBEA functions in strict observance of applicable European and national legislation, namely the Directive 2010/63/UE, of the European Parliament and Council, from the 22nd September 2010, the Decreto-Lei nº113/2013, from the 7th August, and the Despacho nº 2880/2015, from the 20th March;

c) accompanying and advising staff of BIOPOLIS-CIBIO in matters related with animal welfare during capture from the wild, temporary housing, maintenance, breeding and use in educational and scientific research activities undertaken in BIOPOLIS-CIBIO;

d) advising the staff on the application of the replacement, reduction and refinement requisites, as well as keeping them informed of technical and scientific developments on the application of these requisites;

e) establishing and revising operational processes to monitor, report and overseeing the welfare of animals housed or used in the research centre;

f) emitting evaluations in the context of preliminary approval of research projects, internal and external, as well as other work or procedures that use animals in teaching and scientific research;

g) representing BIOPOLIS-CIBIO in events and national and international associations of "Órgãos Responsáveis pelo Bem-Estar dos Animais” (Animal Welfare and Ethics Review Bodies).

The activity of ORBEA in BIOPOLIS-CIBIO will be ruled by the principles of replacement, reduction and refinement, promoting the practical application and timely adoption of the most recent technical and scientific knowledge in this area, with the objective of guaranteeing that the number of animals used for scientific and educational purposes is reduced to a minimum and that those animals are adequately treated, without inflicting lasting and unnecessary pain, suffering, affliction or damage.

a) ORBEA is composed by:

i. the responsible for the BIOPOLIS-CIBIO, who presides;

ii. the person or persons responsible for supervising animal welfare and care in BIOPOLIS-CIBIO;

iii. a scientific responsible from BIOPOLIS-CIBIO;

iv. a veterinary doctor;

v. other members, namely other researchers (facultative).

b) ORBEA members are nominated by the Direction of the BIOPOLIS-CIBIO;

c) The mandate of members has a duration of 3 years, and the renewal is allowed for identical periods;

d) ORBEA members should act with the necessary independence for the functions that are attributed to them, and to declare any conflicts of interest that may exist for the questions under appreciation;

e) ORBEA members are obliged to keep confidentiality about matters they are appreciating or that they knew during the exercise of their mandate;

f) ORBEA members are obliged to respect intellectual property rights of the projects submitted to their appreciation;

g) When considered necessary or in case of conflict of interests, ORBEA may ask for support of external experts;

h) ORBEA should have the means to guarantee the confidentiality of the processes and allow their respective archival, preservation and security.

The responsible persons for internal or external research projects, as well as other work or procedures that use animals in teaching or scientific research activities, should submit to ORBEA the relevant information to allow its examination, approval and emission of an evaluation.

ORBEA evaluations are required for:

a) Future research projects that intend to use animals;

b) Research, technological development or formative activities, or others, that include the use of or experimentation with animals, namely animal experimentation projects, as defined by DL nº 113/2013, from the 7th August, that require permission by the "Direção-Geral da Alimentação e Veterinária” (DGAV);

c) All activities noted in the previous numbers, under the responsibility of organizations or persons external to the BIOPOLIS-CIBIO, that intend to use animals in the facilities of the BIOPOLIS-CIBIO;

d) Projects that require the capture, housing, handling, marking, taking biological samples, or transportation of wildlife (regulated by Decreto-Lei nº140/99, from the 24th April, with changes in the Decreto-Lei nº49/2005, from the 24th February, Decreto-Lei nº316/89, from the 22nd Seteptember, and Decreto-Lei nº139/90, from the 27th April) and that require a request of License/Credential for capture or housing wildlife specimens;

e) All activities noted in the previous numbers that take place in other countries by researchers of the BIOPOLIS-CIBIO.

Evaluation requests take place according to the following procedure:

a) The requests should be made by the responsible person for the project/activity to the email address orbea@cibio.up.pt;

b) In case of doubt about the need of an evaluation or of a Declaration about exemption of evaluation, ORBEA should be contacted beforehand;

c) Evaluation requests are based on the "Formulário para pedido de Autorização de Projeto da DGAV” (Formulary to request project authorization of DGAV), available in the web page of that entity.

d) Requests for evaluations are treated under confidentiality by ORBEA;

e) ORBEA meets when summoned by its president to analyse proposals according to applicable regulations.

ORBEA issues an evaluation in a maximum of 30 working days according with the following procedure:

a) Reception of the process, verification that it is sufficiently instructed and, if so, sending it to ORBEA members;

b) Reception by the President, in a maximum of 10 work days, of the individual evaluations of ORBEA members;

c) In case of a favourable evaluation, the President issues a final evaluation with an approval stamp. Alternatively, in case further clarifications are necessary, the evaluation is negative or changes are suggested, the responsible researcher will have the opportunity to submit clarifications or a revised proposal with changes during the following 10 work days;

d) In case the changes to the project are in accordance with the recommendations in the ORBEA evaluation, the President issues a final positive evaluation during the 10 work days after receiving the revised version;

e) Decision about the evaluation requires a simple majority of votes in ORBEA, and the comments that led to the decision and referring to the individual evaluation of each member are written in the evaluation.

f) After a positive evaluation, it is the responsibility of the proponent that the project is executed as was approved, and the proponent should report to ORBEA any changes in the project relatively to the initial proposal that involve animal use;

g) Evaluations are archived by ORBEA during 3 years (n.º3 of article 35 in the Decreto-Lei nº113/2013, from the 7th August) for consultation be the competent authorities.