must be preceded by careful assessment of predictable risks and burdens to the individuals and communities involved in the research in comparison with foreseeable benefits to them and to other individuals or communities affected by the condition under investigation. Ethical Principles for Medical Research Involving Human Subjects, World Medical Association Declaration of Helsinki, 2008 paragraph 18. For all epidemiological research involving human subjects, the investigator must ensure that potential benefits and harms are reasonably balanced and risks are minimized. CIOMS International Ethical Guidelines for Epidemiological Studies, 2009 Guideline 8 The risks to which research subjects may be exposed have been classified as physical, psychological, social, and economic. OHRP Institutional Review Board Guidebook 3. 16Ethical issues in Patient Safety Research International guidelines define minimal risk research as research that poses no greater risk than the risks attached to routine daily life or to routine medical or psychological examination. For providers, minimal risk might be defined as risks no greater than those encountered in conducting their usual practice. Determining the level of risk posed by a study is important, because some countries’ regulations state that research that poses no more than minimal risk may generally be reviewed using an expedited mechanism.13 This means that RECs may choose to have only one or two members of the committee, rather than the full convened committee, review the protocol. In addition, international guidelines state that minimal risk studies may be eligible for a waiver of informed consent (see Guidance Point 6). While many patient safety studies are likely to pose minimal risk to patients, any study that poses higher risks to patients, providers, or institutions will require greater oversight and protections. Proportionate reviews are schemes that offer different forms of review in proportion to the risks and ethical issues involved in the research being undertaken.14 In Case Study 2, because the items on the checklist were based on established clinical practice recommendations and did not therefore create a risk of leading to substandard care, the risk to patients and providers was minimal. However, in Case Study 3, where providers were interviewed by researchers about why a patient safety incident may have occurred and about EXISTING GUIDELINES Minimal risk refers to “risk that is no more likely and not greater than that attached to routine medical or psychological examination.” CIOMS, International Ethical Guidelines for Epidemiological Studies, 2009 Commentary to Guideline 4 (Documentation of consent) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. The "Common Rule" (United States) Physicians may not participate in a research study involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed. Physicians must immediately stop a study when the risks are found to outweigh the potential benefits or when there is conclusive proof of positive and beneficial results. Ethical Principles for Medical Research Involving Human Subjects, World Medical Association Declaration of Helsinki, 2008 Paragraph 20 Determining the level of risk Guidance point 3 Patient safety research may be considered of minimal risk if all of the following factors are present: ñ The intervention does not modify clinical management or the treatment plan for the patient; ñ Data are not individually identifiable, or adequate protections against breaches of confidentiality of data are in place; ñ The intervention is unlikely to divert staff from existing responsibilities in ways that are likely to pose a risk to patient wellbeing and safety; ñ Nothing in applicable laws, or institutional rules, or the local cultural context suggests that conducting the study in the particular environment would pose higher risks to the patient; ñ No other features of the activity suggest an increased level of risk to patients, providers, or