Regulation of the Ethical Commission for Health

 

Article 1

Scope


1. The MALO CLINIC Ethics Committee for Health (CES), in its action, is governed, in particular, by the legal provisions contained in the Decree Law No. 80/2018, of 15 October, without prejudice to other provisions established in the Portuguese Law, Ethics Codes and International Guidelines and Declarations.
2. This Regulation contains the rules, operating rules and structure of the CES.

Article 2

Assignments

1. The CES is an advisory body of MALO CLINIC, with technical and scientific independence, and its mission is to contribute to the observance of ethical and bioethical principles in the provision of health care and in carrying out clinical research.
2. The CES must ensure compliance with the ethical standards required in the provision of health care, namely, in the practice of medicine in order to ensure greater dignity in the procedures and greater respect for people and their rights.

Article 3

Comission´s Powers

It is especially incumbent upon the CES:
a.) Monitor the procedures and practices of MALO CLINIC observing its ethical standards, safeguarding the principle of dignity and integrity of the human person;
b.) Issue opinions, reports, recommendations and proposals on ethical issues related to MALO CLINIC ’s activities, taking into account the best clinical practices and costumer reception and follow-up;
c.) Strive for respect for the rights and duties of clients and health professionals;
d.) Promote, within the scope of MALO CLINIC, a culture of bioethics and its dissemination;
e.) Issue opinions on the scientific and ethical suitability of researchers to carry out clinical research studies;
f.) Assess the methodological, ethical and legal aspects of clinical research studies that are submitted to CES and issue opinions on their realization;
g.) Develop, within the scope of MALO CLINIC, reflection studies on ethical and bioethical issues, proceed with the respective disclosure and promote a training and learning culture.


Article 4

Composition

1. The MALO CLINIC CES is composed of nine members, including the president and the vice-president.
2. The members of the CES have training different areas, namely, in dentistry, oral hygiene, nursing, pharmacy, dental assistance, dental prosthesis, medicine and law, with experience and recognized merit, and at least two of them must be external to MALO CLINIC.
3. The members of CES will elect its president and vice-president, the first being responsible for coordinating the work of the committee, and the second, to cover the absence or impediments of the the latter.
4. The CES, when justified, may request the collaboration of other technicians or experts, without giving them right to vote.

Article 5

Mandate

1. The members of the CES will not earn any retribution and are appointed by deliberation of the management body of MALO CLINIC, for a term of four years, renewable once, for an equal period of time.
2. Any expenses incurred by CES members, within the scope of its attributions, will be paid by MALO CLINIC.
3. The functions of CES members cease in the following situations:
a) At the end of their term of office;

b) On the date of taking office in another position or function incompatible with the exercise of the functions of member of the Ethics Committee;

c) By resignation, by letter addressed to the management body of MALO CLINIC, with knowledge to CES;

d) By resolution of the management body of the MALO CLINIC, after hearing the CES, based on non-compliance with the duties of a member of the CES.
4. The unjustified absence at three consecutive meetings regularly called, will be considered non-compliance with the duties of a member of the Ethics Committee.


Article 6

Operation Rules

1. The CES meets when convened by its president or, in his absence or impediment, by its vice-president, whenever deemed justified, at least once a month, or extraordinarily, at the request of any of its members.
2. For the CES deliberations to be validly taken, it’s necessary that, at its meetings, at least five of its members are present.
3. In the event of a tie in any vote, the chairman it that specific meeting has the casting vote;
4. Any member of the CES prohibited from voting when matters that in any way concern him/her are under discussion.
5. It is incumbent upon the president and in his/her absences or impediments to the vice-president, to represent the CES and its articulation with other departments of the MALO CLINIC and with third parties.
6. Taking into account the composition of the CES and the issues in question, on the initiative of its president, specialized committees may be created, with the responsibility for preparing the opinion or the report on those matters that are expressly submitted to them.
7. Minutes of all meetings will be drawn up by the secretary who may be assigned by the MALO CLINIC to the CES, or, failing that, by the member of the CES designated by the president for this purpose.
8. Any opinions, reports, suggestions or simple guidelines of the CES will always be transmitted in writing and with knowledge of the management body of MALO CLINIC.


Article 7

Members Rights

The members of the CES have the right to:
a) Obtain from the management body all information deemed pertinent;
b) Participate in meetings and voting;
c) Attend training activities considered to be of interest within the scope of the CES, with the knowledge and authorization of the management body;
d) Be excused from their activities within the scope of the MALO CLINIC, during the periods in which they will be assigned to the works of the CES.


Article 8

Duties

1. It is the duty of all CES members to strive for the observance of rigorous principles of ethics and bioethics and, specifically, each member must:
a) Exercise his/hers mandate with zeal and diligence;
b) Keep confidentiality on all matters dealt with, without prejudice to those that should be disclosed;
c) Actively participate, with a view to the scope of the CES, collaborating with the other members and meeting the deadlines for carrying out the work assigned to it;
d) Keep up-to-date on ethics and bioethics topics and commenting on matters on the agenda of the meetings.
2. The duty of secrecy stated in paragraph b) extends to all those who attend (on request, by invitation or by secondment) to CES meetings.


Article 9

Logistic, administrative and financial support

1. MALO CLINIC will provide the necessary logistical, administrative, and financial support for the proper functioning of the CES.
2. There should be created an area on the MALO CLINIC website, containing the composition, the calendar of its meetings, the activity, the opinions produced and the internal regulations of the CES, and the identification of the projects or clinical research studies under evaluation, in the applicable cases.



Article 10

National Network of Ethics Committees for Health

The Ethics Committee for Health (CES), by virtue of its attributions, integrates the National Network of Ethics Committees for Health (RNCES), established in the Law No. 21/2014, of 16 April, in its current version, so it is proposed to collaborate, whenever necessary, with the respective coordinating entity.


Article 11

Annual report

CES must prepare an annual report, at the end of each calendar year, on the activities carried out, which will be sent to the management body of MALO CLINIC by the 15th of February of the following year and must be placed in the area of the ethics committee on the MALO CLINIC website and at RNCES.

Article 12

Final dispositions

1. The present regulation of the CES may be amended at any time, provided that there are reasonable reasons for doing so.
2. Any change to this regulation requires prior approval from the administration.
3. The internal regulations for the functioning of the CES, after being approved, are disclosed in the area of the respective ethics committee on the institution's website.


Approved by the Ethics Committee for Health of MALO CLINIC S.A. Approved by the Board of Directors of MALO CLINIC S.A. March 2022.