Table 1.

Ethical principles underpinning reporting and learning.

Beneficence, non-maleficence	Collection and analysis of information related to patient safety incidents are pivotal in improving the risks-benefit ratio of medical interventions. As long as systems of reporting are effective in providing such learning, they might also help health care providers to be more efficient in their practices and to improve risk prevention. This responsibility is clearly expressed in professional policies.* How disclosure and reporting are exerted is key.
Governance: transparency, accountability, responsiveness	Based on the principles of transparency and accountability, health services should be prepared to disclose information about adverse events; mechanisms of compensation for patients potentially harmed may need to be in place. Appropriate responses to prevent the repetition of such events would be in consonance with these ethical principles.
Respect for dignity, autonomy, privacy	Patients are entitled to be informed in order to make free and informed decisions; the communication of potential risks is consistent with the information needed by the patients to make choice. Improving access to reliable information about potential adverse events could help fulfilling this ethical principle. A written informed consent is usually not requested for surveillance activities, however a general disclosure informing patients about the existence of reporting systems might be beneficial.° Due to the difficult delimitation between surveillance and research, specific guidance could be developed to define when a full informed consent process is required. People suffering harm due to an adverse event have a fundamental right to receive transparent information. It is the responsibility of health care providers to inform them and their relatives. Health professional may need to be trained to improve their communication skills. Reporting systems must prevent breaches of confidentiality and protect all personal data. Anonymous disclosure may be preferred for this reason, however this may need to be balanced with the need to come back to the patient if needed in some instances.
Empowerment	Good reporting and learning systems may facilitate more equitable access to key information and thus may empower stockholders, including patients organizations and the public and they may contribute to build a common culture of safety.
Integrity, responsibilities	In order to maintain integrity, and facilitate trust, with the public, health systems and health professionals have an ethical duty to disclose information related to adverse events as well as to try limiting their consequences. Health systems should protect health care workers from unjustified denunciations and retaliation; whereas responsibilities and their share need to be identified and fairly allocated.

^*See for example World Medical Association, Declaration on Patient Safety adopted by the 53rd WMA General Assembly, in October 2002 and reaffirmed by the 191st WMA Council Session, in April 2012: National medical associations should cooperate with one another and exchange information about adverse events, including errors, their solutions, and lessons learned to improve patient safety. (http://www.wma.net/en/30publications/10policies/p6/).

^°In cases where individual informed consent from patients will not be sought, general disclosure to patients about patient safety research is highly recommended. WHO Ethical issues in Patient Safety Research Guidance point 6 http://apps.who.int/iris/bitstream/10665/85371/1/9789241505475_eng.pdf.