Objectives: Recent legislative changes within the United Kingdom have stimulated professional debate about access to patient data within research. However, there is currently little awareness of public views about such research. The authors sought to explore attitudes of the public, and their lay representatives, towards the use of primary care medical record data for research when patient consent was not being sought.Methods: 49 members of the public and four non-medical members of local community health councils in South Wales, UK gave (...) their views on the value and acceptability of three current research scenarios, each describing access to data without patient consent.Results: Among focus group participants, awareness of research in primary care was low, and the appropriateness of general practitioners as researchers was questioned. There was general support for research but also concerns expressed about data collection without consent. These included lack of respect and patient control over the process. Unauthorised access to data by external agencies was a common fear. Current data collection practices, including population based disease registers elicited much anxiety. The key informants were equally critical of the scenarios and generally less accepting.Conclusions: This exploratory study has highlighted a number of areas of public concern when medical records are accessed for research without patient consent. Public acceptability regarding the use of medical records in research cannot simply be assumed. Further work is required to determine how widespread such views are and to inform those advising on confidentiality issues. (shrink)

A main objective of this study is to assess the opinions of 50 behavioral health patients on selective control over their behavioral and physical health information. We explored patients' preferences regarding current consent models, what health information should be shared for care and research and whether these preferences vary based on the sensitivity of health information and/or the type of provider involved. The other objective of this study was to solicit opinions of 8 behavioral health providers on patient-driven granular control (...) of health information and potential impact on care.Electronic surveys were implemented at an outpatient Behavioral Health facility that provides care for behavioral health patients with non-serious mental illnesses. The Patient Survey included questions regarding patients' demographics and about their concerns and preferences for data sharing for care and research. The Provider Survey included questions about their view on the current consent process and perceptions on barriers and facilitators to implement patient-controlled granular consent models.This novel study provides valuable preliminary data that can help guide future studies to better understand privacy choices of this underrepresented patient group. (shrink)

BackgroundThe role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues.MethodsWe conducted seven (...) day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly.ResultsBroad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research.ConclusionBecause no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record for purposes other than clinical care. This could be done, for example, through a web-based patient portal to their electronic health record. Researchers and policy makers should continue to engage the public to promote greater public understanding of the research process and to look for feasible alternatives to existing approaches to project-specific consent for observational research. (shrink)

Introduction Understanding the views of the public is essential if generally acceptable policies are to be devised that balance research access to general practice patient records with protection of patients' privacy. However, few large studies have been conducted about public attitudes to research access to personal health information. Methods A mixed methods study was performed. Informed by focus groups and literature review, a questionnaire was designed which assessed attitudes to research access to personal health information and factors that influence these. (...) A postal survey was conducted of an electoral roll-based sample of the adult population of Ireland. Results Completed questionnaires were returned by 1575 (40.6%). Among the respondents, 67.5% were unwilling to allow GPs to decide when researchers could access identifiable personal health information. However, 89.5% said they would agree to ongoing consent arrangements, allowing the sharing by GPs of anonymous personal health information with researchers without the need for consent on a study-by-study basis. Increasing age (by each 10-year increment), being retired and primary level education only were significantly associated with an increased likelihood of agreeing that any personal health information could be shared on an ongoing basis: OR 1.39 (95% CI 1.18 to 1.63), 2.00 (95% CI 1.22 to 3.29) and 3.91 (95% CI 1.95 to 7.85), respectively. Conclusions Although survey data can be prone to response biases, this study suggests that prior consent agreements allowing the supply by GPs of anonymous personal health information to researchers may be widely supported, and that populations willing to opt in to such arrangements may be sufficiently representative to facilitate valid and robust consent-dependent observational research. (shrink)