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Internal Ethics Committee regulations
IRCCS* Ospedale Pediatrico Bambino Gesù Internal Ethics Committee Regulations
(*Institute for Research, Hospitalisation and Healthcare)
Art. 1- The Ethics Committee (hereinafter denominated "Committee") regarding healthcare assistance and research at the IRCCS Ospedale Bambino Gesù (hereinafter denominated "OPBG"), established by the Board of Directors of the Ospedale Pediatrico Bambino Gesù in compliance with the minimum requirements of the applicable laws, is an independent body in accordance with the EU and internal directives and is inspired by the principles set out by the Ethics Committee Statute.
The Chair of the Committee and the Vice Chair - who shall have authority to perform all duties of the Chair in case the Chair is absent or unavailable; is the Chair's primary and closest collaborator; and by regulation must be external to the OPBG - are elected during the inauguration assembly by a majority and recorded vote.
A brief description of the qualifications and professional experience of each member and their membership organization must be submitted to the offices of the Committee's Scientific Committee.
In case of the resignation or expulsion of a member due to more than three unjustified absences (during one calendar year), the Committee shall ask the Chairman of the Ospedale Bambino Gesù Board of Directors to nominate a new member holding equal requirements.
Members of the Ethics Committee hold the seat for three years. A mandate cannot be renewed consecutively more than once. The Chair cannot hold the title for more than two consecutive mandates.
The dissolved Committee retains its functions until the new Committee has been instated.
Art. 2- Members of the Committee and Committee offices are sworn to confidentiality regarding any actions relating to the committee within the applicable laws and regulations.
Art. 3- In compliance with applicable laws, as per the Statute, the Committee is entitled to a qualified Technical-Scientific administration office; said office must be equipped with an adequate number of human, technical and administrative resources to meet the number of clinical trials being carried out, as well as the necessary infrastructures to ensure access to national and international databases and technical support activities to assess unexpected adverse events as well as adverse reactions.
The Committee's Technical-Scientific office receives and files all profit and not-for-profit trial applications that require the Committee's opinion, and verifies the completion and adequacy of the documents presented.
Once the complete information, scientific benefits, methodology and regulatory assurance have been ascertained, if applications for an opinion are submitted within and not later than the 10th day of the month preceding the next meeting of the Committee, they shall be entered into the Order of Business and all relevant documentation shall be sent, along with the Order of Business and the convocation letter, to all Committee members circa ten days before the meeting. For every investigation on the Order of Business, the Chair shall assign the role of supervisor to a member chosen from the healthcare professionals, the Pharmacologist and the local General Medicine Paediatrician, or from experts in Bioethics, Genetics, Medical devices, Nutrition, the Interventional Radiologist, and Biostatistician. The documentation relative to Committee activities, including documents received by the promoters of the clinical trial, is filed by the Technical-Scientific office and is available for the length of time foreseen by the applicable guidelines.
The Committee's Technical-Scientific office receives and files applications for ethic opinions on treatment and clinical approaches.
The application, accompanied by any documentation, must be presented in writing to the Ethics Committee Office Manager.
Art. 4- The Committee usually meets every 30 days, preferably the 2nd Wednesday of the month with the exception of urgent applications for which members can be convened by telephone or by fax/Email.
The Committee examines and formulates a reasoned opinion on the investigation within the period of examination of the application in compliance with applicable laws.
Art. 5- The Committee may request the presence of the applicant, or any other person involved in the conduct of the investigation, to the meetings in order to request supplementary explanations or information about the investigation. The investigator, applicant or any other person involved in the conduct of the investigation cannot participate in Committee decision making, opinion or vote.
The Committee, for specific consults, can also avail itself of the advise of external experts who have experience in specific areas that are not covered by the qualifications of Committee members.
Art. 6- Only those members who are independent of the trial investigator and sponsors can vote to approve a trial.
Ex officio members cannot participate in the vote.
Furthermore, once nominated and at each yearly deadline, each member of the Committee must sign a statement declaring their commitment to disclose conflict of interest, direct or indirect, or rather, any involvement in the development, management or supervision of the trial as well as any working relationship with the investigator or any consulting capacities with the pharmaceutical company that produces the drug.
Art. 7- Committee meetings are deemed valid, for the purposes of expressing an opinion, when half plus one of the Committee is present; on-call members cannot contribute to reaching the quorum.
All decisions are valid if voted by the majority of members qualified to vote; in case of a draw, the Chair's vote shall prevail.
At the beginning of every meeting, in order to avoid situations of conflict of interest, members who are qualified to vote must state, as defined in Art. 6 whether any direct or indirect conflict of interest subsists in the trials on the Order of Business.
Art. 8- The Ethics Committee adopts the guidelines, "as far as applicable", prescribed in order to institute and engage an Ethics Committee in compliance with D.M. [Ministerial Decree] 15.7.1997, D.M. 18.3.1998, D.L. [Legislative Decree] 24.6.2003, D.M. 12.05.2006, D.M. 08.02.2013 as well as EU, national and regional laws that regulate clinical trial activities for pharmaceuticals.
In particular the ethical, scientific and methodological assessment of clinical trials by the Committee must comply with the provisions stated in legislative decree n. 211 dated 2003, the most recent revision of the Declaration of Helsinki, the Oviedo Convention, good clinical practice (GCP), and by updated guidelines set out by the European Medicines Agency (EMA) regarding the evaluation of medicinal products to assess them for the use in clinical trials. The rights, safety and wellbeing of human subjects involved in a clinical trial are the most important aspects and must prevail over the interests of science and society.
In carrying out its activities, the Ethics Committee shall take into consideration National Bioethics Committee documentation, international organizations regarding the protection of human beings in biomedical research and clinical practice.
Art. 9- The Ethics Committee's responsibility is to protect the rights, safety and wellbeing of all those persons involved, in whatever capacity, in a trial with particular attention on trials that involve more vulnerable subjects (cfr GCP/ICH, 3.1.1).
To this end, the Ethics Committee reviews, in compliance with the standards of good clinical practice, the scientific and ethical details of the experimental protocols offered within the OPBG or by external applicants, and then expresses a binding, written opinion. Analysis of the protocol is carried out in compliance with the applicable laws and the "procedures for evaluating clinical trials".
The Ethics Committee also expresses, upon request, a specific opinion for medicinal products different from those in recent distribution, in compliance with D.L. [Legislative Decree] 24.6.2003.
Art. 10- The Ethics Committee, upon request from the healthcare professionals or patients or their legal representative, assesses cases or clinical problems relative to the activities carried out within the OPBG and expresses opinions and recommendations for the course of action.
Moreover, the Ethics Committee promotes the publishing of documents regarding bioethical issues and guidelines to foster quality improvement in clinical practice, humanize the healthcare institution, and encourage a better understanding of the meaning and approach of healthcare.
The Ethics Committee develops and promotes training events on the ethical aspects of biomedical methods and research for both healthcare workers and the general public.
Art. 11- In preparing an assessment and opinion on clinical trials, the Ethics Committee shall consider, in particular:
a) whether the submitted documentation provides satisfactory data on the clinical safety of the product;
b) any previous opinions of non-acceptance expressed by other Ethics Committees on the same trial, events that must be notified by the applicant of the trial to the Committee in cases of applications following an opinion of non-acceptance;
c) if the documentation and the informed consent and any use of placebos are in compliance with the Declaration of Helsinki and regulations stated in Ministerial Decree dated 12 May 2006. As a general rule, patients in the controlled group cannot be treated with placebos if effective treatment is available or if the placebo causes distress, prolongation of the illness or risk. The use of a placebo can be admitted if an effective treatment approach for the controlled group is not available, or as a complement to a treatment approach of proven efficacy in order to allow double-blind tests;
d) the overall risk/benefit factors of the clinical trial, considering that informed consent is not enough to guarantee the scientific and ethical quality of the trial protocol;
e) the scientific validity and rationale behind the project, the adequacy of the protocol, regarding all the objectives of the trial, the design, conduct, and the potential achievement of established conclusions with the lowest possible exposure to subjects;
f) the qualifications, experience and suitability of the investigators and supporting staff involved in the clinical trial and the adequacy of the facilities in which the trial is carried out;
g) that the trial protocol specifies that in promoting and publishing the results by the investigators who carry out the trial, the rights to privacy and to the protection of personal data and patents are safeguarded, and that no restrictions are founded for promoting and publishing the results on the part of the sponsor;
Based on the abovementioned assessments, the Committee shall confer and notify the subjects about deliberation in compliance with the provisions laid down by law.
Art. 12- In expressing its assessment and opinion on the clinical investigation of medical devices, taking into consideration the type of medical device, or implantable medical devices, for ethical, scientific, technical and methodological aspects, the Ethics Committee can also refer to:
a) where specified by the promoters of the clinical trial, the relative technical standards as indicated in Art. 3 of Legislative Decree No. 507 of 14 December 1992, and amendments, or Art. 6 of Legislative Decree No. 46 of 24 February 1997 and amendments, and UNI EN ISO14155:2011 technical standards, Clinical investigation of medical devices for human subjects -- Good clinical practice and revisions, or any equivalent technical standards;
b) European Union guidelines regarding good clinical practice in the execution of clinical trials of medical products, in accordance with Ministry of Health Decree of 15 July 1997 with regards to clinical investigations of medical devices on human beings;
Art. 13- The Ethics Committee assessment on clinical investigation of medical devices or active implantable medical devices shall also consider the following legal provisions:
a) Art. 7 and appendixes 6 and 7 of Legislative Decree No. 507 of 14 December 1992 and amendments;
b) Art. 14 and appendixes VIII and X of Legislative Decree No. 46 of 24 February 1997 and amendments.
Art. 14- In case of studies on edible products, the Ethics Committee shall verify that the controlled group is defined based on the characteristics of the product subject to the trial and the objectives of the trial.
Art. 15- In cases where the protocol indicates that the trial should be used exclusively in emergency situations and therefore it is not possible to obtain consent from the subject or their legal representative, the Committee, after verifying that the proposed protocol and/or other documentation satisfies the basic ethical principles and are in compliance with the applicable provisions laid down by law for this type of clinical investigation, will express the specific regulations which the investigator for the trial in question must adhere to.
Art. 16 – Subjects that are unfit to understand and take action, mentally unsound, incapacitated, must be excluded from the trial even with the informed consent of their legal representative with the exception of conditions foreseen by the Oviedo Convention and applicable regulations.
Art. 17 – The Chief Medical Officer, the Chief Scientific Officer, and the Managing Director of Pharmacies that are ex officio members of the Committee must, in addition to participating in discussions regarding the proposed trials, express, each for their specific field, opinions and the necessary information required by the Committee regarding:
- the scientific validity of the proposed trial;
- the availability within the Ospedale Bambino Gesù facilities of all the necessary equipment for the trial; or in alternative information on equipment supplied by the sponsor or the holder of Ospedale Bambino Gesù research funds, equipment and all other materials that can be inventoried and are not at the disposal in the facilities but necessary for the research;
- the supply, on behalf of the sponsor or holder of Ospedale Bambino Gesù research funds, of all the necessary materials, including medical products, to be used in the trial;
- the feasibility of the trial, with reference to the possibility of enrolling an adequate number of subjects for the duration of the trial, the facilities, the human resources and the structural and technical resources.
Art. 18 – The Committee verifies that the sponsor or Ospedale Bambino Gesù research funds will cover any and all additional costs that the Ospedale Bambino Gesù or its patients may have to face in order to participate in and carry out the trial.
The Committee also verifies that the sponsor, or hospital research funds, can guarantee adequate insurance coverage to trial subjects to protect them from any direct or indirect damage attributable to a trial, as well as insurance to cover the liability of the investigators, according to maximum coverage and criterion to be assessed based on the proposed trial.
Art. 19 – The Committee appointed to expressing a single opinion, within 30 days from the date of receipt of a valid application, must release one of the following opinions, including valid reasons:
If the opinion is unfavourable, the sponsor of the trial may not apply for a single opinion to another Ethical Committee nor for a new single opinion for the same trial, even if it is amended in part or parts, with the exception of when the sponsor of the trial retains he must make amendments to the elements of the same trial, acknowledging the reasons for which the Committee issued an unfavourable opinion. Should the sponsor want to present a new application for the same trial, amended in part or parts, he can present the new application only to the same Committee that expressed an unfavourable single opinion, accompanied by said opinion.
Art. 20- For justified reasons of urgency verified by the Chair, wherein it is not possible to convene an emergency Committee meeting, in special circumstances using procedures established each time by the Chair, the opinion of Committee members on single specific matters can be accepted. The Secretary shall collect all the written opinions expressed by the individual members and the definitive opinion shall be chosen according to majority consensus in compliance with the procedures described previously regarding deliberations accepted during regular meetings. At the Committee meeting immediately following the request, the Secretary will provide a memorandum stating the emergency procedures carried out.
The Committee can be consulted via unofficial channels in cases of urgent requests for expanded access (prolonged use of a medical product in a trial) by fax, email or telephone.
Art. 21 – Committee meeting minutes shall be drafted by the Technical-Scientific office.
The minutes of the meetings must include the following decisions:
- endorsement, if applicable, of the trial protocol;
- the requested amendments needed to express endorsement;
- non-acceptance with relevant reasoned opinions;
- any further information from trials currently underway for any revisions for acceptance;
After the Chair has approved the minutes of the meeting, they shall be sent to every member of the Committee.
Once the minutes have been approved, or following a period of 4 days of tacit approval after the minutes have been sent, the Technical-Scientific committee secretary shall transmit the minutes in extract, as far as their area of responsibility is concerned, to the sponsor and the investigator of the trial. Furthermore, the minutes shall be sent to the President of the Ospedale Pediatrico Bambino Gesù and in cases in accordance to applicable laws, the Committee's opinion shall be sent to the Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali (Italian Medicines Agency). In the case of substantial results, the minutes will be retained as temporarily approved in regards to the points that are not under disagreement in order to communicate favourable opinions approved by the Committee to those who have a right to it in the shortest time possible.
The definitive version of the minutes shall be approved by the Committee at the following meeting and should there be further amendments, the secretary shall send or deliver the revised minutes to the Committee members.
Art. 22 – In light of information that could raise doubts about the scientific validity or safety of the clinical trial, the Committee can reassess the opinion previously issued and if necessary can annul or suspend a favourable opinion and inform the competent authorities. At the same time, the Ethics Committee shall request, in name and as a representative of the local competent authority, the assessments of the trial's sponsor or investigator and any other facilities participating in the trial, with the exception of any timely interventions of immediate danger.
Art. 23 - In case of changes and/or amendments made to the protocol after the approval and commencement of a clinical trial, the Committee shall examine them during the course of the next meeting; in case of urgency, the Chair or a delegated representative can convene the Committee via fax, email or telephone.
Art. 24 – The Technical Scientific office shall file and store the following:
a) the register containing the recognized opinions of the medicinal products not in current use issued by the OPBG Committee (until the date of repeal);
b) the register of the clinical trials on authorized medicinal products in compliance with current regulations, available from the Ministry of Health to ensure that rules and regulations are observed;
c) all documentation relating to the activities: written standard operating procedures (SOPs), a list of members and their respective professions/institutions, documentation submitted by trial applicants, minutes of all meetings, all correspondence, etc. for the duration in compliance with regulations in force for the purposes ensuring that Ministry of Health rules and regulations are observed.
Art. 25 – The investigator shall sign the final report and findings of the trial. Should the investigator be a person other than the Director of the hospital department, the final report shall be countersigned by the aforementioned.
The final report on the clinical trial, the original documentation, as well as the code establishing the connection between said documentation and the patients participating in the trial must be retained by the supervisor of the trial for a period of time in accordance with GCP.
Art. 26 – Where provided for by law, a review of Committee deliberations is permitted. The request for review must have satisfactory motivations and be submitted to the Committee Chair. The appeal will be assessed within the period of time stipulated by legislation.
Art. 27 – The Chairman of the Administrative Board of the Ospedale Bambino Gesù designates a supervisor to evaluate that all administrative tasks relative to requests for clinical trials have been fulfilled and to raise the necessary funds for carrying out Committee functions.
The Chairman of the Administrative Board of the Ospedale Bambino Gesù shall establish the amount of the attendance token for participation in Ethics Committee meetings.
The Chairman of the Administrative Board of the Ospedale Bambino Gesù shall also establish the quota that the external Sponsor of a trial must pay to the Ospedale Bambino Gesù for the assessment, by the Committee, of the trial protocol.
For matters not included in these regulations, refer to Ministerial Decree of 8 February 2013 (Criteria for the Composition and Responsibilities of Ethics Committees), Ministerial Decree of 12 May 2006 (Minimum Requirements for the Institution, Organization and Function of Ethics Committees for Clinical Investigation of Medicinal Products), Legislative Decree No. 211 of 24 June 2003, Ministerial Decree of 15 July 1997 (European Union Guidelines for Good Clinical Practice), and Legislative Decree No. 196 of 30 June 2003.
Ethics Committee Regulations 23/10/2013