Public and patient perspectives on the use of clinical and administrative health data to identify and contact people at risk of future illness-The case of chronic kidney disease.

For decades, researchers have used linkable administrative health data for evaluating the health care system, subject to local privacy legislation. In Ontario, Canada, the relevant privacy legislation permits some organizations (prescribed entities) to conduct this kind of research but is silent on their ability to identify and contact individuals in those datasets. Following consultation with the Office of the Information and Privacy Commissioner of Ontario, we developed a pilot study to identify and contact by mail a sample of people at high risk for kidney failure within the next 2 years, based on laboratory and administrative data from provincial datasets held by ICES, to ensure they receive needed kidney care. Before proceeding, we conducted six focus groups to understand the acceptability to the public and people living with chronic kidney disease of direct mail outreach to people at high risk of developing kidney failure. While virtually all participants indicated they would likely participate in the study, most felt strongly that the message should come directly from their primary care provider or whoever ordered the laboratory tests, rather than from an unknown organization. If this is not possible, they felt the health care provider should be made aware of the concern related to their kidney health. Most agreed that, if health authorities could identify people at high risk of a treatable life-threatening illness if caught early enough, there is a social responsibility to notify people. While privacy laws allow for free flow of health information among health care providers who provide direct clinical care, the proposed case-finding and outreach falls outside that model. Enabling this kind of information flow will require greater clarity in existing laws or revisions to these laws. This also requires adequate notification and culture change for health care providers and the public around information uses and flows.

The Influence of Age, Sex, and Socioeconomic Status on Glycemic Control Among People With Type 1 and Type 2 Diabetes in Canada: Patient-Led Longitudinal Retrospective Cross-sectional Study With Multiple Time Points of Measurement.

BACKGROUND: Clinical guidelines for most adults with diabetes recommend maintaining hemoglobin A1c (HbA1c) levels ≤7% (≤53 mmol/mol) to avoid microvascular and macrovascular complications. People with diabetes of different ages, sexes, and socioeconomic statuses may differ in their ease of attaining this goal. OBJECTIVE: As a team of people with diabetes, researchers, and health professionals, we aimed to explore patterns in HbA1c results among people with type 1 or type 2 diabetes in Canada. Our research question was identified by people living with diabetes. METHODS: In this patient-led retrospective cross-sectional study with multiple time points of measurement, we used generalized estimating equations to analyze the associations of age, sex, and socioeconomic status with 947,543 HbA1c results collected from 2010 to 2019 among 90,770 people living with type 1 or type 2 diabetes in Canada and housed in the Canadian National Diabetes Repository. People living with diabetes reviewed and interpreted the results. RESULTS: HbA1c results ≤7.0% represented 30.5% (male people living with type 1 diabetes), 21% (female people living with type 1 diabetes), 55% (male people living with type 2 diabetes) and 59% (female people living with type 2 diabetes) of results in each subcategory. We observed higher HbA1c values during adolescence, and for people living with type 2 diabetes, among people living in lower income areas. Among those with type 1 diabetes, female people tended to have lower HbA1c levels than male people during childbearing years but higher HbA1c levels than male people during menopausal years. Team members living with diabetes confirmed that the patterns we observed reflected their own life courses and suggested that these results be communicated to health professionals and other stakeholders to improve the treatment for people living with diabetes. CONCLUSIONS: A substantial proportion of people with diabetes in Canada may need additional support to reach or maintain the guideline-recommended glycemic control goals. Blood sugar management goals may be particularly challenging for people going through adolescence or menopause or those living with fewer financial resources. Health professionals should be aware of the challenging nature of glycemic management, and policy makers in Canada should provide more support for people with diabetes to live healthy lives.

Deliberation on Childhood Vaccination in Canada: Public Input on Ethical Trade-Offs in Vaccination Policy.

BACKGROUND: Policy decisions about childhood vaccination require consideration of multiple, sometimes conflicting, public health and ethical imperatives. Examples of these decisions are whether vaccination should be mandatory and, if so, whether to allow for non-medical exemptions. In this article we argue that these policy decisions go beyond typical public health mandates and therefore require democratic input. METHODS: We report on the design, implementation, and results of a deliberative public forum convened over four days in Ontario, Canada, on the topic of childhood vaccination. RESULTS: 25 participants completed all four days of deliberation and collectively developed 20 policy recommendations on issues relating to mandatory vaccinations and exemptions, communication about vaccines and vaccination, and AEFI (adverse events following immunization) compensation and reporting. Notable recommendations include unanimous support for mandatory childhood vaccination in Ontario, the need for broad educational communication about vaccination, and the development of a no-fault compensation scheme for AEFIs. There was persistent disagreement among deliberants about the form of exemptions from vaccination (conscience, religious beliefs) that should be permissible, as well as appropriate consequences if parents do not vaccinate their children. CONCLUSIONS: We conclude that conducting deliberative democratic processes on topics that are polarizing and controversial is viable and should be further developed and implemented to support democratically legitimate and trustworthy policy about childhood vaccination.

Artificial intelligence for good health: a scoping review of the ethics literature.

BACKGROUND: Artificial intelligence (AI) has been described as the "fourth industrial revolution" with transformative and global implications, including in healthcare, public health, and global health. AI approaches hold promise for improving health systems worldwide, as well as individual and population health outcomes. While AI may have potential for advancing health equity within and between countries, we must consider the ethical implications of its deployment in order to mitigate its potential harms, particularly for the most vulnerable. This scoping review addresses the following question: What ethical issues have been identified in relation to AI in the field of health, including from a global health perspective? METHODS: Eight electronic databases were searched for peer reviewed and grey literature published before April 2018 using the concepts of health, ethics, and AI, and their related terms. Records were independently screened by two reviewers and were included if they reported on AI in relation to health and ethics and were written in the English language. Data was charted on a piloted data charting form, and a descriptive and thematic analysis was performed. RESULTS: Upon reviewing 12,722 articles, 103 met the predetermined inclusion criteria. The literature was primarily focused on the ethics of AI in health care, particularly on carer robots, diagnostics, and precision medicine, but was largely silent on ethics of AI in public and population health. The literature highlighted a number of common ethical concerns related to privacy, trust, accountability and responsibility, and bias. Largely missing from the literature was the ethics of AI in global health, particularly in the context of low- and middle-income countries (LMICs). CONCLUSIONS: The ethical issues surrounding AI in the field of health are both vast and complex. While AI holds the potential to improve health and health systems, our analysis suggests that its introduction should be approached with cautious optimism. The dearth of literature on the ethics of AI within LMICs, as well as in public health, also points to a critical need for further research into the ethical implications of AI within both global and public health, to ensure that its development and implementation is ethical for everyone, everywhere.

An alternate level of care plan: Co-designing components of an intervention with patients, caregivers and providers to address delayed hospital discharge challenges.

OBJECTIVE: To engage with patients, caregivers and care providers to co-design components of an intervention that aims to improve delayed hospital discharge experiences. DESIGN: This is a qualitative study, which entailed working groups and co-design sessions utilizing World Café and deliberative dialogue techniques to continually refine the intervention. SETTING AND PARTICIPANTS: Our team engaged with 61 participants (patients, caregivers and care providers) in urban and rural communities across Ontario, Canada. A 7-member Patient and Caregiver Advisory Council participated in all stages of the research. RESULTS: Key challenges experienced during a delayed discharge by patients, caregivers and care providers were poor communication and a lack of care services. Participants recommended a communication guide to support on-going conversation between care providers, patients and caregivers. The guide included key topics to cover and questions to ask during initial and on-going conversations to manage expectations and better understand the priorities and goals of patients and caregivers. Service recommendations included getting out of bed and dressed each day, addressing the psycho-social needs of patients through tailored activities and having a storyboard at the bedside to facilitate on-going engagement. DISCUSSION AND CONCLUSIONS: Our findings outline ways to meaningfully engage patients and caregivers during a delayed hospital discharge. Combining this with a minimal basket of services can potentially facilitate a better care experience and outcomes for patients, their care providers and families.

Participatory governance over research in an academic research network: the case of Diabetes Action Canada.

Digital data generated in the course of clinical care are increasingly being leveraged for a wide range of secondary purposes. Researchers need to develop governance policies that can assure the public that their information is being used responsibly. Our aim was to develop a generalisable model for governance of research emanating from health data repositories that will invoke the trust of the patients and the healthcare professionals whose data are being accessed for health research. We developed our governance principles and processes through literature review and iterative consultation with key actors in the research network including: a data governance working group, the lead investigators and patient advisors. We then recruited persons to participate in the governing and advisory bodies. Our governance process is informed by eight principles: (1) transparency; (2) accountability; (3) follow rule of law; (4) integrity; (5) participation and inclusiveness; (6) impartiality and independence; (7) effectiveness, efficiency and responsiveness and (8) reflexivity and continuous quality improvement. We describe the rationale for these principles, as well as their connections to the subsequent policies and procedures we developed. We then describe the function of the Research Governing Committee, the majority of whom are either persons living with diabetes or physicians whose data are being used, and the patient and data provider advisory groups with whom they consult and communicate. In conclusion, we have developed a values-based information governance framework and process for Diabetes Action Canada that adds value over-and-above existing scientific and ethics review processes by adding a strong patient perspective and contextual integrity. This model is adaptable to other secure data repositories.

Survey of Awareness and Perceptions of Canadians on the Benefits and Risks of Clinical Trials.

BACKGROUND: Little is known about the Canadian public's perspective regarding clinical trials. METHODS: We surveyed 1602 Ontario and British Columbia residents to ascertain their understanding of and willingness to participate in clinical trials. RESULTS: Clinical trials are regarded positively with overall perceptions that they provide societal and personal benefits. Most respondents were somewhat (49%) or very willing (19%) to participate in a clinical trial. This increased with age and level of education. It was also greater among those with poor or very poor health, those with multiple chronic conditions, and those who had previously been invited into a clinical trial, all of which were correlated with age. Still, there was room for improvement in awareness and understanding of clinical trials. Forty-three percent of those surveyed felt not very informed or not at all informed and 37% had no opinion regarding clinical trials. Respondents would most often turn to their treating physician if considering participating in a clinical trial and least often to social media. CONCLUSION: While Canadians' views about clinical trials are generally positive, they are somewhat muted and a significant minority feels poorly or not at all informed. They are less willing to participate in clinical research than Americans and are roughly equivalent to Europeans. While clinicians are the top choice for learning about clinical trials, they have little or no training and little time for this role. As we move toward integrating clinical trials into the practice setting, these issues of time, training, and resources must be addressed.

If you build it, they will come: unintended future uses of organised health data collections.

BACKGROUND: Health research increasingly relies on organized collections of health data and biological samples. There are many types of sample and data collections that are used for health research, though these are collected for many purposes, not all of which are health-related. These collections exist under different jurisdictional and regulatory arrangements and include: 1) Population biobanks, cohort studies, and genome databases 2) Clinical and public health data 3) Direct-to-consumer genetic testing 4) Social media 5) Fitness trackers, health apps, and biometric data sensors Ethical, legal, and social challenges of such collections are well recognized, but there has been limited attention to the broader societal implications of the existence of these collections. DISCUSSION: Although health research conducted using these collections is broadly recognized as beneficent, secondary uses of these data and samples may be controversial. We examine both documented and hypothetical scenarios of secondary uses of health data and samples. In particular, we focus on the use of health data for purposes of: Forensic investigations Civil lawsuits Identification of victims of mass casualty events Denial of entry for border security and immigration Making health resource rationing decisions Facilitating human rights abuses in autocratic regimes CONCLUSIONS: Current safeguards relating to the use of health data and samples include research ethics oversight and privacy laws. These safeguards have a strong focus on informed consent and anonymization, which are aimed at the protection of the individual research subject. They are not intended to address broader societal implications of health data and sample collections. As such, existing arrangements are insufficient to protect against subversion of health databases for non-sanctioned secondary uses, or to provide guidance for reasonable but controversial secondary uses. We are concerned that existing debate in the scholarly literature and beyond has not sufficiently recognized the secondary data uses we outline in this paper. Our main purpose, therefore, is to raise awareness of the potential for unforeseen and unintended consequences, in particular negative consequences, of the increased availability and development of health data collections for research, by providing a comprehensive review of documented and hypothetical non-health research uses of such data.

A risk screening tool for ethical appraisal of evidence-generating initiatives.

BACKGROUND: The boundaries between health-related research and practice have become blurred as initiatives traditionally considered to be practice (e.g., quality improvement, program evaluation) increasingly use the same methodology as research. Further, the application of different ethical requirements based on this distinction raises concerns because many initiatives commonly labelled as "non-research" are associated with risks to patients, participants, and other stakeholders, yet may not be subject to any ethical oversight. Accordingly, we sought to develop a tool to facilitate the systematic identification of risks to human participants and determination of risk level across a broad range of projects (e.g., clinical research, laboratory-based projects, population-based surveillance, and program evaluation) and health-related contexts. This paper describes the development of the Public Health Ontario (PHO) Risk Screening Tool. METHOD: Development of the PHO Risk Screening Tool included: (1) preparation of a draft risk tool (n = 47 items); (2) expert appraisal; (3) internal stakeholder validation; (4) external validation; (5) pilot testing and evalution of the draft tool; and (6) revision after 1 year of testing. RESULTS: A risk screening tool was generated consisting of 20 items organized into five risk domains: Sensitivity; Participant Selection, Recruitment and Consent; Data/Sample Collection; Identifiability and Privacy Risk; and Commercial Interests. The PHO Risk Screening Tool is an electronic tool, designed to identify potential project-associated risks to participants and communities and to determine what level of ethics review is required, if any. The tool features an easy to use checklist format that generates a risk score (0-3) associated with a suggested level of ethics review once all items have been completed. The final score is based on a threshold approach to ensure that the final score represents the highest level of risk identified in any of the domains of the tool. CONCLUSIONS: The PHO Risk Screening Tool offers a practical solution to the problem of how to maintain accountability and appropriate risk oversight that transcends the boundaries of research and practice. We hope that the PHO Risk Screening Tool will prove useful in minimizing the problems of over and under protection across a wide range of disciplines and jurisdictions.

What makes public health studies ethical? Dissolving the boundary between research and practice.

BACKGROUND: The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling outside the purview of the research ethics board. However, the boundaries between research and these other evaluative activities are not distinct. Efforts to delineate a boundary - whether on grounds of primary purpose, temporality, underlying legal authority, departure from usual practice, or direct benefits to participants - have been unsatisfactory.Public Health Ontario has eschewed this distinction between research and other evaluative activities, choosing to adopt a common framework and process to guide ethical reflection on all public health evaluative projects throughout their lifecycle - from initial planning through to knowledge exchange. DISCUSSION: The Public Health Ontario framework was developed by a working group of public health and ethics professionals and scholars, in consultation with individuals representing a wide range of public health roles. The first part of the framework interprets the existing Canadian research ethics policy statement (commonly known as the TCPS 2) through a public health lens. The second part consists of ten questions that guide the investigator in the application of the core ethical principles to public health initiatives.The framework is intended for use by those designing and executing public health evaluations, as well as those charged with ethics review of projects. The goal is to move toward a culture of ethical integrity among investigators, reviewers and decision-makers, rather than mere compliance with rules. The framework is consonant with the perspective of the learning organization and is generalizable to other public health organizations, to health services organizations, and beyond. SUMMARY: Public Health Ontario has developed an ethics framework that is applicable to any evidence-generating activity, regardless of whether it is labelled research. While developed in a public health context, it is readily adaptable to other health services organizations and beyond.

Influenza serological studies to inform public health action: best practices to optimise timing, quality and reporting.

BACKGROUND: Serological studies can detect infection with a novel influenza virus in the absence of symptoms or positive virology, providing useful information on infection that goes beyond the estimates from epidemiological, clinical and virological data. During the 2009 A(H1N1) pandemic, an impressive number of detailed serological studies were performed, yet the majority of serological data were available only after the first wave of infection. This limited the ability to estimate the transmissibility and severity of this novel infection, and the variability in methodology and reporting limited the ability to compare and combine the serological data. OBJECTIVES: To identify best practices for conduct and standardisation of serological studies on outbreak and pandemic influenza to inform public policy. METHODS/SETTING: An international meeting was held in February 2011 in Ottawa, Canada, to foster the consensus for greater standardisation of influenza serological studies. RESULTS: Best practices for serological investigations of influenza epidemiology include the following: classification of studies as pre-pandemic, outbreak, pandemic or inter-pandemic with a clearly identified objective; use of international serum standards for laboratory assays; cohort and cross-sectional study designs with common standards for data collection; use of serum banks to improve sampling capacity; and potential for linkage of serological, clinical and epidemiological data. Advance planning for outbreak studies would enable a rapid and coordinated response; inclusion of serological studies in pandemic plans should be considered. CONCLUSIONS: Optimising the quality, comparability and combinability of influenza serological studies will provide important data upon emergence of a novel or variant influenza virus to inform public health action.

Views on health information sharing and privacy from primary care practices using electronic medical records.

OBJECTIVE: To determine how patients and physicians balance the perceived benefits and harms of sharing electronic health data for patient care and for secondary purposes. DESIGN: Before-after survey of patients and providers in practices using electronic medical records (EMRs) enrolled in a clinical trial in Ontario, Canada. MEASUREMENTS: Outcomes were measured using the Health Information Privacy Questionnaire (HIPQ) at baseline and end of study. Thirteen questions in 4 general domains investigated attitudes towards the privacy of EMRs, outsider's use of patient's health information, the sharing of patient's information within the health care system, and the overall perception of benefits versus harms of computerization in health care. RESULTS: 511 patients (mean age 60.3 years, 49.6% female) and 46 physicians (mean age 47.2 years, 37.0% female) participated. Most (>90%) supported the computerized sharing of the patient's health records among their health care professionals and to provide clinical advice. Fewer agreed that the patient's de-identified information should be shared outside of the health care circle (<70%). Only a minority of either group supported the notion that computerized records can be keep more private than paper records (38-50%). Overall, a majority (58% patients, 70% physicians) believed that the benefits of computerization were greater than the risks of confidentiality loss. This was especially true for patients who were frequent computer users. DISCUSSION: While these primary care physicians and their patients valued the clinical features of EMRs, a substantial minority have concerns about the secondary use of de-identified information.

Perceptions of immunization information systems for collecting pandemic H1N1 immunization data within Canada's public health community: a qualitative study.

BACKGROUND: Immunization information systems (IISs) are electronic registries used to monitor individual vaccination status and assess vaccine coverage. IISs are currently not widely used across Canada, where health jurisdictions employ a range of approaches to capture influenza immunization information. Conducted in advance of the 2009 H1N1 vaccination campaign, the objectives of this study were to understand the perceived value of individual-level data and IISs for influenza control, identify ideal system functions, and explore barriers to implementation. METHODS: In July and August 2009, semi-structured interviews were conducted with key informants engaged in vaccine delivery and/or pandemic planning at regional, provincial/territorial and federal levels across Canada. Key informants were recruited using a combination of convenience and snowball sampling methodologies. Qualitative analysis was used to extract themes from interview content. RESULTS: Patient management, assessment of vaccine coverage, and evaluation of safety and effectiveness were identified as public health priorities that would be achieved in a more timely manner, and with greater accuracy, through the use of an IIS. Features described as ideal included system flexibility, rapid data entry, and universality. Financial and human resource constraints as well as coordination between immunization providers were expressed as barriers to implementation. CONCLUSIONS: IISs were perceived as valuable by key informants for strengthening management capacity and improving evaluation of both seasonal and pandemic influenza vaccination campaigns. However, certain implementation restrictions may need to be overcome for these benefits to be achieved.

Association between the 2008-09 seasonal influenza vaccine and pandemic H1N1 illness during Spring-Summer 2009: four observational studies from Canada.

BACKGROUND: In late spring 2009, concern was raised in Canada that prior vaccination with the 2008-09 trivalent inactivated influenza vaccine (TIV) was associated with increased risk of pandemic influenza A (H1N1) (pH1N1) illness. Several epidemiologic investigations were conducted through the summer to assess this putative association. STUDIES INCLUDED: (1) test-negative case-control design based on Canada's sentinel vaccine effectiveness monitoring system in British Columbia, Alberta, Ontario, and Quebec; (2) conventional case-control design using population controls in Quebec; (3) test-negative case-control design in Ontario; and (4) prospective household transmission (cohort) study in Quebec. Logistic regression was used to estimate odds ratios for TIV effect on community- or hospital-based laboratory-confirmed seasonal or pH1N1 influenza cases compared to controls with restriction, stratification, and adjustment for covariates including combinations of age, sex, comorbidity, timeliness of medical visit, prior physician visits, and/or health care worker (HCW) status. For the prospective study risk ratios were computed. Based on the sentinel study of 672 cases and 857 controls, 2008-09 TIV was associated with statistically significant protection against seasonal influenza (odds ratio 0.44, 95% CI 0.33-0.59). In contrast, estimates from the sentinel and three other observational studies, involving a total of 1,226 laboratory-confirmed pH1N1 cases and 1,505 controls, indicated that prior receipt of 2008-09 TIV was associated with increased risk of medically attended pH1N1 illness during the spring-summer 2009, with estimated risk or odds ratios ranging from 1.4 to 2.5. Risk of pH1N1 hospitalization was not further increased among vaccinated people when comparing hospitalized to community cases. CONCLUSIONS: Prior receipt of 2008-09 TIV was associated with increased risk of medically attended pH1N1 illness during the spring-summer 2009 in Canada. The occurrence of bias (selection, information) or confounding cannot be ruled out. Further experimental and epidemiological assessment is warranted. Possible biological mechanisms and immunoepidemiologic implications are considered.

Consent for use of personal information for health research: do people with potentially stigmatizing health conditions and the general public differ in their opinions?

BACKGROUND: Stigma refers to a distinguishing personal trait that is perceived as or actually is physically, socially, or psychologically disadvantageous. Little is known about the opinion of those who have more or less stigmatizing health conditions regarding the need for consent for use of their personal information for health research. METHODS: We surveyed the opinions of people 18 years and older with seven health conditions. Participants were drawn from: physicians' offices and clinics in southern Ontario; and from a cross-Canada marketing panel of individuals with the target health conditions. For each of five research scenarios presented, respondents chose one of five consent choices: (1) no need for me to know; (2) notice with opt-out; (3) broad opt-in; (4) project-specific permission; and (5) this information should not be used. Consent choices were regressed onto: demographics; health condition; and attitude measures of privacy, disclosure concern, and the benefits of health research. We conducted focus groups to discuss possible reasons for observed consent choices. RESULTS: We observed substantial variation in the control that people wish to have over use of their personal information for research. However, consent choice profiles were similar across health conditions, possibly due to sampling bias. Research involving profit or requiring linkage of health information with income, education, or occupation were associated with more restrictive consent choices. People were more willing to link their health information with biological samples than with information about their income, occupation, or education. CONCLUSIONS: The heterogeneity in consent choices suggests individuals should be offered some choice in use of their information for different types of health research, even if limited to selectively opting-out. Some of the implementation challenges could be designed into the interoperable electronic health record. However, many questions remain, including how best to capture the opinions of those who are more privacy sensitive.

Written informed consent and selection bias in observational studies using medical records: systematic review.

OBJECTIVES: To determine whether informed consent introduces selection bias in prospective observational studies using data from medical records, and consent rates for such studies. DESIGN: Systematic review. DATA SOURCES: Embase, Medline, and the Cochrane Library up to March 2008, reference lists from pertinent articles, and searches of electronic citations. STUDY SELECTION: Prospective observational studies reporting characteristics of participants and non-participants approached for informed consent to use their medical records. Studies were selected independently in duplicate; a third reviewer resolved disagreements. DATA EXTRACTION: Age, sex, race, education, income, or health status of participants and non-participants, the participation rate in each study, and susceptibility of these calculations to threats of selection and reporting bias. RESULTS: Of 1650 citations 17 unique studies met inclusion criteria and had analysable data. Across all outcomes there were differences between participants and non-participants; however, there was a lack of consistency in the direction and the magnitude of effect. Of 161 604 eligible patients, 66.9% consented to use of data from their medical records. CONCLUSIONS: Significant differences between participants and non-participants may threaten the validity of results from observational studies that require consent for use of data from medical records. To ensure that legislation on privacy does not unduly bias observational studies using medical records, thoughtful decision making by research ethics boards on the need for mandatory consent is necessary.

Who's minding the shop? The role of Canadian research ethics boards in the creation and uses of registries and biobanks.

BACKGROUND: The amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and biobanks. METHODS: Chairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank. RESULTS: There was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied. CONCLUSION: Participants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation.