patient and the aims of the research when clinically therapeutic results are withheld from individual subjects, particularly when this information is ‘incidental’ to the study’s main outcomes measures.8 Patient safety designs may also involve an individual simulating a patient, for example, someone who buys medicine from a pharmacy to determine whether a medicine’s formulation is up to standard. 8Ethical issues in Patient Safety Research 1. Introduction Patient safety activities can raise ethical issues even when those activities are not formally labelled as research. For example, quality assurance and audit programmes review how care is delivered and compare it to a set of explicit criteria to determine whether standards are being met and how care can be improved. Other programmes, often labelled as quality or patient safety improvement, may implement activities that alter how care is delivered in order to reduce problems or improve efficiencies. Many of these programmes address a defined question, systematically collect data, and/or evaluate new strategies to examine whether new approaches actually result in improvement.9 Thus, they share several essential features with research, even though they may not always be explicitly labelled as such. These activities, therefore, raise similar ethical concerns as would 9 Box 1: Some of the ethical questions raised by patient safety activities ñ Which patient safety projects should be considered research requiring Research Ethics Committee (REC) review? ñ What types of risks exist in patient safety research? ñ What protections must be in place for patients and/or providers to reduce the risks from patient safety studies? ñ Under what circumstances are informed consent or other forms of disclosure or permission needed from research participants? ñ In particular, under what circumstances, if any, is deception allowable in patient safety research? ñ What are the best practices for addressing privacy and confidentiality issues? ñ Are there any potential direct or indirect benefits to, or incentives for, participating in patient safety research? ñ Under what circumstances, if any, do researchers have a duty to intervene regarding past or imminent errors? research. For example, how can patients’ privacy and confidentiality be ensured when examining records systematically? How can providers be protected from reprisals when patient safety efforts result in the documentation of health-care failures? (See Box 1) Additional complexities arise when such activities, not originally intended as research, are submitted for publication because the data, once analysed, appears to be of generalizable relevance. Finally, patient safety improvement programmes in hospitals and other health-care settings have purposes that extend beyond the immediate interests of the patients directly enrolled or affected by them, just as is true for activities more commonly viewed as research. These patients, too, deserve the health-care system’s commitment to ensuring that their welfare and rights are protected. Interpreting existing guidance 10Ethical issues in Patient Safety Research The application of research ethics principles to patient safety activities EXISTING GUIDELINES All proposals to conduct research involving human subjects must be submitted for review of their scientific merit and ethical acceptability to one or more scientific review and ethical review committees. The investigator must obtain their approval or clearance before undertaking the research. CIOMS International Ethical Guidelines for Epidemiological studies, 2009 Guideline 2 It is conventional to define “research” as involving activities that are designed to develop or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principles or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference. CIOMS International Ethical Guidelines for Epidemiological Studies, 2009 Introduction Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. The “Common Rule” (USA)