RegulationS of internal organisation and operation of the Spanish Bioethics Committee

TITLE I. THE SPANISH BIOETHICS COMMITTEE

Article 1. The legal nature of the Committee.

1. The Spanish Bioethics Committee is a collegiate, independent and consultative professional body, which will develop its responsibilities, with full transparency, on materials related to the social and ethical implications of Biomedicine and Health Sciences with full compliance with the Constitution and the rest of the legal system. In its conduct, the Committee will also be able to take into account other standards and international reference documentation relevant to the material.

Article 2. Responsibilities of the Spanish Bioethics Committee.

1. In conformity with that which is established in the Law on Biomedical Research and in these regulations, the responsibilities of the Bioethics Committee are to produce and approve reports, proposals and recommendations and other documents, and specifically, the following:
   1. To issue reports, proposals and recommendations on relevant ethical matters for public authorities at state and regional level.
   2. To issue reports, proposals and recommendations on matters related to the ethical and social implications of Biomedicine and Health Sciences that are considered relevant by the Committee.
   3. To establish general principles for the production of codes of good practice in scientific research, that will be developed by the Research Ethics Committees.
   4. To represent Spain in supranational and international forums and bodies involved in Bioethics.
   5. Any other responsibilities ascribed in the rules of development of this Law law 14/2007, 3^rd June
2. The Spanish Bioethics Committee will be required to produce a yearly record of activities which will be presented to the relevant public authorities and institutions and the general public.
3. The role of the Spanish Bioethics Committee is to collaborate with other committees at state level and regional level which have consultative responsibilities in regard to the ethical and social implications of Biomedicine and Health Sciences. To carry out this role, the Committee will foster communication with other Committees and will establish cooperation and exchange of information, without prejudice to the relevant competencies of each body.
4. The reports, proposals, recommendations and other documents produced by the Committee will be disseminated via the associated website and can be published, respecting at all times the fundamental rights of those who could be affected by said disclosure, with particular regard to reputation, personal and familial privacy, image and to protection of personal data.

TITLE II. COMPOSITION AND APPOINTMENT OF THE SPANISH BIOETHICS COMMITTEE

Area I. The Members of the Spanish Bioethics Committee.

Article 3. Appointment of Members of the Spanish Bioethics Committee.

The Spanish Bioethics Committee is made up of a maximum of twelve members who will be appointed in conformity to that which is stated in article 79 of the Law 14/2007, of 3rd July, on Biomedical Research.

Article 4. Independence and Conflicts of Interest.

The members of the Committee will act with independence from the authorities who proposed or nominated them and will not be able to belong to governing bodies of the Administration of State, Autonomous Regions or Local Government, as well as the Spanish Parliament or Legislative Assemblies of the Autonomous Regions.

Area II. The Presidency of the Committee.

Article 5. Regarding the election of the President.

1. The President of the Committee will be proposed from among the members and needs a majority of two thirds.
2. The duration of the mandate of the President will be two years, renewable for two further years, for only one consecutive time.

Article 6. The Responsibilities of the President of the Committee.

Regarding the Presidency of the Spanish Bioethics Committee:

1. To represent the body.
2. To agree to convocation of ordinary and extraordinary sessions and to set the order of the day. Points solicited from at least four members of the Committee, communicated to the President at least ten days in advance, will also be included in the order of the day.
3. To chair the sessions of the Plenary and of the Permanent Commission and to moderate debates.
4. To resolve impasses with his/her vote, if this is necessary, in order to reach agreement.
5. Ensure the application of the regulation is fulfilled.
6. Endorse the records of proceedings and certification of adopted agreements.
7. Produce the draft of annual record that must be submitted for de approbal of the Committee.
8. Solicit, when it is considered necessary and with the favourable judgement of the Committee, the opinions of experts outside of the same or other individuals of whom the opinion or statement could be useful for the work of the Committee.
9. 1.To exercise other responsibilities inherent in his/her role as a President of the Committee.

Area III. The Vice-presidency of the Committee.

Article 7. The Vice-President.

1. The Committee will name a Vice-president from amongst the members of the Permanent Commission.
2. The Vice-president will stand in for the President in case of vacancy, absence or illness.

Area IV. The Secretary of the Spanish Bioethics Committee.

Article 8. The Secretary of the Committee.

1. In conformity with that which is established in art 79 of Law 14/2007, of 3rd July, on Biomedical Research, the Secretary to the Committee will be a civil servant with the rank of sub-director General, belonging to the Carlos III Institute of Health, who will act with the right to speak in debate but without vote.
2. In the case of vacancy, absence or sickness of the Secretary, another civil servant of the same rank and appointment can assume said responsibilities, for the time strictly necessary.

Article 9. The Responsibilitiess of the Secretary of the Committee.

The duties of the Secretary will be:

1. To attend meetings with the right to speak in debate but without vote.
2. To call the Committee’s sessions by order of the President, as well as summoning members of the Committee. The call for the session should be made sufficiently in advance and include the agenda for the day. The information on the subjects that will be included in the agenda will be available to members of the Committee at the same time.
3. To receive communications from the members with the Committee and therefore the notifications, information requests, corrections and any other kinds of written communications of which note must be taken, to send out the Committee’s correspondence and to ensure the delivery of circulars, documents and all relevant information, to all members.
4. To prepare with the approval of the president the distribution of various matters, to compile and sign minutes of the sessions which will give proof of attendance, of topics covered and the agreements adopted, as well as individual votes made.
5. To issue with the approval of the president certifications of the agreements adopted.
6. To archive and look after all the information and documentation relating to the Committee.
7. All responsibilities which may be assigned by the President.

Area V. The Permanent Commission.

Article 10. The Permanent Commission.

The Permanent Commission will be made up of the President and five members chosen from within the Committee for a period of two years. It will hold ordinary meetings every two months and extraordinary meetings as instructed by the President. The Secretary will attend the meetings of the Permanent Commission with the right to speak in debate but without vote.

TITLE III. THE RIGHTS AND DUTIES OF THE MEMBERS OF THE SPANISH BIOETHICS COMMITTEE

Area I. The Rights and Duties of the Members of the Committee.

Article 11. Continuity and autonomy.

1. The members of the Committee are fixed for the duration of the time of their mandate without prejudice to the imposition, where appropriate, of the causes of cessation or suspension as established in the law and in these Regulations.
2. The members of the Committee will enjoy full autonomy in the sphere of the work of the Spanish Bioethics Committee.

Article 12. Confidentiality.

The people who compose the Committee have the duty to maintain confidentiality in regard to discussions related to the content of the debates, as well as with the information that will be conveyed to them of this nature or which the Committee itself might recommend as being such.

Article 13. Conflict of Interests.

The members of the Committee will refrain from seeking out knowledge, discussion or decision of matters which could compromise their independence, impartiality or objectivity of judgement, and in all cases when it is established by legislation or at the request of the Committee.

Article 14. Representation of the Committee.

1. The President will represent the Spanish Bioethics Committee.
2. The members of the Committee will not be able to claim this office, except those who, for the reasons and in the manner established in these Regulations, might be acting President.

Article 15. Right of participation.

The members of the Committee have the right of active participation in the initiatives, discussions and decision-making of the Committee, providing reflections, opinions, proposals and collaborating actively in tasks in conformity with what is established by the Law on Biomedical Research and in these Regulations.

Article 16. Right and duty of attendance at sessions.

The members of the Committed have the right and the duty to attend the sessions On acceptance, members are committed to attend meetings or to justify their absence.

Area II. Dismissal and severance of Members of the Committee.

Article 17. Dismissal.

1. The members of the Spanish Bioethics Committee will be suspended for any of the following reasons:
   1. Expiry of their term
   2. Death
   3. Permanent disability
   4. Suspension for legal reasons
2. The members of the Committee can be relieved of their position for the reasons established in the legislation in force and particularly in these Regulations.

Article 18. Resignation.

Members of the Bioethics Committee will be able to resign from their position at any time. The resignation of the post of Committee member will be addressed to the person at the Ministry responsible for the acceptance of the resignation, with a copy for the President and Vice President. The resignation will then be transferred? to the Plenary of the Committee.

Article 19. Conflict of Interests.

If at the beginning of their term or during the same any of the members of the Committee were named for a position which conflicts with another, they must choose, within the period of eight days counted from the nomination, one or the other position.

If the nominee allows the deadline to pass without verifying their choice, opts for the conflicting position, or takes possession of the same, the Plenary of the Committee will raise the matter with the Minister responsible for nomination and dismissal in which they act in conformity to the law.

Article 20. Incapacity.

If during their term any member of the Committee is incapacitated for the performance of their responsibilities, the President or Vice-president will bring it to the attention of the Plenary that, after studying and deliberating, he/she will prepare a report on this matter to the relevant Minister.

TITLE IV. PROCEDURES

Area I. Functions

Article 21. Competencies of the bodies.

1. The Committee will act in Plenary and in Permanent Commission.
2. The Plenary of the Committee will meet in an ordinary session at least once a trimester and in an extraordinary session whenever they are called by the President by his/her proper capacity or by the request of a third of the members, in which case, if very urgent, a period greater than fifteen days from the request should not pass before the session is held.
3. Responsibilities of the Plenary:
   1. The proposal of the nomination of the President
   2. The discussion and resolution of matters which may have been studied by the Permanent Commission in the first instance and/or by the working groups.
   3. The discussion and approval of all Committee activities, including those with representation and collaboration from other bodies, within the terms established in the Biomedical Research Law and in these Regulations.
   4. The discussion and decision on matters related to the statute of the Committee members
   5. The discussion and approval of the annual record. The Report of the Committee's activities will be submitted for the approval of the Plenary within the three months following the period of one year to which the said document refers.
   6. Any other responsibility conferred on it by the legal framework in general and, specifically, the Biomedical Research Law and these Regulations.
4. The Plenary of the Committee will be able to convene at any moment to fulfil their competency on any matter being studied and debated within the Permanent Commission or in any of the working groups of which it could be constituted.
5. Responsibilities of the Permanent Commission:
   1. To organise the meetings of the Plenary.
   2. To propose themes for the consideration of the working groups and to present them to the Plenary.
   3. To monitor the working groups, their composition and their activities to ensure that they are fulfilling the role given them by the Plenary of the Committee.
   4. To carry out an analysis of those matters which could require an immediate response, with the aim of provoking an extraordinary meeting of the Plenary of the Committee.
   5. To ensure the transparency of the Bioethics Committee and its activities. To this end the President will report to the Plenary at the meetings of the Permanent Committee.
   6. Any other responsibility conferred on it by the legal framework in general and, specifically, the Biomedical Research Law and these Regulations.

Article 22. Announcements and agenda.

1. The notifications of the sessions, which are the responsibility of the President, will indicate the agenda, the place, the date and the time of the meeting, and will include the documentation necessary for the consideration of the topics to be dealt with. If the volume or the complexity of the documentation impede their being sent to the members of the Committee, in the notification the deadline will be indicated prior to the meeting by which the members of the committee will be able to consult said documentation that must be in the available in the place where the meeting will be held.
2. The notifications for ordinary and extraordinary meetings will be sent electronically, and with acknowledgement of receipt from each person in the Committee with at least seven working days’ notice, in the case of ordinary meetings, and five days’ notice in the case of extraordinary meetings, except during an emergency, in which the notification can be made at least forty eight hours in advance.
3. The agenda will gather the approval of the minutes from the previous session and the points for consideration. Points not included in the order of the day / agenda can be discussed if the Committee agrees, by a clear majority, at the beginning of the session.
4. The meetings of the Bioethics Committee will be held in its headquarters. Without invalidating the previous point, the Committee will also legitimately be able to hold its meetings, whether the Plenary, the Permanent Committee or the working groups, at a different venue, when this has been approved by the Plenary of the Committee, by a simple clear majority. Special attention will be paid to the possibility of holding the sessions of the Committee in the different Autonomous Communities when this is requested by these Communities and/or by public and private institutions and bodies of the respective territories or any of the members of the Committee.

Article 23. Minutes.

1. From each session, whether it be the Plenary or the Permanent Commission, the minutes will be prepared by the Secretary with an indication of the attendances, the agenda of the meeting, the time and place it takes place, the development of the discussions, the people who have taken part, the particular statements of the Members who wanted to have them recorded, and the content of the adopted agreements.
2. In the case of disagreements with adopted agreements, members can lodge their particular vote in writing in the eight days following the adoption of the agreement. Individual votes lodged will be incorporated into the text.
3. A draft of the minutes will be sent to all the members for their amendments and corrections, which will be definitively approved in the next session. The Secretary will be able to send, before their approval and subject to approval, certification of specific agreements that have been adopted.

Article 24. The adoption of agreements.

1. For the Constitution of the Committee, for the purposes of the holding of the sessions, discussions and establishing agreements, the presence of at least two thirds of the Committee members will be required. No member will be able to delegate to another their participation in the sessions, nor the conclusion of their own discussions, nor to be temporarily substituted.
2. Any of the members of the Committee will be able to disseminate, also in writing, including electronically, opinions or individual votes on the reports adopted by the Committee. Individual votes will be disseminated in the same way as the approved report.
3. The agreements will be adopted by a simple clear majority from among at least two thirds of the members of the Committee, except in the exceptions established in these Regulations. The voting will be secret when requested by a member of the Committee and, in all cases, when it concerns the election of posts, or permanence in the same or in the Committee.

Article 25. Working groups and the participation of experts outside the Committee.

1. The Plenary will be able to agree the setting up, in its midst, of papers or working groups for the study or preparation of matters on which it must declare an opinion.
2. The Plenary will also be able to agree the setting up of the working groups formed as much by the members of the Committee as by external members. These groups will be coordinated by a member of the Committee.
3. The Plenary, at the proposal of the spokesperson of the working group, will be able to ask for the report or the collaboration of experts outside the Committee.
4. The Plenary and the working groups will be able to require the testimony of experts in order to technically advise on matters within their competency.
5. The external experts will need to commit to keeping the matters dealt with confidential.

Area II. Procedure for writing reports, proposals, recommendations and other documents.

Article 26. The production and approval of documents.

1. In conformity with what is established in article 78 of the Biomedical Research Law, the documents produced by the Committee will take the form of reports, proposals, recommendations and rulings with relevant ethical implications. Equally, they will be able to draw up general principles for the production of codes of good practice in scientific research.
2. The procedure to follow in the Plenary will be:
   1. Presentation of the document by the spokesperson or president of the group.
   2. Opening of a period of 15 days for the presentation of amendments written by the members of the Committee.
   3. Discussion and decision on the presented amendments.
   4. Discussion by the Plenary of the Committee. In this phase, the members of the Plenary will be able to present amendments in voce that will be accepted or rejected by the Plenary and in each case argued in a single process.
   5. Approval by the Plenary of the Committee
   6. Presentation of individual votes if made.

Article 27. Other proposals and decisions of the Committee.

1. The proposals of activities, studies, cooperative relationships and representation of the Committee in national and international fora, that may be formulated by any member of the Committee or by any members together, will be the object of discussion and study by the Plenary that will decide by a simple clear majority.
2. Equally, the Committee will be able to propose the holding of scientific meetings or of public debates with the participation of experts.

Article 28. The dissemination of documents.

1. Documents approved by the Committee will be made public.
2. The members of the Committee will not be able to make documents public before they have been approved, nor will they be able to issue partial or complete information about the topics covered by the Committee before they are made public.
3. The anual report will be published after its approval.

TITLE V. REGARDING THE BUDGET

Article 29. Budget.

The Committee will have its own budget. The Plenary of the Committee will aprove a budget annually according to the scheduled activities for take place in this period.

TITLE VI. THE MODIFICATION OF RULES ON INTERNAL ORGANISATION AND FUNCTIONING

Article 30. Changes to Regulations.

The proposal of any modification of the Internal Regulations must be presented in writing to the Committee, with the aim of being analysed in an ordinary session. It will not be possible to suggest any modification of the Regulations in contradiction to the Law 14/2007, of the 3rd July, on Biomedical Research, or of any other precept of current legislation. In the case of doubt on the existence of a contradiction between the proposed modification and the legislation in force, the study of the modification may be subject to ruling of the State Juridical Services that, in conformity with article 22 of the Regulation of the Judicial Service of the State, will be optional and non-binding.

The approval of any modification to the Internal Regulations will require an absolute majority of the members of the Committee.

Provisional first position.

The Committee will have its provisional headquarters in the Chamartin Campus of the Institute of Health Carlos III, Pabellon 13, Calle Monforte de Lemos, num 1.

Second transitory disposition.

That provisions in articles 10 and 21.3 and 5 of this Regulation will be applicable until the implementation of the regulatory norms referred to in 81.1 of the Law on Biomedical Research.