Opt-In and Opt-Out Consent Procedures for the Reuse of Routinely Recorded Health Data in Scientific Research and Their Consequences for Consent Rate and Consent Bias: Systematic Review.

BACKGROUND: Scientific researchers who wish to reuse health data pertaining to individuals can obtain consent through an opt-in procedure or opt-out procedure. The choice of procedure may have consequences for the consent rate and representativeness of the study sample and the quality of the research, but these consequences are not well known. OBJECTIVE: This review aimed to provide insight into the consequences for the consent rate and consent bias of the study sample of opt-in procedures versus opt-out procedures for the reuse of routinely recorded health data for scientific research purposes. METHODS: A systematic review was performed based on searches in PubMed, Embase, CINAHL, PsycINFO, Web of Science Core Collection, and the Cochrane Library. Two reviewers independently included studies based on predefined eligibility criteria and assessed whether the statistical methods used in the reviewed literature were appropriate for describing the differences between consenters and nonconsenters. Statistical pooling was conducted, and a description of the results was provided. RESULTS: A total of 15 studies were included in this meta-analysis. Of the 15 studies, 13 (87%) implemented an opt-in procedure, 1 (7%) implemented an opt-out procedure, and 1 (7%) implemented both the procedures. The average weighted consent rate was 84% (60,800/72,418 among the studies that used an opt-in procedure and 96.8% (2384/2463) in the single study that used an opt-out procedure. In the single study that described both procedures, the consent rate was 21% in the opt-in group and 95.6% in the opt-out group. Opt-in procedures resulted in more consent bias compared with opt-out procedures. In studies with an opt-in procedure, consenting individuals were more likely to be males, had a higher level of education, higher income, and higher socioeconomic status. CONCLUSIONS: Consent rates are generally lower when using an opt-in procedure compared with using an opt-out procedure. Furthermore, in studies with an opt-in procedure, participants are less representative of the study population. However, both the study populations and the way in which opt-in or opt-out procedures were organized varied widely between the studies, which makes it difficult to draw general conclusions regarding the desired balance between patient control over data and learning from health data. The reuse of routinely recorded health data for scientific research purposes may be hampered by administrative burdens and the risk of bias.

Setting up a Governance Framework for Secondary Use of Routine Health Data in Nursing Homes: Development Study Using Qualitative Interviews.

BACKGROUND: In the nursing home sector, reusing routinely recorded data from electronic health records (EHRs) for knowledge development and quality improvement is still in its infancy. Trust in appropriate and responsible reuse is crucial for patients and nursing homes deciding whether to share EHR data for these purposes. A data governance framework determines who may access the data, under what conditions, and for what purposes. This can help obtain that trust. Although increasing attention is being paid to data governance in the health care sector, little guidance is available on development and implementation of a data governance framework in practice. OBJECTIVE: This study aims to describe the development process of a governance framework for the "Registry Learning from Data in Nursing Homes," a national registry for EHR data on care delivered by nursing home physicians (in Dutch: specialist ouderengeneeskunde) in Dutch nursing homes-to allow data reusage for research and quality improvement of care. METHODS: Relevant stakeholders representing practices, policies, and research in the nursing home sector were identified. Semistructured interviews were conducted with 20 people from 14 stakeholder organizations. The main aim of the interviews was to explore stakeholders' perspectives regarding the Registry's aim, data access criteria, and governing bodies' tasks and composition. Interview topics and analyses were guided by 8 principles regarding governance for reusing health data, as described in the literature. Interview results, together with legal advice and consensus discussions by the Registry's consortium partners, were used to shape the rules, regulations, and governing bodies of the governance framework. RESULTS: Stakeholders valued the involvement of nursing home residents and their representatives, nursing home physicians, nursing homes' boards of directors, and scientists and saw this as a prerequisite for a trustworthy data governance framework. For the Registry, involvement of these groups can be achieved through a procedure in which residents can provide their consent or objection to the reuse of the data, transparency about the decisions made, and providing them a position in a governing body. In addition, a data request approval procedure based on predefined assessment criteria indicates that data reuse by third parties aligns with the aims of the Registry, benefits the nursing home sector, and protects the privacy of data subjects. CONCLUSIONS: The stakeholders' views, expertise, and knowledge of other frameworks and relevant legislation serve to inform the application of governance principles to the contexts of both the nursing home sector and the Netherlands. Many different stakeholders were involved in the development of the Registry Learning from Data in Nursing Homes' governance framework and will continue to be involved. Engagement of the full range of stakeholders in an early stage of governance framework development is important to generate trust in appropriate and responsible data reuse.