79C3C34C52B45572883A05D425EB0F82
Ethical Issues in Patient Safety Research: Interpreting Existing Guidance
https://apps.who.int/iris/bitstream/handle/10665/85371/9789241505475_eng.pdf?sequence=1
http://leaux.net/URLS/ConvertAPI Text Files/D22D7692BB1DD38CC8A47023F1C9B425.en.txt
Examining the file media/Synopses/D22D7692BB1DD38CC8A47023F1C9B425.html:
This file was generated: 2020-12-01 09:27:20
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / political affiliation
Searching for indicator party:
(return to top)
p.000010: Ethics Committee (REC).
p.000010: For purposes of REC oversight, patient safety activi- ties constitute research when:
p.000010: ñ they are aimed at addressing a specific question; and ñ they use a predefined approach or method for collect-
p.000010: ing data in response to the question they intend to address; and
p.000010: ñ their findings are intended to be applied to settings beyond those in which the activity or programme is implemented.
p.000010:
p.000010:
p.000010: International guidelines define research as a systematic activity designed to develop or contribute to generalizable
p.000010: knowledge. Before conducting any study, researchers should consider whether the research is warranted and whether the
p.000010: selection and recruitment of participants is fair. There should be good reason to explore safety practice in research
p.000010: beyond routine evaluation. Furthermore, vulnerable populations should not be differentially exposed to any extra risks
p.000010: brought up by the research without good reason to avoid exacerbating pre-existing inequalities.10 While health research
p.000010: has the potential to bring benefits to society and to the research communities, it can be associated
p.000010: with risks to the research participants. It is the obligation of those responsible for conducting the research
p.000010: to protect participants by minimizing those risks and seeking approval of an independent Research Ethics Committee
p.000010: (REC).
p.000010:
p.000010: The rationale for requiring third party review of research is that the participants are often asked to undertake risks
p.000010: that are not offset by any potential personal benefit, in order to develop scientific knowledge that may benefit others
p.000010: in the future. REC review is designed to ensure that the risks assumed by the participants are carefully
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: examined and minimized to the extent that is reasonably possible, that the risks that remain are reasonable in relation
p.000010: to the potential benefits of the study, and that other ethical considerations, such as informed consent and
p.000010: confidentiality, are adequately addressed.
p.000010:
p.000010: Patient safety research may entail potential risks to both patients and health-care providers, and like any other
p.000010: research activity must be submitted to a research ethics committee for review. Patient safety research must be
p.000010: distinguished from activities designed to provide benefits to an existing patient population, including activities
p.000010: characterized as “programme implementation or practice,” such as surveillance or quality improvement.
p.000010: Such patient safety activities are in many instances mandated by regulatory or administrative authorities or units of
p.000010: health-care organizations, and are typically
p.000010: undertaken to serve the interests of the individuals who are cared for in these same organizations. In general, current
p.000010: regulations do not require these activities to be reviewed by an REC.
p.000010:
p.000010: For instance, a hospital may implement a patient safety programme in which data are systematically collected from
...
p.000011: quality improvement practice led
p.000011: to public controversy around this particular case, and questioning from government authorities, highlighting the need
p.000011: for clearer guidance around when projects such as this should be subject
p.000011: to ethical oversight and when they should not.
p.000011:
p.000011:
p.000011:
p.000011: EXISTING GUIDELINES
p.000011: The distinction between research and practice in public health does not correlate with the extent
p.000011: to which an activity carries risks for individuals and communities
p.000011:
p.000011:
p.000011:
p.000011: Figure 1. Suggested flow diagram
p.000011:
p.000011: or otherwise raises ethical issues that would benefit from
p.000011: a prospective review process. The distinction has no bearing
p.000011: Patient Safety Activity
p.000011:
p.000011: if poses a greater
p.000011: Patient Safety Research
p.000011:
p.000011: either on the ultimate question of whether a particular public health response is scientifically and ethically
p.000011: justifiable. … Despite the conceptual problems
p.000011: of distinguishing between research and non-research, the distinction is deeply ingrained in many countries’ regulatory
p.000011: structures and is unlikely to be changed
p.000011: any time soon. However, this does not mean that all research must undergo full REC review, nor does it mean that
p.000011: activities that fall outside local or international definitions of research should escape ethics review entirely.
p.000011: WHO Technical Consultation on Research Ethics in International Epidemic Response
p.000011: than minimal risk
p.000011:
p.000011:
p.000011:
p.000011: Review by Third Party
p.000011: if not
p.000011:
p.000011:
p.000011:
p.000011: No Review needed
p.000011:
p.000011: if poses a greater than minimal risk
p.000011:
p.000011:
p.000011:
p.000011: ERC
p.000011: review
p.000011:
p.000011:
p.000011:
p.000011: ERC
p.000011: Submission
p.000011:
p.000011:
p.000011: if not
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: No Review needed
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Understanding risk
p.000011: in patient safety research
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Nature of the risks surrounding patient safety research
p.000011: Patient safety research may involve the following types of risks:
p.000011:
p.000011: Clinical risks: Clinical risks refer to the likelihood that patients may experience a worsening of their health
p.000011: status due to the conduct of the research study. Because patient safety studies do not generally modify the
p.000011: treatment plans for individual patients, they tend to involve considerably fewer clinical risks than other
p.000011: types of health- care research. However, the possibility of clinical risks should always be assessed. In
p.000011: many cases, patient safety studies may target how care is delivered, for example, through new reminder systems
p.000011: to avoid medication errors or testing the effect of different staffing ratios. These changes, while designed
p.000011: to improve the quality of care patients receive, could actually result in lower quality of care or could
p.000011: create errors rather than reduce them. This could happen due to inadequate training of staff on how to use the new
...
Searching for indicator political:
(return to top)
p.000017: competency and skills, decision-making style, openness to change, duration in the service or job, the amount and
p.000017: quality of supervision they had received,
p.000017: and the relationship of the incident to the timing of their shift. Consent was not obtained from patients within the
p.000017: unit. Project staff reported that several of the medical staff who had made errors did not want to discuss those errors
p.000017: with interviewers because they were scared about being reprimanded for their mistake. As stated by the project staff
p.000017: member, “We had to reassure them about the confidentiality issues and
p.000017: it worked most of the time.” The project was approved by the REC at each of the two hospitals. During the review
p.000017: process, it was decided that if, during the course of the project, staff identified patterns of care that were harmful
p.000017: to a patient,
p.000017: it was the duty of the project staff to immediately inform the hospital staff and the appropriate authorities so that
p.000017: the recurring error could be corrected, but without retribution to any individual employees.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Minimizing social and psychological risk in patient safety studies
p.000017:
p.000017:
p.000017: Guidance point 4
p.000017: ñ Before conducting a study, researchers should consider discussing with leadership of the health-care institution
p.000017: under study the importance of avoiding a culture
p.000017: of blame with regard to patient safety.
p.000017: ñ Patient safety researchers should also consider whether the political, social, institutional, or cultural context in
p.000017: which the project will be implemented could alter the project’s risk profile.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: The following strategies can help minimize risks in patient safety research:
p.000017:
p.000017: The “no blame” approach to patient safety improvement
p.000017: Patient safety improvement is based on the
p.000017: understanding that most harmful incidents occur not because of negligent or unprofessional behaviour, but, instead,
p.000017: because of systemic problems with the manner in which health care
p.000017: is delivered. Strong evidence suggests that a culture of blame threatens the ability to learn from errors and
p.000017: understand why these occur, and thus threatens the ability to improve the public’s health. It is important that
p.000017: institutions involved in patient safety research understand this fact, and that
p.000017: a no blame approach will actually increase the chances that practice improvements can ultimately occur and results can
p.000017: be used to make systemic improvements. Nonetheless, it is worth acknowledging that those exposed to harm have
p.000017: a right to accountability where harm occurs through negligence or unprofessional behaviour.
p.000017:
p.000017: Decreasing the chances of identification of poorly performing individuals or institutions
p.000017: If individuals or groups that consistently provide
p.000017: poor care are identified by patient safety research, there is a risk that the result will be punitive action.
...
p.000035: more than minimal risk to patients and health-care providers in some situations. It is the responsibility of those
p.000035: working in patient safety activities to be aware of ethical issues and seek guidance as needed.
p.000035: Guidance point 3
p.000035: Patient safety research may be considered of minimal risk if all of the following factors are present:
p.000035: ñ The intervention does not modify clinical management or the treatment plan for the patient;
p.000035: ñ Data are not individually identifiable, or adequate protections against breaches of confidentiality
p.000035: of data are in place;
p.000035: ñ The intervention is unlikely to divert staff from existing responsibilities in ways that are likely to pose a risk to
p.000035: patient wellbeing and safety;
p.000035: ñ Nothing in applicable laws, or institutional rules, or the local cultural context suggests that conducting the study
p.000035: in the particular environment would pose higher risks to the patient;
p.000035: ñ No other features of the activity suggest an increased level of risk to patients, providers, or
p.000039: 39
p.000039: institutions, compared with the patient safety activity not being implemented.
p.000039: Guidance point 4
p.000039: ñ Before conducting a study, researchers should consider discussing with leadership of the health-care institution
p.000039: under study the importance of avoiding a culture of blame with regard to patient safety.
p.000039: ñ Patient safety researchers should also consider whether the political, social, institutional, or cultural context in
p.000039: which the project will be implemented could alter the project’s risk profile.
p.000039:
p.000039: Guidance point 5
p.000039: Individuals involved in patient safety research who are interviewing or observing patients or providers should
p.000039: anticipate any distress participants may experience as a consequence of the conduct of the study and be prepared to
p.000039: offer solutions. Some options are:
p.000039: ñ Be trained to ask participants if they would like to skip questions or stop the interview if they become distressed;
p.000039: ñ Be equipped with referrals for supportive care or counselling in case participants become significantly distressed;
p.000039: ñ Be equipped with the names of hospital authorities to whom participants and families can be referred if they have
p.000039: questions; and
p.000039: ñ Ensure that all services and providers whose names will be given out as referrals have agreed to have their names
p.000039: provided to patients and families.
p.000039:
p.000039: Guidance point 6
p.000039: Researchers conducting patient safety research studies must generally seek individual informed consent from patients.
p.000039: However, the require- ment of obtaining individual informed consent from patients can be waived by an REC if
p.000039: ñ The research does not directly inform or alter the individual patients’ therapeutic or medical treatment plans; and
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: ñ Risks posed to patients by the research are minimal; and
p.000039: ñ The research could not practically be carried
...
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p.000010: or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principles or relationships, or
p.000010: the accumulation of information on which they are based, that can be corroborated by accepted
p.000010: scientific methods of observation and inference.
p.000010: CIOMS International Ethical Guidelines for Epidemiological Studies, 2009 Introduction
p.000010:
p.000010: Research means a systematic investigation, including research development, testing, and evaluation, designed to develop
p.000010: or contribute to generalizable knowledge.
p.000010: The “Common Rule” (USA)
p.000010:
p.000010: Guidance point 1
p.000010: Any patient safety activity that constitutes research, regardless of its methodology, should be submitted to a Research
p.000010: Ethics Committee (REC).
p.000010: For purposes of REC oversight, patient safety activi- ties constitute research when:
p.000010: ñ they are aimed at addressing a specific question; and ñ they use a predefined approach or method for collect-
p.000010: ing data in response to the question they intend to address; and
p.000010: ñ their findings are intended to be applied to settings beyond those in which the activity or programme is implemented.
p.000010:
p.000010:
p.000010: International guidelines define research as a systematic activity designed to develop or contribute to generalizable
p.000010: knowledge. Before conducting any study, researchers should consider whether the research is warranted and whether the
p.000010: selection and recruitment of participants is fair. There should be good reason to explore safety practice in research
p.000010: beyond routine evaluation. Furthermore, vulnerable populations should not be differentially exposed to any extra risks
p.000010: brought up by the research without good reason to avoid exacerbating pre-existing inequalities.10 While health research
p.000010: has the potential to bring benefits to society and to the research communities, it can be associated
p.000010: with risks to the research participants. It is the obligation of those responsible for conducting the research
p.000010: to protect participants by minimizing those risks and seeking approval of an independent Research Ethics Committee
p.000010: (REC).
p.000010:
p.000010: The rationale for requiring third party review of research is that the participants are often asked to undertake risks
p.000010: that are not offset by any potential personal benefit, in order to develop scientific knowledge that may benefit others
p.000010: in the future. REC review is designed to ensure that the risks assumed by the participants are carefully
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: examined and minimized to the extent that is reasonably possible, that the risks that remain are reasonable in relation
p.000010: to the potential benefits of the study, and that other ethical considerations, such as informed consent and
p.000010: confidentiality, are adequately addressed.
p.000010:
p.000010: Patient safety research may entail potential risks to both patients and health-care providers, and like any other
p.000010: research activity must be submitted to a research ethics committee for review. Patient safety research must be
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.000011: researchers and pose risks to the participants in the study. Investigators documenting errors should also talk to
p.000011: trusted informants in local settings to know the chance of retribution for providers, if errors are found, as well as
p.000011: providers’ anticipated anxiety about possible retribution. Patient safety professionals
p.000011: must also be sensitive to power relationships that exist between senior and junior hospital staff.
p.000011: In Case Study 3, those involved in the patient safety activity made clear to providers that all data would be kept
p.000011: confidential and therefore that no individual level data would be reported to hospital management. In settings where
p.000011: the local context could increase risks related to reporting or retribution, researchers may need to consider
p.000011: whether it would be ethically preferable to abandon the study, in order to prevent additional risks to participants, or
p.000011: whether it would be effective and feasible to build additional safeguards into the study. In some circumstances,
p.000011: collecting data anonymously (rather than confidentially) may be sufficient to protect against risk of harm.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000017: 17
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Case study 3 – Assessing the level of risk and minimizing risk
p.000017:
p.000017:
p.000017:
p.000017: Cullen DJ, Sweitzer BJ, Bates DW, et. al. Preventable adverse drug events in hospitalized patients: a comparative study
p.000017: of intensive care and general care units.
p.000017: Crit Care Med, 1997, 25:1289-1297.
p.000017: A patient safety project was implemented at 11 different ICUs and general care units in two tertiary care hospitals in
p.000017: the United States, with the objective of understanding the causes of adverse drug events (ADEs) resulting from
p.000017: 18 human errors in drug use, so that they might be prevented in the future. Data on all ADEs that occurred in
p.000017: any of those 11 units over a six-month period were included in the project. Data on ADEs were collected in several
p.000017: ways: all nurses and pharmacists in those 11 units were asked to report all ADEs to nurse investigators involved in the
p.000017: project, a nurse investigator visited each unit
p.000017: twice a day on weekdays to obtain information from hospital staff on any ADEs that had recently occurred, and each day,
p.000017: the nurse investigator also reviewed all medical charts to collect information on reported and potential ADEs.
p.000017: All data were then reviewed by two physicians. These physicians judged the severity of the ADE and whether or not it
p.000017: had been preventable.
p.000017: For each ADE judged to have been preventable,
p.000017:
p.000017: the hospital staff involved in providing the patient with the medication were interviewed by a peer and asked to
p.000017: describe the circumstances surrounding the incident, to describe how the event had occurred, and to self-assess their
p.000017: competency and skills, decision-making style, openness to change, duration in the service or job, the amount and
p.000017: quality of supervision they had received,
p.000017: and the relationship of the incident to the timing of their shift. Consent was not obtained from patients within the
p.000017: unit. Project staff reported that several of the medical staff who had made errors did not want to discuss those errors
p.000017: with interviewers because they were scared about being reprimanded for their mistake. As stated by the project staff
p.000017: member, “We had to reassure them about the confidentiality issues and
...
p.000025: Error Rate: A Randomized Controlled Trial.
p.000025: Arch Intern Med, 2003:163:2359-2367
p.000025: This patient safety project was implemented in two hospitals in the United States to understand if having a nurse
p.000025: dedicated to administering medications to patients would reduce the rate of medication administration errors. Four
p.000025: nursing
p.000025: units in each hospital were selected to participate in the project. Within those units, the project staff recruited
p.000025: nurses to participate in the project.
p.000025: Informed consent was obtained from each of the nurse participants and the REC at each of
p.000025: the hospitals approved the project. Once consent was obtained, the nurses were randomly assigned to the intervention or
p.000025: the control group. Those
p.000025: in the intervention group attended a medication safety programme and for two days each week for twelve weeks these
p.000025: nurses were exclusively
p.000025: responsible for administering medications to patients. Those in the control arm did not attend the programme and
p.000025: maintained all of their normal nursing activities.
p.000025:
p.000025: The nurses in the intervention arm were observed by project staff the two days a week that they were exclusively
p.000025: responsible for administering
p.000025: medications. The nurses in the control arm were 29
p.000025: observed by the project staff the other three days of the week. The observers were all nurses or pharmacy technicians
p.000025: who attended an observer training session. They were responsible for “recording all aspects of drug retrieval,
p.000025: preparation, and administration” as well as “variations from safe medication practices”. If, during the course
p.000025: of their observations, the observer recognized an error that could cause harm to a patient, the observer was instructed
p.000025: to intervene and prevent the error from occurring.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: For incidents identified through chart reviews, or through any other mechanism, which are generally conducted
p.000025: retrospectively, any harm associated with the error is less likely to still be reversible.
p.000025: It may also be unclear from medical records alone whether the event was ever reported, whether others were aware of the
p.000025: event, whether any interventions have already occurred or whether, indeed, a harmful incident actually occurred. There
p.000025: will be a relatively small number of cases where intervention, after the fact, can change the clinical course. However,
p.000025: in such very rare cases, and if the patient can still be located, the hospital should be informed so that the patient
p.000025: can be contacted for further evaluation.
p.000025:
p.000025: Nevertheless, researchers are not best placed
p.000025: to make judgements or take any action based on the findings of the research. Some groups have established “reference
p.000025: groups” or “safety committees” to provide advice on the adequate course of action in situations that may develop during
p.000025: patient safety research and where researchers may not have the expertise and capacity to manage the situation, as has
p.000025: been described under guidance points 4 and 5 (Case Study 4).
p.000025: These committees may constitute a good resource for researchers.
p.000025:
...
p.000030:
p.000030: circumstances, where projects are low risk, where it is necessary for obtaining the relevant
p.000030: data, where the project could significantly advance the field of patient safety, and where it does not change the
p.000030: overall risk profile of the study.
p.000030: For instance, in a study to determine the extent of a problem of fake or substandard quality drugs being sold by
p.000030: pharmacists, “mystery clients” were asked to go to public marketplaces for remedies
p.000030: for their children when they didn’t really have a sick child, and the researchers then examined the pharmacological
p.000030: make-up of the products they were given. This study design was allowed by the local REC, because this was considered to
p.000030: be the only way of obtaining access to
p.000030: the pharmaceutical products actually being sold to patients and the study posed very few risks, if any, to those
p.000030: involved.
p.000030:
p.000030:
p.000030:
p.000030: Case study 7 – Withholding information 31
p.000030: (with permission for publication from author)
p.000030:
p.000030:
p.000030:
p.000030: Counterfeit and substandard drugs have been increasingly recognized as a global public health threat. They impact
p.000030: health and the economy in many ways, including increased morbidity and mortality due to inadequate treatment; cause
p.000030: adverse effects from toxic ingredients; promote drug resistance; foster loss of confidence in the health system; and
p.000030: cause unnecessary suffering and economic hardship for patients and families. Previous studies in a landlocked central
p.000030: Asian country have found counterfeit and substandard drugs, but the extent of the problem is not known. In order to
p.000030: gain insight into the extent and nature of the problem of counterfeit and substandard drugs in the country and help
p.000030: efforts to ensure
p.000030: a safe and effective medication supply, a cross- sectional descriptive study was undertaken to determine the prevalence
p.000030: of selected counterfeit/ substandard drugs in the capital city and determine the prevalence of drug outlets selling the
p.000030: selected counterfeit and substandard drugs in that city.
p.000030:
p.000030: Drug outlets were randomly selected stratified by geographic setting and type of drug outlets. Nine drugs from 3 groups
p.000030: of medicines were selected for testing, based on their therapeutic
p.000030: importance, and earlier reports of being counterfeit or sub-standard. None of these drugs were prescription drugs and
p.000030: all can be purchased over the counter in that country.
p.000030:
p.000030: A group of paid field workers, who acted as simulated customers, anonymously purchased the drug samples from drug
p.000030: outlets based in a district
p.000030:
p.000030:
p.000030: different from their home district. The field workers were trained to give a specified set of symptoms and ask the
p.000030: questions that usual patients normally would ask pharmacists (can you give me this antibiotic, is this a good brand,
p.000030: can you give me another brand, is this the brand that other people also purchase, etc.). Following appropriate
p.000030: training, the field workers were provided with a list of the drugs and amount needed of each one from the assigned drug
p.000030: outlet. The identity of the drug outlet or the field worker were not on the data collection form; instead a sample
p.000030: number was recorded by the PI when the field worker returned.
p.000030: This sample number was linked to a code for
p.000030: the drug unit known only to the PI. Any potentially identifying information about the drug outlets
p.000030: was coded and removed from samples and data collection tools prior to sample analysis so researchers involved in the
p.000030: analysis would not know the source of any of the samples. If a selected
p.000030: drug outlet did not have the required sample of a drug, the PI arranged for a repeat visit to
p.000030: this facility at a later time or substituted a different randomly selected drug outlet.
p.000030:
p.000030: Results of the study were provided in an aggregated form to the National Drug Regulatory Authority
p.000030: and the Ministry of Health, in order to allow
p.000030: them to take further action, such as strengthening their regulations. Since the data were analysed anonymously, the
p.000030: Ministry did not receive
p.000030: any information about specific drug outlets, and no punitive action was possible as a result of this research study.
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: Since withholding information can lead to distrust, additional restrictions are placed on such studies. These include
p.000030: requirements that other designs not involving withholding information be used wherever possible to address the research
p.000030: question, that only minimal risk studies may withhold information,
p.000030: and that as much information about the study be provided as possible, even if one key element is not disclosed. The
p.000030: researcher should also consider whether disclosing information in a more general way (for example, “There will be some
p.000030: clients coming to your shop in the next six months, who may not be the ‘real clients’”) is possible, as a way
p.000030: 32 of honouring commitments to truth telling while also trying to achieve important scientific ends. Another
p.000030: option is to ask participants to consent to research without knowing the full aspects of the study, with the assurance
p.000030: that the research intervention will not harm them and that a full disclosure will be made in a debriefing session.
p.000030:
p.000030: Information should not be withheld solely because providing it might cause some individuals to refuse to participate.
p.000030: Withholding information is only appropriate if doing so is the sole way of addressing a socially important research
p.000030: question, and researchers and REC members should carefully consider the necessity of withholding or misleading
p.000030: participants about each aspect of the study. If some information could be provided without jeopardizing the study, that
...
Health / Healthy People
Searching for indicator volunteers:
(return to top)
p.000035: protections as participants in research studies? JAMA. 2000; 284:1786-1788.
p.000035: 61. Tapp L, Edwards A, Elwyn G, Holm S, Eriksson T. Quality improvement in general practice: enabling general
p.000035: practitioners to judge ethical dilemmas. Journal of Medical Ethics. 2010; 36:184-188.
p.000035: 62. Wynia MK, Kurlander JE, Morse R. Physician ethics and participation in quality improvement: renewing
p.000035: a professional obligation. In: Jennings B, Maily MA, Bottrell M, Lynn J, eds. Health Care Quality Improvement: Ethical
p.000035: and Regulatory Issues. Garrison, NY: The Hastings Center. 2007. Available at www.thehastingscenter.org
p.000035: 63. Office for Human Research Protections, Institutional Review Board Guidebook. Electronic publication available at :
p.000035: http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm
p.000035: 64. Miller FG, Mello MM, Joffe S. Incidental Findings in Human Subjects Research: What Do Investigators Owe Research
p.000035: Participants? Journal of Law, Medicine & Ethics., 2008; 36: 271-279.
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: 65. Wolf SM, Lawrenz FP, Nelson CA, Kahn JP, Cho MK, Clayton EW, Fletcher JG, Georgieff MK,
p.000035: Hammerschmidt D, Hudson K, Illes J, Kapur V, Keane MA, Koenig BA, Leroy BS, McFarland EG, Paradise J, Parker LS, Terry
p.000035: SF, Van Ness B, Wilfond BS. Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations.
p.000035: Journal of Law, Medicine & Ethics. 2008; 36: 219-211.
p.000035: 66. Woodward CI, Toms AP. Incidental findings in ‘normal’ volunteers. Clinical Radiology. 2009; 64: 951-953.
p.000035: 67. Institute of Medicine. Committee on Quality
p.000035: of Health Care in America. To Err Is Human: Building
p.000035: 38 a Safer Health System. Eds: Kohn LT, Corrigan JM, Donaldson, MS. National Academy Press. Washington
p.000035: DC, 2000.
p.000035: 68. Neily J, Mills PD, Eldridge N, Carney BT, Pfeffer D, Turner JR, Young-Xu Y, Gunnar W, Bagian JP. Incorrect surgical
p.000035: procedures within and outside of the operating room. Archives of Surgery. 2009; 144: 1028-1034.
p.000035: 69. Sax HC, Browne P, Mayewski RJ, Panzer RJ, Hittner KC, Burke RL, Coletta S. Can aviation-based team training elicit
p.000035: sustainable behavioral change? Archives of Surgery. 2009; 144: 1133-1137.
p.000035: 70. Meaney ME. Error reduction, patient safety
p.000035: and institutional ethical committees. Journal of Law, Medicine & Ethics. 2004; 32:358-364.
p.000035: 71. Miller FG, Gluck JP, Wendler D. Debriefing and accountability in deceptive research. Kennedy Institute of Ethics
p.000035: Journal. 2008; 18:235-251.
p.000035: 72. Herrera CD. Two arguments for ‘covert methods’ in social research. British Journal of Sociology. 1999; 50: 331-343.
p.000035: 73. Baraitser P, Pearce V, Walsh N, Cooper R, Brown KC, Holmes J, Smith L, Boynton P. Look who’s taking notes in your
p.000035: clinic: mystery shoppers as evaluators in sexual health services. Health Expectations. 2008; 11:54-62.
p.000035: 74. Benham B. Moral accountability and debriefing. Kennedy Institute of Ethics Journal. 2008; 18:253-273.
p.000035: 75. Baumrind D. Research using intentional deception: Ethical issues revisited. American Psychologist. 1985; 40:
p.000035: 165-174.
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000017: provinces in Canada. In this large and complex study, which involved the review of more
p.000017: 20 than 3 700 medical charts, and where it would be
p.000017: possible to uncover some possible evidence of intentional harm or incompetence, the researchers set up a “safety
p.000017: committee” of recognized experts who agreed to provide back-up to the researchers and review data and make a decision
p.000017: about possibly informing the hospital or other relevant personnel about potential risks or unsafe providers. The
p.000017: researchers had to use the committee in one instance where a patient had been injured and provider actions were deemed
p.000017: worthy of further review.
p.000017:
p.000017:
p.000017:
p.000017: General disclosure about the conduct of and findings from patient safety research Institutions with more positive
p.000017: patient safety
p.000017: cultures are more likely to be open to the conduct
p.000017: of research studies that aim to improve patient safety. General awareness of patient safety principles in the
p.000017: institutions where research will take place can help to increase understanding of the issues involved and decrease
p.000017: concerns
p.000017: and stress related to the research study. Disclosing general details about the way the study will be conducted and
p.000017: disseminated may contribute
p.000017: to reducing anxiety. This sharing of information also demonstrates respect for the individuals involved in the
p.000017: research.
p.000017:
p.000017: Anticipating risks from interviewing patients or their families
p.000017: Some types of patient safety studies involve
p.000017: interviewing patients or family members after adverse incidents have occurred. These interviews are designed to learn
p.000017: more about the patients’ and families’ experience and understanding of the events that occurred, as well as about the
p.000017: background conditions associated with the incident.This information may provide important insights that can be useful
p.000017: for future prevention strategies. In some cases, patients or family members may become distressed during such
p.000017: interviews, either because they are asked to recall the harm that occurred, or they learn about or come to suspect
p.000017: errors or problems that had not been fully apparent to them previously. In other instances, patients may be asked about
p.000017: their doctors’ performance (even in the absence of
p.000017: an incident) and this might lead to mistrust, concern or fear about the care they are receiving.
p.000017: Researchers should reassure participants that the information provided in the context of the research will be treated
p.000017: with the utmost
p.000017: confidentiality. Despite this, patients may still feel uncomfortable or fear retribution when disclosing
p.000017:
p.000017: aspects of the behaviour of providers. Those conducting interviews with patients and families must anticipate, and be
p.000017: prepared for such events and should have adequate responses and mechanisms in place in the form of referral
p.000017: or counselling for those that become distressed, as appropriate. Referral sites should be contacted in advance to
p.000017: ensure that they are willing and prepared to respond to requests.
p.000017:
p.000017: Anticipating risks from interviewing or observing providers
p.000017: Providers may be interviewed as part of patient
p.000017: safety research, to understand how systemic issues can contribute to harmful incidents. In the course of these
p.000017: interviews it is possible that providers may be questioned about their colleagues, their supervisors or hospital
p.000017: management. In such circumstances, providers may feel that they are
p.000017: at risk of repercussions if the information provided by them is not treated confidentially. In such cases they must
...
p.000033: The formation of a functional reference group, or patient safety committee, whether stable or ad-hoc, may represent a
p.000033: possible solution in these circumstances. Such a group
p.000033: or committee should be composed of respected professionals, able to provide their honest judgment to assist researchers
p.000033: and patient safety improvement bodies in solving issues of an ethical nature arising during the design or conduct of a
p.000033: given study.
p.000033:
p.000033: This report could not possibly cover all ethical issues that could arise during the design and conduct of patient
p.000033: safety research and other related activities. Furthermore, the guidance provided here for the issues under
p.000033: consideration cannot be exhaustive.
p.000033: Instead it is a modest reflection of the discussions and debate held by its contributors. For this reason, this report
p.000033: aspires to be the first edition of a series, soon to be updated with new evidence and more elaborated debate. WHO
p.000033: encourages evaluation and feedback from the guidance described here, as well as increased and new discussion in this
p.000033: important field of ethics as applied to patient safety research.
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: 9. References
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034: 1 The Research Priority Setting Working Group of WHO Patient Safety: Summary of the evidence on patient safety:
p.000034: Implications for research. WHO, Geneva. 2008.
p.000034: 2 Sandars J, Esmail A. The frequency and nature of medical error in primary care: understanding the diversity across
p.000034: studies. Family Practice. 2003;20:231-6.
p.000034: 3 Jha AK, Prasopa-Plaizier N, Larizgoitia I, Bates DW. Research Priority Setting Working Group of the WHO World
p.000034: Alliance for Patient Safety. Patient safety research: an overview of the global evidence. Quality & Safety in Health
p.000034: Care. 2010;19:42-7.
p.000034: 4 Wilson RM, Michel P, Olsen S, Gibberd RW, Vincent C, El-Assady R, Rasslan O, Qsous S, Macharia WM, Sahel A, Whittaker
p.000034: S, Abdo-Ali M, Letaief M, Ahmed NA, Abdellatif A, Larizgoitia I, for the WHO Patient Safety EMRO/AFRO Working Group.
p.000034: Patient safety in developing countries: retrospective estimation of scale and nature of harm to patients in hospital.
p.000034: BMJ. 2012;344:e832. doi: 10.1136/bmj.e832
p.000034: 5 Aranaz-Andrés JM, Aibar-Remon C, Limon-Ramirez R, Amarilla Analia C, Restrepo-Parra FR, Urroz-Torres O,
p.000034: Sarabia-González O, Garcia-Corcuera L, Terol-Garcia E, Agra-Varela J, Gonseth-Garcia J, Bates DW, Larizgoitia-
p.000034: Jauregui I. Prevalence of adverse events in the hospitals of five Latin American countries: results of the
p.000034: “Iberoamerican study of adverse events” (IBEAS). BMJ Quality & Safety. 2011; 20:1043-1051.
p.000034: 6 Grady C. Quality Improvement and Ethical Oversight. Annals of Internal Medicine. 2007; 146: 680-681.
p.000034: 7 Andrew D McRae, Charles Weijer, Ariella Binik, Angela White, Jeremy M Grimshaw, Robert Boruch, Jamie C Brehaut, Allan
p.000034: Donner, Martin P Eccles, Raphael Saginur, Merrick Zwarenstein, Monica Taljaard. Who is the research subject in cluster
p.000034: randomized trials in health research?
p.000034: Trials. 2011; 12: 183.
p.000034: 8 Sharp HM, Orr RD. When “minimal risk” research yields clinically significant data, maybe the risks aren’t so minimal.
...
p.000034: Interests” form to the WHO Secretariat. None declared any conflicts or potential conflicts.
p.000034: 6. A drafting group produced the different iterations of this document, based on recommendations from the expert
p.000034: consultation and the two rounds of external review. The drafting group considered all suggestions made by the
p.000034: reviewers.
p.000034: All participants in this process are listed in the Acknow- ledgements section that accompanies this document.
p.000035: 35
p.000035: List of references reviewed during
p.000035: the systematic review of the literature:
p.000035: 1. World Medical Association, Declaration Of Helsinki. Ethical Principles for Medical Research Involving
p.000035: Human Subjects 59th WMA General Assembly, Seoul, October 2008 available at http://www.wma.net/en/
p.000035: 30publications/10policies/b3/17c.pdf
p.000035: 2. World Health Organization Technical Consultation on Research Ethics in International Epidemic Response, WHO 2010.
p.000035: WHO/HSE/GIP/ITP/10.1. Available at: http://www.who.int/ethics/gip_research_ethics_.pdf
p.000035: 3. Institute of Medicine. Committee on Quality
p.000035: of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. National Academy
p.000035: Press. Washington DC. 2001. Available
p.000035: at: http://www.iom.edu/Reports/2001/Crossing-the- Quality-Chasm-A-New-Health-System-for-the-
p.000035: 21st-Century.aspx
p.000035: 4. Wiseman B, Kaprielian VS. Patient safety – Quality improvement. Online training for physician assistants. Duke
p.000035: University Medical Center. Department of Community and Family Medicine. Duke Center for Instructional Technology.
p.000035: Available at: http://pamodules.mc.duke.edu/launch4.asp
p.000035: 5. Grady C. Quality Improvement and Ethical Oversight. Annals of Internal Medicine. 2007; 146: 680-681.
p.000035: 6. Stroup D, Berlin J, Morton S, Olkin I, Williamson GD, Rennie D, Moher D, Becker B, Sipe T, Thacker S. Meta-analysis
p.000035: of observational of observational studies in epidemiology: a proposal for reporting. JAMA. 2000; 283: 2008-2012
p.000035: 7. Institute of Medicine. Committee on Standards for Systematic Reviews of Comparative Effectiveness.
p.000035: Finding what works in health care: Standards
p.000035: for systematic reviews. National Academies Press. Washington DC. 2011. Available at:
p.000035: http://iom.edu/Reports/2011/Finding-What-Works-in- Health-Care-Standards-for-Systematic-Reviews.aspx
p.000035: 8. O’Connor D, Green S, Higgins J. Defining the review question and developing criteria for
p.000035: including studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions.
p.000035: Version 5.1.0 [updated March 2011].
p.000035: The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: 9. Tanon AA, Champagne F, Contandriopoulos AP, Pomey MP, Vadeboncoeur A, Nguyen H. Patient safety and systematic
p.000035: reviews: finding papers indexed in MEDLINE, EMBASE and CINAHL. Quality and Safety
p.000035: in Health Care. 2010; 19: 452-61.
p.000035: 10. Federal Policy for the Protection of Human Subjects (“Common Rule”), 45 C.F.R. 46.101. US Department
...
Health / Physically Disabled
Searching for indicator physically:
(return to top)
p.000021:
p.000021: In a published article describing this project,
p.000021: the project team members indicated that all hospital ICU staff were informed about the project and
p.000021: its objectives and were excited to participate.
p.000021: In addition, project team members indicated that the need for ethical approval for this project was waived because
p.000021: “all that was done was observation”. Names of hospital staff members and patients were not collected as part of this
p.000021: project. Data collection took place over a period of four months, during which time 554 human errors were reported by
p.000021: hospital staff. The results
p.000021: of this project cannot be directly applied to other ICUs at other hospitals, as the errors reported in this setting
p.000021: were almost certainly unique to this setting and the staff employed there. However, the project staff published this
p.000021: project because the methods used to complete it were innovative and it was felt that similar studies could be easily
p.000021: carried out in other settings.
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021: 5. Privacy and confidentiality
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021: Guidance point 8
p.000021: Staff involved in the conduct of patient safety research and patient safety activities should be aware of the
p.000021: principles and methods related to preserving privacy
p.000021: and confidentiality.
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021: Privacy and confidentiality are two separate but related issues. The United States Office for Human Research
p.000021: Protections has stated that “Privacy can be defined in terms of having control over the extent, timing, and
p.000021: circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. Confidentiality pertains to
p.000021: the treatment of information that an individual has disclosed in
p.000021: a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent
p.000021: with the understanding
p.000021: of the original disclosure without permission.”17
p.000021:
p.000021: As CIOMS has recognized, “patients have the right to expect that their physicians and other health-care professionals
p.000021: will hold all information about them
p.000021: in strict confidence and disclose it only to those who need, or have a legal right to, the information.”18 The medical
p.000021: profession sees confidentiality as essential, not only for successful health care, but more importantly to protect the
p.000021: trust that is placed in doctors by their patients.
p.000021:
p.000021: There are many strategies for safeguarding the personal information of individuals involved in patient safety research.
p.000021: These include coding abstracted data
p.000021: with unique identifiers rather than names and masking features of specific cases, institutions, or settings
p.000021: that may make them recognizable even without names. Masking features of cases may be more challenging for sentinel
p.000021: events, such as a wrong site surgery or
p.000025: 25
p.000025: EXISTING GUIDELINES
p.000025: Research relating to individuals and groups may involve
p.000025: the collection and storage
p.000025: of information that, if disclosed to third parties, could cause harm or distress. Investigators should arrange to
p.000025: protect the
...
Health / Physically Ill
Searching for indicator sick:
(return to top)
p.000030: the consequences for the subject of being deceived, and whether and how deceived subjects should be informed of the
p.000030: deception upon completion of the research.
p.000030: CIOMS International Ethical Guidelines for Epidemiological Studies 2009 – Commentary on Guideline.
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: Researchers have a commitment to telling the truth, but omission of some information (e.g. the specific purpose of the
p.000030: study) is considered acceptable in some situations. In general, the type of information that is withheld from
p.000030: participants may include
p.000030: not informing participants that they are in research,
p.000030: not informing them of the true purpose of the research, not informing them which behaviours or interventions are being
p.000030: studied, or taking on
p.000030: a false identity in order to gain additional research information. Such withholding of information from research
p.000030: participants is allowable in exceptional
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: circumstances, where projects are low risk, where it is necessary for obtaining the relevant
p.000030: data, where the project could significantly advance the field of patient safety, and where it does not change the
p.000030: overall risk profile of the study.
p.000030: For instance, in a study to determine the extent of a problem of fake or substandard quality drugs being sold by
p.000030: pharmacists, “mystery clients” were asked to go to public marketplaces for remedies
p.000030: for their children when they didn’t really have a sick child, and the researchers then examined the pharmacological
p.000030: make-up of the products they were given. This study design was allowed by the local REC, because this was considered to
p.000030: be the only way of obtaining access to
p.000030: the pharmaceutical products actually being sold to patients and the study posed very few risks, if any, to those
p.000030: involved.
p.000030:
p.000030:
p.000030:
p.000030: Case study 7 – Withholding information 31
p.000030: (with permission for publication from author)
p.000030:
p.000030:
p.000030:
p.000030: Counterfeit and substandard drugs have been increasingly recognized as a global public health threat. They impact
p.000030: health and the economy in many ways, including increased morbidity and mortality due to inadequate treatment; cause
p.000030: adverse effects from toxic ingredients; promote drug resistance; foster loss of confidence in the health system; and
p.000030: cause unnecessary suffering and economic hardship for patients and families. Previous studies in a landlocked central
p.000030: Asian country have found counterfeit and substandard drugs, but the extent of the problem is not known. In order to
p.000030: gain insight into the extent and nature of the problem of counterfeit and substandard drugs in the country and help
p.000030: efforts to ensure
p.000030: a safe and effective medication supply, a cross- sectional descriptive study was undertaken to determine the prevalence
p.000030: of selected counterfeit/ substandard drugs in the capital city and determine the prevalence of drug outlets selling the
...
Health / hospitalized patients
Searching for indicator hospitalized patients:
(return to top)
p.000011: trusted informants in local settings to know the chance of retribution for providers, if errors are found, as well as
p.000011: providers’ anticipated anxiety about possible retribution. Patient safety professionals
p.000011: must also be sensitive to power relationships that exist between senior and junior hospital staff.
p.000011: In Case Study 3, those involved in the patient safety activity made clear to providers that all data would be kept
p.000011: confidential and therefore that no individual level data would be reported to hospital management. In settings where
p.000011: the local context could increase risks related to reporting or retribution, researchers may need to consider
p.000011: whether it would be ethically preferable to abandon the study, in order to prevent additional risks to participants, or
p.000011: whether it would be effective and feasible to build additional safeguards into the study. In some circumstances,
p.000011: collecting data anonymously (rather than confidentially) may be sufficient to protect against risk of harm.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000017: 17
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Case study 3 – Assessing the level of risk and minimizing risk
p.000017:
p.000017:
p.000017:
p.000017: Cullen DJ, Sweitzer BJ, Bates DW, et. al. Preventable adverse drug events in hospitalized patients: a comparative study
p.000017: of intensive care and general care units.
p.000017: Crit Care Med, 1997, 25:1289-1297.
p.000017: A patient safety project was implemented at 11 different ICUs and general care units in two tertiary care hospitals in
p.000017: the United States, with the objective of understanding the causes of adverse drug events (ADEs) resulting from
p.000017: 18 human errors in drug use, so that they might be prevented in the future. Data on all ADEs that occurred in
p.000017: any of those 11 units over a six-month period were included in the project. Data on ADEs were collected in several
p.000017: ways: all nurses and pharmacists in those 11 units were asked to report all ADEs to nurse investigators involved in the
p.000017: project, a nurse investigator visited each unit
p.000017: twice a day on weekdays to obtain information from hospital staff on any ADEs that had recently occurred, and each day,
p.000017: the nurse investigator also reviewed all medical charts to collect information on reported and potential ADEs.
p.000017: All data were then reviewed by two physicians. These physicians judged the severity of the ADE and whether or not it
p.000017: had been preventable.
p.000017: For each ADE judged to have been preventable,
p.000017:
p.000017: the hospital staff involved in providing the patient with the medication were interviewed by a peer and asked to
p.000017: describe the circumstances surrounding the incident, to describe how the event had occurred, and to self-assess their
p.000017: competency and skills, decision-making style, openness to change, duration in the service or job, the amount and
p.000017: quality of supervision they had received,
...
Health / injured
Searching for indicator injured:
(return to top)
p.000017: practice, is to set up
p.000017: a “safety committee” of recognized expert clinicians who agree to review data and make a decision about the case and
p.000017: subsequent actions, including informing relevant hospital management or personnel about potential risks or unsafe
p.000017: providers. This safety committee may also advise health professionals reviewing health records who are
p.000017: in some cases compelled to report instances where they suspect incompetence and where intervention with the patient may
p.000017: still be beneficial. See Case Study 4 for an illustration of this.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Case study 4 – Providing neutral expert advice on the course of action
p.000017:
p.000017:
p.000017: Baker GR, Norton PG, Flintoft V, et.al. The Canadian Adverse Events Study:
p.000017: the incidence of adverse events among hospital patients in Canada
p.000017: CMAJ 2004; 170 (11): 1678-1686
p.000017: This patient safety project involved the analysis for adverse events in a sample of 20 hospitals spread across five
p.000017: provinces in Canada. In this large and complex study, which involved the review of more
p.000017: 20 than 3 700 medical charts, and where it would be
p.000017: possible to uncover some possible evidence of intentional harm or incompetence, the researchers set up a “safety
p.000017: committee” of recognized experts who agreed to provide back-up to the researchers and review data and make a decision
p.000017: about possibly informing the hospital or other relevant personnel about potential risks or unsafe providers. The
p.000017: researchers had to use the committee in one instance where a patient had been injured and provider actions were deemed
p.000017: worthy of further review.
p.000017:
p.000017:
p.000017:
p.000017: General disclosure about the conduct of and findings from patient safety research Institutions with more positive
p.000017: patient safety
p.000017: cultures are more likely to be open to the conduct
p.000017: of research studies that aim to improve patient safety. General awareness of patient safety principles in the
p.000017: institutions where research will take place can help to increase understanding of the issues involved and decrease
p.000017: concerns
p.000017: and stress related to the research study. Disclosing general details about the way the study will be conducted and
p.000017: disseminated may contribute
p.000017: to reducing anxiety. This sharing of information also demonstrates respect for the individuals involved in the
p.000017: research.
p.000017:
p.000017: Anticipating risks from interviewing patients or their families
p.000017: Some types of patient safety studies involve
p.000017: interviewing patients or family members after adverse incidents have occurred. These interviews are designed to learn
p.000017: more about the patients’ and families’ experience and understanding of the events that occurred, as well as about the
p.000017: background conditions associated with the incident.This information may provide important insights that can be useful
p.000017: for future prevention strategies. In some cases, patients or family members may become distressed during such
p.000017: interviews, either because they are asked to recall the harm that occurred, or they learn about or come to suspect
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000021: with the understanding
p.000021: of the original disclosure without permission.”17
p.000021:
p.000021: As CIOMS has recognized, “patients have the right to expect that their physicians and other health-care professionals
p.000021: will hold all information about them
p.000021: in strict confidence and disclose it only to those who need, or have a legal right to, the information.”18 The medical
p.000021: profession sees confidentiality as essential, not only for successful health care, but more importantly to protect the
p.000021: trust that is placed in doctors by their patients.
p.000021:
p.000021: There are many strategies for safeguarding the personal information of individuals involved in patient safety research.
p.000021: These include coding abstracted data
p.000021: with unique identifiers rather than names and masking features of specific cases, institutions, or settings
p.000021: that may make them recognizable even without names. Masking features of cases may be more challenging for sentinel
p.000021: events, such as a wrong site surgery or
p.000025: 25
p.000025: EXISTING GUIDELINES
p.000025: Research relating to individuals and groups may involve
p.000025: the collection and storage
p.000025: of information that, if disclosed to third parties, could cause harm or distress. Investigators should arrange to
p.000025: protect the
p.000025: confidentiality of such information by, for example, omitting information that might lead to
p.000025: the identification of individual subjects, limiting access to the information, anonymizing data, or other means.
p.000025: CIOMS International Ethical Guidelines for Epidemiological Research 2009 Commentary on Guideline 18
p.000025:
p.000025: Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal
p.000025: information
p.000025: and to minimize the impact of the study on their physical, mental and social integrity.
p.000025: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association Declaration of Helsinki,
p.000025: 2008 paragraph 23
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: a patient death. Grouping similar cases together can help minimize the chance that individual providers or institutions
p.000025: will be identified.
p.000025:
p.000025: In general, access to patient information before it is de-identified should be granted to as few individuals as
p.000025: possible. This might be achieved by assigning medical staff, who already have permission and confidentiality
p.000025: commitments
p.000025: to review patient charts, or asking data collectors to sign the same level of confidentiality agreement(s) required of
p.000025: hospital staff. Absent these safeguards, patients’ consent to abstract
p.000025: 26 data from hospital records, or a waiver of consent from a REC (see guidance point 6) should be sought.
p.000025: Where providers’ behaviour is being analysed, by contrast, it may be more protective of privacy if outsiders, rather
p.000025: than colleagues,
p.000025: are the ones who document errors.
p.000025:
p.000025: In some situations, such as when using a single case to illustrate some findings, confidentiality may be more difficult
p.000025: to ensure. Nevertheless, this principle must be respected even if to achieve it, some patients’ details may need to be
p.000025: altered to protect the identity of individuals who would otherwise be identifiable based on the details
p.000025: of their case.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 6. Duty to intervene or report
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Guidance point 9
p.000025: Individuals involved in patient safety research may, occasionally, observe practices that may put patients at risk.
...
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: Researchers have a commitment to telling the truth, but omission of some information (e.g. the specific purpose of the
p.000030: study) is considered acceptable in some situations. In general, the type of information that is withheld from
p.000030: participants may include
p.000030: not informing participants that they are in research,
p.000030: not informing them of the true purpose of the research, not informing them which behaviours or interventions are being
p.000030: studied, or taking on
p.000030: a false identity in order to gain additional research information. Such withholding of information from research
p.000030: participants is allowable in exceptional
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: circumstances, where projects are low risk, where it is necessary for obtaining the relevant
p.000030: data, where the project could significantly advance the field of patient safety, and where it does not change the
p.000030: overall risk profile of the study.
p.000030: For instance, in a study to determine the extent of a problem of fake or substandard quality drugs being sold by
p.000030: pharmacists, “mystery clients” were asked to go to public marketplaces for remedies
p.000030: for their children when they didn’t really have a sick child, and the researchers then examined the pharmacological
p.000030: make-up of the products they were given. This study design was allowed by the local REC, because this was considered to
p.000030: be the only way of obtaining access to
p.000030: the pharmaceutical products actually being sold to patients and the study posed very few risks, if any, to those
p.000030: involved.
p.000030:
p.000030:
p.000030:
p.000030: Case study 7 – Withholding information 31
p.000030: (with permission for publication from author)
p.000030:
p.000030:
p.000030:
p.000030: Counterfeit and substandard drugs have been increasingly recognized as a global public health threat. They impact
p.000030: health and the economy in many ways, including increased morbidity and mortality due to inadequate treatment; cause
p.000030: adverse effects from toxic ingredients; promote drug resistance; foster loss of confidence in the health system; and
p.000030: cause unnecessary suffering and economic hardship for patients and families. Previous studies in a landlocked central
p.000030: Asian country have found counterfeit and substandard drugs, but the extent of the problem is not known. In order to
p.000030: gain insight into the extent and nature of the problem of counterfeit and substandard drugs in the country and help
p.000030: efforts to ensure
p.000030: a safe and effective medication supply, a cross- sectional descriptive study was undertaken to determine the prevalence
p.000030: of selected counterfeit/ substandard drugs in the capital city and determine the prevalence of drug outlets selling the
p.000030: selected counterfeit and substandard drugs in that city.
p.000030:
p.000030: Drug outlets were randomly selected stratified by geographic setting and type of drug outlets. Nine drugs from 3 groups
...
Social / Child
Searching for indicator child:
(return to top)
p.000030: deception upon completion of the research.
p.000030: CIOMS International Ethical Guidelines for Epidemiological Studies 2009 – Commentary on Guideline.
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: Researchers have a commitment to telling the truth, but omission of some information (e.g. the specific purpose of the
p.000030: study) is considered acceptable in some situations. In general, the type of information that is withheld from
p.000030: participants may include
p.000030: not informing participants that they are in research,
p.000030: not informing them of the true purpose of the research, not informing them which behaviours or interventions are being
p.000030: studied, or taking on
p.000030: a false identity in order to gain additional research information. Such withholding of information from research
p.000030: participants is allowable in exceptional
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: circumstances, where projects are low risk, where it is necessary for obtaining the relevant
p.000030: data, where the project could significantly advance the field of patient safety, and where it does not change the
p.000030: overall risk profile of the study.
p.000030: For instance, in a study to determine the extent of a problem of fake or substandard quality drugs being sold by
p.000030: pharmacists, “mystery clients” were asked to go to public marketplaces for remedies
p.000030: for their children when they didn’t really have a sick child, and the researchers then examined the pharmacological
p.000030: make-up of the products they were given. This study design was allowed by the local REC, because this was considered to
p.000030: be the only way of obtaining access to
p.000030: the pharmaceutical products actually being sold to patients and the study posed very few risks, if any, to those
p.000030: involved.
p.000030:
p.000030:
p.000030:
p.000030: Case study 7 – Withholding information 31
p.000030: (with permission for publication from author)
p.000030:
p.000030:
p.000030:
p.000030: Counterfeit and substandard drugs have been increasingly recognized as a global public health threat. They impact
p.000030: health and the economy in many ways, including increased morbidity and mortality due to inadequate treatment; cause
p.000030: adverse effects from toxic ingredients; promote drug resistance; foster loss of confidence in the health system; and
p.000030: cause unnecessary suffering and economic hardship for patients and families. Previous studies in a landlocked central
p.000030: Asian country have found counterfeit and substandard drugs, but the extent of the problem is not known. In order to
p.000030: gain insight into the extent and nature of the problem of counterfeit and substandard drugs in the country and help
p.000030: efforts to ensure
p.000030: a safe and effective medication supply, a cross- sectional descriptive study was undertaken to determine the prevalence
p.000030: of selected counterfeit/ substandard drugs in the capital city and determine the prevalence of drug outlets selling the
p.000030: selected counterfeit and substandard drugs in that city.
...
Searching for indicator children:
(return to top)
p.000030: to participate. The ethical review committee should determine
p.000030: the consequences for the subject of being deceived, and whether and how deceived subjects should be informed of the
p.000030: deception upon completion of the research.
p.000030: CIOMS International Ethical Guidelines for Epidemiological Studies 2009 – Commentary on Guideline.
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: Researchers have a commitment to telling the truth, but omission of some information (e.g. the specific purpose of the
p.000030: study) is considered acceptable in some situations. In general, the type of information that is withheld from
p.000030: participants may include
p.000030: not informing participants that they are in research,
p.000030: not informing them of the true purpose of the research, not informing them which behaviours or interventions are being
p.000030: studied, or taking on
p.000030: a false identity in order to gain additional research information. Such withholding of information from research
p.000030: participants is allowable in exceptional
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: circumstances, where projects are low risk, where it is necessary for obtaining the relevant
p.000030: data, where the project could significantly advance the field of patient safety, and where it does not change the
p.000030: overall risk profile of the study.
p.000030: For instance, in a study to determine the extent of a problem of fake or substandard quality drugs being sold by
p.000030: pharmacists, “mystery clients” were asked to go to public marketplaces for remedies
p.000030: for their children when they didn’t really have a sick child, and the researchers then examined the pharmacological
p.000030: make-up of the products they were given. This study design was allowed by the local REC, because this was considered to
p.000030: be the only way of obtaining access to
p.000030: the pharmaceutical products actually being sold to patients and the study posed very few risks, if any, to those
p.000030: involved.
p.000030:
p.000030:
p.000030:
p.000030: Case study 7 – Withholding information 31
p.000030: (with permission for publication from author)
p.000030:
p.000030:
p.000030:
p.000030: Counterfeit and substandard drugs have been increasingly recognized as a global public health threat. They impact
p.000030: health and the economy in many ways, including increased morbidity and mortality due to inadequate treatment; cause
p.000030: adverse effects from toxic ingredients; promote drug resistance; foster loss of confidence in the health system; and
p.000030: cause unnecessary suffering and economic hardship for patients and families. Previous studies in a landlocked central
p.000030: Asian country have found counterfeit and substandard drugs, but the extent of the problem is not known. In order to
p.000030: gain insight into the extent and nature of the problem of counterfeit and substandard drugs in the country and help
p.000030: efforts to ensure
p.000030: a safe and effective medication supply, a cross- sectional descriptive study was undertaken to determine the prevalence
...
Social / Laboratory Staff
Searching for indicator research staff:
(return to top)
p.000025: commitments
p.000025: to review patient charts, or asking data collectors to sign the same level of confidentiality agreement(s) required of
p.000025: hospital staff. Absent these safeguards, patients’ consent to abstract
p.000025: 26 data from hospital records, or a waiver of consent from a REC (see guidance point 6) should be sought.
p.000025: Where providers’ behaviour is being analysed, by contrast, it may be more protective of privacy if outsiders, rather
p.000025: than colleagues,
p.000025: are the ones who document errors.
p.000025:
p.000025: In some situations, such as when using a single case to illustrate some findings, confidentiality may be more difficult
p.000025: to ensure. Nevertheless, this principle must be respected even if to achieve it, some patients’ details may need to be
p.000025: altered to protect the identity of individuals who would otherwise be identifiable based on the details
p.000025: of their case.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 6. Duty to intervene or report
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Guidance point 9
p.000025: Individuals involved in patient safety research may, occasionally, observe practices that may put patients at risk.
p.000025: Researchers observing clinical encounters have a duty to intervene to protect these patients if all of the following
p.000025: are present and the research staff observing these events have sufficient expertise and experience to interpret these
p.000025: situations appropriately:
p.000025: ñ they are highly suspicious that an error is imminent;
p.000025: ñ they believe it is highly likely that the error will result in direct, severe or irreversible harm;
p.000025: ñ their immediate action or intervention will prevent or reverse some of the negative effects of the error;
p.000025: Where sufficient expertise and experience to interpret the situation is not present, staff should seek advice from more
p.000025: experienced professionals.
p.000025:
p.000025:
p.000025:
p.000025: Guidance point 10
p.000025: Similarly, researchers who are abstracting information from patient medical records have
p.000025: a duty to intervene if the research staff reviewing the records have sufficient expertise and experience to interpret
p.000025: the situation appropria- tely and all of the following are present:
p.000025: ñ they are highly suspicious that an incident has occurred;
p.000025: ñ they are confident that intervening could reverse some of the negative medical effects of the inci- dent;
p.000025: ñ there is no evidence to suspect that an intervention has already occurred in response to the (potential) incident;
p.000025: ñ the consequences of the incident are of direct severe or irreversible harm;
p.000025: Where sufficient expertise and experience to interpret the situation is not present, staff should seek advice from more
p.000025: experienced professionals.
p.000025: EXISTING GUIDELINES 27
p.000025: The WHO expert working group reviewed existing international ethical guidelines on research with human participants and
p.000025: found no discussion of researchers’ duties to intervene when they observe practices that put patients at risk. In
p.000025: addition, a literature review conducted by WHO staff was “unable to identify literature that describes when or whether
p.000025: there is a duty to intervene
p.000025: when errors are observed either prospectively or as part of medical chart review.”
p.000025: The guidance set forth in this section
p.000025: of the report is based on the WHO expert working group’s recommendations,
p.000025: which were developed through a process of group discussion.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Guidance point 11
p.000025: Those involved in patient safety research have a duty to report the study results back to hospitals and units once the
p.000025: project is complete.
p.000025:
p.000025:
p.000025:
...
p.000025: develop programmes to improve care. At the same time, researchers, as human beings and as professionals, cannot simply
p.000025: witness egregious, preventable, and imminent problems without intervening. Research teams must anticipate
p.000025: this problem and plan for the types of situations that may occur in studies, given their own methodology, setting, and
p.000025: population. In general, the expectation is that the above criteria would very rarely be met and researchers would very
p.000025: rarely be intervening. In rare cases, when researchers
p.000025: are qualified to assess risk, and if the risk of harm seems imminent, if the harm would be severe and irreversible,
p.000025: and if interfering could prevent
p.000025: the harm, then researchers should indeed intervene. To facilitate this process, the information sheet given to
p.000025: providers must mention the possibility
p.000025: of the observer commenting and intervening in such circumstances.
p.000025:
p.000025: For example, if researchers are conducting a surgery checklist study, they should discuss at the protocol planning
p.000025: stage what types of possible incidents would count as highly likely to result in severe
p.000025: harm. An example might be awareness that
p.000025: the anaesthesiologist has included a life-threatening dose of a medication, and the observer is qualified to make such
p.000025: an assessment. In these extremely rare occurrences where a severe or irreversible incident may be imminent and the
p.000025: research staff have the experience and the knowledge to make such a critical observation, intervention should occur.
p.000025: The nature of the intervention will depend on the situation, but will probably involve asking the clinical staff a
p.000025: question related to confirming or double-checking the dose, or the surgical approach, or something similarly important.
p.000025: In case study 6, because the researchers observing the nurses
p.000025: were themselves nurses or pharmacy technicians, they had the expertise necessary to know when an error occurred. They
p.000025: were also instructed
p.000025: to intervene when errors that could cause harm to patients were made.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Case study 6 – Reporting serious errors that can cause direct and severe harm to patients
p.000025:
p.000025:
p.000025:
p.000025: Greengold N, Shane R, Schneider P, et. al. The Impact of Dedicated Medication Nurses on the Medication Administration
p.000025: Error Rate: A Randomized Controlled Trial.
p.000025: Arch Intern Med, 2003:163:2359-2367
p.000025: This patient safety project was implemented in two hospitals in the United States to understand if having a nurse
p.000025: dedicated to administering medications to patients would reduce the rate of medication administration errors. Four
p.000025: nursing
p.000025: units in each hospital were selected to participate in the project. Within those units, the project staff recruited
p.000025: nurses to participate in the project.
p.000025: Informed consent was obtained from each of the nurse participants and the REC at each of
...
p.000039: In cases where individual informed consent from patients will not be sought, general disclosure
p.000039: to patients about patient safety research is highly recommended.
p.000039: 40 Guidance point 7
p.000039: Individual informed consent from providers participating in a research study must generally be obtained. However, the
p.000039: requirement of obtaining individual informed consent from patients can be waived by an REC if
p.000039: ñ The research does not directly inform or alter individual patients’ therapeutic or medical treatment plans; and
p.000039: ñ Risks to the provider are minimal (see Guidance Point 3); and
p.000039: ñ The research could not practicably be carried out with the consent of providers.
p.000039: In cases where individual informed consent from providers will not be sought, general disclosure to providers about
p.000039: patient safety activities is highly recommended.
p.000039: Guidance point 8
p.000039: Staff involved in the conduct of patient safety research and patient safety activities should be aware of the
p.000039: principles and methods related to preserving privacy
p.000039: and confidentiality.
p.000039:
p.000039: Guidance point 9
p.000039: Individuals involved in patient safety research may, occasionally, observe practices that may put patients at risk.
p.000039: Researchers observing clinical encounters have a duty to intervene to protect these patients if all of the following
p.000039: are present and the research staff observing these events have sufficient expertise and experience to interpret these
p.000039: situations appropriately:
p.000039: ñ they are highly suspicious that an error is imminent;
p.000039: ñ they believe it is highly likely that the error will result in direct, severe or irreversible harm;
p.000039: ñ their immediate action or intervention will prevent or reverse some of the negative effects of the error;
p.000039: Where sufficient expertise and experience to interpret the situation is not present, staff should seek advice from more
p.000039: experienced professionals.
p.000039: Guidance point 10
p.000039: Similarly, researchers who are abstracting information from patient medical records have a duty to intervene if the
p.000039: research staff
p.000039: reviewing the records have sufficient expertise and experience to interpret the situation appropriately and all of the
p.000039: following are present:
p.000039: ñ they are highly suspicious that an incident has occurred;
p.000039: ñ they are confident that intervening could reverse some of the negative medical effects of the incident;
p.000039: ñ there is no evidence to suspect that an intervention has already occurred in response to the (potential) incident;
p.000039: ñ the consequences of the incident are of direct severe or irreversible harm;
p.000039: Where sufficient expertise and experience to interpret the situation is not present, staff should seek advice from more
p.000039: experienced professionals.
p.000039:
p.000039: Guidance point 11
p.000039: Those involved in patient safety research have a duty to report the study results back to hospitals and units once the
p.000039: project is complete.
p.000039:
p.000039: Guidance point 12
p.000039: Patient safety researchers who propose to withhold information from potential research participants as part of their
p.000039: research must do all of the following:
p.000039: ñ Demonstrate to a research ethics committee that no other research method will suffice;
p.000039: ñ Persuasively argue that significant advances could result from the research either for the local setting or more
p.000039: broadly;
p.000039: ñ Consider whether asking participants to consent to participate, without disclosing the nature or precise timing of
p.000039: the intervention, is reasonable;
p.000039: ñ Ensure that withholding information itself will not cause a study to involve greater than minimal risk.
p.000039:
p.000039: Guidance point 13
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000011: EXISTING GUIDELINES
p.000011: The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics
p.000011: committee before the study begins. This committee must be independent of the researcher, the sponsor and any other
p.000011: undue influence.
p.000011: It must take into consideration the laws and regulations of the country or countries in which the
p.000011: research is to be performed as well as applicable international norms and standards but these must not be allowed to
p.000011: reduce or eliminate any of the protections for research subjects set forth in this Declaration. The committee must have
p.000011: the right to monitor on-going studies. The researcher must provide monitoring information
p.000011: to the committee, especially information about any serious adverse events. No change to
p.000011: the protocol may be made without consideration and approval by
p.000011: the committee.
p.000011: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association Declaration of Helsinki,
p.000011: 2008 paragraph 15
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Case study 1 – Obtaining research ethics oversight
p.000011:
p.000011:
p.000011:
p.000011: Dovey S, Hall K, Makeham M, et. al.
p.000011: Seeking ethical approval for an international study in primary care patient safety.
p.000011: Br J Gen Pract 2011; 61: 197-204
p.000011: Seeking ethics committee approval for research
p.000011: can be challenging even for relatively simple studies occurring in single settings. Complicating factors such as
p.000011: multicentre studies and/or contentious research issues can challenge review processes,
p.000011: 12 and conducting such studies internationally adds a further layer of complexity. This paper drew on the
p.000011: experiences of the LINNAEUS Collaboration,
p.000011: an international group of primary care researchers, in obtaining ethics approval to conduct an international study
p.000011: investigating medical error
p.000011: in general practice in six countries. It describes
p.000011:
p.000011: the ethics review processes applied to exactly the same research protocol for a study run in Australia, Canada,
p.000011: England, the Netherlands, New Zealand, and the US. Wide variations in ethics review responses to the research proposal
p.000011: occurred, from no approval being deemed necessary to the study plan narrowly avoiding rejection. The ethics committees
p.000011: in each country had different concerns about the study protocol they were presented with, which was exactly the same in
p.000011: each country. The authors’ experiences demonstrated that ethics committees operate in their own historical and cultural
p.000011: context, which can lead to radically different subjective interpretations of commonly- held ethical principles, and
p.000011: raised further issues such as ‘what is research?’
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Guidance point 2
...
p.000021: providers. In addition, hospital, clinic, or facility staff should be informed about how results from patient safety
p.000021: activities will be reported to the hospital, clinic or facility leadership.
p.000021: Group disclosure and discussion can take place at staff meetings or through letters or emails. See Case Study 5 for an
p.000021: illustration.
p.000021:
p.000021: Institutions participating in patient safety research activities for which individual consent of providers is not
p.000021: necessary should consider whether staff will
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021: have the option of opting out. There could be some cases in which allowing individual staff members
p.000021: to opt out may not be feasible.
p.000021:
p.000021: Sometimes, consent from providers might be waived, not because the risks are minimal but because
p.000021: the research could not practicably be carried out with their individual consent. This situation could arise, for
p.000021: example, because the research itself is likely to alter practice and so skew the results i.e. the Hawthorne Effect, or
p.000021: the effect of merely knowing one is being observed. This may be more likely
p.000021: for some research than for others, e.g. rates of hand
p.000021: 24 washing to reduce infection rates.
p.000021:
p.000021:
p.000021: Case study 5 – Group disclosure about patient safety activities
p.000021:
p.000021:
p.000021:
p.000021: Donchin Y, Gopher D, Olin M, et al. A look into the nature and causes of human errors in the intensive care unit.
p.000021: Qual Saf Health Care 2003, 12; 143-147
p.000021: In a single hospital in Israel, a patient safety project was conducted to understand the causes of human errors in the
p.000021: intensive care unit (ICU) so that
p.000021: these errors could be prevented in the future. Data on human errors were reported by the hospital staff immediately
p.000021: after they were
p.000021: discovered. Information that was reported included the time that the error occurred, the time the error was discovered,
p.000021: the profession of the person
p.000021: who committed the error (physician, nurse, etc.), the profession of the person who reported the error and a short
p.000021: description of what happened and the presumed cause. Individuals involved in the project rated the severity of each of
p.000021: the error reports on a five point Likert scale. In addition,
p.000021: to understand the number of activities that occur in the ICU on a daily basis, 46 randomly selected patients were
p.000021: observed continuously for 24 hours by outside trained observers from the Israeli Institute of Technology. The observer
p.000021: recorded
p.000021:
p.000021: all encounters between the patient and his or her immediate bedside surroundings, including any human errors that
p.000021: occurred.
p.000021:
p.000021: In a published article describing this project,
p.000021: the project team members indicated that all hospital ICU staff were informed about the project and
p.000021: its objectives and were excited to participate.
p.000021: In addition, project team members indicated that the need for ethical approval for this project was waived because
p.000021: “all that was done was observation”. Names of hospital staff members and patients were not collected as part of this
p.000021: project. Data collection took place over a period of four months, during which time 554 human errors were reported by
p.000021: hospital staff. The results
...
p.000025:
p.000025: Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal
p.000025: information
p.000025: and to minimize the impact of the study on their physical, mental and social integrity.
p.000025: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association Declaration of Helsinki,
p.000025: 2008 paragraph 23
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: a patient death. Grouping similar cases together can help minimize the chance that individual providers or institutions
p.000025: will be identified.
p.000025:
p.000025: In general, access to patient information before it is de-identified should be granted to as few individuals as
p.000025: possible. This might be achieved by assigning medical staff, who already have permission and confidentiality
p.000025: commitments
p.000025: to review patient charts, or asking data collectors to sign the same level of confidentiality agreement(s) required of
p.000025: hospital staff. Absent these safeguards, patients’ consent to abstract
p.000025: 26 data from hospital records, or a waiver of consent from a REC (see guidance point 6) should be sought.
p.000025: Where providers’ behaviour is being analysed, by contrast, it may be more protective of privacy if outsiders, rather
p.000025: than colleagues,
p.000025: are the ones who document errors.
p.000025:
p.000025: In some situations, such as when using a single case to illustrate some findings, confidentiality may be more difficult
p.000025: to ensure. Nevertheless, this principle must be respected even if to achieve it, some patients’ details may need to be
p.000025: altered to protect the identity of individuals who would otherwise be identifiable based on the details
p.000025: of their case.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 6. Duty to intervene or report
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Guidance point 9
p.000025: Individuals involved in patient safety research may, occasionally, observe practices that may put patients at risk.
p.000025: Researchers observing clinical encounters have a duty to intervene to protect these patients if all of the following
p.000025: are present and the research staff observing these events have sufficient expertise and experience to interpret these
p.000025: situations appropriately:
p.000025: ñ they are highly suspicious that an error is imminent;
p.000025: ñ they believe it is highly likely that the error will result in direct, severe or irreversible harm;
p.000025: ñ their immediate action or intervention will prevent or reverse some of the negative effects of the error;
p.000025: Where sufficient expertise and experience to interpret the situation is not present, staff should seek advice from more
p.000025: experienced professionals.
p.000025:
p.000025:
p.000025:
p.000025: Guidance point 10
p.000025: Similarly, researchers who are abstracting information from patient medical records have
...
Social / Occupation
Searching for indicator job:
(return to top)
p.000017: of intensive care and general care units.
p.000017: Crit Care Med, 1997, 25:1289-1297.
p.000017: A patient safety project was implemented at 11 different ICUs and general care units in two tertiary care hospitals in
p.000017: the United States, with the objective of understanding the causes of adverse drug events (ADEs) resulting from
p.000017: 18 human errors in drug use, so that they might be prevented in the future. Data on all ADEs that occurred in
p.000017: any of those 11 units over a six-month period were included in the project. Data on ADEs were collected in several
p.000017: ways: all nurses and pharmacists in those 11 units were asked to report all ADEs to nurse investigators involved in the
p.000017: project, a nurse investigator visited each unit
p.000017: twice a day on weekdays to obtain information from hospital staff on any ADEs that had recently occurred, and each day,
p.000017: the nurse investigator also reviewed all medical charts to collect information on reported and potential ADEs.
p.000017: All data were then reviewed by two physicians. These physicians judged the severity of the ADE and whether or not it
p.000017: had been preventable.
p.000017: For each ADE judged to have been preventable,
p.000017:
p.000017: the hospital staff involved in providing the patient with the medication were interviewed by a peer and asked to
p.000017: describe the circumstances surrounding the incident, to describe how the event had occurred, and to self-assess their
p.000017: competency and skills, decision-making style, openness to change, duration in the service or job, the amount and
p.000017: quality of supervision they had received,
p.000017: and the relationship of the incident to the timing of their shift. Consent was not obtained from patients within the
p.000017: unit. Project staff reported that several of the medical staff who had made errors did not want to discuss those errors
p.000017: with interviewers because they were scared about being reprimanded for their mistake. As stated by the project staff
p.000017: member, “We had to reassure them about the confidentiality issues and
p.000017: it worked most of the time.” The project was approved by the REC at each of the two hospitals. During the review
p.000017: process, it was decided that if, during the course of the project, staff identified patterns of care that were harmful
p.000017: to a patient,
p.000017: it was the duty of the project staff to immediately inform the hospital staff and the appropriate authorities so that
p.000017: the recurring error could be corrected, but without retribution to any individual employees.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Minimizing social and psychological risk in patient safety studies
p.000017:
p.000017:
p.000017: Guidance point 4
p.000017: ñ Before conducting a study, researchers should consider discussing with leadership of the health-care institution
p.000017: under study the importance of avoiding a culture
p.000017: of blame with regard to patient safety.
p.000017: ñ Patient safety researchers should also consider whether the political, social, institutional, or cultural context in
...
p.000025: The guidance set forth in this section
p.000025: of the report is based on the WHO expert working group’s recommendations,
p.000025: which were developed through a process of group discussion.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Guidance point 11
p.000025: Those involved in patient safety research have a duty to report the study results back to hospitals and units once the
p.000025: project is complete.
p.000025:
p.000025:
p.000025:
p.000025: Patient safety studies sometimes involve observation of health care practices. Occasionally, researchers may face a
p.000025: situation in which they wonder if they
p.000025: 28 should intervene with the care they are observing, in order to prevent a harmful incident they think may
p.000025: soon occur. Similarly, researchers who are reviewing medical records may come across an error or probable error that
p.000025: they believe was never reported. In such situations researchers must decide when, if ever, they should intervene.19, 20
p.000025: In general, the role of the researcher is different from the role of a clinician or hospital manager: researchers’
p.000025: primary role is to document the occurrence and nature of some features in order to identify better strategies in the
p.000025: future, or to measure rigorously whether new approaches to preventing harm are systematically better than older
p.000025: strategies. To intervene whenever they see a problem would almost certainly negate their ability to collect sound data,
p.000025: which are necessary for making more widespread progress in improving patient safety. Indeed, in some cases, part of the
p.000025: patient safety researcher’s job is to document the rate and nature of substandard or unsafe practices in order to
p.000025: develop programmes to improve care. At the same time, researchers, as human beings and as professionals, cannot simply
p.000025: witness egregious, preventable, and imminent problems without intervening. Research teams must anticipate
p.000025: this problem and plan for the types of situations that may occur in studies, given their own methodology, setting, and
p.000025: population. In general, the expectation is that the above criteria would very rarely be met and researchers would very
p.000025: rarely be intervening. In rare cases, when researchers
p.000025: are qualified to assess risk, and if the risk of harm seems imminent, if the harm would be severe and irreversible,
p.000025: and if interfering could prevent
p.000025: the harm, then researchers should indeed intervene. To facilitate this process, the information sheet given to
p.000025: providers must mention the possibility
p.000025: of the observer commenting and intervening in such circumstances.
p.000025:
p.000025: For example, if researchers are conducting a surgery checklist study, they should discuss at the protocol planning
p.000025: stage what types of possible incidents would count as highly likely to result in severe
p.000025: harm. An example might be awareness that
p.000025: the anaesthesiologist has included a life-threatening dose of a medication, and the observer is qualified to make such
p.000025: an assessment. In these extremely rare occurrences where a severe or irreversible incident may be imminent and the
...
Social / Property Ownership
Searching for indicator home:
(return to top)
p.000011: and are sanctioned by regulations or statutes.
p.000011: CIOMS International Ethical Guidelines for Epidemiological Studies, 2009 Introduction
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Case study 2 – Distinguishing research from other programmes
p.000011:
p.000011:
p.000011:
p.000011: Pronovost P, Needham D, Berenholz S, et. al. An Intervention to Decrease Catheter Related Bloodstream Infections in the
p.000011: ICU.
p.000011: N Engl J Med, 2006, 355:272.
p.000011: This patient safety project was implemented to determine the effectiveness of an evidence-based intervention aimed at
p.000011: reducing rates of catheter- acquired bloodstream infections in ICUs. The intervention aimed at improving physicians’
p.000011: use
p.000011: of five procedures that have been previously shown
p.000011: 14 to reduce infections. These procedures include proper hand washing, full barrier precautions during
p.000011: insertion of the catheter, cleaning the patient’s
p.000011: skin with chlorhexidine, avoiding the femoral site if possible, and removing unnecessary catheters. Agreement to
p.000011: participate was obtained from
p.000011: 108 ICUs from 67 hospitals in the state of Michigan,
p.000011: United States. Each of the ICUs implemented
p.000011: the evidence-based intervention, and infection rates
p.000011:
p.000011: before the implementation of the intervention were compared with infection rates after its implementation. Each ICU was
p.000011: responsible
p.000011: for reporting aggregate infection data back to the project staff. The project staff developed the intervention and
p.000011: conducted the evaluation
p.000011: but were not members of any of the ICUs involved in the study. The study was submitted to the REC of the home
p.000011: institution of the project staff before implementation.
p.000011:
p.000011: Indeed, confusion by experienced professionals about whether projects like this should be classified as research vs.
p.000011: quality improvement practice led
p.000011: to public controversy around this particular case, and questioning from government authorities, highlighting the need
p.000011: for clearer guidance around when projects such as this should be subject
p.000011: to ethical oversight and when they should not.
p.000011:
p.000011:
p.000011:
p.000011: EXISTING GUIDELINES
p.000011: The distinction between research and practice in public health does not correlate with the extent
p.000011: to which an activity carries risks for individuals and communities
p.000011:
p.000011:
p.000011:
p.000011: Figure 1. Suggested flow diagram
p.000011:
p.000011: or otherwise raises ethical issues that would benefit from
p.000011: a prospective review process. The distinction has no bearing
p.000011: Patient Safety Activity
p.000011:
p.000011: if poses a greater
p.000011: Patient Safety Research
p.000011:
p.000011: either on the ultimate question of whether a particular public health response is scientifically and ethically
p.000011: justifiable. … Despite the conceptual problems
p.000011: of distinguishing between research and non-research, the distinction is deeply ingrained in many countries’ regulatory
p.000011: structures and is unlikely to be changed
p.000011: any time soon. However, this does not mean that all research must undergo full REC review, nor does it mean that
p.000011: activities that fall outside local or international definitions of research should escape ethics review entirely.
p.000011: WHO Technical Consultation on Research Ethics in International Epidemic Response
...
p.000030: adverse effects from toxic ingredients; promote drug resistance; foster loss of confidence in the health system; and
p.000030: cause unnecessary suffering and economic hardship for patients and families. Previous studies in a landlocked central
p.000030: Asian country have found counterfeit and substandard drugs, but the extent of the problem is not known. In order to
p.000030: gain insight into the extent and nature of the problem of counterfeit and substandard drugs in the country and help
p.000030: efforts to ensure
p.000030: a safe and effective medication supply, a cross- sectional descriptive study was undertaken to determine the prevalence
p.000030: of selected counterfeit/ substandard drugs in the capital city and determine the prevalence of drug outlets selling the
p.000030: selected counterfeit and substandard drugs in that city.
p.000030:
p.000030: Drug outlets were randomly selected stratified by geographic setting and type of drug outlets. Nine drugs from 3 groups
p.000030: of medicines were selected for testing, based on their therapeutic
p.000030: importance, and earlier reports of being counterfeit or sub-standard. None of these drugs were prescription drugs and
p.000030: all can be purchased over the counter in that country.
p.000030:
p.000030: A group of paid field workers, who acted as simulated customers, anonymously purchased the drug samples from drug
p.000030: outlets based in a district
p.000030:
p.000030:
p.000030: different from their home district. The field workers were trained to give a specified set of symptoms and ask the
p.000030: questions that usual patients normally would ask pharmacists (can you give me this antibiotic, is this a good brand,
p.000030: can you give me another brand, is this the brand that other people also purchase, etc.). Following appropriate
p.000030: training, the field workers were provided with a list of the drugs and amount needed of each one from the assigned drug
p.000030: outlet. The identity of the drug outlet or the field worker were not on the data collection form; instead a sample
p.000030: number was recorded by the PI when the field worker returned.
p.000030: This sample number was linked to a code for
p.000030: the drug unit known only to the PI. Any potentially identifying information about the drug outlets
p.000030: was coded and removed from samples and data collection tools prior to sample analysis so researchers involved in the
p.000030: analysis would not know the source of any of the samples. If a selected
p.000030: drug outlet did not have the required sample of a drug, the PI arranged for a repeat visit to
p.000030: this facility at a later time or substituted a different randomly selected drug outlet.
p.000030:
p.000030: Results of the study were provided in an aggregated form to the National Drug Regulatory Authority
p.000030: and the Ministry of Health, in order to allow
...
Social / Soldier
Searching for indicator military:
(return to top)
p.000035: patients in quality improvement projects. In: Jennings B, Baily MA, Bottrell M, Lynn J, eds. Health Care Quality
p.000035: Improvement: Ethical and Regulatory Issues. Garrison, NY: The Hastings Center. 2007 Available at
p.000035: www.thehastingscenter.org.
p.000035: 32. Lindenauer PK, Benjamin EM, Naglieri-Prescod D, Fitzgerald J, Pekow P. The role of the Institutional Review Board
p.000035: in quality improvement: a survey of quality officers, institutional review board chairs, and journal editors. American
p.000035: Journal of Medicine. 2002; 113: 575-579.
p.000035: 33. Bottrell M. The ethics of quality improvement: Practitioners’ perspectives. A paper commissioned by the RAND Center
p.000035: to Improve Care of the Dying. 2003. Available at: http://www.innovation.cc/
p.000035: peer-reviewed/bottrell-ethics.pdf.
p.000035: 34. Bellin E, Dubler NN. The quality improvement- research divide and the need for external oversight. American Journal
p.000035: of Public Health. 2001; 91:
p.000035: 1512-1517.
p.000035: 35. Kass N, Pronovost PJ, Sugarman J, Goeschel CA, Lubomski LH, Faden R. Controversy and quality improvement: Lingering
p.000035: questions about ethics, oversight, and patient safety research. Joint
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: Commission Journal on Quality and Patient Safety. 2008; 36: 349-353.
p.000035: 36. Platteborze LS, Young-McCaughan S,
p.000035: King-Letzkus I, McClinton A, Halliday A, Jefferson TC. Performance Improvement/Research Advisory Panel:
p.000035: a model for determining whether a project
p.000035: is a performance or quality improvement activity
p.000035: or research. Military Medicine. 2010; 175: 289-291.
p.000035: 37. Nerenz DR. Ethical Issues in Using data from Quality Management Programs. European Spine Journal, 2009; 18(Suppl
p.000035: 3):S321-S330.
p.000035: 38. Doezema D, Hauswald M. Quality Improvement or Research: A distinction without a difference?
p.000035: IRB: Ethics & Human Research. 2002; 24: 9-12.
p.000035: 39. Kofke WA, Rie MA. Research ethics and law
p.000035: of healthcare system quality improvement: The conflict of cost containment and quality. Critical Care Medicine. 2003 ;
p.000035: 31(3 Suppl): S143-S152.
p.000035: 40. Nerenz DR, Stoltz PK, Jordan J. Quality Improvement and the Need for IRB Review. Quality Management in Health Care.
p.000035: 2003; 12:159-170.
p.000035: 41. Koschnitzke L, McCracken SC, Pranulis M. Ethical Considerations for Quality Assurance Versus Scientific Research.
p.000035: Western Journal of Nursing Research. 1992; 14:392-96.
p.000035: 42. Hagen B, O’Beirne M, Desai S, Stingl M, Pachnowski C, Hayward S. Innovations in the ethical review of
p.000035: health-related quality improvement and research: the Alberta Research Ethics Community Consensus Initiative (ARECCI).
p.000035: Health Policy. 2007; 2:1-14.
p.000035: 43. Davidoff F. Publication and the Ethics of Quality Improvement. In: Jennings B, Maily MA, Bottrell M, Lynn J, eds.
p.000035: Health Care Quality Improvement: Ethical and Regulatory Issues. Garrison, NY: The Hastings Center. 2007. Available at
p.000035: www.thehastingscenter.org
p.000035: 44. Davidoff F, Batalden P. Toward stronger evidence on quality improvement. Draft publication guidelines: the
p.000035: beginning of a consensus project. Quality & Safety in Health Care. 2005; 14: 319-325.
...
Social / Threat of Stigma
Searching for indicator stigma:
(return to top)
p.000021: the standard therapeutic plan, and the risks posed to patients by the research as a whole are minimal.
p.000021: In general consent is not ordinarily sought from patients when reminding providers about best practices.
p.000021:
p.000021: When individual informed consent is required, it must usually be documented through the signature on
p.000021: a consent form. However, in some situations, RECs may approve other methods of documentation, such as allowing
p.000021: participants to express their willingness to participate orally, or allowing participants to imply
p.000021: consent through voluntary actions (such as completing a mailed questionnaire). RECs should not waive the requirement of
p.000021: obtaining written consent for research involving more than minimal risk, except in situations in which the principal
p.000021: risk to patients is the potential harm resulting from being linked to participation in the research, in which case oral
p.000021: consent should be sought. For example, in a study examining counselling services for women seeking abortions, an REC
p.000021: might conclude that the principal risk to participants is the stigma that could result if the fact that they were
p.000021: seeking abortion services was discovered, and that this risk could be minimized by allowing for an oral consent
p.000021: process.
p.000021:
p.000021: Permission from patients
p.000021: Some patient safety research studies involve
p.000021: the observation of health-care providers’ behaviour and practices. In such studies, the researchers do not interfere
p.000021: with the practice other than by their presence in the health-care setting. When individual patient encounters are
p.000021: planned, as in observation of patient- physician interactions, requirements for obtaining
p.000021: the informed consent of patients may be waived if the object of study is the health-care staff and not the patient and
p.000021: the study does not involve changing
p.000021: the way that care is provided. In these cases, assuming it is feasible (i.e. that the patient is conscious and the
p.000021: situation is not an emergency), patients should be told that an observation will take place during their medical visit
p.000021: or interaction, as part of a larger effort to study how care works at that facility and to ensure that care is provided
p.000021: in the best possible way. Although patients need not be asked to provide prior informed consent to participate in these
p.000021: situations, they should be informed clearly that they have the right to opt out of the observation and any patient who
p.000021: expresses concerns should be helped to exercise this right. This right is not based on the principle of informed
...
Searching for indicator threat:
(return to top)
p.000017: with the utmost
p.000017: confidentiality. Despite this, patients may still feel uncomfortable or fear retribution when disclosing
p.000017:
p.000017: aspects of the behaviour of providers. Those conducting interviews with patients and families must anticipate, and be
p.000017: prepared for such events and should have adequate responses and mechanisms in place in the form of referral
p.000017: or counselling for those that become distressed, as appropriate. Referral sites should be contacted in advance to
p.000017: ensure that they are willing and prepared to respond to requests.
p.000017:
p.000017: Anticipating risks from interviewing or observing providers
p.000017: Providers may be interviewed as part of patient
p.000017: safety research, to understand how systemic issues can contribute to harmful incidents. In the course of these
p.000017: interviews it is possible that providers may be questioned about their colleagues, their supervisors or hospital
p.000017: management. In such circumstances, providers may feel that they are
p.000017: at risk of repercussions if the information provided by them is not treated confidentially. In such cases they must
p.000017: know where they can ask questions, and feel comfortable with the interview, including the possibility that they can
p.000017: withdraw at any time or skip any question. Sometimes, providers may be distressed by the recollection of a harmful
p.000017: incident during the conduct of an interview, and it may be necessary to facilitate counseling or psychological support.
p.000017: On other occasions, research studies may
p.000017: involve the direct observation of provider behaviour and performance. Observing providers, even in the context of a
p.000017: research study, can often be perceived as a threat to the authority or the competence of the providers. In all of these
p.000017: cases, the research team must be sensitive to the concerns that may arise in these types of studies and anticipate such
p.000017: an event, having firewalls and referral mechanisms in place, and explaining the purpose of observations in advance.
p.000017: Referral sites should be contacted in advance to ensure that they are willing and prepared to respond to requests.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: 4. Informed consent
p.000017:
p.000017: EXISTING GUIDELINES
p.000017: People have a right to know that their medical records or biological specimens may be used for research. ….
p.000017: Investigators should not initiate epidemiological research involving human subjects without first obtaining each
p.000017:
p.000017: Waivers of informed consent from patients
p.000017: Guidance point 6
p.000017: Researchers conducting patient safety research studies must generally seek individual informed consent from patients.
p.000017: However,
p.000017: the requirement of obtaining individual informed consent from patients can be waived by an REC if
p.000017: ñ The research does not directly inform or alter the individual patients’ therapeutic or medical treatment plans; and
p.000017: ñ Risks posed to patients by the research are minimal; and
p.000017: ñ The research could not practically be carried out if individual informed consent were required; and
...
p.000017: the research activity is authorized by legislation or competent authorities in
p.000017: accord with the ethical principles in these Guidelines
p.000017: CIOMS International Ethical Guidelines for Epidemiological Studies - 2009 - Commentary on Guideline 4
p.000017:
p.000017: Consent may be indicated in a number of ways. The subject may imply consent by voluntary actions, express consent
p.000017: orally, or sign
p.000017: a consent form. As a general rule, the subject should sign a consent form, or, in the case of incompetence, a legal
p.000017: guardian or other duly authorized representative should do so.
p.000017: The ethical review committee may approve waiver of the requirement of a signed consent form if the research carries no
p.000017: more than minimal risk–that is, risk that is no more likely and not greater than that attached to routine medical or
p.000017: psychological examination–and if the procedures
p.000017: to be used are only those for which signed consent forms are not customarily required outside
p.000017: the research context. Such waivers may also be approved when the existence of a signed consent form would be an
p.000017: unjustified threat
p.000017: to the subject’s confidentiality. CIOMS International Ethical Guidelines for Epidemiological
p.000017: Studies - 2009 Commentary
p.000017: on Guideline 4
p.000021: 21
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021: EXISTING GUIDELINES
p.000021: In medical research involving competent human subjects, each potential subject must be adequately informed of the aims,
p.000021: methods, sources of funding,
p.000021: any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and
p.000021: potential risks of the study and the discomfort it
p.000021: 22 may entail, and any other relevant aspects of the study. The potential subject must be informed of the
p.000021: right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal.
p.000021: Special attention should
p.000021: be given to the specific information needs of individual potential subjects as well as to the methods used to deliver
p.000021: the information. After ensuring that the potential subject has
p.000021: understood the information, the physician or another appropriately qualified individual must then seek the potential
p.000021: subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-
p.000021: written consent must be formally documented and witnessed.
p.000021: For medical research using identifiable human material or data, physicians must normally seek consent for its
p.000021: collection, analysis, storage and/or reuse. There may be situations where consent would be impossible or impractical to
p.000021: obtain for such research or would pose a threat to the validity of the research. In such situations, the research may
p.000021: be done only after the consideration and approval of a research ethics committee.
p.000021: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association Declaration
p.000021: of Helsinki, 2008
p.000021: paragraphs 24 and 25
p.000021: For example, reminding providers to follow evidence- based practices, and measuring the impact of
p.000021: the reminder on patient outcomes (based on review and confidential documentation of medical charts), may not require
p.000021: patient-level informed consent.
p.000021: This is because there are no experimental interventions administered to patients, the study does not alter
p.000021: the standard therapeutic plan, and the risks posed to patients by the research as a whole are minimal.
p.000021: In general consent is not ordinarily sought from patients when reminding providers about best practices.
p.000021:
p.000021: When individual informed consent is required, it must usually be documented through the signature on
p.000021: a consent form. However, in some situations, RECs may approve other methods of documentation, such as allowing
p.000021: participants to express their willingness to participate orally, or allowing participants to imply
p.000021: consent through voluntary actions (such as completing a mailed questionnaire). RECs should not waive the requirement of
...
p.000030: a false identity in order to gain additional research information. Such withholding of information from research
p.000030: participants is allowable in exceptional
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: circumstances, where projects are low risk, where it is necessary for obtaining the relevant
p.000030: data, where the project could significantly advance the field of patient safety, and where it does not change the
p.000030: overall risk profile of the study.
p.000030: For instance, in a study to determine the extent of a problem of fake or substandard quality drugs being sold by
p.000030: pharmacists, “mystery clients” were asked to go to public marketplaces for remedies
p.000030: for their children when they didn’t really have a sick child, and the researchers then examined the pharmacological
p.000030: make-up of the products they were given. This study design was allowed by the local REC, because this was considered to
p.000030: be the only way of obtaining access to
p.000030: the pharmaceutical products actually being sold to patients and the study posed very few risks, if any, to those
p.000030: involved.
p.000030:
p.000030:
p.000030:
p.000030: Case study 7 – Withholding information 31
p.000030: (with permission for publication from author)
p.000030:
p.000030:
p.000030:
p.000030: Counterfeit and substandard drugs have been increasingly recognized as a global public health threat. They impact
p.000030: health and the economy in many ways, including increased morbidity and mortality due to inadequate treatment; cause
p.000030: adverse effects from toxic ingredients; promote drug resistance; foster loss of confidence in the health system; and
p.000030: cause unnecessary suffering and economic hardship for patients and families. Previous studies in a landlocked central
p.000030: Asian country have found counterfeit and substandard drugs, but the extent of the problem is not known. In order to
p.000030: gain insight into the extent and nature of the problem of counterfeit and substandard drugs in the country and help
p.000030: efforts to ensure
p.000030: a safe and effective medication supply, a cross- sectional descriptive study was undertaken to determine the prevalence
p.000030: of selected counterfeit/ substandard drugs in the capital city and determine the prevalence of drug outlets selling the
p.000030: selected counterfeit and substandard drugs in that city.
p.000030:
p.000030: Drug outlets were randomly selected stratified by geographic setting and type of drug outlets. Nine drugs from 3 groups
p.000030: of medicines were selected for testing, based on their therapeutic
p.000030: importance, and earlier reports of being counterfeit or sub-standard. None of these drugs were prescription drugs and
p.000030: all can be purchased over the counter in that country.
p.000030:
p.000030: A group of paid field workers, who acted as simulated customers, anonymously purchased the drug samples from drug
p.000030: outlets based in a district
p.000030:
...
Social / Women
Searching for indicator women:
(return to top)
p.000004: Secretariat of the WHO Ethics Review Committee, which steered and managed the process. I commend them all for taking on
p.000004: this important task.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Dr Marie-Paule Kieny Assistant Director-General Health Systems and Innovation World Health Organization
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Acknowledgements
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: 4
p.000004: The World Health Organization is grateful to all expert collaborators who contributed to the conception, design and
p.000004: execution of this report. Their names and affiliations as well as their main contribution are listed below.
p.000004:
p.000004: Contributors at the International Expert Consultation on Ethical Issues for Patient Safety Research, May 2010
p.000004: Gertrude Sika Avortri Ghana Health Service, Ghana Anant Bhan Independent Researcher, Pune, India Sarah Edwards
p.000004: University College London, UK Samia Hurst Université de Genève, Switzerland Janis Lazdins Independent Researcher,
p.000004: Switzerland
p.000004: Mondher Letaief University Hospital of Monastir, Tunisia Osnat Levtzion-Korach Assaf Harofeh Medical Center, Israel
p.000004: Richard Lilford University of Birmingham, UK
p.000004: Josephine Ocloo King’s Patient Safety and Service Quality Research Centre, UK
p.000004: Les Olson External Member of the WHO Ethics Review Committee
p.000004:
p.000004:
p.000004: External Reviewers
p.000004: Carlos Aibar Zaragoza University, Spain
p.000004: Ross Baker University of Toronto, Canada David Bates Brigham & Women’s Hospital, USA Anant Bhan Independent
p.000004: Researcher, India
p.000004: Hans Van Delden University Medical Center, Utrecht, Netherlands, President, CIOMS
p.000004: Susan Dovey University of Otago, New Zealand
p.000004: Ruth Faden Johns Hopkins Berman Institute of Bioethics, USA
p.000004: Sev Fluss Senior Advisor, CIOMS
p.000004: Otmar Kloiber World Medical Association
p.000004: Rieke Van der Graaf University Medical Center, Utrecht, Netherlands
p.000004: George Liu La Trobe University, Australia
p.000004: Philippe Michel University Hospital Lyon, France
p.000004: William Runciman University of South Australia, Australia
p.000004: Asavaroengchai Santawat King Chulalongkorn Memorial Hospital, Thailand
p.000004: Claudia Travassos Fundaçao Oswaldo Cruz, Brazil
p.000004: Michel Valloton University of Geneva, Switzerland, Former President, CIOMS
p.000004: Douglas Wassenaar University of KwaZulu-Natal, South Africa
p.000004: William Weeks The Dartmouth Institute, USA
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005: Systematic Review of the literature
p.000005: Danielle Whicher Johns Hopkins Bloomberg School of Public Health, USA
p.000005: Kendra Harris Johns Hopkins School of Medicine, USA
p.000005: Jonathan Knocke Mayo Clinic, USA
p.000005:
p.000005:
p.000005: WHO Staff Contributors
p.000005: Marie Charlotte Bouesseau Ethics and Social Determinants, WHO
...
p.000021: patient-level informed consent.
p.000021: This is because there are no experimental interventions administered to patients, the study does not alter
p.000021: the standard therapeutic plan, and the risks posed to patients by the research as a whole are minimal.
p.000021: In general consent is not ordinarily sought from patients when reminding providers about best practices.
p.000021:
p.000021: When individual informed consent is required, it must usually be documented through the signature on
p.000021: a consent form. However, in some situations, RECs may approve other methods of documentation, such as allowing
p.000021: participants to express their willingness to participate orally, or allowing participants to imply
p.000021: consent through voluntary actions (such as completing a mailed questionnaire). RECs should not waive the requirement of
p.000021: obtaining written consent for research involving more than minimal risk, except in situations in which the principal
p.000021: risk to patients is the potential harm resulting from being linked to participation in the research, in which case oral
p.000021: consent should be sought. For example, in a study examining counselling services for women seeking abortions, an REC
p.000021: might conclude that the principal risk to participants is the stigma that could result if the fact that they were
p.000021: seeking abortion services was discovered, and that this risk could be minimized by allowing for an oral consent
p.000021: process.
p.000021:
p.000021: Permission from patients
p.000021: Some patient safety research studies involve
p.000021: the observation of health-care providers’ behaviour and practices. In such studies, the researchers do not interfere
p.000021: with the practice other than by their presence in the health-care setting. When individual patient encounters are
p.000021: planned, as in observation of patient- physician interactions, requirements for obtaining
p.000021: the informed consent of patients may be waived if the object of study is the health-care staff and not the patient and
p.000021: the study does not involve changing
p.000021: the way that care is provided. In these cases, assuming it is feasible (i.e. that the patient is conscious and the
p.000021: situation is not an emergency), patients should be told that an observation will take place during their medical visit
p.000021: or interaction, as part of a larger effort to study how care works at that facility and to ensure that care is provided
p.000021: in the best possible way. Although patients need not be asked to provide prior informed consent to participate in these
...
Social / employees
Searching for indicator employees:
(return to top)
p.000017: the nurse investigator also reviewed all medical charts to collect information on reported and potential ADEs.
p.000017: All data were then reviewed by two physicians. These physicians judged the severity of the ADE and whether or not it
p.000017: had been preventable.
p.000017: For each ADE judged to have been preventable,
p.000017:
p.000017: the hospital staff involved in providing the patient with the medication were interviewed by a peer and asked to
p.000017: describe the circumstances surrounding the incident, to describe how the event had occurred, and to self-assess their
p.000017: competency and skills, decision-making style, openness to change, duration in the service or job, the amount and
p.000017: quality of supervision they had received,
p.000017: and the relationship of the incident to the timing of their shift. Consent was not obtained from patients within the
p.000017: unit. Project staff reported that several of the medical staff who had made errors did not want to discuss those errors
p.000017: with interviewers because they were scared about being reprimanded for their mistake. As stated by the project staff
p.000017: member, “We had to reassure them about the confidentiality issues and
p.000017: it worked most of the time.” The project was approved by the REC at each of the two hospitals. During the review
p.000017: process, it was decided that if, during the course of the project, staff identified patterns of care that were harmful
p.000017: to a patient,
p.000017: it was the duty of the project staff to immediately inform the hospital staff and the appropriate authorities so that
p.000017: the recurring error could be corrected, but without retribution to any individual employees.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Minimizing social and psychological risk in patient safety studies
p.000017:
p.000017:
p.000017: Guidance point 4
p.000017: ñ Before conducting a study, researchers should consider discussing with leadership of the health-care institution
p.000017: under study the importance of avoiding a culture
p.000017: of blame with regard to patient safety.
p.000017: ñ Patient safety researchers should also consider whether the political, social, institutional, or cultural context in
p.000017: which the project will be implemented could alter the project’s risk profile.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: The following strategies can help minimize risks in patient safety research:
p.000017:
p.000017: The “no blame” approach to patient safety improvement
p.000017: Patient safety improvement is based on the
p.000017: understanding that most harmful incidents occur not because of negligent or unprofessional behaviour, but, instead,
p.000017: because of systemic problems with the manner in which health care
p.000017: is delivered. Strong evidence suggests that a culture of blame threatens the ability to learn from errors and
p.000017: understand why these occur, and thus threatens the ability to improve the public’s health. It is important that
p.000017: institutions involved in patient safety research understand this fact, and that
p.000017: a no blame approach will actually increase the chances that practice improvements can ultimately occur and results can
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000004: Interpreting existing guidance
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Ethical issues in Patient Safety Research
p.000004: Interpreting existing guidance
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: WHO Library Cataloguing-in-Publication Data:
p.000004:
p.000004: Ethical issues in patient safety research: interpreting existing guidance.
p.000004:
p.000004: 1. Patient safety. 2. Ethics, Research. 3. Ethical review. 4. Humans.
p.000004: 5. General practice – standards. 6. Medical errors – prevention and control. I.World Health Organization.
p.000004:
p.000004: ISBN 978 92 4 150547 5 (NLM classification: WX 185)
p.000004:
p.000004: © World Health Organization 2013
p.000004:
p.000004: All rights reserved. Publications of the World Health Organization are available on the WHO web site (www.who.int) or
p.000004: can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22
p.000004: 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int).
p.000004:
p.000004: Requests for permission to reproduce or translate WHO publications –whether for sale or for non-commercial
p.000004: distribution– should be addressed to WHO Press through the WHO web site
p.000004: (www.who.int/about/licensing/copyright_form/en/index.html).
p.000004: The designations employed and the presentation of the material in this publication do not imply the expression of any
p.000004: opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory,
p.000004: city
p.000004: or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps
p.000004: represent approximate border lines for which there may not yet be full agreement.
p.000004:
p.000004: The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or
p.000004: recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors
p.000004: and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
p.000004:
p.000004: All reasonable precautions have been taken by the World Health Organization to verify the information contained in this
p.000004: publication. However, the published material is being distributed without warranty of any kind, either expressed
p.000004: or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall
p.000004: the World Health Organization be liable
p.000004: for damages arising from its use.
p.000004:
p.000004: Design by CommonSense, Greece
p.000004: Printed by the WHO document Production Services, Geneva, Switzerland.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Foreword
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Research involving human participants must be conducted in a manner that respects the dignity, safety, and rights of
p.000004: research participants. This principle has formed the basis of ethically acceptable clinical and epidemiological
p.000004: research for decades.
...
Economic / Economic/Poverty
Searching for indicator poor:
(return to top)
p.000004: have been challenging ethics committees around the globe.
p.000004:
p.000004: Tens of millions of patients worldwide suffer disabling injuries or death every year due to unsafe medical practices
p.000004: and care. As such, the World Health Organization (WHO) recognizes the ethical imperative to identify strategies that
p.000004: can improve the safety of patients as they receive care
p.000004: worldwide. In identifying ethical principles to guide this and other types of human research, WHO endorses the
p.000004: widely-used Council on International Organizations of Medical Sciences (CIOMS) “International Ethical Guidelines for
p.000004: Biomedical Research involving Human Subjects” (2002) and
p.000004: “International Ethical Guidelines for Epidemiological 3
p.000004: Research (2009),” and the World Medical Association (WMA) Declaration of Helsinki (2008). This report represents an
p.000004: important effort to apply the ethical guidance provided through these documents to the specific field of patient safety
p.000004: research. The report aims to help patient safety professionals, investigators, health-care institutions, ethics review
p.000004: committees, health authorities and others ensure the ethical conduct of patient safety activities. It synthesizes the
p.000004: organized deliberations of a highly respected group of research ethics and patient safety specialists from all over the
p.000004: world who, over the past years, have collaborated with WHO to produce this guidance. This document
p.000004: is especially important in resource-poor settings, where there is a pressing need to conduct more locally applicable
p.000004: research for health, including studies related to patient safety.
p.000004:
p.000004: The guidance included in this report, is the first version of which we expect to be a continually maturing document.
p.000004: WHO, therefore, encourages readers and users of this document to provide feedback, allowing the continuous review and
p.000004: refinement of the guidance, based on additional input and new scholarly work.
p.000004:
p.000004: This report represents the joint effort of
p.000004: the international experts who have provided their deliberations, together with the WHO Patient Safety Programme and the
p.000004: Secretariat of the WHO Ethics Review Committee, which steered and managed the process. I commend them all for taking on
p.000004: this important task.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Dr Marie-Paule Kieny Assistant Director-General Health Systems and Innovation World Health Organization
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Acknowledgements
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: 4
p.000004: The World Health Organization is grateful to all expert collaborators who contributed to the conception, design and
p.000004: execution of this report. Their names and affiliations as well as their main contribution are listed below.
p.000004:
p.000004: Contributors at the International Expert Consultation on Ethical Issues for Patient Safety Research, May 2010
p.000004: Gertrude Sika Avortri Ghana Health Service, Ghana Anant Bhan Independent Researcher, Pune, India Sarah Edwards
p.000004: University College London, UK Samia Hurst Université de Genève, Switzerland Janis Lazdins Independent Researcher,
...
p.000034: 1. Introduction
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000008: 8
p.000008: This report responds to a request from patient safety researchers and research ethics committees (REC) for advice on
p.000008: how to interpret existing research ethics guidelines in the context of patient safety research. The report, which was
p.000008: produced by the WHO Patient Safety Programme and the WHO ERC Secretariat, builds on the reflections
p.000008: of an international expert group and was further enhanced by internal and external expert reviews by research ethics
p.000008: specialists and patient safety and quality improvement scientists from across the world. As explained in the foreword,
p.000008: this is
p.000008: the first version of this report, which will be revised to include future input, as evidence and scholarship in the
p.000008: area of patient safety research evolve.
p.000008:
p.000008: This document is not intended to establish any new ethical principles. Rather, it represents
p.000008: an interpretation and application of existing, internationally accepted ethical principles
p.000008: to specific questions that arise in the context of patient safety activities. It is designed to be
p.000008: useful to patient safety professionals, investigators, health-care institutions, ethics review committees, health
p.000008: authorities and others aiming to ensure ethical conduct of patient safety research activities. It is hoped that the
p.000008: document will increase the attention given to ethical issues around patient safety research around the world, but
p.000008: particularly in resource poor-settings, where the need for locally applicable research findings is especially needed.
p.000008:
p.000008: Ethical issues to consider when conducting patient safety research WHO estimates that tens of millions of patients
p.000008: worldwide suffer disabling injuries or death every year due to unsafe medical practices and care.
p.000008: Nearly one in ten patients is harmed due to preventable causes while receiving health care in well-funded and
p.000008: technologically advanced hospital settings.1 Much less is known about
p.000008: the burden of unsafe care in non-hospital settings, where most health-care services are delivered.2 Furthermore, there
p.000008: is little evidence concerning
p.000008:
p.000008: the burden of unsafe care in developing countries, where the risk of harm to patients is likely to be greater, due to
p.000008: limitations in infrastructure, technologies, and human resources.3 A retrospective analysis of medical records of
p.000008: patients admitted
p.000008: to 26 hospitals in eight developing and transitional countries estimated an incidence of preventable harm of almost 1
p.000008: in 10.4,5
p.000008:
p.000008: Research to understand the causes of unsafe care and to identify potential solutions involves diverse scientific
p.000008: designs and methodologies. For example, research may be based on a review of medical records, observations, surveys
p.000008: or interviews. It may use controlled randomized designs, allocating different hospitals or clinical units to
p.000008: alternative ways of delivering care, or it
...
p.000017: of blame with regard to patient safety.
p.000017: ñ Patient safety researchers should also consider whether the political, social, institutional, or cultural context in
p.000017: which the project will be implemented could alter the project’s risk profile.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: The following strategies can help minimize risks in patient safety research:
p.000017:
p.000017: The “no blame” approach to patient safety improvement
p.000017: Patient safety improvement is based on the
p.000017: understanding that most harmful incidents occur not because of negligent or unprofessional behaviour, but, instead,
p.000017: because of systemic problems with the manner in which health care
p.000017: is delivered. Strong evidence suggests that a culture of blame threatens the ability to learn from errors and
p.000017: understand why these occur, and thus threatens the ability to improve the public’s health. It is important that
p.000017: institutions involved in patient safety research understand this fact, and that
p.000017: a no blame approach will actually increase the chances that practice improvements can ultimately occur and results can
p.000017: be used to make systemic improvements. Nonetheless, it is worth acknowledging that those exposed to harm have
p.000017: a right to accountability where harm occurs through negligence or unprofessional behaviour.
p.000017:
p.000017: Decreasing the chances of identification of poorly performing individuals or institutions
p.000017: If individuals or groups that consistently provide
p.000017: poor care are identified by patient safety research, there is a risk that the result will be punitive action.
p.000017: Because patient safety research is premised on a “no blame” approach, researchers should
p.000017: consider setting up firewalls to minimize this risk. Some suggestions in this regard include:
p.000017: ñ Avoiding the use of names on data forms, aggregating data as soon as possible, and avoiding the identification of
p.000017: people or unique characteristics of cases in reports;
p.000017: Guidance point 5
p.000017: Individuals involved in patient safety research who are interviewing or observing patients or providers should
p.000017: anticipate any distress participants may experience as a consequence of the conduct of the study and be prepared to
p.000017: offer solutions. Some options are:
p.000017: ñ Be trained to ask participants if they would like 19
p.000017: to skip questions or stop the interview if they
p.000017: become distressed;
p.000017: ñ Be equipped with referrals for supportive care or counselling in case participants become significantly distressed;
p.000017: ñ Be equipped with the names of hospital authorities to whom participants and families can be referred if they have
p.000017: questions; and
p.000017: ñ Ensure that all services and providers whose names will be given out as referrals have agreed to have their names
p.000017: provided to patients
p.000017: and families.
p.000017:
p.000017:
p.000017: ñ Expanding the study population to include several different provider teams or several
p.000017: different institutions, in order to avoid inadvertent identification of particular institutions or groups, or to avoid
p.000017: the appearance of targeting; and
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000021: risk to patients is the potential harm resulting from being linked to participation in the research, in which case oral
p.000021: consent should be sought. For example, in a study examining counselling services for women seeking abortions, an REC
p.000021: might conclude that the principal risk to participants is the stigma that could result if the fact that they were
p.000021: seeking abortion services was discovered, and that this risk could be minimized by allowing for an oral consent
p.000021: process.
p.000021:
p.000021: Permission from patients
p.000021: Some patient safety research studies involve
p.000021: the observation of health-care providers’ behaviour and practices. In such studies, the researchers do not interfere
p.000021: with the practice other than by their presence in the health-care setting. When individual patient encounters are
p.000021: planned, as in observation of patient- physician interactions, requirements for obtaining
p.000021: the informed consent of patients may be waived if the object of study is the health-care staff and not the patient and
p.000021: the study does not involve changing
p.000021: the way that care is provided. In these cases, assuming it is feasible (i.e. that the patient is conscious and the
p.000021: situation is not an emergency), patients should be told that an observation will take place during their medical visit
p.000021: or interaction, as part of a larger effort to study how care works at that facility and to ensure that care is provided
p.000021: in the best possible way. Although patients need not be asked to provide prior informed consent to participate in these
p.000021: situations, they should be informed clearly that they have the right to opt out of the observation and any patient who
p.000021: expresses concerns should be helped to exercise this right. This right is not based on the principle of informed
p.000021: consent, but rather on the basic ethical importance of treating people with respect.
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021: Group disclosure for patients
p.000021: Even in circumstances where formal consent procedures have been waived, it is best practice to disclose to patients
p.000021: that patient safety research may be ongoing in the clinical setting, and to explain the implications of such activities
p.000021: on them. For example, a general disclosure may be provided by a poster or as leaflets either in waiting rooms or as
p.000021: part of patient information material during
p.000021: a medical consultation that states “As part of
p.000021: the quality improvement activities of our hospital, we periodically review patient charts, or observe doctors and
p.000021: nurses providing care to patients,
p.000021: to make sure that quality care is provided to patients and to examine which practices lead to optimal outcomes. Please
p.000021: let us know if you are uncomfortable with or unwilling to be part of any direct observational activities.”
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Distinguishing between research and programme implementation is not always straightforward. For example, even though
p.000011: patient safety programmes are typically designed to improve care within a particular organization, their results may be
p.000011: disseminated to other organizations. Just as with research, the benefits of patient safety activities may ultimately
p.000011: extend beyond the population that was exposed to the risks. Moreover, the methodologies of many patient safety
p.000011: initiatives closely resemble those used in research, especially
p.000011: in cluster designs, including alterations to standard practice, use of randomization, and the systematic collection of
p.000011: data. Thus, as CIOMS has recognized in
p.000011: the context of epidemiology, and the Ottawa Statement in the context of cluster studies,12 even activities that
p.000011: do not formally meet the definition of research may benefit from undergoing “careful ethical scrutiny
p.000011: or even reconsideration.” Based on this principle, patient safety activities that do not constitute research may
p.000011: benefit from ethical oversight or advice whenever those activities involve greater-than-minimal risks.
p.000011:
p.000011: For activities that do not formally meet the definition of research, this risk assessment may be made by
p.000011: a reference group that is independent of the activity and who are well versed in both ethics and the principles of
p.000011: patient safety improvement. Some institutions
p.000011: may choose to give this review authority to an REC. For those who may wish to publish the results of non-research
p.000011: activity, it would be advisable to obtain advice from a REC prior to starting the activity.
p.000011: Regardless of an activity’s label, the most important question to consider when undertaking patient safety activities
p.000011: is whether the patients and providers who participate in these programmes will be subjected
p.000011: to any risks they would otherwise not assume.
p.000011: EXISTING GUIDELINES
p.000011: The “generalizable knowledge” definition works well for medical and behavioural studies pertaining to human health,
p.000011: which are commonly denominated “biomedical research” to indicate its relation to health. But
p.000011: the definition works less well in 13
p.000011: separating practice from research in the field of epidemiology.
p.000011: Many studies using the tools of epidemiology which are performed on a regular basis by public health agencies, such as
p.000011: routine surveillance for disease outbreaks, are correctly viewed as “practice” even though the information produced may
p.000011: contribute to generalizable knowledge. Thus,
p.000011: in carrying out their activities, epidemiologists (and others examining the activities) need to apply careful judgment
p.000011: to determine whether the activity should be classified as research or practice. Of course, it does not necessarily
p.000011: follow that everything placed in the former category
p.000011: is problematic or is even subject to all the requirements for advanced approval and individualized informed consent
p.000011: usually associated with research. Conversely, some activities that are routinely carried out by epidemiologists do
p.000011: raise ethical issues that may benefit from careful scrutiny or even reconsideration, even if they have long traditions
...
p.000017:
p.000017: aspects of the behaviour of providers. Those conducting interviews with patients and families must anticipate, and be
p.000017: prepared for such events and should have adequate responses and mechanisms in place in the form of referral
p.000017: or counselling for those that become distressed, as appropriate. Referral sites should be contacted in advance to
p.000017: ensure that they are willing and prepared to respond to requests.
p.000017:
p.000017: Anticipating risks from interviewing or observing providers
p.000017: Providers may be interviewed as part of patient
p.000017: safety research, to understand how systemic issues can contribute to harmful incidents. In the course of these
p.000017: interviews it is possible that providers may be questioned about their colleagues, their supervisors or hospital
p.000017: management. In such circumstances, providers may feel that they are
p.000017: at risk of repercussions if the information provided by them is not treated confidentially. In such cases they must
p.000017: know where they can ask questions, and feel comfortable with the interview, including the possibility that they can
p.000017: withdraw at any time or skip any question. Sometimes, providers may be distressed by the recollection of a harmful
p.000017: incident during the conduct of an interview, and it may be necessary to facilitate counseling or psychological support.
p.000017: On other occasions, research studies may
p.000017: involve the direct observation of provider behaviour and performance. Observing providers, even in the context of a
p.000017: research study, can often be perceived as a threat to the authority or the competence of the providers. In all of these
p.000017: cases, the research team must be sensitive to the concerns that may arise in these types of studies and anticipate such
p.000017: an event, having firewalls and referral mechanisms in place, and explaining the purpose of observations in advance.
p.000017: Referral sites should be contacted in advance to ensure that they are willing and prepared to respond to requests.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: 4. Informed consent
p.000017:
p.000017: EXISTING GUIDELINES
p.000017: People have a right to know that their medical records or biological specimens may be used for research. ….
p.000017: Investigators should not initiate epidemiological research involving human subjects without first obtaining each
p.000017:
p.000017: Waivers of informed consent from patients
p.000017: Guidance point 6
p.000017: Researchers conducting patient safety research studies must generally seek individual informed consent from patients.
p.000017: However,
p.000017: the requirement of obtaining individual informed consent from patients can be waived by an REC if
p.000017: ñ The research does not directly inform or alter the individual patients’ therapeutic or medical treatment plans; and
p.000017: ñ Risks posed to patients by the research are minimal; and
p.000017: ñ The research could not practically be carried out if individual informed consent were required; and
p.000017: ñ The privacy and confidentiality or anonimity
...
p.000030: different from their home district. The field workers were trained to give a specified set of symptoms and ask the
p.000030: questions that usual patients normally would ask pharmacists (can you give me this antibiotic, is this a good brand,
p.000030: can you give me another brand, is this the brand that other people also purchase, etc.). Following appropriate
p.000030: training, the field workers were provided with a list of the drugs and amount needed of each one from the assigned drug
p.000030: outlet. The identity of the drug outlet or the field worker were not on the data collection form; instead a sample
p.000030: number was recorded by the PI when the field worker returned.
p.000030: This sample number was linked to a code for
p.000030: the drug unit known only to the PI. Any potentially identifying information about the drug outlets
p.000030: was coded and removed from samples and data collection tools prior to sample analysis so researchers involved in the
p.000030: analysis would not know the source of any of the samples. If a selected
p.000030: drug outlet did not have the required sample of a drug, the PI arranged for a repeat visit to
p.000030: this facility at a later time or substituted a different randomly selected drug outlet.
p.000030:
p.000030: Results of the study were provided in an aggregated form to the National Drug Regulatory Authority
p.000030: and the Ministry of Health, in order to allow
p.000030: them to take further action, such as strengthening their regulations. Since the data were analysed anonymously, the
p.000030: Ministry did not receive
p.000030: any information about specific drug outlets, and no punitive action was possible as a result of this research study.
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: Since withholding information can lead to distrust, additional restrictions are placed on such studies. These include
p.000030: requirements that other designs not involving withholding information be used wherever possible to address the research
p.000030: question, that only minimal risk studies may withhold information,
p.000030: and that as much information about the study be provided as possible, even if one key element is not disclosed. The
p.000030: researcher should also consider whether disclosing information in a more general way (for example, “There will be some
p.000030: clients coming to your shop in the next six months, who may not be the ‘real clients’”) is possible, as a way
p.000030: 32 of honouring commitments to truth telling while also trying to achieve important scientific ends. Another
p.000030: option is to ask participants to consent to research without knowing the full aspects of the study, with the assurance
p.000030: that the research intervention will not harm them and that a full disclosure will be made in a debriefing session.
p.000030:
p.000030: Information should not be withheld solely because providing it might cause some individuals to refuse to participate.
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000010: the activity as quality improvement and thus, not require external ethics review, despite the fact that identifiable
p.000010: human data are being collected.
p.000010:
p.000010: On the other hand, if a project abstracts data from medical charts in a series of hospitals to determine how infection
p.000010: rates can be reduced among hospitals more broadly, so that hospitals can learn more widely from the information, the
p.000010: project would generally fall within accepted definitions of research requiring REC review. In practice, however, there
p.000010: is a great variability in the interpretation of what constitutes research across
p.000010: different research committees and national legislations,11 as illustrated in Case Study 1 and 2 and will be expanded in
p.000010: the next section. When in doubt, it is recommended that patient safety projects are submitted to ethics committees at
p.000010: an early stage, to determine whether or not they consider them as research that should receive their oversight.
p.000010: An important criterion to bear in mind
p.000010: is whether or not the proposed intervention is evidence based. If it is not evidence-based, then it is recommended that
p.000010: the activity be developed within a research framework.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011: EXISTING GUIDELINES
p.000011: The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics
p.000011: committee before the study begins. This committee must be independent of the researcher, the sponsor and any other
p.000011: undue influence.
p.000011: It must take into consideration the laws and regulations of the country or countries in which the
p.000011: research is to be performed as well as applicable international norms and standards but these must not be allowed to
p.000011: reduce or eliminate any of the protections for research subjects set forth in this Declaration. The committee must have
p.000011: the right to monitor on-going studies. The researcher must provide monitoring information
p.000011: to the committee, especially information about any serious adverse events. No change to
p.000011: the protocol may be made without consideration and approval by
p.000011: the committee.
p.000011: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association Declaration of Helsinki,
p.000011: 2008 paragraph 15
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Case study 1 – Obtaining research ethics oversight
p.000011:
p.000011:
p.000011:
p.000011: Dovey S, Hall K, Makeham M, et. al.
p.000011: Seeking ethical approval for an international study in primary care patient safety.
p.000011: Br J Gen Pract 2011; 61: 197-204
p.000011: Seeking ethics committee approval for research
p.000011: can be challenging even for relatively simple studies occurring in single settings. Complicating factors such as
p.000011: multicentre studies and/or contentious research issues can challenge review processes,
p.000011: 12 and conducting such studies internationally adds a further layer of complexity. This paper drew on the
p.000011: experiences of the LINNAEUS Collaboration,
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.000004: operational framework for improving the ethical conduct of research and building appropriate safeguards.
p.000004:
p.000004: The recent expansion of research aiming to analyse the nature, behaviour and consequences of patient safety incidents
p.000004: and their surrounding circumstances, as well as the impact of innovative strategies to address patient safety problems,
p.000004: poses new research questions that raise new,
p.000004: and unresolved, ethical questions. For example, what does the ethical principle of “beneficence” require in studies
p.000004: that identify physician errors in on-going or recorded clinical practice? What does the principle of “respect for
p.000004: persons” require in studies that involve the observation of patients’ and professionals’ behaviour? When evaluating
p.000004: a strategy to reduce errors, is ethics committee review required when the only difference from usual practice is the
p.000004: collection of data to see if the strategy improves care? These and other challenges raised by patient safety research
p.000004: have been challenging ethics committees around the globe.
p.000004:
p.000004: Tens of millions of patients worldwide suffer disabling injuries or death every year due to unsafe medical practices
p.000004: and care. As such, the World Health Organization (WHO) recognizes the ethical imperative to identify strategies that
p.000004: can improve the safety of patients as they receive care
p.000004: worldwide. In identifying ethical principles to guide this and other types of human research, WHO endorses the
p.000004: widely-used Council on International Organizations of Medical Sciences (CIOMS) “International Ethical Guidelines for
p.000004: Biomedical Research involving Human Subjects” (2002) and
p.000004: “International Ethical Guidelines for Epidemiological 3
p.000004: Research (2009),” and the World Medical Association (WMA) Declaration of Helsinki (2008). This report represents an
p.000004: important effort to apply the ethical guidance provided through these documents to the specific field of patient safety
p.000004: research. The report aims to help patient safety professionals, investigators, health-care institutions, ethics review
p.000004: committees, health authorities and others ensure the ethical conduct of patient safety activities. It synthesizes the
p.000004: organized deliberations of a highly respected group of research ethics and patient safety specialists from all over the
p.000004: world who, over the past years, have collaborated with WHO to produce this guidance. This document
p.000004: is especially important in resource-poor settings, where there is a pressing need to conduct more locally applicable
p.000004: research for health, including studies related to patient safety.
p.000004:
p.000004: The guidance included in this report, is the first version of which we expect to be a continually maturing document.
p.000004: WHO, therefore, encourages readers and users of this document to provide feedback, allowing the continuous review and
p.000004: refinement of the guidance, based on additional input and new scholarly work.
p.000004:
p.000004: This report represents the joint effort of
p.000004: the international experts who have provided their deliberations, together with the WHO Patient Safety Programme and the
...
p.000004: this important task.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Dr Marie-Paule Kieny Assistant Director-General Health Systems and Innovation World Health Organization
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Acknowledgements
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: 4
p.000004: The World Health Organization is grateful to all expert collaborators who contributed to the conception, design and
p.000004: execution of this report. Their names and affiliations as well as their main contribution are listed below.
p.000004:
p.000004: Contributors at the International Expert Consultation on Ethical Issues for Patient Safety Research, May 2010
p.000004: Gertrude Sika Avortri Ghana Health Service, Ghana Anant Bhan Independent Researcher, Pune, India Sarah Edwards
p.000004: University College London, UK Samia Hurst Université de Genève, Switzerland Janis Lazdins Independent Researcher,
p.000004: Switzerland
p.000004: Mondher Letaief University Hospital of Monastir, Tunisia Osnat Levtzion-Korach Assaf Harofeh Medical Center, Israel
p.000004: Richard Lilford University of Birmingham, UK
p.000004: Josephine Ocloo King’s Patient Safety and Service Quality Research Centre, UK
p.000004: Les Olson External Member of the WHO Ethics Review Committee
p.000004:
p.000004:
p.000004: External Reviewers
p.000004: Carlos Aibar Zaragoza University, Spain
p.000004: Ross Baker University of Toronto, Canada David Bates Brigham & Women’s Hospital, USA Anant Bhan Independent
p.000004: Researcher, India
p.000004: Hans Van Delden University Medical Center, Utrecht, Netherlands, President, CIOMS
p.000004: Susan Dovey University of Otago, New Zealand
p.000004: Ruth Faden Johns Hopkins Berman Institute of Bioethics, USA
p.000004: Sev Fluss Senior Advisor, CIOMS
p.000004: Otmar Kloiber World Medical Association
p.000004: Rieke Van der Graaf University Medical Center, Utrecht, Netherlands
p.000004: George Liu La Trobe University, Australia
p.000004: Philippe Michel University Hospital Lyon, France
p.000004: William Runciman University of South Australia, Australia
p.000004: Asavaroengchai Santawat King Chulalongkorn Memorial Hospital, Thailand
p.000004: Claudia Travassos Fundaçao Oswaldo Cruz, Brazil
p.000004: Michel Valloton University of Geneva, Switzerland, Former President, CIOMS
p.000004: Douglas Wassenaar University of KwaZulu-Natal, South Africa
p.000004: William Weeks The Dartmouth Institute, USA
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005: Systematic Review of the literature
p.000005: Danielle Whicher Johns Hopkins Bloomberg School of Public Health, USA
p.000005: Kendra Harris Johns Hopkins School of Medicine, USA
p.000005: Jonathan Knocke Mayo Clinic, USA
p.000005:
p.000005:
p.000005: WHO Staff Contributors
p.000005: Marie Charlotte Bouesseau Ethics and Social Determinants, WHO
p.000005: Melba Gomes Tropical Disease Research, WHO & member of the WHO Ethics Review Committee
p.000005: Brooke R Johnson Reproductive Health and Research, WHO & Chair of WHO Ethics Review Committee
p.000005: Kwok-Cho Tang Chronic Disease and Health promotion, WHO & member of the WHO Ethics Review Committee
p.000005: Sergio Nishioka Immunization Vaccines and Biologicals, WHO & member of the WHO Ethics Review Committee
p.000005: Katthyana Aparicio WHO Patient Safety Programme
p.000005: Mobasher Butt WHO Patient Safety Programme (currently in the National Health Service, UK)
p.000005: Nittita Prasopa-Plaizier WHO Patient Safety Programme
p.000005:
p.000005: Drafting & Steering Group
p.000005: Nancy Kass WHO Research Policy & Cooperation (currently at Johns Hopkins Bloomberg School of Public Health, USA)
p.000005: Carl Coleman Independent Ethics Consultant
...
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: Box 1: Some of the ethical questions raised by patient safety activities
p.000008:
p.000008:
p.000008: ñ Which patient safety projects should be considered research requiring Research Ethics Committee (REC) review?
p.000008: ñ What types of risks exist in patient safety research?
p.000008: ñ What protections must be in place for patients and/or providers to reduce the risks from patient safety studies?
p.000008: ñ Under what circumstances are informed consent or other forms of disclosure or permission needed from research
p.000008: participants?
p.000008: ñ In particular, under what circumstances, if any, is deception allowable in patient safety research?
p.000008: ñ What are the best practices for addressing privacy and confidentiality issues?
p.000008: ñ Are there any potential direct or indirect benefits to, or incentives for, participating in patient safety research?
p.000008: ñ Under what circumstances, if any, do researchers have a duty to intervene regarding past or imminent errors?
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: The application of research ethics principles to patient safety activities
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000010: 10
p.000010: EXISTING GUIDELINES
p.000010: All proposals to conduct research involving human subjects must be submitted for review of their scientific merit and
p.000010: ethical acceptability to one or more scientific review and ethical review committees. The investigator must obtain
p.000010: their approval or clearance before undertaking the research.
p.000010: CIOMS International Ethical Guidelines for Epidemiological studies, 2009 Guideline 2
p.000010:
p.000010: It is conventional to define “research” as involving activities that are designed to develop
p.000010: or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principles or relationships, or
p.000010: the accumulation of information on which they are based, that can be corroborated by accepted
p.000010: scientific methods of observation and inference.
p.000010: CIOMS International Ethical Guidelines for Epidemiological Studies, 2009 Introduction
p.000010:
p.000010: Research means a systematic investigation, including research development, testing, and evaluation, designed to develop
p.000010: or contribute to generalizable knowledge.
p.000010: The “Common Rule” (USA)
p.000010:
p.000010: Guidance point 1
p.000010: Any patient safety activity that constitutes research, regardless of its methodology, should be submitted to a Research
p.000010: Ethics Committee (REC).
p.000010: For purposes of REC oversight, patient safety activi- ties constitute research when:
p.000010: ñ they are aimed at addressing a specific question; and ñ they use a predefined approach or method for collect-
p.000010: ing data in response to the question they intend to address; and
p.000010: ñ their findings are intended to be applied to settings beyond those in which the activity or programme is implemented.
p.000010:
p.000010:
p.000010: International guidelines define research as a systematic activity designed to develop or contribute to generalizable
p.000010: knowledge. Before conducting any study, researchers should consider whether the research is warranted and whether the
p.000010: selection and recruitment of participants is fair. There should be good reason to explore safety practice in research
p.000010: beyond routine evaluation. Furthermore, vulnerable populations should not be differentially exposed to any extra risks
p.000010: brought up by the research without good reason to avoid exacerbating pre-existing inequalities.10 While health research
p.000010: has the potential to bring benefits to society and to the research communities, it can be associated
...
p.000011: each country. The authors’ experiences demonstrated that ethics committees operate in their own historical and cultural
p.000011: context, which can lead to radically different subjective interpretations of commonly- held ethical principles, and
p.000011: raised further issues such as ‘what is research?’
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Guidance point 2
p.000011: Patient safety activities, even when they do not meet the definition of research requiring ethical review, may involve
p.000011: more than minimal risk to patients and health-care providers in some situa- tions. It is the responsibility of those
p.000011: working in patient safety activities to be aware of ethical issues and seek guidance as needed.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Distinguishing between research and programme implementation is not always straightforward. For example, even though
p.000011: patient safety programmes are typically designed to improve care within a particular organization, their results may be
p.000011: disseminated to other organizations. Just as with research, the benefits of patient safety activities may ultimately
p.000011: extend beyond the population that was exposed to the risks. Moreover, the methodologies of many patient safety
p.000011: initiatives closely resemble those used in research, especially
p.000011: in cluster designs, including alterations to standard practice, use of randomization, and the systematic collection of
p.000011: data. Thus, as CIOMS has recognized in
p.000011: the context of epidemiology, and the Ottawa Statement in the context of cluster studies,12 even activities that
p.000011: do not formally meet the definition of research may benefit from undergoing “careful ethical scrutiny
p.000011: or even reconsideration.” Based on this principle, patient safety activities that do not constitute research may
p.000011: benefit from ethical oversight or advice whenever those activities involve greater-than-minimal risks.
p.000011:
p.000011: For activities that do not formally meet the definition of research, this risk assessment may be made by
p.000011: a reference group that is independent of the activity and who are well versed in both ethics and the principles of
p.000011: patient safety improvement. Some institutions
p.000011: may choose to give this review authority to an REC. For those who may wish to publish the results of non-research
p.000011: activity, it would be advisable to obtain advice from a REC prior to starting the activity.
p.000011: Regardless of an activity’s label, the most important question to consider when undertaking patient safety activities
p.000011: is whether the patients and providers who participate in these programmes will be subjected
p.000011: to any risks they would otherwise not assume.
p.000011: EXISTING GUIDELINES
p.000011: The “generalizable knowledge” definition works well for medical and behavioural studies pertaining to human health,
p.000011: which are commonly denominated “biomedical research” to indicate its relation to health. But
p.000011: the definition works less well in 13
p.000011: separating practice from research in the field of epidemiology.
p.000011: Many studies using the tools of epidemiology which are performed on a regular basis by public health agencies, such as
p.000011: routine surveillance for disease outbreaks, are correctly viewed as “practice” even though the information produced may
p.000011: contribute to generalizable knowledge. Thus,
p.000011: in carrying out their activities, epidemiologists (and others examining the activities) need to apply careful judgment
p.000011: to determine whether the activity should be classified as research or practice. Of course, it does not necessarily
p.000011: follow that everything placed in the former category
p.000011: is problematic or is even subject to all the requirements for advanced approval and individualized informed consent
p.000011: usually associated with research. Conversely, some activities that are routinely carried out by epidemiologists do
p.000011: raise ethical issues that may benefit from careful scrutiny or even reconsideration, even if they have long traditions
p.000011: and are sanctioned by regulations or statutes.
p.000011: CIOMS International Ethical Guidelines for Epidemiological Studies, 2009 Introduction
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Case study 2 – Distinguishing research from other programmes
p.000011:
p.000011:
p.000011:
p.000011: Pronovost P, Needham D, Berenholz S, et. al. An Intervention to Decrease Catheter Related Bloodstream Infections in the
p.000011: ICU.
p.000011: N Engl J Med, 2006, 355:272.
p.000011: This patient safety project was implemented to determine the effectiveness of an evidence-based intervention aimed at
p.000011: reducing rates of catheter- acquired bloodstream infections in ICUs. The intervention aimed at improving physicians’
p.000011: use
p.000011: of five procedures that have been previously shown
p.000011: 14 to reduce infections. These procedures include proper hand washing, full barrier precautions during
p.000011: insertion of the catheter, cleaning the patient’s
p.000011: skin with chlorhexidine, avoiding the femoral site if possible, and removing unnecessary catheters. Agreement to
p.000011: participate was obtained from
p.000011: 108 ICUs from 67 hospitals in the state of Michigan,
p.000011: United States. Each of the ICUs implemented
p.000011: the evidence-based intervention, and infection rates
p.000011:
p.000011: before the implementation of the intervention were compared with infection rates after its implementation. Each ICU was
p.000011: responsible
p.000011: for reporting aggregate infection data back to the project staff. The project staff developed the intervention and
p.000011: conducted the evaluation
p.000011: but were not members of any of the ICUs involved in the study. The study was submitted to the REC of the home
p.000011: institution of the project staff before implementation.
p.000011:
...
p.000011: interview patients or families about harmful incidents that occurred previously or about their perceptions of the
p.000011: quality of care may cause them to question the quality of their medical providers and to become anxious. Also, health
p.000011: providers may become anxious if they believe that researchers are evaluating their professional
p.000011: performance, particularly if they fear that the results may result in reprisals.
p.000011:
p.000011: Economic risks: Economic risks refer to the possibility that research participants will be required to incur
p.000011: additional financial costs as a result of their participation in a study. For example, providers may have concerns
p.000011: about the economic implications of studies that uncover errors in how care is provided, including the
p.000011: possibility that negative information uncovered during a study could lead to litigation.
p.000011:
p.000011: EXISTING GUIDELINES
p.000011: Every medical research study 15
p.000011: involving human subjects must be preceded by careful assessment of predictable risks and burdens
p.000011: to the individuals and communities involved in the research in comparison with foreseeable benefits to them and to
p.000011: other individuals or communities affected by the condition under investigation.
p.000011: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association Declaration of Helsinki,
p.000011: 2008 paragraph 18.
p.000011:
p.000011: For all epidemiological research involving human subjects,
p.000011: the investigator must ensure
p.000011: that potential benefits and harms are reasonably balanced and risks are minimized.
p.000011: CIOMS International Ethical Guidelines for Epidemiological Studies, 2009 Guideline 8
p.000011:
p.000011: The risks to which research subjects may be exposed have been classified as physical, psychological, social, and
p.000011: economic.
p.000011: OHRP Institutional Review Board Guidebook
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: EXISTING GUIDELINES
p.000011: Minimal risk refers to “risk that
p.000011: 16 is no more likely and not greater than that attached to routine medical or psychological examination.”
p.000011: CIOMS, International Ethical Guidelines for Epidemiological Studies, 2009 Commentary to Guideline 4 (Documentation of
p.000011: consent)
p.000011:
p.000011: Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater
p.000011: in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or
p.000011: psychological examinations or tests.
p.000011: The "Common Rule" (United States)
p.000011:
p.000011: Physicians may not participate in a research study involving human subjects unless they are confident that the risks
p.000011: involved have been adequately assessed and can be satisfactorily managed. Physicians must immediately stop a study when
p.000011: the risks are found to outweigh the potential benefits
p.000011: or when there is conclusive proof of positive and beneficial results.
p.000011: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association Declaration of Helsinki,
p.000011: 2008 Paragraph 20
p.000011: Determining the level of risk
p.000011:
p.000011: Guidance point 3
p.000011: Patient safety research may be considered of mini- mal risk if all of the following factors are present:
p.000011: ñ The intervention does not modify clinical management or the treatment plan for the patient;
p.000011: ñ Data are not individually identifiable, or adequate protections against breaches of confidentiality of data are in
p.000011: place;
...
p.000017: ñ The privacy and confidentiality or anonimity
p.000017: of individual patients are assured (see Guidance Point 8).
p.000017: In cases where individual informed consent from patients will not be sought, general disclosure to patients about
p.000017: patient safety research is highly recommended.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: As outlined in existing international ethical guidelines, voluntary, informed consent is generally required in research
p.000017: involving human participants. Informed consent involves informing potential participants, through documents and
p.000017: discussion, of the purpose, procedures, risks, potential benefits, and voluntary nature of the proposed research, and
p.000017: documenting the participant’s agreement. According to international guidelines, RECs may waive the usual requirement of
p.000017: individual informed consent when the research involves no more than minimal risk, and a requirement of obtaining
p.000017: individual informed consent would make the research impracticable.16
p.000017: subject’s informed consent, unless they have received explicit approval to do so from an ethical review committee or
p.000017: the research activity is authorized by legislation or competent authorities in
p.000017: accord with the ethical principles in these Guidelines
p.000017: CIOMS International Ethical Guidelines for Epidemiological Studies - 2009 - Commentary on Guideline 4
p.000017:
p.000017: Consent may be indicated in a number of ways. The subject may imply consent by voluntary actions, express consent
p.000017: orally, or sign
p.000017: a consent form. As a general rule, the subject should sign a consent form, or, in the case of incompetence, a legal
p.000017: guardian or other duly authorized representative should do so.
p.000017: The ethical review committee may approve waiver of the requirement of a signed consent form if the research carries no
p.000017: more than minimal risk–that is, risk that is no more likely and not greater than that attached to routine medical or
p.000017: psychological examination–and if the procedures
p.000017: to be used are only those for which signed consent forms are not customarily required outside
p.000017: the research context. Such waivers may also be approved when the existence of a signed consent form would be an
p.000017: unjustified threat
p.000017: to the subject’s confidentiality. CIOMS International Ethical Guidelines for Epidemiological
p.000017: Studies - 2009 Commentary
p.000017: on Guideline 4
p.000021: 21
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021: EXISTING GUIDELINES
p.000021: In medical research involving competent human subjects, each potential subject must be adequately informed of the aims,
p.000021: methods, sources of funding,
p.000021: any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and
p.000021: potential risks of the study and the discomfort it
p.000021: 22 may entail, and any other relevant aspects of the study. The potential subject must be informed of the
p.000021: right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal.
p.000021: Special attention should
p.000021: be given to the specific information needs of individual potential subjects as well as to the methods used to deliver
p.000021: the information. After ensuring that the potential subject has
p.000021: understood the information, the physician or another appropriately qualified individual must then seek the potential
p.000021: subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-
p.000021: written consent must be formally documented and witnessed.
p.000021: For medical research using identifiable human material or data, physicians must normally seek consent for its
...
p.000021: project. Data collection took place over a period of four months, during which time 554 human errors were reported by
p.000021: hospital staff. The results
p.000021: of this project cannot be directly applied to other ICUs at other hospitals, as the errors reported in this setting
p.000021: were almost certainly unique to this setting and the staff employed there. However, the project staff published this
p.000021: project because the methods used to complete it were innovative and it was felt that similar studies could be easily
p.000021: carried out in other settings.
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021: 5. Privacy and confidentiality
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021: Guidance point 8
p.000021: Staff involved in the conduct of patient safety research and patient safety activities should be aware of the
p.000021: principles and methods related to preserving privacy
p.000021: and confidentiality.
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021: Privacy and confidentiality are two separate but related issues. The United States Office for Human Research
p.000021: Protections has stated that “Privacy can be defined in terms of having control over the extent, timing, and
p.000021: circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. Confidentiality pertains to
p.000021: the treatment of information that an individual has disclosed in
p.000021: a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent
p.000021: with the understanding
p.000021: of the original disclosure without permission.”17
p.000021:
p.000021: As CIOMS has recognized, “patients have the right to expect that their physicians and other health-care professionals
p.000021: will hold all information about them
p.000021: in strict confidence and disclose it only to those who need, or have a legal right to, the information.”18 The medical
p.000021: profession sees confidentiality as essential, not only for successful health care, but more importantly to protect the
p.000021: trust that is placed in doctors by their patients.
p.000021:
p.000021: There are many strategies for safeguarding the personal information of individuals involved in patient safety research.
p.000021: These include coding abstracted data
p.000021: with unique identifiers rather than names and masking features of specific cases, institutions, or settings
p.000021: that may make them recognizable even without names. Masking features of cases may be more challenging for sentinel
p.000021: events, such as a wrong site surgery or
p.000025: 25
p.000025: EXISTING GUIDELINES
p.000025: Research relating to individuals and groups may involve
p.000025: the collection and storage
p.000025: of information that, if disclosed to third parties, could cause harm or distress. Investigators should arrange to
p.000025: protect the
p.000025: confidentiality of such information by, for example, omitting information that might lead to
p.000025: the identification of individual subjects, limiting access to the information, anonymizing data, or other means.
p.000025: CIOMS International Ethical Guidelines for Epidemiological Research 2009 Commentary on Guideline 18
p.000025:
p.000025: Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal
p.000025: information
p.000025: and to minimize the impact of the study on their physical, mental and social integrity.
p.000025: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association Declaration of Helsinki,
p.000025: 2008 paragraph 23
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: a patient death. Grouping similar cases together can help minimize the chance that individual providers or institutions
p.000025: will be identified.
p.000025:
p.000025: In general, access to patient information before it is de-identified should be granted to as few individuals as
p.000025: possible. This might be achieved by assigning medical staff, who already have permission and confidentiality
p.000025: commitments
p.000025: to review patient charts, or asking data collectors to sign the same level of confidentiality agreement(s) required of
p.000025: hospital staff. Absent these safeguards, patients’ consent to abstract
p.000025: 26 data from hospital records, or a waiver of consent from a REC (see guidance point 6) should be sought.
p.000025: Where providers’ behaviour is being analysed, by contrast, it may be more protective of privacy if outsiders, rather
p.000025: than colleagues,
p.000025: are the ones who document errors.
p.000025:
...
p.000030: ñ Persuasively argue that significant advances could result from the research either for the local setting or more
p.000030: broadly;
p.000030: ñ Consider whether asking participants to consent to participate, without disclosing the nature or precise timing of
p.000030: the intervention, is reasonable;
p.000030: ñ Ensure that withholding information itself will not cause a study to involve greater than minimal risk.
p.000030:
p.000030:
p.000030:
p.000030: Guidance point 13
p.000030: In those cases where a research ethics committee approves an activity where information has been withheld from the
p.000030: participants, the committee must also:
p.000030: ñ Ensure that nothing has been withheld that, if divulged, would cause a reasonable person to refuse to participate;
p.000030: ñ Determine if debriefing of those who participated is possible or appropriate;
p.000030: ñ Ensure that a general disclosure of the type of research that is proposed is in place, if possible.
p.000030:
p.000030: EXISTING GUIDELINES
p.000030: When deception is deemed indispensable to the methods
p.000030: of a study, the investigators must demonstrate to an ethical review committee that no other research method would
p.000030: suffice; that significant advances could result from the research; and that nothing has been withheld that, if
p.000030: divulged, would cause a reasonable person to refuse
p.000030: to participate. The ethical review committee should determine
p.000030: the consequences for the subject of being deceived, and whether and how deceived subjects should be informed of the
p.000030: deception upon completion of the research.
p.000030: CIOMS International Ethical Guidelines for Epidemiological Studies 2009 – Commentary on Guideline.
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: Researchers have a commitment to telling the truth, but omission of some information (e.g. the specific purpose of the
p.000030: study) is considered acceptable in some situations. In general, the type of information that is withheld from
p.000030: participants may include
p.000030: not informing participants that they are in research,
p.000030: not informing them of the true purpose of the research, not informing them which behaviours or interventions are being
p.000030: studied, or taking on
p.000030: a false identity in order to gain additional research information. Such withholding of information from research
p.000030: participants is allowable in exceptional
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: circumstances, where projects are low risk, where it is necessary for obtaining the relevant
p.000030: data, where the project could significantly advance the field of patient safety, and where it does not change the
p.000030: overall risk profile of the study.
p.000030: For instance, in a study to determine the extent of a problem of fake or substandard quality drugs being sold by
p.000030: pharmacists, “mystery clients” were asked to go to public marketplaces for remedies
p.000030: for their children when they didn’t really have a sick child, and the researchers then examined the pharmacological
p.000030: make-up of the products they were given. This study design was allowed by the local REC, because this was considered to
...
p.000034: of Cluster Randomized Trials Consensus Group. The Ottawa Statement on the Ethical Design and Conduct of Cluster
p.000034: Randomized Trials. PLoS Medicine. 2012; 9: e1001346 doi:10.1371.
p.000034: 13 World Health Organization. Standards and Operational Guidance for Ethics Review of Health-Related Research with
p.000034: Human Participants. WHO, Geneva, 2012.
p.000034: 14 National Research Ethics Service. Developing Commensurate Review: a report of the National Research Ethics Service
p.000034: “Fast Track” project. National Patient Safety Agency, November 2008. Electronic version available at:
p.000034: http://www.nres.nhs.uk/about-the-national-research-ethics- service/building-on-improvement/proportionate-review/
p.000034: 15 Federal Policy for the Protection of Human Subjects (“Common Rule”), 45 C.F.R. 46.101. US Department of Health and
p.000034: Human Services. Electronic publication available at http://www.hhs.gov/ohrp/humansubjects/commonrule/ index.html
p.000034: 16 Miller FG, Emanuel EJ. Quality-Improvement Research and Informed Consent. New England Journal of Medicine. 2008;
p.000034: 353:765-767.
p.000034: 17 Office for Human Research Protections, Institutional Review Board Guidebook. Electronic publication available at:
p.000034: http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm
p.000034: 18 Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for
p.000034: Epidemiological Studies. CIOMS, Geneva, 2009.
p.000034: 19 Miller FG, Mello MM, Joffe S. Incidental Findings
p.000034: in Human Subjects Research: What do investigators owe research participants? Journal of Law, Medicine & Ethics. 2008;
p.000034: 36: 271-279
p.000034: 20 Wolf SM, Lawrenz FP, Nelson CA, Kahn JP, Cho MK, Clayton EW, Fletcher JG, Georgieff MK, Hammerschmidt D, Hudson K,
p.000034: Illes J, Kapur V, Keane MA, Koenig BA, Leroy BS, McFarland EG, Paradise J, Parker LS, Terry SF, Van Ness B, Wilfond BS.
p.000034: Managing incidental findings in human subjects research: Analysis and recommendations. Journal of Law, Medicine &
p.000034: Ethics. 2008; 36:219-248.
p.000034: 21 Miller FG, Gluck JP, Wendler D. Debriefing and accountability in deceptive research. Kennedy Institute of Ethics
p.000034: Journal. 2008; 18:235-251.
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034: Appendix 1:
p.000034: How this guide was developed
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034: The production of the “Ethical issues in patient safety research” included the following key steps:
p.000034: 1. Identification of ethical issues related to patient safety research, through an issue-spotting workshop with WHO
p.000034: staff and ERC members in March 2010.
p.000034: 2. Systematic review of the literature on ethical issues related to patient safety/quality improvement research, aiming
p.000034: to synthesize existing knowledge on the subject, in order to inform next steps in the process. Over
p.000034: 60 journal articles, monographs and other publications were reviewed to produce a synthesis of the state
...
p.000035: of observational of observational studies in epidemiology: a proposal for reporting. JAMA. 2000; 283: 2008-2012
p.000035: 7. Institute of Medicine. Committee on Standards for Systematic Reviews of Comparative Effectiveness.
p.000035: Finding what works in health care: Standards
p.000035: for systematic reviews. National Academies Press. Washington DC. 2011. Available at:
p.000035: http://iom.edu/Reports/2011/Finding-What-Works-in- Health-Care-Standards-for-Systematic-Reviews.aspx
p.000035: 8. O’Connor D, Green S, Higgins J. Defining the review question and developing criteria for
p.000035: including studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions.
p.000035: Version 5.1.0 [updated March 2011].
p.000035: The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: 9. Tanon AA, Champagne F, Contandriopoulos AP, Pomey MP, Vadeboncoeur A, Nguyen H. Patient safety and systematic
p.000035: reviews: finding papers indexed in MEDLINE, EMBASE and CINAHL. Quality and Safety
p.000035: in Health Care. 2010; 19: 452-61.
p.000035: 10. Federal Policy for the Protection of Human Subjects (“Common Rule”), 45 C.F.R. 46.101. US Department
p.000035: of Health and Human Services. Electronic publication available at http://www.hhs.gov/ohrp/humansubjects/
p.000035: commonrule/index.html
p.000035: 11. Council for International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical
p.000035: Research Involving Human Subjects. November 2002.
p.000035: 36 Available at http://www.cioms.ch/publications/layout_
p.000035: guide2002.pdf.
p.000035: 12. Grady C. Science in the Service of Healing. Hastings Center Report. 1998; 28: 34-38.
p.000035: 13. Byers JF, Aragon ED. What quality improvement professionals need to know about IRBs. Journal for Healthcare
p.000035: Quality. 2003; 25: 4-10.
p.000035: 14. Diamond LH, Kliger AS, Goldman RS, Palevsky PM. Quality improvement projects: How do we protect patients’ rights?.
p.000035: American Journal of Medical Quality. 2004; 19: 25-27.
p.000035: 15. Nelson WA, Gardent PB. Ethics and quality improvement. Quality care and ethical principles cannot be separated when
p.000035: considering quality improvement activities. Healthcare Executive. 2008; 23:40-41.
p.000035: 16. Harrington L. Quality improvement, research, and the institutional review board. Journal Healthcare Quality. 2007;
p.000035: 29: 4-9.
p.000035: 17. Casarett D, Karlawish JHT, Sugarman J. Determining when quality improvement initiatives should be considered
p.000035: research: Proposed criteria and potential implications. JAMA. 2000; 283: 2275-2280.
p.000035: 18. Lynn J. When does quality improvement count as research? Human subject protection and theories
p.000035: of knowledge. Quality and Safety in Health Care. 2004; 13: 67-70.
p.000035: 19. Newhouse RP, Poe S, Pettit JC, Rocco L.
p.000035: The slippery slope: Differentiating between quality improvement and research. Journal of Nursing Administration. 2006;
p.000035: 36: 211-219.
p.000035: 20. Lemaire F. Informed consent and studies
p.000035: of a quality improvement program. JAMA. 2008; 300: 1762.
p.000035: 21. Cacchione PZ. When is institutional review board approval necessary for quality improvement projects? Clinical
...
General/Other / common rule
Searching for indicator commonXrule:
(return to top)
p.000008: ñ Are there any potential direct or indirect benefits to, or incentives for, participating in patient safety research?
p.000008: ñ Under what circumstances, if any, do researchers have a duty to intervene regarding past or imminent errors?
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: The application of research ethics principles to patient safety activities
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000010: 10
p.000010: EXISTING GUIDELINES
p.000010: All proposals to conduct research involving human subjects must be submitted for review of their scientific merit and
p.000010: ethical acceptability to one or more scientific review and ethical review committees. The investigator must obtain
p.000010: their approval or clearance before undertaking the research.
p.000010: CIOMS International Ethical Guidelines for Epidemiological studies, 2009 Guideline 2
p.000010:
p.000010: It is conventional to define “research” as involving activities that are designed to develop
p.000010: or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principles or relationships, or
p.000010: the accumulation of information on which they are based, that can be corroborated by accepted
p.000010: scientific methods of observation and inference.
p.000010: CIOMS International Ethical Guidelines for Epidemiological Studies, 2009 Introduction
p.000010:
p.000010: Research means a systematic investigation, including research development, testing, and evaluation, designed to develop
p.000010: or contribute to generalizable knowledge.
p.000010: The “Common Rule” (USA)
p.000010:
p.000010: Guidance point 1
p.000010: Any patient safety activity that constitutes research, regardless of its methodology, should be submitted to a Research
p.000010: Ethics Committee (REC).
p.000010: For purposes of REC oversight, patient safety activi- ties constitute research when:
p.000010: ñ they are aimed at addressing a specific question; and ñ they use a predefined approach or method for collect-
p.000010: ing data in response to the question they intend to address; and
p.000010: ñ their findings are intended to be applied to settings beyond those in which the activity or programme is implemented.
p.000010:
p.000010:
p.000010: International guidelines define research as a systematic activity designed to develop or contribute to generalizable
p.000010: knowledge. Before conducting any study, researchers should consider whether the research is warranted and whether the
p.000010: selection and recruitment of participants is fair. There should be good reason to explore safety practice in research
p.000010: beyond routine evaluation. Furthermore, vulnerable populations should not be differentially exposed to any extra risks
p.000010: brought up by the research without good reason to avoid exacerbating pre-existing inequalities.10 While health research
p.000010: has the potential to bring benefits to society and to the research communities, it can be associated
p.000010: with risks to the research participants. It is the obligation of those responsible for conducting the research
p.000010: to protect participants by minimizing those risks and seeking approval of an independent Research Ethics Committee
p.000010: (REC).
p.000010:
...
p.000011: 2008 paragraph 18.
p.000011:
p.000011: For all epidemiological research involving human subjects,
p.000011: the investigator must ensure
p.000011: that potential benefits and harms are reasonably balanced and risks are minimized.
p.000011: CIOMS International Ethical Guidelines for Epidemiological Studies, 2009 Guideline 8
p.000011:
p.000011: The risks to which research subjects may be exposed have been classified as physical, psychological, social, and
p.000011: economic.
p.000011: OHRP Institutional Review Board Guidebook
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: EXISTING GUIDELINES
p.000011: Minimal risk refers to “risk that
p.000011: 16 is no more likely and not greater than that attached to routine medical or psychological examination.”
p.000011: CIOMS, International Ethical Guidelines for Epidemiological Studies, 2009 Commentary to Guideline 4 (Documentation of
p.000011: consent)
p.000011:
p.000011: Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater
p.000011: in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or
p.000011: psychological examinations or tests.
p.000011: The "Common Rule" (United States)
p.000011:
p.000011: Physicians may not participate in a research study involving human subjects unless they are confident that the risks
p.000011: involved have been adequately assessed and can be satisfactorily managed. Physicians must immediately stop a study when
p.000011: the risks are found to outweigh the potential benefits
p.000011: or when there is conclusive proof of positive and beneficial results.
p.000011: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association Declaration of Helsinki,
p.000011: 2008 Paragraph 20
p.000011: Determining the level of risk
p.000011:
p.000011: Guidance point 3
p.000011: Patient safety research may be considered of mini- mal risk if all of the following factors are present:
p.000011: ñ The intervention does not modify clinical management or the treatment plan for the patient;
p.000011: ñ Data are not individually identifiable, or adequate protections against breaches of confidentiality of data are in
p.000011: place;
p.000011: ñ The intervention is unlikely to divert staff from existing responsibilities in ways that are likely to pose a risk to
p.000011: patient wellbeing and safety;
p.000011: ñ Nothing in applicable laws, or institutional rules, or the local cultural context suggests that conducting the study
p.000011: in the particular environment would pose higher risks to the patient;
p.000011: ñ No other features of the activity suggest an increased level of risk to patients, providers, or institutions,
p.000011: compared with the patient safety activity not being implemented.
...
p.000034: Research: A Review of the Literature. Submitted for publication. 2012
p.000034: 10 Conrad E, Edwards SJL. Inequalities and Fairness in Cluster Trials. Research Ethics. 2011; 7: 58-65
p.000034: 11 Dovey S, Hall K, Rosser W, Makeham M, Kuzel A, van Weel C, Esmail A, Phillips R. Seeking ethical approval
p.000034:
p.000034: for an international study in primary care patient safety. British Journal General Practice. 2011; 61:197-204.
p.000034: 12 Weijer C, Grimshaw JM, Eccles MP, McRae AD, White A, Brehaut JC, Taljaard M, Althabe F, the Ottawa Ethics
p.000034: of Cluster Randomized Trials Consensus Group. The Ottawa Statement on the Ethical Design and Conduct of Cluster
p.000034: Randomized Trials. PLoS Medicine. 2012; 9: e1001346 doi:10.1371.
p.000034: 13 World Health Organization. Standards and Operational Guidance for Ethics Review of Health-Related Research with
p.000034: Human Participants. WHO, Geneva, 2012.
p.000034: 14 National Research Ethics Service. Developing Commensurate Review: a report of the National Research Ethics Service
p.000034: “Fast Track” project. National Patient Safety Agency, November 2008. Electronic version available at:
p.000034: http://www.nres.nhs.uk/about-the-national-research-ethics- service/building-on-improvement/proportionate-review/
p.000034: 15 Federal Policy for the Protection of Human Subjects (“Common Rule”), 45 C.F.R. 46.101. US Department of Health and
p.000034: Human Services. Electronic publication available at http://www.hhs.gov/ohrp/humansubjects/commonrule/ index.html
p.000034: 16 Miller FG, Emanuel EJ. Quality-Improvement Research and Informed Consent. New England Journal of Medicine. 2008;
p.000034: 353:765-767.
p.000034: 17 Office for Human Research Protections, Institutional Review Board Guidebook. Electronic publication available at:
p.000034: http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm
p.000034: 18 Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for
p.000034: Epidemiological Studies. CIOMS, Geneva, 2009.
p.000034: 19 Miller FG, Mello MM, Joffe S. Incidental Findings
p.000034: in Human Subjects Research: What do investigators owe research participants? Journal of Law, Medicine & Ethics. 2008;
p.000034: 36: 271-279
p.000034: 20 Wolf SM, Lawrenz FP, Nelson CA, Kahn JP, Cho MK, Clayton EW, Fletcher JG, Georgieff MK, Hammerschmidt D, Hudson K,
p.000034: Illes J, Kapur V, Keane MA, Koenig BA, Leroy BS, McFarland EG, Paradise J, Parker LS, Terry SF, Van Ness B, Wilfond BS.
p.000034: Managing incidental findings in human subjects research: Analysis and recommendations. Journal of Law, Medicine &
p.000034: Ethics. 2008; 36:219-248.
p.000034: 21 Miller FG, Gluck JP, Wendler D. Debriefing and accountability in deceptive research. Kennedy Institute of Ethics
p.000034: Journal. 2008; 18:235-251.
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
...
p.000035: University Medical Center. Department of Community and Family Medicine. Duke Center for Instructional Technology.
p.000035: Available at: http://pamodules.mc.duke.edu/launch4.asp
p.000035: 5. Grady C. Quality Improvement and Ethical Oversight. Annals of Internal Medicine. 2007; 146: 680-681.
p.000035: 6. Stroup D, Berlin J, Morton S, Olkin I, Williamson GD, Rennie D, Moher D, Becker B, Sipe T, Thacker S. Meta-analysis
p.000035: of observational of observational studies in epidemiology: a proposal for reporting. JAMA. 2000; 283: 2008-2012
p.000035: 7. Institute of Medicine. Committee on Standards for Systematic Reviews of Comparative Effectiveness.
p.000035: Finding what works in health care: Standards
p.000035: for systematic reviews. National Academies Press. Washington DC. 2011. Available at:
p.000035: http://iom.edu/Reports/2011/Finding-What-Works-in- Health-Care-Standards-for-Systematic-Reviews.aspx
p.000035: 8. O’Connor D, Green S, Higgins J. Defining the review question and developing criteria for
p.000035: including studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions.
p.000035: Version 5.1.0 [updated March 2011].
p.000035: The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: 9. Tanon AA, Champagne F, Contandriopoulos AP, Pomey MP, Vadeboncoeur A, Nguyen H. Patient safety and systematic
p.000035: reviews: finding papers indexed in MEDLINE, EMBASE and CINAHL. Quality and Safety
p.000035: in Health Care. 2010; 19: 452-61.
p.000035: 10. Federal Policy for the Protection of Human Subjects (“Common Rule”), 45 C.F.R. 46.101. US Department
p.000035: of Health and Human Services. Electronic publication available at http://www.hhs.gov/ohrp/humansubjects/
p.000035: commonrule/index.html
p.000035: 11. Council for International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical
p.000035: Research Involving Human Subjects. November 2002.
p.000035: 36 Available at http://www.cioms.ch/publications/layout_
p.000035: guide2002.pdf.
p.000035: 12. Grady C. Science in the Service of Healing. Hastings Center Report. 1998; 28: 34-38.
p.000035: 13. Byers JF, Aragon ED. What quality improvement professionals need to know about IRBs. Journal for Healthcare
p.000035: Quality. 2003; 25: 4-10.
p.000035: 14. Diamond LH, Kliger AS, Goldman RS, Palevsky PM. Quality improvement projects: How do we protect patients’ rights?.
p.000035: American Journal of Medical Quality. 2004; 19: 25-27.
p.000035: 15. Nelson WA, Gardent PB. Ethics and quality improvement. Quality care and ethical principles cannot be separated when
p.000035: considering quality improvement activities. Healthcare Executive. 2008; 23:40-41.
p.000035: 16. Harrington L. Quality improvement, research, and the institutional review board. Journal Healthcare Quality. 2007;
p.000035: 29: 4-9.
p.000035: 17. Casarett D, Karlawish JHT, Sugarman J. Determining when quality improvement initiatives should be considered
p.000035: research: Proposed criteria and potential implications. JAMA. 2000; 283: 2275-2280.
p.000035: 18. Lynn J. When does quality improvement count as research? Human subject protection and theories
p.000035: of knowledge. Quality and Safety in Health Care. 2004; 13: 67-70.
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000004: and their surrounding circumstances, as well as the impact of innovative strategies to address patient safety problems,
p.000004: poses new research questions that raise new,
p.000004: and unresolved, ethical questions. For example, what does the ethical principle of “beneficence” require in studies
p.000004: that identify physician errors in on-going or recorded clinical practice? What does the principle of “respect for
p.000004: persons” require in studies that involve the observation of patients’ and professionals’ behaviour? When evaluating
p.000004: a strategy to reduce errors, is ethics committee review required when the only difference from usual practice is the
p.000004: collection of data to see if the strategy improves care? These and other challenges raised by patient safety research
p.000004: have been challenging ethics committees around the globe.
p.000004:
p.000004: Tens of millions of patients worldwide suffer disabling injuries or death every year due to unsafe medical practices
p.000004: and care. As such, the World Health Organization (WHO) recognizes the ethical imperative to identify strategies that
p.000004: can improve the safety of patients as they receive care
p.000004: worldwide. In identifying ethical principles to guide this and other types of human research, WHO endorses the
p.000004: widely-used Council on International Organizations of Medical Sciences (CIOMS) “International Ethical Guidelines for
p.000004: Biomedical Research involving Human Subjects” (2002) and
p.000004: “International Ethical Guidelines for Epidemiological 3
p.000004: Research (2009),” and the World Medical Association (WMA) Declaration of Helsinki (2008). This report represents an
p.000004: important effort to apply the ethical guidance provided through these documents to the specific field of patient safety
p.000004: research. The report aims to help patient safety professionals, investigators, health-care institutions, ethics review
p.000004: committees, health authorities and others ensure the ethical conduct of patient safety activities. It synthesizes the
p.000004: organized deliberations of a highly respected group of research ethics and patient safety specialists from all over the
p.000004: world who, over the past years, have collaborated with WHO to produce this guidance. This document
p.000004: is especially important in resource-poor settings, where there is a pressing need to conduct more locally applicable
p.000004: research for health, including studies related to patient safety.
p.000004:
p.000004: The guidance included in this report, is the first version of which we expect to be a continually maturing document.
p.000004: WHO, therefore, encourages readers and users of this document to provide feedback, allowing the continuous review and
p.000004: refinement of the guidance, based on additional input and new scholarly work.
p.000004:
p.000004: This report represents the joint effort of
p.000004: the international experts who have provided their deliberations, together with the WHO Patient Safety Programme and the
p.000004: Secretariat of the WHO Ethics Review Committee, which steered and managed the process. I commend them all for taking on
p.000004: this important task.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
...
p.000010: the next section. When in doubt, it is recommended that patient safety projects are submitted to ethics committees at
p.000010: an early stage, to determine whether or not they consider them as research that should receive their oversight.
p.000010: An important criterion to bear in mind
p.000010: is whether or not the proposed intervention is evidence based. If it is not evidence-based, then it is recommended that
p.000010: the activity be developed within a research framework.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011: EXISTING GUIDELINES
p.000011: The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics
p.000011: committee before the study begins. This committee must be independent of the researcher, the sponsor and any other
p.000011: undue influence.
p.000011: It must take into consideration the laws and regulations of the country or countries in which the
p.000011: research is to be performed as well as applicable international norms and standards but these must not be allowed to
p.000011: reduce or eliminate any of the protections for research subjects set forth in this Declaration. The committee must have
p.000011: the right to monitor on-going studies. The researcher must provide monitoring information
p.000011: to the committee, especially information about any serious adverse events. No change to
p.000011: the protocol may be made without consideration and approval by
p.000011: the committee.
p.000011: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association Declaration of Helsinki,
p.000011: 2008 paragraph 15
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Case study 1 – Obtaining research ethics oversight
p.000011:
p.000011:
p.000011:
p.000011: Dovey S, Hall K, Makeham M, et. al.
p.000011: Seeking ethical approval for an international study in primary care patient safety.
p.000011: Br J Gen Pract 2011; 61: 197-204
p.000011: Seeking ethics committee approval for research
p.000011: can be challenging even for relatively simple studies occurring in single settings. Complicating factors such as
p.000011: multicentre studies and/or contentious research issues can challenge review processes,
p.000011: 12 and conducting such studies internationally adds a further layer of complexity. This paper drew on the
p.000011: experiences of the LINNAEUS Collaboration,
p.000011: an international group of primary care researchers, in obtaining ethics approval to conduct an international study
p.000011: investigating medical error
p.000011: in general practice in six countries. It describes
p.000011:
p.000011: the ethics review processes applied to exactly the same research protocol for a study run in Australia, Canada,
p.000011: England, the Netherlands, New Zealand, and the US. Wide variations in ethics review responses to the research proposal
p.000011: occurred, from no approval being deemed necessary to the study plan narrowly avoiding rejection. The ethics committees
...
p.000011:
p.000011: Psychological risks: Psychological risks include the possibility that research participants will become
p.000011: emotionally distressed, fearful or anxious as a result of their participation. For example, studies that
p.000011: interview patients or families about harmful incidents that occurred previously or about their perceptions of the
p.000011: quality of care may cause them to question the quality of their medical providers and to become anxious. Also, health
p.000011: providers may become anxious if they believe that researchers are evaluating their professional
p.000011: performance, particularly if they fear that the results may result in reprisals.
p.000011:
p.000011: Economic risks: Economic risks refer to the possibility that research participants will be required to incur
p.000011: additional financial costs as a result of their participation in a study. For example, providers may have concerns
p.000011: about the economic implications of studies that uncover errors in how care is provided, including the
p.000011: possibility that negative information uncovered during a study could lead to litigation.
p.000011:
p.000011: EXISTING GUIDELINES
p.000011: Every medical research study 15
p.000011: involving human subjects must be preceded by careful assessment of predictable risks and burdens
p.000011: to the individuals and communities involved in the research in comparison with foreseeable benefits to them and to
p.000011: other individuals or communities affected by the condition under investigation.
p.000011: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association Declaration of Helsinki,
p.000011: 2008 paragraph 18.
p.000011:
p.000011: For all epidemiological research involving human subjects,
p.000011: the investigator must ensure
p.000011: that potential benefits and harms are reasonably balanced and risks are minimized.
p.000011: CIOMS International Ethical Guidelines for Epidemiological Studies, 2009 Guideline 8
p.000011:
p.000011: The risks to which research subjects may be exposed have been classified as physical, psychological, social, and
p.000011: economic.
p.000011: OHRP Institutional Review Board Guidebook
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: EXISTING GUIDELINES
p.000011: Minimal risk refers to “risk that
p.000011: 16 is no more likely and not greater than that attached to routine medical or psychological examination.”
p.000011: CIOMS, International Ethical Guidelines for Epidemiological Studies, 2009 Commentary to Guideline 4 (Documentation of
p.000011: consent)
p.000011:
p.000011: Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater
p.000011: in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or
p.000011: psychological examinations or tests.
p.000011: The "Common Rule" (United States)
p.000011:
p.000011: Physicians may not participate in a research study involving human subjects unless they are confident that the risks
p.000011: involved have been adequately assessed and can be satisfactorily managed. Physicians must immediately stop a study when
p.000011: the risks are found to outweigh the potential benefits
p.000011: or when there is conclusive proof of positive and beneficial results.
p.000011: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association Declaration of Helsinki,
p.000011: 2008 Paragraph 20
p.000011: Determining the level of risk
p.000011:
p.000011: Guidance point 3
p.000011: Patient safety research may be considered of mini- mal risk if all of the following factors are present:
p.000011: ñ The intervention does not modify clinical management or the treatment plan for the patient;
p.000011: ñ Data are not individually identifiable, or adequate protections against breaches of confidentiality of data are in
p.000011: place;
p.000011: ñ The intervention is unlikely to divert staff from existing responsibilities in ways that are likely to pose a risk to
p.000011: patient wellbeing and safety;
p.000011: ñ Nothing in applicable laws, or institutional rules, or the local cultural context suggests that conducting the study
p.000011: in the particular environment would pose higher risks to the patient;
p.000011: ñ No other features of the activity suggest an increased level of risk to patients, providers, or institutions,
p.000011: compared with the patient safety activity not being implemented.
p.000011:
p.000011:
p.000011:
p.000011: International guidelines define minimal risk research as research that poses no greater risk than the risks attached to
p.000011: routine daily life or to routine medical or psychological examination. For providers, minimal risk might be defined as
p.000011: risks no greater than those encountered in conducting their usual practice.
p.000011:
...
p.000021: 22 may entail, and any other relevant aspects of the study. The potential subject must be informed of the
p.000021: right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal.
p.000021: Special attention should
p.000021: be given to the specific information needs of individual potential subjects as well as to the methods used to deliver
p.000021: the information. After ensuring that the potential subject has
p.000021: understood the information, the physician or another appropriately qualified individual must then seek the potential
p.000021: subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-
p.000021: written consent must be formally documented and witnessed.
p.000021: For medical research using identifiable human material or data, physicians must normally seek consent for its
p.000021: collection, analysis, storage and/or reuse. There may be situations where consent would be impossible or impractical to
p.000021: obtain for such research or would pose a threat to the validity of the research. In such situations, the research may
p.000021: be done only after the consideration and approval of a research ethics committee.
p.000021: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association Declaration
p.000021: of Helsinki, 2008
p.000021: paragraphs 24 and 25
p.000021: For example, reminding providers to follow evidence- based practices, and measuring the impact of
p.000021: the reminder on patient outcomes (based on review and confidential documentation of medical charts), may not require
p.000021: patient-level informed consent.
p.000021: This is because there are no experimental interventions administered to patients, the study does not alter
p.000021: the standard therapeutic plan, and the risks posed to patients by the research as a whole are minimal.
p.000021: In general consent is not ordinarily sought from patients when reminding providers about best practices.
p.000021:
p.000021: When individual informed consent is required, it must usually be documented through the signature on
p.000021: a consent form. However, in some situations, RECs may approve other methods of documentation, such as allowing
p.000021: participants to express their willingness to participate orally, or allowing participants to imply
p.000021: consent through voluntary actions (such as completing a mailed questionnaire). RECs should not waive the requirement of
p.000021: obtaining written consent for research involving more than minimal risk, except in situations in which the principal
p.000021: risk to patients is the potential harm resulting from being linked to participation in the research, in which case oral
...
p.000021: trust that is placed in doctors by their patients.
p.000021:
p.000021: There are many strategies for safeguarding the personal information of individuals involved in patient safety research.
p.000021: These include coding abstracted data
p.000021: with unique identifiers rather than names and masking features of specific cases, institutions, or settings
p.000021: that may make them recognizable even without names. Masking features of cases may be more challenging for sentinel
p.000021: events, such as a wrong site surgery or
p.000025: 25
p.000025: EXISTING GUIDELINES
p.000025: Research relating to individuals and groups may involve
p.000025: the collection and storage
p.000025: of information that, if disclosed to third parties, could cause harm or distress. Investigators should arrange to
p.000025: protect the
p.000025: confidentiality of such information by, for example, omitting information that might lead to
p.000025: the identification of individual subjects, limiting access to the information, anonymizing data, or other means.
p.000025: CIOMS International Ethical Guidelines for Epidemiological Research 2009 Commentary on Guideline 18
p.000025:
p.000025: Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal
p.000025: information
p.000025: and to minimize the impact of the study on their physical, mental and social integrity.
p.000025: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association Declaration of Helsinki,
p.000025: 2008 paragraph 23
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: a patient death. Grouping similar cases together can help minimize the chance that individual providers or institutions
p.000025: will be identified.
p.000025:
p.000025: In general, access to patient information before it is de-identified should be granted to as few individuals as
p.000025: possible. This might be achieved by assigning medical staff, who already have permission and confidentiality
p.000025: commitments
p.000025: to review patient charts, or asking data collectors to sign the same level of confidentiality agreement(s) required of
p.000025: hospital staff. Absent these safeguards, patients’ consent to abstract
p.000025: 26 data from hospital records, or a waiver of consent from a REC (see guidance point 6) should be sought.
p.000025: Where providers’ behaviour is being analysed, by contrast, it may be more protective of privacy if outsiders, rather
p.000025: than colleagues,
p.000025: are the ones who document errors.
p.000025:
p.000025: In some situations, such as when using a single case to illustrate some findings, confidentiality may be more difficult
p.000025: to ensure. Nevertheless, this principle must be respected even if to achieve it, some patients’ details may need to be
p.000025: altered to protect the identity of individuals who would otherwise be identifiable based on the details
p.000025: of their case.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 6. Duty to intervene or report
p.000025:
p.000025:
p.000025:
...
p.000034: Harris K, Knoche J, Saxena A. The list
p.000034: of the documents reviewed is provided at the end of this Appendix.
p.000034: 3. An International Expert Consultation held in May 2010 reviewed the set of ethical issues and initial synthesis of
p.000034: the literature. Experts were patient safety researchers, health facility managers, ethicists, ethics committee members,
p.000034: and patient advocate representatives. Using small group discussions and
p.000034: a case-based approach, the consultation identified a core set of issues that would benefit from further guidance and
p.000034: built consensus on the core concepts included in this guidance.
p.000034: 4. Two rounds of external reviewers, involving international academics with expertise in quality improvement, patient
p.000034: safety, research methods or ethics from all six WHO Regions, advised on the various iterations of the document.
p.000034: 5. Every external contributor in the working group and in the review process submitted a standard WHO “Declaration of
p.000034: Interests” form to the WHO Secretariat. None declared any conflicts or potential conflicts.
p.000034: 6. A drafting group produced the different iterations of this document, based on recommendations from the expert
p.000034: consultation and the two rounds of external review. The drafting group considered all suggestions made by the
p.000034: reviewers.
p.000034: All participants in this process are listed in the Acknow- ledgements section that accompanies this document.
p.000035: 35
p.000035: List of references reviewed during
p.000035: the systematic review of the literature:
p.000035: 1. World Medical Association, Declaration Of Helsinki. Ethical Principles for Medical Research Involving
p.000035: Human Subjects 59th WMA General Assembly, Seoul, October 2008 available at http://www.wma.net/en/
p.000035: 30publications/10policies/b3/17c.pdf
p.000035: 2. World Health Organization Technical Consultation on Research Ethics in International Epidemic Response, WHO 2010.
p.000035: WHO/HSE/GIP/ITP/10.1. Available at: http://www.who.int/ethics/gip_research_ethics_.pdf
p.000035: 3. Institute of Medicine. Committee on Quality
p.000035: of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. National Academy
p.000035: Press. Washington DC. 2001. Available
p.000035: at: http://www.iom.edu/Reports/2001/Crossing-the- Quality-Chasm-A-New-Health-System-for-the-
p.000035: 21st-Century.aspx
p.000035: 4. Wiseman B, Kaprielian VS. Patient safety – Quality improvement. Online training for physician assistants. Duke
p.000035: University Medical Center. Department of Community and Family Medicine. Duke Center for Instructional Technology.
p.000035: Available at: http://pamodules.mc.duke.edu/launch4.asp
p.000035: 5. Grady C. Quality Improvement and Ethical Oversight. Annals of Internal Medicine. 2007; 146: 680-681.
p.000035: 6. Stroup D, Berlin J, Morton S, Olkin I, Williamson GD, Rennie D, Moher D, Becker B, Sipe T, Thacker S. Meta-analysis
p.000035: of observational of observational studies in epidemiology: a proposal for reporting. JAMA. 2000; 283: 2008-2012
p.000035: 7. Institute of Medicine. Committee on Standards for Systematic Reviews of Comparative Effectiveness.
p.000035: Finding what works in health care: Standards
p.000035: for systematic reviews. National Academies Press. Washington DC. 2011. Available at:
...
General/Other / participants in a control group
Searching for indicator control group:
(return to top)
p.000025: question related to confirming or double-checking the dose, or the surgical approach, or something similarly important.
p.000025: In case study 6, because the researchers observing the nurses
p.000025: were themselves nurses or pharmacy technicians, they had the expertise necessary to know when an error occurred. They
p.000025: were also instructed
p.000025: to intervene when errors that could cause harm to patients were made.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: Case study 6 – Reporting serious errors that can cause direct and severe harm to patients
p.000025:
p.000025:
p.000025:
p.000025: Greengold N, Shane R, Schneider P, et. al. The Impact of Dedicated Medication Nurses on the Medication Administration
p.000025: Error Rate: A Randomized Controlled Trial.
p.000025: Arch Intern Med, 2003:163:2359-2367
p.000025: This patient safety project was implemented in two hospitals in the United States to understand if having a nurse
p.000025: dedicated to administering medications to patients would reduce the rate of medication administration errors. Four
p.000025: nursing
p.000025: units in each hospital were selected to participate in the project. Within those units, the project staff recruited
p.000025: nurses to participate in the project.
p.000025: Informed consent was obtained from each of the nurse participants and the REC at each of
p.000025: the hospitals approved the project. Once consent was obtained, the nurses were randomly assigned to the intervention or
p.000025: the control group. Those
p.000025: in the intervention group attended a medication safety programme and for two days each week for twelve weeks these
p.000025: nurses were exclusively
p.000025: responsible for administering medications to patients. Those in the control arm did not attend the programme and
p.000025: maintained all of their normal nursing activities.
p.000025:
p.000025: The nurses in the intervention arm were observed by project staff the two days a week that they were exclusively
p.000025: responsible for administering
p.000025: medications. The nurses in the control arm were 29
p.000025: observed by the project staff the other three days of the week. The observers were all nurses or pharmacy technicians
p.000025: who attended an observer training session. They were responsible for “recording all aspects of drug retrieval,
p.000025: preparation, and administration” as well as “variations from safe medication practices”. If, during the course
p.000025: of their observations, the observer recognized an error that could cause harm to a patient, the observer was instructed
p.000025: to intervene and prevent the error from occurring.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: For incidents identified through chart reviews, or through any other mechanism, which are generally conducted
p.000025: retrospectively, any harm associated with the error is less likely to still be reversible.
p.000025: It may also be unclear from medical records alone whether the event was ever reported, whether others were aware of the
p.000025: event, whether any interventions have already occurred or whether, indeed, a harmful incident actually occurred. There
...
Orphaned Trigger Words
p.000004: city
p.000004: or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps
p.000004: represent approximate border lines for which there may not yet be full agreement.
p.000004:
p.000004: The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or
p.000004: recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors
p.000004: and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
p.000004:
p.000004: All reasonable precautions have been taken by the World Health Organization to verify the information contained in this
p.000004: publication. However, the published material is being distributed without warranty of any kind, either expressed
p.000004: or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall
p.000004: the World Health Organization be liable
p.000004: for damages arising from its use.
p.000004:
p.000004: Design by CommonSense, Greece
p.000004: Printed by the WHO document Production Services, Geneva, Switzerland.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Foreword
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Research involving human participants must be conducted in a manner that respects the dignity, safety, and rights of
p.000004: research participants. This principle has formed the basis of ethically acceptable clinical and epidemiological
p.000004: research for decades.
p.000004: Research teams all over the world have increasingly recognized the need for external oversight in securing ethical
p.000004: advice, and independent ethics committees have been established to carry out
p.000004: this role. At the same time, significant scholarly work and international guidance have provided the philosophical and
p.000004: operational framework for improving the ethical conduct of research and building appropriate safeguards.
p.000004:
p.000004: The recent expansion of research aiming to analyse the nature, behaviour and consequences of patient safety incidents
p.000004: and their surrounding circumstances, as well as the impact of innovative strategies to address patient safety problems,
p.000004: poses new research questions that raise new,
p.000004: and unresolved, ethical questions. For example, what does the ethical principle of “beneficence” require in studies
p.000004: that identify physician errors in on-going or recorded clinical practice? What does the principle of “respect for
p.000004: persons” require in studies that involve the observation of patients’ and professionals’ behaviour? When evaluating
p.000004: a strategy to reduce errors, is ethics committee review required when the only difference from usual practice is the
p.000004: collection of data to see if the strategy improves care? These and other challenges raised by patient safety research
p.000004: have been challenging ethics committees around the globe.
p.000004:
p.000004: Tens of millions of patients worldwide suffer disabling injuries or death every year due to unsafe medical practices
p.000004: and care. As such, the World Health Organization (WHO) recognizes the ethical imperative to identify strategies that
p.000004: can improve the safety of patients as they receive care
p.000004: worldwide. In identifying ethical principles to guide this and other types of human research, WHO endorses the
...
p.000004: William Weeks The Dartmouth Institute, USA
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005: Systematic Review of the literature
p.000005: Danielle Whicher Johns Hopkins Bloomberg School of Public Health, USA
p.000005: Kendra Harris Johns Hopkins School of Medicine, USA
p.000005: Jonathan Knocke Mayo Clinic, USA
p.000005:
p.000005:
p.000005: WHO Staff Contributors
p.000005: Marie Charlotte Bouesseau Ethics and Social Determinants, WHO
p.000005: Melba Gomes Tropical Disease Research, WHO & member of the WHO Ethics Review Committee
p.000005: Brooke R Johnson Reproductive Health and Research, WHO & Chair of WHO Ethics Review Committee
p.000005: Kwok-Cho Tang Chronic Disease and Health promotion, WHO & member of the WHO Ethics Review Committee
p.000005: Sergio Nishioka Immunization Vaccines and Biologicals, WHO & member of the WHO Ethics Review Committee
p.000005: Katthyana Aparicio WHO Patient Safety Programme
p.000005: Mobasher Butt WHO Patient Safety Programme (currently in the National Health Service, UK)
p.000005: Nittita Prasopa-Plaizier WHO Patient Safety Programme
p.000005:
p.000005: Drafting & Steering Group
p.000005: Nancy Kass WHO Research Policy & Cooperation (currently at Johns Hopkins Bloomberg School of Public Health, USA)
p.000005: Carl Coleman Independent Ethics Consultant
p.000005: Carmen Audera-Lopez WHO Patient Safety Programme
p.000005: Abha Saxena Ethics and Social Determinants, WHO, and Secretary of the WHO Ethics Review Committee
p.000005: Itziar Larizgoitia WHO Patient Safety Programme
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Table of contents
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000007: 7
p.000007:
p.000007: 1. Introduction
p.000008: 8
p.000008: 2. The application of research ethics principles to patient safety activities 10
p.000008: 3. Understanding risk in patient safety research
p.000015: 15
p.000015: 4. Informed consent
p.000021: 21
p.000021: 5. Privacy and confidentiality
p.000025: 25
p.000025: 6. Duty to intervene or report
p.000027: 27
p.000027: 7. Withholding information
p.000030: 30
p.000030: 8. Conclusions and way forward
p.000033: 33
p.000033: 9. References
p.000034: 34
p.000034: Appendix 1: How this Guide was developed 35
p.000034: Appendix 2: Summary of the ethical guidance related to patient safety research 39
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034: 1. Introduction
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000008: 8
p.000008: This report responds to a request from patient safety researchers and research ethics committees (REC) for advice on
p.000008: how to interpret existing research ethics guidelines in the context of patient safety research. The report, which was
p.000008: produced by the WHO Patient Safety Programme and the WHO ERC Secretariat, builds on the reflections
p.000008: of an international expert group and was further enhanced by internal and external expert reviews by research ethics
p.000008: specialists and patient safety and quality improvement scientists from across the world. As explained in the foreword,
p.000008: this is
p.000008: the first version of this report, which will be revised to include future input, as evidence and scholarship in the
p.000008: area of patient safety research evolve.
p.000008:
p.000008: This document is not intended to establish any new ethical principles. Rather, it represents
p.000008: an interpretation and application of existing, internationally accepted ethical principles
...
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: examined and minimized to the extent that is reasonably possible, that the risks that remain are reasonable in relation
p.000010: to the potential benefits of the study, and that other ethical considerations, such as informed consent and
p.000010: confidentiality, are adequately addressed.
p.000010:
p.000010: Patient safety research may entail potential risks to both patients and health-care providers, and like any other
p.000010: research activity must be submitted to a research ethics committee for review. Patient safety research must be
p.000010: distinguished from activities designed to provide benefits to an existing patient population, including activities
p.000010: characterized as “programme implementation or practice,” such as surveillance or quality improvement.
p.000010: Such patient safety activities are in many instances mandated by regulatory or administrative authorities or units of
p.000010: health-care organizations, and are typically
p.000010: undertaken to serve the interests of the individuals who are cared for in these same organizations. In general, current
p.000010: regulations do not require these activities to be reviewed by an REC.
p.000010:
p.000010: For instance, a hospital may implement a patient safety programme in which data are systematically collected from
p.000010: medical charts of surgery patients to better understand hospital-specific circumstances leading to infection (for
p.000010: example, staffing patterns, scheduling of procedures, or availability of equipment). The hospital’s goal is to identify
p.000010: specific aspects of its organization or delivery of care aiming to reduce the risk of infection. When conducted as part
p.000010: of quality improvement practice, such activities are generally expected to quickly change clinical protocols and
p.000010: practices at the institution in question. Although patient data will be collected
p.000010: in a systematic way, the programme’s focus on hospital- specific circumstances means that the data collected are
p.000010: unlikely to be generalizable beyond that particular setting. As such, many institutions would characterize
p.000010: the activity as quality improvement and thus, not require external ethics review, despite the fact that identifiable
p.000010: human data are being collected.
p.000010:
p.000010: On the other hand, if a project abstracts data from medical charts in a series of hospitals to determine how infection
p.000010: rates can be reduced among hospitals more broadly, so that hospitals can learn more widely from the information, the
p.000010: project would generally fall within accepted definitions of research requiring REC review. In practice, however, there
p.000010: is a great variability in the interpretation of what constitutes research across
p.000010: different research committees and national legislations,11 as illustrated in Case Study 1 and 2 and will be expanded in
p.000010: the next section. When in doubt, it is recommended that patient safety projects are submitted to ethics committees at
p.000010: an early stage, to determine whether or not they consider them as research that should receive their oversight.
p.000010: An important criterion to bear in mind
p.000010: is whether or not the proposed intervention is evidence based. If it is not evidence-based, then it is recommended that
p.000010: the activity be developed within a research framework.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
...
p.000011:
p.000011: Clinical risks: Clinical risks refer to the likelihood that patients may experience a worsening of their health
p.000011: status due to the conduct of the research study. Because patient safety studies do not generally modify the
p.000011: treatment plans for individual patients, they tend to involve considerably fewer clinical risks than other
p.000011: types of health- care research. However, the possibility of clinical risks should always be assessed. In
p.000011: many cases, patient safety studies may target how care is delivered, for example, through new reminder systems
p.000011: to avoid medication errors or testing the effect of different staffing ratios. These changes, while designed
p.000011: to improve the quality of care patients receive, could actually result in lower quality of care or could
p.000011: create errors rather than reduce them. This could happen due to inadequate training of staff on how to use the new
p.000011: systems, or by diverting staff attention to the new patient safety system at the expense of usual care
p.000011: responsibilities.
p.000011:
p.000011: Social risks: Social risks are the risks that research participants encounter due to how others might
p.000011: treat them as a result of their participation in a study. While there may be minimal social risks for
p.000011: patients who take part in patient safety studies, medical providers or institutions may be concerned about social risks
p.000011: if they participate in research that exposes their own system failures or ineffectiveness. For example, research
p.000011: documenting the factors associated with significant health-care incidents that occurred in the past or rates of
p.000011: particular types of errors runs the risk that the providers involved with these incidents, or the
p.000011: institutions themselves, could suffer reputational and professional harm.
p.000011:
p.000011: Psychological risks: Psychological risks include the possibility that research participants will become
p.000011: emotionally distressed, fearful or anxious as a result of their participation. For example, studies that
p.000011: interview patients or families about harmful incidents that occurred previously or about their perceptions of the
p.000011: quality of care may cause them to question the quality of their medical providers and to become anxious. Also, health
p.000011: providers may become anxious if they believe that researchers are evaluating their professional
p.000011: performance, particularly if they fear that the results may result in reprisals.
p.000011:
p.000011: Economic risks: Economic risks refer to the possibility that research participants will be required to incur
p.000011: additional financial costs as a result of their participation in a study. For example, providers may have concerns
p.000011: about the economic implications of studies that uncover errors in how care is provided, including the
p.000011: possibility that negative information uncovered during a study could lead to litigation.
p.000011:
p.000011: EXISTING GUIDELINES
p.000011: Every medical research study 15
p.000011: involving human subjects must be preceded by careful assessment of predictable risks and burdens
p.000011: to the individuals and communities involved in the research in comparison with foreseeable benefits to them and to
p.000011: other individuals or communities affected by the condition under investigation.
...
p.000011: 2008 Paragraph 20
p.000011: Determining the level of risk
p.000011:
p.000011: Guidance point 3
p.000011: Patient safety research may be considered of mini- mal risk if all of the following factors are present:
p.000011: ñ The intervention does not modify clinical management or the treatment plan for the patient;
p.000011: ñ Data are not individually identifiable, or adequate protections against breaches of confidentiality of data are in
p.000011: place;
p.000011: ñ The intervention is unlikely to divert staff from existing responsibilities in ways that are likely to pose a risk to
p.000011: patient wellbeing and safety;
p.000011: ñ Nothing in applicable laws, or institutional rules, or the local cultural context suggests that conducting the study
p.000011: in the particular environment would pose higher risks to the patient;
p.000011: ñ No other features of the activity suggest an increased level of risk to patients, providers, or institutions,
p.000011: compared with the patient safety activity not being implemented.
p.000011:
p.000011:
p.000011:
p.000011: International guidelines define minimal risk research as research that poses no greater risk than the risks attached to
p.000011: routine daily life or to routine medical or psychological examination. For providers, minimal risk might be defined as
p.000011: risks no greater than those encountered in conducting their usual practice.
p.000011:
p.000011: Determining the level of risk posed by a study is important, because some countries’ regulations state that research
p.000011: that poses no more than minimal risk may generally be reviewed using an expedited mechanism.13 This means that RECs may
p.000011: choose to have only one or two members of the committee, rather than the full convened committee, review the protocol.
p.000011: In addition, international guidelines state that minimal risk studies may be eligible for a waiver of informed consent
p.000011: (see Guidance Point 6). While many patient safety studies are likely to pose minimal risk to patients, any study that
p.000011: poses higher risks to patients, providers, or
p.000011: institutions will require greater oversight and protections. Proportionate reviews are schemes that offer different
p.000011: forms of review in proportion to the risks and ethical issues involved in the research being undertaken.14
p.000011:
p.000011: In Case Study 2, because the items on the checklist were based on established clinical practice recommendations and did
p.000011: not therefore create a risk of leading to substandard care, the risk to patients and
p.000011: providers was minimal. However, in Case Study 3, where providers were interviewed by researchers about why
p.000011: a patient safety incident may have occurred and about
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: self-perceived competency and skills, providers might have potentially exposed some failures
p.000011: of their own or of their team or institution, thereby creating some level of social, psychological or even economic
p.000011: risks.The REC would have to determine, once safeguards have been put in place, whether
p.000011: a study like Case Study 3 poses more than minimal risks to the individuals involved.
p.000011:
p.000011: Some types of studies are usually recognized as posing minimal risk. For example, research where individually
p.000011: identifiable human data are not collected, or when the data of the study is already in the public domain, tends to be
p.000011: considered
p.000011: of minimal risk and in many contexts may be exempt from a REC review altogether.15 Similarly, projects that are
p.000011: randomized, whether at the clinic/institution level, or at the level of individual patients, may be considered minimal
p.000011: risk research if, based on best evidence, no study arms are considered therapeutically experimental and
p.000011: no study arms pose a significant deviation from the care usually received by patients in the study setting.
p.000011:
p.000011: Certain projects may pose minimal risk when implemented in some settings, but may pose greater than minimal risk in
p.000011: other contexts,
p.000011: for example, in settings that are retributive towards providers or where confidentiality protections cannot be
p.000011: guaranteed. It is, therefore, important for those involved in patient safety research to understand the institutional
p.000011: culture, norms, laws and regulations where the research takes place, and identify those laws and regulations which are
p.000011: relevant to their work. For studies that document rates of errors, it may be especially important to know whether any
p.000011: local laws require the reporting of provider error to any authorities or licensing boards, as well as whether any
p.000011: exceptions
p.000011: to such policies exist for patient safety research. The existence of such laws may compromise the neutrality of
p.000011: researchers and pose risks to the participants in the study. Investigators documenting errors should also talk to
p.000011: trusted informants in local settings to know the chance of retribution for providers, if errors are found, as well as
p.000011: providers’ anticipated anxiety about possible retribution. Patient safety professionals
p.000011: must also be sensitive to power relationships that exist between senior and junior hospital staff.
p.000011: In Case Study 3, those involved in the patient safety activity made clear to providers that all data would be kept
p.000011: confidential and therefore that no individual level data would be reported to hospital management. In settings where
p.000011: the local context could increase risks related to reporting or retribution, researchers may need to consider
p.000011: whether it would be ethically preferable to abandon the study, in order to prevent additional risks to participants, or
p.000011: whether it would be effective and feasible to build additional safeguards into the study. In some circumstances,
...
p.000017: ñ Avoiding the use of names on data forms, aggregating data as soon as possible, and avoiding the identification of
p.000017: people or unique characteristics of cases in reports;
p.000017: Guidance point 5
p.000017: Individuals involved in patient safety research who are interviewing or observing patients or providers should
p.000017: anticipate any distress participants may experience as a consequence of the conduct of the study and be prepared to
p.000017: offer solutions. Some options are:
p.000017: ñ Be trained to ask participants if they would like 19
p.000017: to skip questions or stop the interview if they
p.000017: become distressed;
p.000017: ñ Be equipped with referrals for supportive care or counselling in case participants become significantly distressed;
p.000017: ñ Be equipped with the names of hospital authorities to whom participants and families can be referred if they have
p.000017: questions; and
p.000017: ñ Ensure that all services and providers whose names will be given out as referrals have agreed to have their names
p.000017: provided to patients
p.000017: and families.
p.000017:
p.000017:
p.000017: ñ Expanding the study population to include several different provider teams or several
p.000017: different institutions, in order to avoid inadvertent identification of particular institutions or groups, or to avoid
p.000017: the appearance of targeting; and
p.000017: ñ Avoiding collecting data from providers or institutions in environments that seem likely to take retaliatory action.
p.000017: However, if by such
p.000017: avoidance, the result would be a biased sample, the researcher should consider redesigning
p.000017: the study.
p.000017:
p.000017: Support for researchers facing complex and sensitive issues
p.000017: A mechanism that might be a useful resource
p.000017: to advise on the course of action if uncovering possible evidence of intentional harm or incompetence or unethical
p.000017: practice, is to set up
p.000017: a “safety committee” of recognized expert clinicians who agree to review data and make a decision about the case and
p.000017: subsequent actions, including informing relevant hospital management or personnel about potential risks or unsafe
p.000017: providers. This safety committee may also advise health professionals reviewing health records who are
p.000017: in some cases compelled to report instances where they suspect incompetence and where intervention with the patient may
p.000017: still be beneficial. See Case Study 4 for an illustration of this.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Case study 4 – Providing neutral expert advice on the course of action
p.000017:
p.000017:
p.000017: Baker GR, Norton PG, Flintoft V, et.al. The Canadian Adverse Events Study:
p.000017: the incidence of adverse events among hospital patients in Canada
p.000017: CMAJ 2004; 170 (11): 1678-1686
p.000017: This patient safety project involved the analysis for adverse events in a sample of 20 hospitals spread across five
p.000017: provinces in Canada. In this large and complex study, which involved the review of more
p.000017: 20 than 3 700 medical charts, and where it would be
p.000017: possible to uncover some possible evidence of intentional harm or incompetence, the researchers set up a “safety
p.000017: committee” of recognized experts who agreed to provide back-up to the researchers and review data and make a decision
p.000017: about possibly informing the hospital or other relevant personnel about potential risks or unsafe providers. The
...
p.000021: or interaction, as part of a larger effort to study how care works at that facility and to ensure that care is provided
p.000021: in the best possible way. Although patients need not be asked to provide prior informed consent to participate in these
p.000021: situations, they should be informed clearly that they have the right to opt out of the observation and any patient who
p.000021: expresses concerns should be helped to exercise this right. This right is not based on the principle of informed
p.000021: consent, but rather on the basic ethical importance of treating people with respect.
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021:
p.000021: Group disclosure for patients
p.000021: Even in circumstances where formal consent procedures have been waived, it is best practice to disclose to patients
p.000021: that patient safety research may be ongoing in the clinical setting, and to explain the implications of such activities
p.000021: on them. For example, a general disclosure may be provided by a poster or as leaflets either in waiting rooms or as
p.000021: part of patient information material during
p.000021: a medical consultation that states “As part of
p.000021: the quality improvement activities of our hospital, we periodically review patient charts, or observe doctors and
p.000021: nurses providing care to patients,
p.000021: to make sure that quality care is provided to patients and to examine which practices lead to optimal outcomes. Please
p.000021: let us know if you are uncomfortable with or unwilling to be part of any direct observational activities.”
p.000021: Waivers of informed consent for providers
p.000021: Guidance point 7
p.000021: Individual informed consent from providers participating in a research study must generally be obtained. However, the
p.000021: requirement of obtaining individual informed consent from patients can be waived by an REC if
p.000021: ñ The research does not directly inform or alter individual patients’ therapeutic or medical
p.000021: treatment plans; and 23
p.000021: ñ Risks to the provider are minimal (see Guidance Point 3); and
p.000021: ñ The research could not practicably be carried out with the consent of providers.
p.000021: In cases where individual informed consent from providers will not be sought, general disclosure to providers about
p.000021: patient safety activities is highly recommended.
p.000021:
p.000021:
p.000021:
p.000021: Even where studies pose minimal risks, it is a matter of basic respect to provide general disclosure to providers about
p.000021: patient safety research occurring
p.000021: in their clinical unit or setting, particularly when information from medical records identifies
p.000021: the providers, when team behaviour is observed, or when team results are recorded. Discussions with clinical staff
p.000021: about patient safety research can
p.000021: serve as an opportunity to raise the topic of patient safety more broadly, as well as to discuss strategies to improve
p.000021: patient safety and quality of care within the institution. Such discussions should include
p.000021: a focus on the fact that monitoring quality and evaluating new strategies to reduce incidents can help providers and
p.000021: institutions learn, through
p.000021: evidence, what is working and where improvements are needed. It must be stressed that the goal
p.000021: of such monitoring and evaluation is to improve the overall system and is not to implicate individual providers.
p.000021: Protections to ensure this (i.e. firewalls between individual data and authorities) should be communicated to
p.000021: providers. In addition, hospital, clinic, or facility staff should be informed about how results from patient safety
p.000021: activities will be reported to the hospital, clinic or facility leadership.
p.000021: Group disclosure and discussion can take place at staff meetings or through letters or emails. See Case Study 5 for an
p.000021: illustration.
p.000021:
p.000021: Institutions participating in patient safety research activities for which individual consent of providers is not
...
p.000030: requirements that other designs not involving withholding information be used wherever possible to address the research
p.000030: question, that only minimal risk studies may withhold information,
p.000030: and that as much information about the study be provided as possible, even if one key element is not disclosed. The
p.000030: researcher should also consider whether disclosing information in a more general way (for example, “There will be some
p.000030: clients coming to your shop in the next six months, who may not be the ‘real clients’”) is possible, as a way
p.000030: 32 of honouring commitments to truth telling while also trying to achieve important scientific ends. Another
p.000030: option is to ask participants to consent to research without knowing the full aspects of the study, with the assurance
p.000030: that the research intervention will not harm them and that a full disclosure will be made in a debriefing session.
p.000030:
p.000030: Information should not be withheld solely because providing it might cause some individuals to refuse to participate.
p.000030: Withholding information is only appropriate if doing so is the sole way of addressing a socially important research
p.000030: question, and researchers and REC members should carefully consider the necessity of withholding or misleading
p.000030: participants about each aspect of the study. If some information could be provided without jeopardizing the study, that
p.000030: information should be provided.
p.000030:
p.000030: Debriefing is a method of minimizing the infringement of subjects’ right against experimentation without consent. In
p.000030: studies in which information is withheld, the REC should determine whether debriefing of participants should be
p.000030: required following data collection, taking into consideration factors such as the existence of
p.000030: an ongoing relationship between participants and researchers (which would favor debriefing)
p.000030: and whether debriefing would increase or decrease the likelihood that participants could experience psychological harm.
p.000030: The objective of debriefing participants involved in such research is to provide them with more complete information
p.000030: about the study and about why information was not provided to them upfront.21 In general, debriefing involves
p.000030: explaining the purpose of the study, the social significance of the study, and why the particular study design was
p.000030: necessary. It also requires that
p.000030: the researchers identify and manage any harm
p.000030: that participants might have experienced as a result of having been involved in the study, and that researchers give
p.000030: participants the opportunity to withdraw their data from inclusion in the study.
p.000030: Although the right to withdraw data does not constitute informed consent, it allows participants
p.000030: to regain some control over how their private information is used. The risk of selection bias or having an underpowered
p.000030: study are not adequate reasons for choosing not to debrief study participants. If debriefing is to be performed,
p.000030: it should ideally occur immediately after data are collected.
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: 8. Conclusions and way forward
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: The protection of research participants from harm caused by the conduct of research studies has become a central area
p.000030: of attention by researchers and ethicists worldwide. A vast corpus of scholarly debate has ensued thereafter, leading
p.000030: to widely accepted recommendations in general and as applied to various research disciplines. The general uptake and
p.000030: extension of research ethics committee reviews and of good practices by researcher bodies and scientific journals
p.000030: worldwide, promoting compliance with good ethical conduct in research, is proof of the commitment to and respect of
p.000030: these principles by professionals and institutions.
p.000030:
p.000030: Nevertheless, new fields of research may challenge the application of existing ethical principles, if research
p.000030: questions or some specific circumstances of the conduct of particular studies lead to new situations for which there is
p.000030: no prior experience
p.000030: of ethical debate. This may be the case for patient safety research, quality improvement and in patient safety
p.000030: activities in general. These are still relatively new fields of enquiry, where some circumstances may seem to present
p.000030: new ethical questions and challenges. This is what led to the production of the guidance included in this report, in
p.000030: the expectation that some advice about the application of the existing ethical guidance to the field of patient safety
p.000030: research might help researchers and ethical review committee members in their ethical assessment and design of the
p.000030: studies.
p.000030:
p.000030: As described in this report, there are a number
p.000030: of instances where researchers may be confronted with new situations and possibly with ethical controversies. The
p.000030: guidance provided in this report offers an initial response to many of the challenges faced by patient safety
p.000030: researchers and quality improvement professionals building from the existing corpus of ethical standards. Furthermore,
p.000030: this guidance also calls attention to the potential ethical risks that may be brought up by activities and programmes
p.000030: of patient safety or quality improvement, though usually not considered part
p.000033: 33
p.000033: of research and therefore not usually under the oversight of ethics review committees.
p.000033: This guidance raises the importance of considering potential risks inherent in such activities and suggests to
p.000033: institutions involved in such important activities to facilitate some level of ethical advice or oversight as feasible.
p.000033: The formation of a functional reference group, or patient safety committee, whether stable or ad-hoc, may represent a
p.000033: possible solution in these circumstances. Such a group
p.000033: or committee should be composed of respected professionals, able to provide their honest judgment to assist researchers
p.000033: and patient safety improvement bodies in solving issues of an ethical nature arising during the design or conduct of a
p.000033: given study.
p.000033:
p.000033: This report could not possibly cover all ethical issues that could arise during the design and conduct of patient
p.000033: safety research and other related activities. Furthermore, the guidance provided here for the issues under
p.000033: consideration cannot be exhaustive.
p.000033: Instead it is a modest reflection of the discussions and debate held by its contributors. For this reason, this report
p.000033: aspires to be the first edition of a series, soon to be updated with new evidence and more elaborated debate. WHO
p.000033: encourages evaluation and feedback from the guidance described here, as well as increased and new discussion in this
p.000033: important field of ethics as applied to patient safety research.
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033: 9. References
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034: 1 The Research Priority Setting Working Group of WHO Patient Safety: Summary of the evidence on patient safety:
p.000034: Implications for research. WHO, Geneva. 2008.
...
p.000035: 29: 4-9.
p.000035: 17. Casarett D, Karlawish JHT, Sugarman J. Determining when quality improvement initiatives should be considered
p.000035: research: Proposed criteria and potential implications. JAMA. 2000; 283: 2275-2280.
p.000035: 18. Lynn J. When does quality improvement count as research? Human subject protection and theories
p.000035: of knowledge. Quality and Safety in Health Care. 2004; 13: 67-70.
p.000035: 19. Newhouse RP, Poe S, Pettit JC, Rocco L.
p.000035: The slippery slope: Differentiating between quality improvement and research. Journal of Nursing Administration. 2006;
p.000035: 36: 211-219.
p.000035: 20. Lemaire F. Informed consent and studies
p.000035: of a quality improvement program. JAMA. 2008; 300: 1762.
p.000035: 21. Cacchione PZ. When is institutional review board approval necessary for quality improvement projects? Clinical
p.000035: Nursing Research. 2011; 20:3-6.
p.000035: 22. O’Kane M. Do patients need to be protected from quality improvement? In: Jennings B, Maily MA, Bottrell M, Lynn J,
p.000035: eds. Health Care Quality Improvement: Ethical and Regulatory Issues. Garrison, NY: The Hastings Center, 2007. Available
p.000035: at www.thehastingscenter.org
p.000035: 23. James BC. Quality-improvement policy at Intermountain Healthcare. In: Jennings B, Maily MA,
p.000035: Bottrell M, Lynn J, eds. Health Care Quality Improvement: Ethical and Regulatory Issues. Garrison, NY: The Hastings
p.000035: Center, 2007. Available at www.thehastingscenter.org
p.000035: 24. Office for Human Research Protections (OHRP). Quality improvement activities frequently asked questions. U.S.
p.000035: Department of Health & Human Services. Available at http://answers.hhs.gov/ohrp/categories/1569
p.000035: 25. Baily MA, Bottrell M, Lynn J, Jennings B. Ethics of using QI methods to Improve health care quality and safety.
p.000035: Hastings Center Special Report. 2006. Available at: http://www.thehastingscenter.org/
p.000035: Publications/SpecialReports/Detail.aspx?id=1342
p.000035: 26. Lynn J, Baily MA, Bottrell M, Jennings B, Levine RJ, Davidoff F, Casarett D, Corrigan J, Fox E, Wynia MK, Agich GJ,
p.000035: O’Kane M, Speroff T, Schyve P, Batalden P, Tunis S, Berlinger N, Cronenwett L, Fitzmaurice JM, Dubler NN, James B. The
p.000035: Ethics of using quality improvement methods in health care. Annals of Internal Medicine. 2007; 146:666-673.
p.000035: 27. Siegel MD, Alfano SL. Ethics of quality improvement research. Critical Care Medicine. 2009; 37: 791-792.
p.000035: 28. Baily MA. Harming through protection?. New England Journal of Medicine. 2008; 358: 768-769.
p.000035: 29. McNett M, Lawry K. Research and quality improvement activities: When is Institutional Review Board review needed?
p.000035: Journal of Neuroscience Nursing. 2009; 41:344-347.
p.000035: 30. Redman RW. Knowledge development, quality improvement, and research ethics. Research and theory for Nursing
p.000035: Practice. 2007; 21:217-219.
p.000035: 31. Dubler NN, Blustein J, Bhalla R, Bernard D. Informed participation: an alternative ethical process for including
p.000035: patients in quality improvement projects. In: Jennings B, Baily MA, Bottrell M, Lynn J, eds. Health Care Quality
p.000035: Improvement: Ethical and Regulatory Issues. Garrison, NY: The Hastings Center. 2007 Available at
p.000035: www.thehastingscenter.org.
p.000035: 32. Lindenauer PK, Benjamin EM, Naglieri-Prescod D, Fitzgerald J, Pekow P. The role of the Institutional Review Board
p.000035: in quality improvement: a survey of quality officers, institutional review board chairs, and journal editors. American
p.000035: Journal of Medicine. 2002; 113: 575-579.
p.000035: 33. Bottrell M. The ethics of quality improvement: Practitioners’ perspectives. A paper commissioned by the RAND Center
p.000035: to Improve Care of the Dying. 2003. Available at: http://www.innovation.cc/
p.000035: peer-reviewed/bottrell-ethics.pdf.
p.000035: 34. Bellin E, Dubler NN. The quality improvement- research divide and the need for external oversight. American Journal
p.000035: of Public Health. 2001; 91:
p.000035: 1512-1517.
p.000035: 35. Kass N, Pronovost PJ, Sugarman J, Goeschel CA, Lubomski LH, Faden R. Controversy and quality improvement: Lingering
p.000035: questions about ethics, oversight, and patient safety research. Joint
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: Commission Journal on Quality and Patient Safety. 2008; 36: 349-353.
p.000035: 36. Platteborze LS, Young-McCaughan S,
p.000035: King-Letzkus I, McClinton A, Halliday A, Jefferson TC. Performance Improvement/Research Advisory Panel:
...
p.000035: 2003; 12:159-170.
p.000035: 41. Koschnitzke L, McCracken SC, Pranulis M. Ethical Considerations for Quality Assurance Versus Scientific Research.
p.000035: Western Journal of Nursing Research. 1992; 14:392-96.
p.000035: 42. Hagen B, O’Beirne M, Desai S, Stingl M, Pachnowski C, Hayward S. Innovations in the ethical review of
p.000035: health-related quality improvement and research: the Alberta Research Ethics Community Consensus Initiative (ARECCI).
p.000035: Health Policy. 2007; 2:1-14.
p.000035: 43. Davidoff F. Publication and the Ethics of Quality Improvement. In: Jennings B, Maily MA, Bottrell M, Lynn J, eds.
p.000035: Health Care Quality Improvement: Ethical and Regulatory Issues. Garrison, NY: The Hastings Center. 2007. Available at
p.000035: www.thehastingscenter.org
p.000035: 44. Davidoff F, Batalden P. Toward stronger evidence on quality improvement. Draft publication guidelines: the
p.000035: beginning of a consensus project. Quality & Safety in Health Care. 2005; 14: 319-325.
p.000035: 45. Dovey S, Hall K, Rosser W, Makeham M, Kuzel A, van Weel C, Esmail A, Phillips R. Seeking ethical approval for an
p.000035: international study in primary care patient safety. British Journal General Practice. 2011; 61:197-204.
p.000035: 46. Ezzat H, Ross S, Dadelszen P, et al Ezzat H, Ross S, von Dadelszen P, Morris T, Liston R, Magee LA; CPN
p.000035: Collaborative Group. Ethical review as a component of institutional approval for a multicenter continuous quality
p.000035: improvement project: the investigator’s perspective. BMC Health Services Research. 2010; 10:223-229.
p.000035: 47. Kass NE, Pronovost PJ. Quality, Safety, and Institutional review Boards: Navigating ethics and oversight in applied
p.000035: health systems research. American Journal of Medical Quality. 2011; 26: 157-159.
p.000035: 48. Lo B, Groman M. Oversight of Quality Improvement: Focusing on Benefits and Risks. Archives of Internal Medicine.
p.000035: 2003; 163:1481-1486.
p.000035: 49. Perneger TV. Why we need ethical oversight
p.000035: of quality improvement projects. International Journal for Quality in Health Care. 2004; 16:343-344.
p.000035: 50. Wells RJ. Overseeing Quality Improvement. Hastings Center Report. 2007; 37:6-7.
p.000035: 51. Horsfall I, Cleary M. Mental health quality improvement: What about ethics? International Journal of Mental Health
p.000035: Nursing. 2002; 11:40-46.
p.000035: 52. Morris PE, Dracup K. Quality Improvement
p.000035: or Research: the Ethics of Hospital Project Oversight. American Journal of Critical Care. 2007; 16: 424-426.
p.000035: 53. Doyal L. Preserving moral quality in research, audit,
p.000035: and quality improvement. Quality and Safety in Health 37
p.000035: Care. 2004; 13:11-12.
p.000035: 54. Weiserbs KF, Lyutic L, Weinberg J. Should Quality Improvement Projects require IRB Approval? Academic Medicine.
p.000035: 2009; 84:153.
p.000035: 55. Taylor HA, Pronovost PJ, Faden RR; Kass NE, Sugarman J. The Ethical Review of Health Care Quality Improvement
p.000035: Initiatives: Findings from
p.000035: the Field. Issue Brief (The Commonwealth Fund). 2010; 95:1-12.
p.000035: 56. Taylor HA, Pronovost PJ, Sugarman J. Ethics, Oversight and Quality Improvement Initiatives. Quality and Safety in
p.000035: Health Care. 2010;19:271-74.
p.000035: 57. Wise L. Quality Improvement or Research? A Report from the Trenches. American Journal of Critical Care. 2008; 17:
p.000035: 98-99.
p.000035: 58. Miller FG, Emanuel EJ. Quality-Improvement Research and Informed Consent. New England Journal of Medicine. 2008;
p.000035: 353:765-767.
p.000035: 59. Hauswald M. Overseeing Quality Improvement. Hastings Center Report. 2007; 37:6.
p.000035: 60. Cretin S, Lynn J, Batalden PB, Keeler E, Berwick D. Should patients in quality-improvement activities have the same
p.000035: protections as participants in research studies? JAMA. 2000; 284:1786-1788.
p.000035: 61. Tapp L, Edwards A, Elwyn G, Holm S, Eriksson T. Quality improvement in general practice: enabling general
p.000035: practitioners to judge ethical dilemmas. Journal of Medical Ethics. 2010; 36:184-188.
p.000035: 62. Wynia MK, Kurlander JE, Morse R. Physician ethics and participation in quality improvement: renewing
p.000035: a professional obligation. In: Jennings B, Maily MA, Bottrell M, Lynn J, eds. Health Care Quality Improvement: Ethical
p.000035: and Regulatory Issues. Garrison, NY: The Hastings Center. 2007. Available at www.thehastingscenter.org
p.000035: 63. Office for Human Research Protections, Institutional Review Board Guidebook. Electronic publication available at :
p.000035: http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm
p.000035: 64. Miller FG, Mello MM, Joffe S. Incidental Findings in Human Subjects Research: What Do Investigators Owe Research
p.000035: Participants? Journal of Law, Medicine & Ethics., 2008; 36: 271-279.
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: 65. Wolf SM, Lawrenz FP, Nelson CA, Kahn JP, Cho MK, Clayton EW, Fletcher JG, Georgieff MK,
p.000035: Hammerschmidt D, Hudson K, Illes J, Kapur V, Keane MA, Koenig BA, Leroy BS, McFarland EG, Paradise J, Parker LS, Terry
p.000035: SF, Van Ness B, Wilfond BS. Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations.
...
p.000035: procedures within and outside of the operating room. Archives of Surgery. 2009; 144: 1028-1034.
p.000035: 69. Sax HC, Browne P, Mayewski RJ, Panzer RJ, Hittner KC, Burke RL, Coletta S. Can aviation-based team training elicit
p.000035: sustainable behavioral change? Archives of Surgery. 2009; 144: 1133-1137.
p.000035: 70. Meaney ME. Error reduction, patient safety
p.000035: and institutional ethical committees. Journal of Law, Medicine & Ethics. 2004; 32:358-364.
p.000035: 71. Miller FG, Gluck JP, Wendler D. Debriefing and accountability in deceptive research. Kennedy Institute of Ethics
p.000035: Journal. 2008; 18:235-251.
p.000035: 72. Herrera CD. Two arguments for ‘covert methods’ in social research. British Journal of Sociology. 1999; 50: 331-343.
p.000035: 73. Baraitser P, Pearce V, Walsh N, Cooper R, Brown KC, Holmes J, Smith L, Boynton P. Look who’s taking notes in your
p.000035: clinic: mystery shoppers as evaluators in sexual health services. Health Expectations. 2008; 11:54-62.
p.000035: 74. Benham B. Moral accountability and debriefing. Kennedy Institute of Ethics Journal. 2008; 18:253-273.
p.000035: 75. Baumrind D. Research using intentional deception: Ethical issues revisited. American Psychologist. 1985; 40:
p.000035: 165-174.
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035:
p.000035: Appendix 2:
p.000035: Summary of the ethical guidance related to patient safety research
p.000035:
p.000035:
p.000035: Guidance point 1
p.000035: Any patient safety activity that constitutes research, regardless of its methodology, should be submitted to a Research
p.000035: Ethics Committee (REC).
p.000035: For purposes of REC oversight, patient safety activities constitute research when:
p.000035: ñ they are aimed at addressing a specific question; and
p.000035: ñ they use a predefined approach or method for collecting data in response to the question they intend to address; and
p.000035: ñ their findings are intended to be applied to settings beyond those in which the activity or programme is implemented.
p.000035: Guidance point 2
p.000035: Patient safety activities, even when they do not meet the definition of research requiring ethical review, may involve
p.000035: more than minimal risk to patients and health-care providers in some situations. It is the responsibility of those
p.000035: working in patient safety activities to be aware of ethical issues and seek guidance as needed.
p.000035: Guidance point 3
p.000035: Patient safety research may be considered of minimal risk if all of the following factors are present:
p.000035: ñ The intervention does not modify clinical management or the treatment plan for the patient;
p.000035: ñ Data are not individually identifiable, or adequate protections against breaches of confidentiality
p.000035: of data are in place;
p.000035: ñ The intervention is unlikely to divert staff from existing responsibilities in ways that are likely to pose a risk to
p.000035: patient wellbeing and safety;
p.000035: ñ Nothing in applicable laws, or institutional rules, or the local cultural context suggests that conducting the study
p.000035: in the particular environment would pose higher risks to the patient;
...
p.000039: which the project will be implemented could alter the project’s risk profile.
p.000039:
p.000039: Guidance point 5
p.000039: Individuals involved in patient safety research who are interviewing or observing patients or providers should
p.000039: anticipate any distress participants may experience as a consequence of the conduct of the study and be prepared to
p.000039: offer solutions. Some options are:
p.000039: ñ Be trained to ask participants if they would like to skip questions or stop the interview if they become distressed;
p.000039: ñ Be equipped with referrals for supportive care or counselling in case participants become significantly distressed;
p.000039: ñ Be equipped with the names of hospital authorities to whom participants and families can be referred if they have
p.000039: questions; and
p.000039: ñ Ensure that all services and providers whose names will be given out as referrals have agreed to have their names
p.000039: provided to patients and families.
p.000039:
p.000039: Guidance point 6
p.000039: Researchers conducting patient safety research studies must generally seek individual informed consent from patients.
p.000039: However, the require- ment of obtaining individual informed consent from patients can be waived by an REC if
p.000039: ñ The research does not directly inform or alter the individual patients’ therapeutic or medical treatment plans; and
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: ñ Risks posed to patients by the research are minimal; and
p.000039: ñ The research could not practically be carried
p.000039: out if individual informed consent were required; and
p.000039: ñ The privacy and confidentiality or anonimity
p.000039: of individual patients are assured (see Guidance Point 8).
p.000039: In cases where individual informed consent from patients will not be sought, general disclosure
p.000039: to patients about patient safety research is highly recommended.
p.000039: 40 Guidance point 7
p.000039: Individual informed consent from providers participating in a research study must generally be obtained. However, the
p.000039: requirement of obtaining individual informed consent from patients can be waived by an REC if
p.000039: ñ The research does not directly inform or alter individual patients’ therapeutic or medical treatment plans; and
p.000039: ñ Risks to the provider are minimal (see Guidance Point 3); and
p.000039: ñ The research could not practicably be carried out with the consent of providers.
p.000039: In cases where individual informed consent from providers will not be sought, general disclosure to providers about
p.000039: patient safety activities is highly recommended.
p.000039: Guidance point 8
p.000039: Staff involved in the conduct of patient safety research and patient safety activities should be aware of the
p.000039: principles and methods related to preserving privacy
p.000039: and confidentiality.
p.000039:
p.000039: Guidance point 9
p.000039: Individuals involved in patient safety research may, occasionally, observe practices that may put patients at risk.
...
p.000039: following are present:
p.000039: ñ they are highly suspicious that an incident has occurred;
p.000039: ñ they are confident that intervening could reverse some of the negative medical effects of the incident;
p.000039: ñ there is no evidence to suspect that an intervention has already occurred in response to the (potential) incident;
p.000039: ñ the consequences of the incident are of direct severe or irreversible harm;
p.000039: Where sufficient expertise and experience to interpret the situation is not present, staff should seek advice from more
p.000039: experienced professionals.
p.000039:
p.000039: Guidance point 11
p.000039: Those involved in patient safety research have a duty to report the study results back to hospitals and units once the
p.000039: project is complete.
p.000039:
p.000039: Guidance point 12
p.000039: Patient safety researchers who propose to withhold information from potential research participants as part of their
p.000039: research must do all of the following:
p.000039: ñ Demonstrate to a research ethics committee that no other research method will suffice;
p.000039: ñ Persuasively argue that significant advances could result from the research either for the local setting or more
p.000039: broadly;
p.000039: ñ Consider whether asking participants to consent to participate, without disclosing the nature or precise timing of
p.000039: the intervention, is reasonable;
p.000039: ñ Ensure that withholding information itself will not cause a study to involve greater than minimal risk.
p.000039:
p.000039: Guidance point 13
p.000039: In those cases where a research ethics committee approves an activity where information has been withheld from
p.000039: the participants, the committee must also: ñ Ensure that nothing has been withheld that, if divulged, would cause a
p.000039: reasonable person
p.000039: to refuse to participate;
p.000039: ñ Determine if debriefing of those who participated is possible or appropriate;
p.000039: ñ Ensure that a general disclosure of the type of research that is proposed is in place, if possible.
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039:
p.000039: World Health Organization
p.000039: 20 Avenue Appia
p.000039: CH-1211 Geneva 27 Switzerland
p.000039: Tel.: +41 22 791 5060
p.000039:
p.000039: Email: psresearch@who.int Please visit us at:
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| child | Child |
| children | Child |
| cioms | cioms guidelines |
| commonXrule | common rule |
| control group | participants in a control group |
| drug | Drug Usage |
| emergency | Public Emergency |
| employees | employees |
| family | Motherhood/Family |
| helsinki | declaration of helsinki |
| home | Property Ownership |
| hospitalized patients | hospitalized patients |
| injured | injured |
| job | Occupation |
| military | Soldier |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| physically | Physically Disabled |
| political | political affiliation |
| poor | Economic/Poverty |
| research staff | Laboratory Staff |
| sick | Physically Ill |
| single | Marital Status |
| stigma | Threat of Stigma |
| threat | Threat of Stigma |
| undue influence | Undue Influence |
| volunteers | Healthy People |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| party | ['political'] |
| political | ['party'] |
| stigma | ['threat'] |
| threat | ['stigma'] |
Trigger Words
capacity
consent
cultural
developing
ethics
harm
protect
protection
risk
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input