EURAXESS: A Human Resource Strategy to incorporate the Charter and Code

Transcription

1 Científica: Gestión Económica: BIOMEDICAL RESEARCH INSTITUTE OF HOSPITAL CLÍNICO UNIVERSITARIO DE VALENCIA. EURAXESS: A Human Resource Strategy to incorporate the Charter and Code Internal Analysis and Action Plan.

2 Científica: Gestión Económica: EURAXESS: A Human Resource Strategy to incorporate the Charter and Code Internal Analysis and Action Plan Table of Contents Introduction... 3 Methodology... 5 The work plan considered the following points proposed by the European Commission in the HRS4R strategy:... 5 Identification of key issues... 5 Methodology... 6 Key findings of the internal analysis (HRS4R Gap Analysis)... 8 Results from the workshops with the focus groups... 9 Annex I: Gap analysis I. Ethical and professional aspects II. Recruitment III. Working conditions and social security IV. Training Annex II: Action Plan Annex III: Concordance between identified weaknesses and proposed actions

3 Científica: Gestión Económica: EURAXESS: A Human Resource Strategy to incorporate the Charter and Code Internal Analysis and Action Plan Introduction The Biomedical Research Institute INCLIVA, established in 2000 and accredited as a Health Research Institute in 2011, has the mission of fostering, promoting, coordinating and executing quality health-oriented research, integrating the basic and clinical aspects in order to improve the health and quality of life of the population. INCLIVA manages the biomedical research of the Hospital Clínico Universitario de Valencia and its Health Department. It also manages the research of other outstanding scientific research groups including the Facultad de Medicina de la Universidad de Valencia and the Instituto Universitario Valenciano de Infertilidad, (IUIVI). As described in its vision, INCLIVA s objective is serve as a national and international reference institute in clinical and translational research, recognised for its healthcare innovation and excellent management. Approach to the problems of Society Scientific excellence Innovation Transference Management excellence Integration Strategic alliances Internationalization Training multidisciplinary collaboration Bioethics Ongoing Improvement Social Commitment Transparency Environment Sustainability The following values govern INCLIVA s activities: Seeking solutions to society s major health problems Continuous orientation towards scientific excellence Focus on innovation and the transfer of results Integration and multidisciplinary collaboration, and development of strategic alliances Compliance with national and international bioethical research regulations Internationalization of scientific activity Continuous improvement and training of research and management staff Orientation towards excellence in management Commitment to society: transparency, environment and sustainability INCLIVA currently has more than 400 prestigious researchers from the international scientific community and has first-class technology for the development of quality research, strengthened since 2012 by the ISO 9001:2008 Certification in Administrative and Economic Coordination and Scientific Management areas. INCLIVA maintains a firm commitment to quality and dedication of service to researchers, which takes the form of its strategic planning for the Specifically, the Institute has identified its principal strategic objectives as those related to attracting talent and consolidating research careers within the institution, developing its framework of relations and HR strategy. It also maintains and strengthens the consolidation of research platforms to serve the research community and provides training for R&D&I researchers and managers, further reinforcing its commitment to social responsibility, transparency and environment. 3

4 Científica: Gestión Económica: EURAXESS: A Human Resource Strategy to incorporate the Charter and Code Internal Analysis and Action Plan The HRS4R (Human Resource Strategy for Researchers) 1 prepared by the European Commission, is designed as a tool for the implementation of the recommendations regarding the rights and responsibilities of researchers and their employers and/or funders, listed in the European Charter for Researchers and in the Code of Conduct for the Recruitment of Researchers (C&C) 2. In 2014, INCLIVA signed the C&C, accepting the values defined in it and committing itself to align its Human Resource policies and practices with the recommendations made in both documents. In order to advance in the implementation of C&C and using as a framework the HRS4R, a process was carried out to analyse the degree of compliance with each of the 40 principles set out by the C&C, in order to detect deficiencies and areas for improvement to be implemented in the coming years, which have been transferred to INCLIVA s Human Resource Action Plan for R&D&I. This process is aimed at making the Institute more attractive to researchers, creating the most favourable conditions to develop their research careers. This document describes the methodology followed in this process and the main conclusions and results. 1 HRS4R: 2 C&C: 4

5 Científica: Gestión Económica: EURAXESS: A Human Resource Strategy to incorporate the Charter and Code Internal Analysis and Action Plan Methodology The work plan considered the following points proposed by the European Commission in the HRS4R strategy: 1) Gap Analysis: Internal analysis of current practices by comparing institutional policies with the recommendations listed in the C&C, establishing the institution as the key element. 2) Action Plan: Initiatives proposed to achieve the identified objectives (what, who and when), publishing the main results on INCLIVA s official website. 3) Workgroup review: the objectives are reviewed to improve the plan of action and provide internal analysis. 4) Application of knowledge of the strategy by the European Commission. 5) Implementation of HR strategy through internal quality procedures, with self-evaluation after two years. 6) External evaluation of initiatives carried out successfully from the initial proposals. Identification of key issues The following key aspects for success were identified during the analysis of compliance with the C&C recommendations, in order to detect gaps and to define corrective, preventive or improvement actions. Institutional commitment, formalized through a Steering Committee with the participation of institutional leaders in scientific and economic-administrative matters. Feasibility and suitability of INCLIVA s Action Plan on Human Resources for R&D&I to the needs and possibilities of the institution (technical and financial feasibility, timeliness of measures to be implemented). Participatory development strategy: response to real needs of established, emerging, and trainee researchers. Identify key personnel for the development of analysis and prioritization of activities to be carried out within the framework of the future action plan. Identify the person responsible for each priority action, appropriate timing and setting useful and feasible indicators: impact on the implementation and development of the Plan. Integration of the Action Plan within INCLIVA s quality strategy. Increase internal and external visibility of the conclusions reached and the strategy adopted. 5

6 Científica: Gestión Económica: EURAXESS: A Human Resource Strategy to incorporate the Charter and Code Internal Analysis and Action Plan Methodology In order to develop INCLIVA s strategy of human resources in R&D&I covering the key issues identified, the following methodology was applied: Analysis of legal conditions (regulatory review) Analysis of regulatory constraints of INCLIVA) Institutional workgroup Identification of potential areas for improvement Technically feasible improvement actions Gap analysis validation Project steering committee Prioritized improvement actions Prioritized weaknesses Focus groups Responsible allocation and scheduling of selected actions Project steering committee The following work groups and committees were created for the proper development of the methodology described: a. Steering committee, which works on the validation analysis and approves INCLIVA s Human Resource Action Plan for R&D&I. Members: Dr. Rafael Carmena Rodríguez INCLIVA Managing Director Vicente de Juan Martín INCLIVA Economic Director Enrique Cremades Innovation Area Manager Dr. Josep Redón i Mas INCLIVA Scientific Director Marta Peiró Scientific Subdirector b. Institutional workgroup made up of the people in charge of the strategic and operational processes related to management, assessment, training and communication, responsible for carrying out the gap analysis according to the template proposed by the HRS4R strategy. 6

7 Científica: Gestión Económica: EURAXESS: A Human Resource Strategy to incorporate the Charter and Code Internal Analysis and Action Plan Members: Vicente de Juan Martín Economic Director INCLIVA Enrique Cremades Innovation Area Manager Ruth Cano Head of HR and general services Vanessa Aznar HR Technician Rafael Barajas Quality and Planning Unit Marta Peiró Scientific Subdirector Loli Iglesias Clinical Study Management Unit Ana Ferrer Head of International programs Mayca Román Research Project Management Unit Justo Giner Scientific Culture and Innovation Unit Training Events Unit Maite Sáez General Secretariat Anabel Gil HR unit and General services c. Focus groups. - In order to ensure broad participation by different professional profiles assigned to IIS, INCLIVA focus workgroups of up to 6 members were created. These groups prioritized the pre-identified weaknesses and the actions to be undertaken by INCLIVA according the criteria of impact and feasibility. The details of the different focus groups involved are specified below: Head Area Researchers or head research groups researchers Emerging researchers (not included in previous groups) Assistant researchers (not included in previous groups) Young doctors Researchers in training Technical profiles 7

8 Científica: Gestión Económica: EURAXESS: A Human Resource Strategy to incorporate the Charter and Code Internal Analysis and Action Plan Key findings of the internal analysis (HRS4R Gap Analysis) The internal analysis details are included in Annex I (Gap Analysis), with the main conclusions are presented below. Strengths: The INCLIVA Foundation belongs to public foundation sector of the Generalitat Valenciana, and as such is subject to the principles of transparency, efficiency and equality regulated by current legislation. In particular the Generalitat Valenciana advocates compliance with the principles embodied in the C&C. INCLIVA has been accredited as Health Research Institute since September This accreditation, awarded by the Ministry of Science and Innovation, reflects the commitment to quality of the R&D&I Translational activity that takes place within the institution. It has its own strategy that guides both the R&D&I and training activity, strengthening research and innovation developed by its groups, activities. Excellence, People, Innovation, Internationalization, Company and Information Technology are the strategic priorities that govern its activity. Its organizational structure incorporates advisory bodies and promotes the participation of the research community to ensure the principles and commitments established in the C&C. It has a management structure that provides support services to the Institute's researchers with UNE 9001 certification. The scope of this certification includes all human resources, project management, innovation management and transfer knowledge, communication and training processes. The staff s opinions and needs are regularly surveyed and results are considered in successive improvement plans. The selection processes are open and transparent, based on the assessment of the merits and abilities of candidates. The Plan of Training and Support Plan for Emerging Groups includes the tools for professional development of INCLIVA researchers. It also has platforms support research certified or undergoing certification providing technical services to the research INCLIVA staff. The actions to promote R&D&I include subsidy announcements that INCLIVA published annually, and which include specific subsidies for researcher mobility. Advocates translation and transfer of knowledge to society and production. INCLIVA counts on an Equality Plan. 8

9 Científica: Gestión Económica: EURAXESS: A Human Resource Strategy to incorporate the Charter and Code Internal Analysis and Action Plan Weakness: Improved internal procedures to support and promote knowledge, ensuring the adherence and compliance with ethical principles and best scientific practices by all members of INCLIVA. Insufficient mechanisms to recognise the activity of INCLIVA s staff and research groups, and develop a strategy ability to attract personnel, adapted to the applicable legal regulations. Need to promote the development of future INCLIVA researchers. Lack of a collective bargaining agreement. Revision and improvement of selection procedures and internal communication. Enhancing communication and interaction with society. Results of workshops with the constituted focus groups In addition to the internal analysis (Gap Analysis) that was carried out according to the HRS4R strategy for the implementation of the C&C recommendations, the process included the participation of the professional profiles that make up INCLIVA. They were invited to participate in the focus groups described in the previous sections. This participation resulted in the development of workshops where focus groups shared their opinions about current practices implemented in INCLIVA, and prioritized gaps and improvement actions implemented in INCLIVA. A quality methodology was used with a target group to study perceptions of researchers in several aspects. Participants of these groups (34 people) were chosen from INCLIVA s research and technical personnel, so they represented the different groups that comprise it. Results from the workshops with the focus groups The opinion of the members in the focal groups were collected in the structured inquiry developed, according to the following scoring table. Strengths Impact on strategy Very low Low Medium High Very high Satisfaction Somewhat Neither satisfied nor Somewhat satisfied dissatisfied dissatisfied Very satisfied Very dissatisfied Improvement areas Impact on strategy Very low Low Medium High Very high

10 Científica: Gestión Económica: EURAXESS: A Human Resource Strategy to incorporate the Charter and Code Internal Analysis and Action Plan Satisfaction Very satisfied Somewhat satisfied Neither satisfied nor dissatisfied Somewhat dissatisfied Very dissatisfied Actions Impact on strategy Very low Low Medium High Very high The highest impact strengths and improvement areas considered by the focal groups members in the development of the human resources strategy in R&D&I of the INCLIVA are presented below. Priority orders have been established based on the following criteria: Priority 1: Mean values of impact criteria valued greater than or equal to the average score of all the surveyed. Priority 2: Criteria that are not considered Priority 1, but at least three focal groups have heavily prioritized them. It is considered fulfilled when the average score assigned by the group has exceeded or equalled the 4 points. Priority 3: Criteria that are not considered Priority 2, but at least one focal group has heavily prioritized them. It is considered fulfilled when the average score assigned by the group has exceeded or equalled the 4.5 points. Order Higher impact strengths Average score 4 4,5 1 Having an In-house training plan and plan for support of emerging groups. 4, Training plan that includes actions aimed at all the profiles that form the Institute and different formats: conferences, courses, seminars, workshops, scholarships and outreach activities aimed at undergraduate and master. These activities include methodology, techniques, cutting-edge areas of research, knowledge transfer. 2 Having an evaluation mechanism for new access groups and an Integration 4, Plan. 3 Subsidies for training stays in prestigious centres. 4, The Strategic Plan includes a complete Persons axis (recruitment and holding of talent, including future researchers). 5 Defined, public and accessible recruitment processes. Especially at local level, based on the assessment of the merits and abilities of candidates, incorporating different criteria, the degree being the only limiting merit. Selection by a committee. 6 Announcements of public subsidies based on evaluation of merit, with participation by a Selection Committee. As funding agent, makes public its announcements for subsidies, publishing objectives, evaluation system, obligations and rights of beneficiaries. 7 It provides advice and support from the management units and its research support platforms, many of which have been certified or are in the process of being certified. Mechanisms to promote Innovation and transfer of knowledge. 8 Professionals experienced in the training capacity of personnel in the groups, and INCLIVA s management structure and platforms 9 Joint activities with the UV, the UPV and professional training centres. Processes established for the development of training stays. 10 Established legislation in the area of Social Security and Working Conditions, recognizing the rights and obligations of workers and the guarantees of the Social Security system, promotion of arbitration and gender policies. Specifically, the Generalitat Valenciana advocates compliance with the principles included in the C&C (Act 2/2009). 4, , , , , , ,

11 Científica: Gestión Económica: EURAXESS: A Human Resource Strategy to incorporate the Charter and Code Internal Analysis and Action Plan Order Higher impact strengths Average score 11 Its organizational structure incorporates advisory organs and organs for participation in the research community: Internal Scientific Committee and External Scientific Committee. Specifically, the selection of candidates to participate in limited subsidy announcements corresponds to the ISC. The opinions and needs of the staff are surveyed periodically and the results are incorporated into the successive improvement plans. 12 ISO-certified management processes including HR processes (Public job offers, Selection, Welcome, Self-protection, Hiring) communication, project management, and innovation. Quality Management system, control processes, and Intervention audits. 13 Its organizational structure includes an Internal Scientific Committee, CEIC/Ceim, Ethics Committee for Animal Experimentation of the U.V. 14 Client-orientation as one of the pillars of the Quality Management System (systems for detection and handling of issues, improvement actions, and nonconformities). 4 4,5 4, , , , Order Higher impact improvement areas Average 4 4,5 score 1 The lack of sufficient mechanisms for the evaluation and recognition of the 4, activity of INCLIVA s staff and research groups. Respecting the legal and budgetary limits that apply to it as part of the public sector of the Generalitat Valenciana. 2 Mechanisms to guarantee generational hand-off (attracting post-doctoral 4, staff). Lack of criteria or standards to be fulfilled by researchers who would like to form part of INCLIVA (personnel of associated entities) 3 Improve transparency of hiring processes and merit-evaluation processes (in its 4, dual role as an R&D&I and financing institution). 4 Proactive communication of rights, obligations, work conditions, and available 4, resources. Promotion of knowledge of the plans and tools in the area of professional training and development by INCLIVA personnel. 5 There are no formal mechanisms for professional guidance, especially for 4, personnel in training or those who are beginning their careers, especially in the area of science 6 Possibility of improvement of training activity, especially in the initial stages 4, (personnel in training). 7 There is no collective bargaining agreement for the sector 4, Mechanisms for knowledge of objectives, strategic and operational plans, resources, and procedures of INCLIVA, especially promoting the knowledge of the aspects related to intellectual and industrial property, and facilitating compliance with the requirements related to animal experimentation. 9 Development of the innovation policy, including regulation for revenue distribution and creation of businesses. 10 Strengthening of two-way communication with society, adopting collaboration and interrelation mechanisms that make it possible to reinforce social commitment, transfer of knowledge, and exploitation of results 11 Promote equality in all policies and processes (without prejudice to the criteria of merit and ability). Need for formal implementation of the perspective of gender and equality in INCLIVA s strategy that reflects the questions in regard to equal opportunity, work-life balance. Incorporate the gender perspective into the composition of selection and evaluation committees. 12 Guarantee proper compliance with the Personal Information Protection Act by all members of the Institute, improving the information security system. 13 Mechanisms in INCLIVA that guarantee correct management of selection teams and processes. Improvement of welcoming of personnel, especially personnel in training, residents 4, , , , , ,

12 Científica: Gestión Económica: EURAXESS: A Human Resource Strategy to incorporate the Charter and Code Internal Analysis and Action Plan 14 There is no process to facilitate knowledge of the rights and obligations of trainers and personnel in training by the personnel of INCLIVA, and conflict resolution (if necessary), especially between personnel in training and their supervisors. 15 Updating of the quality management system after the implementation of the HRS4R Strategy. Measures must be implemented to make it possible to evaluate the level of satisfaction in regard to the Human Resource Strategy to be implemented (including personnel in training or beginning their professional careers). 16 In the support system for the knowledge, acceptance, and compliance with ethical principles and scientific best practices by all members of INCLIVA. There is no form for acceptance of recognized ethical practices, no document that reflects these rights and limitations, and there is no process outlining actions to be taken in case of non-compliance. 3, , , The results of the survey on the current level of satisfaction are presented in the following table as a measure of improvement areas most important for researchers and technical staff of the INCLIVA Order Higher impact improvement areas Average score 4 4,5 1 There is no collective bargaining agreement for the sector. 3, Lack of sufficient mechanisms for the evaluation and recognition of the activity 3,92 3 of INCLIVA s staff and research groups, respecting the legal and budgetary limits that apply to it in all cases. 3 Mechanisms to guarantee generational hand-off (attracting post-doctoral 3, staff). Lack of criteria or standards to be fulfilled by researchers who would like to form part of INCLIVA (personnel of associated entities). 4 There are no formal mechanisms for professional guidance, especially for 3, personnel in training or those who are beginning their careers, especially in the area of science. 5 Possibility of improvement of training activity, especially in the initial stages 3, (personnel in training). 6 There is no process to facilitate knowledge of the rights and obligations of 3, trainers and personnel in training by the personnel of INCLIVA, and conflict resolution (if necessary), especially between personnel in training and their supervisors. 7 Mechanisms for knowledge of objectives, strategic and operational plans, 3, resources, and procedures of INCLIVA, especially promoting the knowledge of the aspects related to intellectual and industrial property, and facilitating compliance with the requirements related to animal experimentation. 8 Proactive communication of rights, obligations, work conditions, and available 3, resources. Promotion of knowledge of the plans and tools in the area of professional training and development by INCLIVA personnel. 9 Equality in all policies and processes 3, Need for formal implementation of the perspective of gender and equality in INCLIVA s strategy that reflects the questions in regard to equal opportunity, work-life balance. Incorporate the gender perspective into the composition of selection and evaluation committees. 10 Strengthening of two-way communication with society, adopting collaboration 3, and interrelation mechanisms that make it possible to reinforce social commitment transfer of knowledge, and exploitation of results. 11 Development of the innovation policy, including regulation for revenue 3, distribution and creation of businesses. 12 Support system for the knowledge, acceptance, and compliance with ethical principles and scientific best practices by all members of INCLIVA. There is no form for acceptance of recognized ethical practices, no document that reflects these rights and limitations, and there is no process outlining actions to be taken in case of non-compliance. 3,

13 Científica: Gestión Económica: EURAXESS: A Human Resource Strategy to incorporate the Charter and Code Internal Analysis and Action Plan Order Higher impact improvement areas Average score 4 4,5 13 Take another step forward in the transparency of hiring processes and merit 3, evaluation processes (in its dual role as an R&D&I and financing institution). 14 Mechanisms in INCLIVA that guarantee correct management of selection 3, teams and processes. Improvement of welcoming of personnel, especially personnel in training, residents. 15 Guarantee proper compliance with the Personal Information Protection Act by all members of the Institute, improving the information security system. 3,

14 Order Activities JE: Priority for young doctors and / or emerging researchers IF: Priority for Researchers in training CC: Priority for head researchers and / or clinical PT: Priority for technical staff / manager Average satisfaction Number of groups scoring 4 Number of groups scoring 4,5 JE IF CC PT 1 Evaluation and assessment system of staff performance. Career development in the INCLIVA 4, Develop a procedure for the evaluation and assessment of the performance of the groups that make up the Institute 3 Improvement of the procedures related to recruitment. Review calls for additional employment and contract terms. Arbitrate procedures to give feedback applicants for jobs and subsidies of INCLIVA. 4 Forums with companies in the industry that will make it possible to detect opportunities for collaboration to develop products and/or services that respond to the needs of the population 5 Promote the generation of a collective bargaining agreement for the sector, in collaboration with the other institutions in the public foundation sector of the Generalitat Valenciana. 4, , , , Arbitrate a specific policy for post-doctoral recruiting. 4, Review clauses of INCLIVA subsidy announcement. A single announcement will be generated with enough time for researchers to known grants they can solicited. Arbitrate procedures for INCLIVA grants applicants feedback. 8 Availability of the internal regulations in the area of intellectual and industrial property (including profit shares and company creation). 9 Welcome policy. Welcome manual update. This instrument will help strengthen the internal knowledge among members of INCLIVA, and the facilities and services at their disposal for the development of their R&D&i. 4, , , Prepare INCLIVA Code of Ethics and Best Practices 4, Generate specific assistance guidelines for each call for subsidy applications and distribute them to financed 4, researchers, changing the necessary SOPs. 12 Establish the figure of the Researcher Defender and the procedure for handling and tracking issues 4,

15 13 Modification of the Training Plan, including management of teams and selection processes, aimed at the 3, supervisors of groups, platforms, and lines of research (including emerging researchers), BSP, Internationalization, intellectual and industrial property. 14 Criteria or standards to be fulfilled by researchers who would like to form part of INCLIVA (personnel of 3, associated entities). 15 Agreements with patient associations for the development of forums that allow civil society to express its 3, needs and concerns to the researchers of INCLIVA. 16 Provide on-line methods for the submission of candidate applications 3, Establish a procedure to provide support for the submission of evaluation requests to the CEA from the 3, Institute s Management Structure. 18 Analysis of the alignment of INCLIVA s research priorities with the health needs of the population. 3, Establish and publicize a procedure for the implementation of news aimed at civil society that facilitates the 3, involvement of researchers in the institutions, allowing greater communication of the institution s activities and results. 20 Development of an annual satisfaction survey aimed at INCLIVA staff to assess the level of satisfaction with 3, INCLIVA s Human Resource Strategy for Researchers. 21 Analysis and review of all forms for gathering personal information that could be subject to the Personal 3, Information Protection Act. 22 Specific inclusion of mobility as a merit to be evaluated in calls for subsidy applications and in evaluation 3, and selection processes. Incorporate co-authorship (requirements proportionate to the type of position offered). 23 Agreements with educational centres to develop open-house days. 3, To develop the INCLIVA equality plan. 3, Registration by INCLIVA in the EURAXESS portal, and publication of job openings for researchers through 3, the Jobs platform. 26 Mentoring Plan, including the description of the ongoing evaluation process and the procedure for 3, measuring the satisfaction of the staff in training. 27 Arbitrate open selection processes to attract candidates for HR subsidies. Advertising on high-impact websites (preferably in the EURAXESS portal). I.e. Open announcement for pre-selection of candidates for aid Sara Borrell calls. 3,

16 Annex I: Gap analysis I. Ethical and professional aspects 1. Research freedom Researchers should focus their research for the good of mankind and for expanding the frontiers of scientific knowledge, while enjoying the freedom of thought and expression, and the freedom to identify methods by which problems are solved, according to recognised ethical principles and practices. Researchers should, however, recognise the limitations to this freedom that could arise as a result of particular research circumstances (including supervision/guidance/management) or operational constraints, e.g. for budgetary or infrastructural reasons or, especially in the industrial sector, for reasons of intellectual property protection. Such limitations should not, however, contravene recognised ethical principles and practices, to which researchers have to adhere. Spanish constitution (CE). Article 44. 2: The public authorities shall promote science and scientific and technical research in the general interest. Article CE: They are recognized and protected rights: a) to freely express and disseminate thoughts, ideas and opinions by word, writing or any other means of reproduction. b) To the literary, artistic, scientific and technical production and creation. Article CE: These freedoms are limited by respect for the rights recognized in this Title Article º) CE: The State has exclusive power over the promotion and general coordination of scientific and technical research. Law 14/2011, of 1 June, of the Science, Technology and Innovation. Preliminary title. General dispositions. Article 14. Rights of researchers. Law 14/2007 of 3 July, on Biomedical Research Organic Law 6/2001 of 21 December, of Universities. Article 40 and ss. Law 24/2015 on Patents. Title III. Right to the patent and designation of the inventor. Title IV. Inventions made in the context of an employment relationship or service. Law 17/2001, of December 7, on Trademarks Article 2 Acquisition of Rights. Article 3 Legitimation. Strategic Plan Mission: To promote, coordinate and implement quality-oriented translational research of health problems, integrating basic and clinical aspects in order to improve the health and quality of life. Strategic Plan Corporate values: Finding solutions to the major health problems of society; permanent orientation towards scientific excellence; [...]; Enforcement of national and international bioethical standards for research; Commitment to society: transparency, environment and sustainability Investigator Manual: 1.5 Organizational Structure 3.6 Procedures. MC-CE-03 CEIC Management Manual. Presentation of CEIC HCUV and 0. Politics Qualities.P R-EG-CCI Internal Scientific Committee Functions of the JRC Functions of the Executive Committee. 5. Operating system. PR-EG-PPro 3 Procedure project presentation Adjustment economic memory and justification instructions. PR-UAI-Prot Protection Procedure. 4. Responsibilities. PR-UAI-Idea Detection of innovative ideas. PR-EG-HR Human Resources v4 16

17 Law 20/2003 of 7 July, on Legal Protection of Industrial Design. Article 14 Right to registration. Article 15 Designs created in the context of an employment relationship or service. Royal Legislative Decree 2/2015 of 23 October, approving the revised text of the Statute Law Workers approved. Article 5 Job duties. Article 20 Direction and control of labour activity. Resolution of 16 July 2009, from the Ministry of Health, approving the contract template approved that has to be signed between the management of a health centre, the promoter and researchers for conducting a clinical research or post-authorization observational drug and medical testing or studies in organizations health services of Valencia. Annex I Ethical and legal standards. Law 38/2003 of 17 November, general of subsidies. Article 14 Obligations of beneficiaries 2. Ethical principles Researchers should adhere to the recognised ethical practices and fundamental ethical principles appropriate to their discipline(s) as well as to ethical standards as documented in the different national, sectoral or institutional Codes of Ethics. Instrument of Ratification of the Agreement for the protection of human rights and human dignity with regard to the Application of Biology and Medicine (agreement on Human Rights and Biomedicine), made in Oviedo on April 4, (Oviedo Agreement). Additional Instrument of Ratification of the Convention on Human Rights and Biomedicine on transplantation of organs and tissues of human origin, done at Strasbourg on 24 January 2002 Protocol. Law 14/2011, of 1 June, of the Science, Technology and Innovation. Article 10. Spanish Committee for Research Ethics. Article 15 Duties of research staff Law 14/2007 of 3 July, on Biomedical Research. Investigator Manual: 1.5 Organizational Structure 3.6 Procedures. MC-CE-03 CEIC Management Manual. Presentation of CEIC HCUV and 0.Politics Qualities. PR-EG-CCI Internal Scientific Committee Functions of the JRC Functions of the Executive Committee. 5. Operating system. Agreements on kind of labour contracts. Model for agreements with personnel in training. Roles and responsibilities as trainees Strategic Plan Strategic line 8 Ensure compliance with ethical and legal requirements of clinical research sponsored by INCLIVA. Strategic line 9 17

18 Royal Decree 1716/2011, of November 18, by which the basic requirements for authorization and operation of biobanks for biomedical research and treatment of biological samples of human origin are established, and the operation and organization of regulating National registry of Biobanks for biomedical research. Title II Treatment of biological samples of human origin for biomedical research. Order ECC / 1404/2013 of 28 June, by which annex of Royal Decree 1716/2011, of November 18 is modified. Royal Decree 53/2013, of February 1, by which the basic standards for the protection of animals used for experimental and other scientific purposes are established, including teaching. Corrigendum to Royal Decree 53/2013, of February 1, by which the basic standards for the protection of animals used for experimental and other scientific purposes are established, including teaching. Decree 13/2007 of 26 January, the Consell on the protection of animals used for experimental and other scientific purposes in the Valencian Community. Royal Decree 2132/2004, of 29 October, establishing the requirements and procedures for requesting the development of research projects with stem cells obtained from remaining pre-embryos. Royal Decree 1090/2015, of 4 December, by which clinical trials with medications are regulated, the Committees for Research Ethics and Spanish medication trials register. Especially Articles 38 and 41. Order SAS / 3470/2009 of 16 December, establishing the guidelines on observational post-authorization studies for medicinal products for human use are published. In particular Article 5 (ethical considerations) and Article 6 (Identification of those in head and the elements that the study protocol must contain). Resolution of 16 July 2009, of the Department of Health, for regulating procedures, documentation and deadlines to be observed in the presentation and changes in procedures related with clinical trial and post-authorization observational studies of medicines and health products. Preamble and Articles 5-8. train health professionals in the methodological, ethical and legal aspects of clinical research (GCP Course for Investigators 2016). Training Plan 18

19 Resolution of 16 July 2009, from the Ministry of Health, approving the contract template approved that has to be signed between the management of a health center, the promoter and researchers for conducting a clinical research observational authorization post-drug and medical testing or studies in organizations health services of Valencia. Annex I ethical and legal standards. Law 15/1999, of December 13, on Protection of Personal Data (LOPD) Royal Decree 1720/2007, of December 21, by which the Regulation of the LOPD is developed. 3. Professional responsibility Researchers should make every effort to ensure that their research is relevant to society and does not duplicate research previously carried out elsewhere. They must avoid plagiarism of any kind and abide by the principle of intellectual property and joint data ownership in the case of research carried out in collaboration with a supervisor(s) and/or other researchers. The need to validate new observations by showing that experiments are reproducible should not be interpreted as plagiarism, provided that the data to be confirmed are explicitly quoted. Researchers should ensure, if any aspect of their work is delegated, that the person to whom it is delegated has the competence to carry it out. Law 14/2011, of 1 June, of the Science, Technology and Innovation. Article 14 Rights of researchers. Article 15 Duties of research staff. Royal Legislative Decree 1/1996 of 12 April, approving the revised text of the Law on Intellectual Property, regularizing, clarifying and harmonizing the existing legislation on the subject. Articles 7 and 32 quotes and reviews and illustration for teaching or scientific research (and in particular paragraph 1) Law 11/1986 of 20 March on Patents. Article 10, 14 15, 17, 19 y 20. Royal Decree 1090/2015, of 4 December, by which clinical trials with medications are regulated, the Committees for Research Ethics medication and Spanish Trials Register. Article 41. Order SAS / 3470/2009 of 16 December, establishing the guidelines on observational post-authorization studies for medicinal products for human use Strategic Plan Mission: To promote, coordinate and implement quality-oriented translational research of health problems, integrating basic and clinical aspects in order to improve the health and quality of life. Strategic Plan Corporate values: Finding solutions to the major health problems of society; permanent orientation towards scientific excellence; [...]; Enforcement of national and international bioethical standards for research; Commitment to society: transparency, environment and sustainability 19

20 are published. Article 5 Ethical considerations and Article 6 identification of those in head and which elements must contain the study protocol 4. Professional attitude Researchers should be familiar with the strategic goals governing their research environment and funding mechanisms, and should seek all necessary approvals before starting their research or accessing the resources provided. They should inform their employers, funders or supervisor when their research project is delayed, redefined or completed, or give notice if it is to be terminated earlier or suspended for whatever reason Law 14/2007 of 3 July, on Biomedical Research. Article 15 Duties of research staff Royal Decree 63/2006 of 27 January, approving the Statute of research personnel in training. Article 6. Duties of research personnel in training. Royal Decree 1716/2011, of November 18, by which the basic requirements for authorization and operation of biobanks for biomedical research and treatment of biological samples of human origin are established, and the operation and organization of regulating National registry of Biobanks for biomedical research. Royal Decree 2132/2004, of 29 October, establishing the requirements and procedures for requesting the development of research projects with stem cells obtained from remaining pre-embryos. Royal Decree 1090/2015, of 4 December, by which clinical trials with medications are regulated, the Committees for Research Ethics medication and Spanish Trials Register. Order SAS / 3470/2009 of 16 December, establishing the guidelines on observational post-authorization studies for medicinal products for human use. Strategic Plan Scientific Cooperative Plan Integration Plan 2015 Assessment Report of Plan of Support for Emerging Groups ( ) Investigator's Manual. 3. Institutional Information. PR-EG-Difu 2 Dissemination of calls and events Management Manual EGI INCLIVA PR-EG-SPro v1 Monitoring Projects PR-EG-HR Human Resources v4 PR-EG-PPro 3 Presentation of projects INCLIVA bases of support: - Call for scholarships for training INCLIVA stays at prestigious Articles 10 and 12 - I Call for Aid for preparatory activities for Coordinated projects between REDIT Technological Institutes and Researchers and Professionals Health Research Institute INCLIVA. Articles, 8 to Program VLC-Bioclinic Articles 8 to

21 5.Contractual and legal obligations Researchers at all levels must be familiar with the national, sectoral or institutional regulations governing training and/or working conditions. This includes Intellectual Property Rights regulations, and the requirements and conditions of any sponsor or funders, independently of the nature of their contract. Researchers should adhere to such regulations by delivering the required results (e.g. thesis, publications, patents, reports, new products development, etc.) as set out in the terms and conditions of the contract or equivalent document. Law 14/2011, of 1 June, of the Science, Technology and Innovation. Article 10. Spanish Committee for Research Ethics. Law 14/2007 of 3 July, on Biomedical Research. Title II Royal Decree 63/2006 of 27 January, approving the Statute of research personnel in training. Arts. 4, 6 y 7. Royal Decree 2/2015 of 23 October, approving the revised text of the Law of the Statute of workers, Art 4-5. Title I, Chapter I, Section IV, Art Law 11/1986, of 20 March, on Patents. Art. 15, 17 y 19. Royal Decree 55/2002 of 18 January, on exploitation and transfer of inventions made in public research bodies, in accordance with the provisions of art. 20 of Law 11/1986 of 20 March Patents. Organic Law 6/2001 of 21 December, of Universities. Article 40, Title IX, Chapter I Section I, Art F-EG-RRHH v4 Human Resources F-EG-RRHH-12 v1: Information Work Regulatory Private agreements of contracts Investigator's Manual INCLIVA Training Plan 2016 INCLIVA bases of aids: - Call for INCLIVA scholarships for training stays at prestigious centres Articles 10 and 12 - I Call for Aid for preparatory activities for Coordinated projects between REDIT Technological Institutes and Researchers and Professionals Health Research Institute INCLIVA. Articles, 8 to Program VLC-Bioclinic Articles 8 to Accountability Researchers need to be aware that they are accountable towards their employers, funders or other related public or private bodies as well as, on more ethical grounds, towards society as a whole. In particular, researchers funded by public funds are also accountable for the efficient use of taxpayers' money. consequently, they should adhere to the principles of sound, transparent and efficient financial management and cooperate with any authorised audits of their research, whether undertaken by their employers/funders or by ethics committees. Methods of collection and analysis, the outputs and, where applicable, details of the data should be open to internal and external scrutiny, whenever necessary and as requested by the appropriate authorities 21

22 Law 38/2003 of 17 November, General Grants. Article 5. Legal status of grants. Article 6. Legal framework of subsidies financed from E.U. funds. Article 9. Requirements for the granting of subsidies. Article 14. Obligations of the beneficiaries. Article 22. Award procedure. Article 30. Justification of public subsidies. Article 32. Checking subsidies. Article 46. Duty to cooperate Law 2/2015, of April 2, Transparency, Good Governance and Citizen Participation of the Valencian Community. Article 4 General principles. Law 14/2011, of 1 June, of the Science, Technology and Innovation. Article Duties of technical service staff of the Public Research Bodies of the State General Administration. Chapter II. Funding agents. Article 45. Financing agents under the Ministry of Science and Innovation. Eleventh Additional Provision. Point 3. Law 14/2007 of 3 July, on Biomedical Research. Law 11/1986 of 20 March on Patents. Art. 15, 17 y 19. Resolution of 16 July 2009, from the Ministry of Health, approving the contract template approved that has to be signed between the management of a health center, the promoter and researchers for conducting a clinical research observational authorization post-drug and medical testing or studies in organizations health services of the Valencian Community Strategic Plan Mission, Vision and Values for research. Corporate values: [...] Orientation to excellence in managing biomedical research. The commitment to transparency society, environment and sustainability. Agreement for the Conduct of External Practices of the University of Valencia. Educational Cooperation Agreement for the Conduct of External Practices of the Polytechnic University of Valencia. PR-EG-Esta Stays Research and Practice PR-EG-Just Justification INCLIVA bases of support: - Call for scholarships for training INCLIVA stays at prestigious centres Articles 10 and 12 - I Call for Aid for preparatory activities for Coordinated projects between REDIT Technological Institutes and Researchers and Professionals Health Research Institute INCLIVA. Articles, 8 to Program VLC-Bioclinic Articles 8 to Good practice in research Researchers should at all times adopt safe working practices, in line with national legislation, including taking the necessary precautions for health and safety and for recovery from information technology disasters, e.g. by preparing proper back-up strategies. They should also be familiar with the current national legal requirements regarding data protection and confidentiality protection requirements, and undertake the necessary steps to fulfil them at all times Spanish constitution. Article The public authorities shall ensure health and safety at work. Law 31/1995 of 8 November on Prevention of Occupational Risks. Article 38. Committee on Safety and Health. Strategic Plan Strategic line 25. Investigator s manual F-EG-RRHH v4 Human Resources F-EG-RRHH-12 v1: Information Work Regulatory Private agreements of contracts 22