Description
Pursuant to Article 3(4) of the Decree, the composition of the Regional Ethics Committees (CETs) must ensure that members possess the necessary qualifications and experience to assess the ethical, scientific and methodological aspects of the proposed studies and to carry out the functions assigned to them.
Members of the Regional Ethics Committees must possess documented knowledge and experience in clinical trials of medicinal products and medical devices, and in other matters falling within the remit of the Ethics Committee.
With regard to its composition, in accordance with the provisions of the Decree, the CET of the Autonomous Province of Trento comprises the following professional figures: four clinicians with expertise in clinical trials, one of whom specialises in the study of new technical, diagnostic and therapeutic procedures, both invasive and semi-invasive; a local general practitioner; a paediatrician; a biostatistician; a pharmacologist; a hospital pharmacist; a legal expert; an insurance expert; a forensic pathologist; a bioethics expert; a representative from the relevant healthcare professions involved in clinical trials; a representative of patient organisations or citizens’ groups active in health-related issues; a medical devices expert; a clinical engineer and a medical physicist; in relation to the study of food products in humans, a nutrition expert; in relation to genetic studies, an expert in genetics.
In order to ensure that expertise is available in areas not covered by the Committee’s members, the CET may call upon external experts identified in specific registers for the following professional roles: an expert in information technology, in particular generative AI; a psychologist; and a psychiatrist.
1. Eligibility criteria
Those who, by the deadline for submitting an expression of interest, meet the following requirements may submit their expression of interest:
- Italian citizenship or citizenship of a Member State of the European Union;
- documented knowledge and experience in clinical trials of medicinal products and medical devices and in other matters falling within the remit of the Ethics Committee;
- basic knowledge of the use of web platforms and commonly used word processing and spreadsheet programmes (Office suite or equivalent);
- a good command of English (at least at B1 level).
In order to ensure the independence of the CET, individuals may not be appointed as members, nor may they be called upon as external experts, if they:
- are subject to the grounds for ineligibility set out in Article 7 of Legislative Decree No. 235 of 31 December 2012;
- have been convicted of a criminal offence with a final and binding judgement;
- are subject to ongoing criminal proceedings, administrative proceedings for the application of security or preventive measures, or have a criminal record entered in the criminal register pursuant to Article 3 of Presidential Decree No. 313 of 14 November 2002;
- are subject to measures restricting personal liberty or preventive measures;
- have direct interests in companies and/or organisations (i.e. parent companies, subsidiaries, associated companies or affiliates) that develop, manufacture or market pharmaceutical products, medical devices, biological products, chemical products and dietary products; pursuant to Article 4(2)(c) of the Decree (the term ‘direct interests’ means that the individual currently holds, or has held within the last three years: an employment relationship, a strategic consultancy role, an executive role or a leading role in product development, or financial interests).
In the conduct of the CET’s activities, independence is guaranteed by the voters’ lack of involvement in and absence of conflicts of interest with regard to the proposed trial; therefore, members must sign annually, and whenever there are any changes, a declaration obliging them to abstain from participating in the evaluation of those trials for which there may be a direct or indirect conflict of interest, including, by way of example only and by no means an exhaustive list:
- involvement in the design, conduct or management of the trial;
- the existence of any relationship of employment, consultancy or collaboration, in any capacity, with the investigator or the sponsor of the clinical trial, or with the company that manufactures or markets the medicinal product, medical device, foodstuff or other product involved in the trial;
- the absence of any economic or financial interests shared between the members of the Ethics Committee and private companies in the relevant sector;
- further safeguards and rules on incompatibility set out in the ethics committee’s regulations;
- the absence of any undue influence.
2. Submission of applications
Applicants who meet the required criteria must, on pain of exclusion, submit their application, drawn up in accordance with the attached template, in one of the following ways:
- by email or certified email, in accordance with the relevant technical rules and the provisions set out in Provincial Council Resolution No. 2051/2020, to the address serv.politsanitarie@pec.provincia.tn.it;
- by registered post with acknowledgement of receipt;
- by hand delivery to the secretariat of the relevant department (Via Gilli, 4 – Trento) from Monday to Friday between 10.00 and 12.00.
The subject line of the email sending the application must state ‘Response to the public notice for the selection of members of the CET of the Autonomous Province of Trento’.
The following documents must be attached to the application:
- a curriculum vitae, drawn up in accordance with the European format, including a clause authorising the processing of the data contained therein, and duly dated and signed with the following statement: “On my own responsibility, pursuant to Articles 46 and 47 of Presidential Decree No. 445 of 28 December 2000, and aware of the criminal penalties provided for in Article 78 of the aforementioned Presidential Decree for cases of forgery of documents and making false statements, I declare that the information contained in this CV is true”;
- a photocopy of a valid identity document;
- any other documentation which the candidate deems useful to submit for the purposes of assessment.
The Autonomous Province of Trento accepts no liability in the event of communications being lost due to incorrect address details provided by the candidate or failure to notify changes to the details given in the application form, or for any mishaps not attributable to the administration itself or otherwise attributable to third parties, or to unforeseeable circumstances or force majeure.
Applications submitted after the deadline specified or in a manner other than that set out in this notice shall be deemed inadmissible.
Applications failing to meet any of the requirements set out in point 1 shall be deemed ineligible.
3. Categories of qualifications and allocation of marks
The CVs of candidates meeting the eligibility criteria for this selection process will be assessed by the Assessment Panel on the basis of the following categories and their respective allocation of marks.
a) Professional Experience (up to 14 points)
The following will be assessed:
- years of service in roles relevant to the required profile (up to 5 points);
- previous experience as a member of an ethics committee for clinical trials or other committees/commissions dealing with matters falling within the remit of the CET (up to 5 points);
- roles as coordinator of research groups or experience within any research units (up to 4 points).
b) Scientific Activity and Publications (up to 8 points)
The following are subject to assessment:
- Publications in indexed journals;
- Participation in clinical trials as Principal Investigator (PI) or co-investigator in studies conducted in accordance with GCP (Good Clinical Practice).
c) Academic Qualifications and Training (up to 8 points)
The following are assessed:
- a degree relevant to the professional profile for which the application was submitted (up to 2 points);
- PhD or first- or second-level Master’s degrees in subjects falling within the CET’s remit (up to 4 points);
- university teaching experience (up to 1 point);
- specialist training courses (up to 1 point).
4. Preliminary assessment, composition and validity of the lists
The Head of the relevant provincial health service appoints the assessment panel, which is responsible for examining the applications and, on the basis of the scores achieved by the candidates, for drawing up the list of CET members, the list of candidates eligible to serve as CET members and the list of external experts.
In the event of a tie (equal scores), preference is given to the younger candidate, in accordance with Article 2, paragraph 9, of Law No. 191 of 16 June 1998.
Furthermore, when selecting CET members, account will be taken of the necessary balance between professional expertise, gender representation and the age of the candidates, as well as the specific characteristics of the CET in relation to the activities carried out, in order to ensure a composition capable of assessing the widest possible range of clinical trials, without prejudice to the Committee’s independence pursuant to Article 4 of the Decree.
5. Appointment of members and list of eligible candidates and external experts
The Provincial Executive shall appoint the members of the CET by means of its own resolution.
Pursuant to Article 3(7) of the Decree:
- the members of the CET shall remain in office for three years, and in any event until the Committee is renewed, with the possibility of a single consecutive renewal of their term of office;
- the Chair may not hold that office for more than two consecutive terms.
The list of eligible candidates and external experts shall remain valid for the entire duration of the CET, for a period of three years, which may be extended for a further three years.
6. Attendance allowance and reimbursement of expenses
Members of the CET, as provided for in Article 4(1) of the Decree of the Minister of Health of 30 January 2023, entitled ‘Determination of the single tariff for clinical trials, attendance fees and reimbursement of expenses for participation in meetings of the National Co-ordination Centre of Territorial Ethics Committees for Clinical Trials on Medicinal Products for Human Use and Medical Devices, of the territorial ethics committees and of the national ethics committees”, shall be entitled to an attendance allowance, set at €300.00, as well as reimbursement of travel expenses for attending the respective meetings.
External experts are not entitled to any remuneration, as participation in the work of the Ethics Committee is on a voluntary basis (Article 3(6) of the Decree of 30 January 2023).
In order to facilitate attendance at meetings and ensure that a quorum is reached, the CET Regulations provide that meetings may be held online.
7. Insurance costs
Any insurance costs shall be borne by the members and external experts.
8. List of eligible candidates and list of external experts
Applications received that are deemed suitable for the role of CET member will also be included in a dedicated list of available candidates from which to draw for any new appointments or replacements.
For specific consultancy work in the event of assessments relating to areas not covered by its internal members, the CET, in accordance with Article 3(5) of the Decree, may call upon external experts from the relevant list.
9. Communications
All communications relating to this procedure must be made via certified email (PEC).
Participants are therefore required to check the validity and proper functioning of their certified email account (PEC) and to notify the Health and Long-Term Care Policy Service (serv.politsanitarie@pec.provincia.tn.it) of any changes to their PEC address.