when they should not. Case study 2 – Distinguishing research from other programmes Figure 1. Suggested flow diagram Patient Safety Activity Patient Safety Research if not if not Review by Third Party No Review needed ERC review No Review needed ERC Submission 14Ethical issues in Patient Safety Research EXISTING GUIDELINES The distinction between research and practice in public health does not correlate with the extent to which an activity carries risks for individuals and communities or otherwise raises ethical issues that would benefit from a prospective review process. The distinction has no bearing either on the ultimate question of whether a particular public health response is scientifically and ethically justifiable. … Despite the conceptual problems of distinguishing between research and non-research, the distinction is deeply ingrained in many countries’ regulatory structures and is unlikely to be changed any time soon. However, this does not mean that all research must undergo full REC review, nor does it mean that activities that fall outside local or international definitions of research should escape ethics review entirely. WHO Technical Consultation on Research Ethics in International Epidemic Response if poses a greater than minimal risk if poses a greater than minimal risk 15Interpreting existing guidance Nature of the risks surrounding patient safety research Patient safety research may involve the following types of risks: Clinical risks: Clinical risks refer to the likelihood that patients may experience a worsening of their health status due to the conduct of the research study. Because patient safety studies do not generally modify the treatment plans for individual patients, they tend to involve considerably fewer clinical risks than other types of healthcare research. However, the possibility of clinical risks should always be assessed. In many cases, patient safety studies may target how care is delivered, for example, through new reminder systems to avoid medication errors or testing the effect of different staffing ratios. These changes, while designed to improve the quality of care patients receive, could actually result in lower quality of care or could create errors rather than reduce them. This could happen due to inadequate training of staff on how to use the new systems, or by diverting staff attention to the new patient safety system at the expense of usual care responsibilities. Social risks: Social risks are the risks that research participants encounter due to how others might treat them as a result of their participation in a study. While there may be minimal social risks for patients who take part in patient safety studies, medical providers or institutions may be concerned about social risks if they participate in research that exposes their own system failures or ineffectiveness. For example, research documenting the factors associated with significant health-care incidents that occurred in the past or rates of particular types of errors runs the risk that the providers involved with these incidents, or the institutions themselves, could suffer reputational and professional harm. Psychological risks: Psychological risks include the possibility that research participants will become emotionally distressed, fearful or anxious as a result of their participation. For example, studies that interview patients or families about harmful incidents that occurred previously or about their perceptions of the quality of care may cause them to question the quality of their medical providers and to become anxious. Also, health providers may become anxious if they believe that researchers are evaluating their professional performance, particularly if they fear that the results may result in reprisals. Economic risks: Economic risks refer to the possibility that research participants will be required to incur additional financial costs as a result of their participation in a study. For example, providers may have concerns about the economic implications of studies that uncover errors in how care is provided, including the possibility that negative information uncovered during a study could lead to litigation. Understanding risk in patient safety research EXISTING GUIDELINES Every medical research study involving human subjects