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Regulation Governing the Ethics Committee

Art. 1 (Setting up)

The Collegio Carlo Alberto Foundation, having its registered office in Turin, Corso Vittorio Emanuele 75 (hereinafter indicated as the “Foundation” or the “Collegio”), shall set up an independent Ethics Committee, which will operate at the Foundation’s headquarters.

Art. 2 (Functions)

1. The function of the Ethics Committee, hereinafter the Committee, is to evaluate ethical aspects of the research activity promoted by the Foundation and has the responsibility of providing a public guarantee regarding the ethical principles on the research activity carried out at the Collegio. Furthermore, the Committee provides an advisory service to the Foundation’s governing bodies as well as promoting staff training in the ethics field through meetings, seminars, joint study groups in the field of research and preparation of material for dissemination.

2. The Committee evaluates and approves research projects according to the procedures envisaged by art. 6, including, for the parts of its competence, those undertaken in collaboration with other institutions, also taking into account any evaluations expressed by the Ethics Committees of the participant institutions.

Art. 3 (Composition and term of office)

1. The Committee is made up of 3 members, chosen and appointed by the Foundation, and of a Chair elected by the members on taking office. The Committee holds office for 4 years. The Chair’s mandate lasts 2 years, renewable for the following 2 years.

Each member is personally responsible for his/her work on the Committee and cannot delegate others to participate in the works. In the case of the absence of a member, the Committee may take into account in its evaluations any written declarations sent in by the absent member. The members of the Committee agree to their name, position and curriculum being made public.

2. Members undertake to treat as confidential acts related to the work of the Committee and are obliged to declare any case of a conflict of interests before each evaluation.

Art. 4 (Workings)

1. For its workings, the Committee can avail itself of the secretarial services provided by the Foundation with the functions of support, taking minutes and the conservation of documentation regarding the Committee’s activities.

2. The Committee shall meet at least once a year. The meetings are valid if a majority of members is present and the opinions are approved with the manifest vote of the majority of those present. Minority reports are admissible and should be attached to the majority opinion.

In the case of request for opinions that are considered urgent for the Foundation’s activity, the Committee’s opinion may be requested via the Internet and is valid if approved by the majority of members.

3. Committee members’ absence without leave for three consecutive meetings implies their dismissal and replacement.

Art. 5 (Functions of the Chair)

The Chair represents the Committee and has the task of calling meetings, including on the request of the Chair or Scientific Director of the Collegio; to establish the agenda; to chair the works and sign the minutes and the resolutions. For his/her activities the Chair avails him/herself of the support of the secretarial services mentioned in the previous article.

Art. 6 (Procedures for requesting opinions)

1. The following may request the services of the Committee: the Governing Bodies of the Foundation and research staff.

2. The Committee may be presented with requests for evaluation and approval of projects. The requests must be lodged by a qualified researcher and are to be addressed to the Chair of the Committee. Requests should be accompanied by the following documentation:

- The original version of the project;

- The indication of those aspects of the project raising ethical issues;

- The curriculum vitae of the applicant;

- The form for the acquisition of consent and the third party insurance certificate (if pertinent);

- Copy of any opinions of other Committees.

The Committee reserves the right to request additional documentation.

3. The secretariat will register the documentation and ensure copies are sent, also by electronic means, at least two weeks before the date set for the meeting, to the Chair and members of the Committee.

4. The written version of the opinion will contain:

- The reasons for the approval/non approval of the study;

- The names of members who approved;

- Copy of the request for opinion and the list of attached documents;

Any other pertinent documentation.

5. In making the ethical evaluation, the Committee shall take into account the following points:

- The ethical principles relevant to the subject;

- The rationale of the project;

- The adequacy and completeness of the information contained in the documentation;

- The eligibility of the researcher in charge of the study;

- The measures adopted to guarantee the protection of the rights, including the confidentiality of personal data, of the subjects included in the study;

- The scientific importance and the social relevance of the study.

6. The secretariat communicates/transmits the Committee’s evaluation to the applicant within 15 days from the Committee’s deliberation.

7. If case of negative evaluation from the Committee, the research responsible, after an adequate revision, has the possibility to re submit the project to the Committee.

Art. 7 (Revision of the regulation)

This regulation is aimed at achieving objectives of efficiency and transparency. The operating procedures, being a dynamic aspect of the working of the Committee, may be revised periodically by the Committee itself. The individual members of the Committee or the body that has set it up may propose the revision of procedures, making a justified written request to the Chair that will be submitted for the approval of the Committee in the next meeting.