Regulation nr. 978/2019
Summary: Regulation on the functioning of the Ethics Committee of University of Madeira .
Regulation on the functioning of the Ethics Committee of University of Madeira
Preamble
In accordance with the Decree-law 80/2018 of 15th of October, and with the articles 2 and 2-A of the University of Madeira’s Statutes, published in the Legislative Order 14/2015, of 9th of June of 2015, of Diário da República, 2nd series, nr. 132, the University of Madeira’s Rector, after consulting with the Senate’s Academic Committe (“Comissão académica do Senado”), has approved this Regulation, which has been submitted for public consultation for a thirty-day period in accordance with the article 101 of the Administrative Procedure Code.
Article 1
Object
This Regulation establishes the scope of action and the rules of operation of the Ethics Committee of University of Madeira.
Article 2
Definition and Mission
1- The University of Madeira’s Ethics Commitee (“CEUma - Comissão de ética da Universidade da Madeira”) is an independent collegial body of advisory nature, whose mission is to promote and guarantee the compliance with the ethical and deontological principles of the overall functioning of the institution, especially when it comes to scientific research activities, technological development and innovation, training, and other activities that may occur.
2- The University of Madeira’s Ethics committee, hereinafter referred to as CEUMa, in its mission, takes into consideration the current national and international legislation in the matters of ethics and bioethics.
Article 3
Responsibilities
The responsibilities of the Ethics Committee are the following:
1- To ensure the preservation of the highest standards of ethics and bioethics in the University of Madeira’s operation.
2- To create documents that reflect on ethics and bioethics in a general manner, and to propose guidelines and recommendations about ethics and academic practice.
3 – to propose, stimulate and support training actions and awareness-raising activities related to its mission at the university.
4 – To issue advisory reports on questions that may raise ethical problems and that have been posed by UMa’s bodies or by its members, namely when it comes to:
a)Privacy and personal data protection, specifically regarding confidentiality of the information gathered from the participants or their anonymity.
b) Respect for the informed consent and the guarantee that the participants are not exposed to physical, moral, psychological, or any other type of damage.
c) Research, technological development and innovation activities that involve human and/or animal and/or radioactive material and/or biological testing.
d) Diverse activities that may affect the environment or the safety of the members involved.
e) plagiarism, copyright and related rights, and academic fraud.
5 – To comment on the creation of institutional documents that have ethical implications.
6 – to collaborate either locally, nationally or internationally with other relevant institutions within the fields of ethics and bioethics, with the objective of sharing the best practices.
7 – In no case may the Committee consider merit or the scientific quality of the projects.
8 – the CEUMa does not carry out legal or disciplinary assessments.
Article 4
Structure
1- The ethics committee has a multidisciplinary structure, having one representative for each organic unit, elected by its scientific / technical council, namely:
i) Professors or researchers;
ii) Remaining teaching staff and researchers working full-time assigned to the organic unit, with a contract’s duration of not less than a year, and holders of a PhD, regardless of their link with the university;
2- CEUMa's members are elected by the rector’s order, including not only the members stated in paragraph 1, but also other internal or external entities of recognised competence within the scope of CEUMa’s mission;
3 – The ethics committee must be composed of an odd number of members, between 7 and 11 members, including the Committee’s President.
4 – The Committee elects, among its members belonging to UMa, the President, the Secretary and the Vice-President who gives assistance to and substitutes the President on his/her absences or impediments.
5 – The CEUMa may request the collaboration of other specialists, whose expertise is considered to be relevant.
Article 5
Mandates, participations and substitutions
1- The mandate’s duration of the Ethics Committee’s members temporally coincides with the Rector’s mandate.
2 – All CEUMa’s members have the duty to participate in meetings and other activities of the committee or subcommittee to which they are connected, placing all their efforts and knowledge at the service of these activities.
3 – No members of the committee can be substituted at its meetings.
4 – The substitution of members can only take place in the case of resignation, extended or permanent impediment, or, in the case of the members mentioned in the no.1 of article 4, if their link to UMa has ended.
5 – Any member may renounce his/her mandate upon written declaration sent to the rector, remaining in office until a new member is nominated, which must occur within a maximum period of sixty days;
6 – When justified, the Committee’s president may be represented by one of CEUMa’s members;
7 – The members and president of CEUMa’s do not receive any additional payments for their activity.
Article 6
The President and Vice-president's Responsibilities
1- The President of the Ethics Committee shall:
A) Convene meetings and establish its agenda;
B) Preside the meetings and lead the development of the proceedings;
C) Ensure the normal functioning of the Committee, the timely issuance of advisory reports and the compliance with the applicable regulations;
D) Ensure the referral and the disclosure, to the interested parties, of advisory reports, recommendations and proposals;
E) Provide information about the issues, information and documents to him/her addressed;
F) Request the collaboration of third parties when it is proposed by CEUMa;
G) Guarantee the representation of the Committee;
2- The Vice-president of the Ethics Committee shall:
A) Replace the President if he/she is unable to attend;
B) Assist the President in the management of the CEUMa’s proceedings.
Article 7
Operation
1- CEUMa may, by the president’s initiative and when justified, form specialised subcommittees responsible for preparing reports on issues that have been submitted to them, also considering CEUMa’s structure and the specificity of the issue in question.
2- A specialised committee that has been created according to the previous paragraph’s terms may be dissolved with the emission of the report whose preparation justified its creation.
3- the issues submitted for analysis, for the creation of advisory reports or recommendation proposals, are assigned to one or more rapporteurs chosen by the members of the committee or subcommittees that have the strongest affinity to deal with such issues, being the ones preparing the evaluation and decision for the CEUMa’s meeting.
4- Once the proposal has been made, it will be discussed and submitted to a vote in plenary.
5- Upon the members’ proposal, the Committee may request a hearing of other specialists when deemed necessary to support information considered as relevant to the clarification of the issues being discussed.
6- CEUMa's members can’t intervene or debate over issues that they are directly involved with, have particular interest in, and other situations that may affect their impartiality.
7- The administrative support is covered by the rectory.
8- Each year, the Committee forwards to the Rector the critical report of the developed activities and the plan of activities.
9- CEUMa's members and other employees are bound to the duty of professional secrecy, of confidentiality and personal data protection about the issues submitted to their evaluation or of which they become aware of within the scope of CEUMa’s activities.
Article 8
Meetings
1- CEUMa's members meet ordinarily, in plenary, at least once a month, and extraordinarily when convened by the President or on his/her own initiative, in accordance with the article 9 of DL n. 80/2018. N. 248, 26 of December of 2019 page 125 of Diário da República, 2nd series, PART E.
2- When justified, CEUMa may assemble in specialised subcommittees.
3- Each meeting’s notice is sent to CEUMa’s members at least five business days in advance, mentioning the respective agenda and containing the supporting documentation of each subject being discussed.
4- The president may waive an ordinary meeting when there is no justifiable issue to be treated, or when it is possible to distribute tasks and documents via electronic means.
5- The meetings for advice provision are subject to the presence of the majority of the Committee’s members, with the right to vote, including the President or the Vice-president.
6- Any individuals, whose presence is deemed as necessary for the clarification of the issues being discussed, may participate in the meetings upon the President’s invitation.
7- Decisions are made by the simple majority of votes of the members present at the meeting. If there is a tie in the voting process, the Committee’s President or, when the latter is absent, the Vice-President, shall cast the deciding vote.
8- At each meeting is drafted the respective minute, including a summary of the covered issues and of everything considered as relevant for the issuance of advisory reports.
9- The minutes are submitted for the approval of the members present at the end of the reunion, or within the following seven business days of its creation via electronic means, being signed by the President and by the Secretary after its approval.
10- Minutes, preliminary advisory reports and other work documents should be distributed only between CEUMa’s members.
Article 9
Assessment, opinion provision and deadlines
1- Within the scope of its mission, CEUMa issues opinions, by its own initiative or by written request, on ethical issues related to the activities carried out by UMa.
2- When justified, the proposals of research, technological development and innovation projects/protocols to be carried out by UMa must be submitted to CEUMa for the assessment of ethical and deontological issues.
3- The decision on the need for the submission of research project/protocol proposals to CEUMa is of the responsibility of the project manager; the individuals in charge of the project’s approval may, if deemed necessary, require that a submission should take place.
4- Any of UMa’s teaching staff or researcher may submit an opinion request to CEUMa.
5- The opinion requests must be addressed to the Ethics Committee's President, done through a specific form provided by the University of Madeira in conjunction with all the relevant information that is necessary for the CEUMa’s assessment.
6- In the case of research, technological development and innovation projects/protocols, the requests must be accompanied by the declaration provided by the person/people responsible for the Unit(s) where the project will be developed, containing information on the project’s framework, support and feasibility.
7- All documents must be sent in digital format to the Committees e-mail address: etica@mail.uma.pt.
8- CEUMa may request, to the proponents, elements or clarifications deemed as necessary for the assessment.
9- CEUMa will issue a written advisory report, on each research project/protocol submitted, within thirty (30) business days after its submission request, which will be sent to the applicant with the Rector’s knowledge.
Article 10
Logistical and administrative support
1- The Ethics Committee will have logistical and administrative support, namely from a supporting secretariat.
2- Within the same terms as the members of the Ethic Committees and the technicians and experts in collaboration with them, the supporting secretariat is bound to the duty of professional secrecy, of confidentiality and protection of the personal data it has access to within the scope of its activity, even after its expiration.
Article 11
Formalisation of Decisions
1- Advisory Reports are issued in a written format considering the issue under analysis, being a rapporteur or rapporteurs assigned to it.
2- At each meeting, a minute is drafted including the advisory reports that have been issued regarding the projects subject to assessment.
3- CEUMa's decisions may be of “Favourable Opinion”, “Opinion subject to alterations” or “Unfavourable Opinion”.
4- In the situations where “Opinion subject to alterations” or “Unfavourable Opinion” occur, the advisory report must contain the reasons for the decision and, when applicable, it should also indicate the aspects that must be reviewed in order to obtain a “Favourable Opinion”.
5- In the cases where “Opinion subject to alterations” or “Unfavourable Opinion” occur, a new submission of the project to CEUMa must be done.
6- Advisory Reports issued by CEUMa are valid for the duration of the project, based on the information provided by the proponent on the date of the formalisation of the assessment.
7- When projects with “Favourable Opinion” are subject to changes, with ethical or deontological implications in its procedures, those changes must be communicated to CEUMa, which will determine whether the project needs to be resubmitted and evaluated.
8- The advisory reports issued are of a non-binding nature, being the project of the sole responsibility of the primary researcher.
Article 12
Omitted cases and doubts
1- The cases omitted, and the doubts raised in the application of the regulation shall be resolved by the rector’s order, after consulting the Ethics Committee’s President.
2- Within the scope of the interpretation and integration of omissions in this regulation, it will be applied, in a complementary way, the Statutes of UMa, UMa’s code of conduct, the regulation of Intellectual Property of the University of Madeira and other statutes and internal regulations of UMa, of its organic units and research centres, and the Ethical Codes of professional and scientific associations, national and international, within the areas of activity of UMa’s researchers.
Article 13
Implementation
This regulation comes into force on the day following its publication in Diário da República.
24th of November of 2019 – The Rector, Professor Doctor José Carmo.