Compliance

Compliance, Integrity and Good Governance

At IRBLleida, we integrate quality and regulatory compliance as essential pillars of our management. We carry out our activities in accordance with the principles of legality, integrity, transparency, accountability, diligence, and good governance, with the aim of fostering an institutional culture that promotes the prevention of non-compliance and ethical conduct by all individuals associated with the Institute.

This commitment extends to employees and affiliated staff, governing bodies, collaborators, and third parties acting on behalf of IRBLleida. It encompasses all biomedical research activities, administrative and scientific-technical research support services, and training activities carried out at IRBLleida and CREBA facilities.

Compliance Management System

IRBLleida is implementing and consolidating a compliance management system aligned with the principles and requirements of ISO 37301, on compliance management systems, and UNE 19601, on criminal compliance management systems.

The purpose of this system is to identify the compliance obligations applicable to the Institute, prevent and detect potential misconduct, establish the necessary controls, and provide an appropriate response to any risks or non-compliance situations that may arise.

IRBLleida maintains a zero-tolerance policy towards any irregular, corrupt, unethical, illegal, or potentially criminal practice. Furthermore, it promotes training, communication, and awareness among all members of the organisation to ensure that they understand the rules and commitments that must guide their activities.

Organisation and Oversight

The Board of Trustees, as the Foundation's governing body, promotes the culture of compliance, approves the main policies, and periodically evaluates the effectiveness of the system.

IRBLleida has a Compliance Officer, appointed by the Board of Trustees, with direct access to this governing body and with the autonomy, authority, and initiative required to oversee the operation of the compliance system.

The Compliance Officer is supported by a Compliance and Anti-Fraud Committee, composed of representatives from different areas of the Institute. Its responsibilities include risk assessment, monitoring controls, proposing improvements, and supporting training, supervision, and monitoring activities related to the compliance system.

Risk Prevention and Management

IRBLleida has established a methodology to identify, analyse, assess, and address general compliance risks and criminal risks associated with its activities.

This process makes it possible to evaluate the likelihood and impact of risks, identify existing preventive and detection controls, determine residual risk, and, where necessary, establish action plans, assign responsibilities, and define follow-up deadlines.

The system also includes specific mechanisms to identify, declare, assess, and manage potential conflicts of interest, with the aim of preserving impartiality, objectivity, and transparency in decision-making.

Whistleblower Channel

IRBLleida provides an Qhistleblower Channel through which individuals can confidentially and securely report potential irregularities, regulatory breaches, or conduct that violates the Institute's Code of Ethics and internal regulations.

IRBLleida guarantees the confidentiality of communications, their rigorous handling, and protection against retaliation for individuals who report concerns in good faith.

Access to whistleblower channel

A Shared Commitment

Compliance is a shared responsibility. All individuals associated with IRBLleida must be aware of and comply with applicable regulations, the Code of Ethics and Conduct, and internal policies and procedures, as well as actively collaborate in the prevention, detection, and reporting of potential breaches.

IRBLleida periodically reviews its compliance system and promotes its continuous improvement to adapt to regulatory, organisational, and operational changes, as well as to incorporate best practices in ethics, integrity, and good governance.

Compliance Documents

Integrated Quality and Compliance Policy

Organisation and responsibilities of the compliance management system

Code of Ethics and Conduct

CERCA Code of Ethics

Anti-Fraud Plan

Guide to good practice in research in health sciences