Abstract
Research opportunities associated with the proliferation of the electronic health record (EHR), big data initiatives, and innovative approaches to trial design can present challenges for obtaining and documenting informed consent. Broad-scale informed consent (a term used herein to describe institutional models, rather than the Common Rule's strict regulatory definition for "broad consent") may facilitate the use of existing data and samples and speed the pace of research by minimizing barriers to consent. We explored the use of broad-scale informed consent within the Clinical Translational Science Award (CTSA) Program Network. We surveyed CTSA Hubs concerning policies, practices, experiences, and needs within three domains of broad-scale informed consent: (1) participant recontact; (2) biospecimens; and (3) clinical data sharing. Of 61 CTSA Hubs surveyed, 37 (61%) indicated ongoing work related to at least 1 domain of broad-scale informed consent; 18 Hubs (30%) reported work in all 3 domains. The EHR predominated as the implementation system across all three domains. Research and IT leadership and the Institutional Review Board were most commonly endorsed as institutional drivers, while systems/technical issues and impact on clinical workflow were the most commonly reported barriers. While survey results indicate considerable variability in the implementation of broad-scale informed consent across the CTSA consortium, it is clear that all CTSA Hubs are actively considering policy and process related to these concepts. Next steps cluster within three areas: training and workforce development, streamlined policies and templates, and implementation strategies that facilitate integration into clinical workflow.
Highlights
Research opportunities associated with the proliferation of the electronic health record (EHR), big data initiatives, and innovative approaches to trial design can present challenges for obtaining and documenting informed consent
In a typical research context, informed consent is obtained for participation in a single, clearly delineated study and includes information related to disclosure, voluntariness, and comprehension of the study
All 57 Clinical Translational Science Award (CTSA) Hubs receiving funding in fiscal year 2017 and an additional 4 Hubs who had received funding during the previous fiscal year responded to the survey; all institutions provided substantive responses and were included in the analysis
Summary
Research opportunities associated with the proliferation of the electronic health record (EHR), big data initiatives, and innovative approaches to trial design can present challenges for obtaining and documenting informed consent. There is growing diversity in scientific investigation, beyond typical clinical trials, including large pragmatic trials involving comparison of effective interventions, e-health interventions, survey research, and the expansion of biospecimen banking.[2] In addition, new opportunities associated with the proliferation of the electronic health record (EHR), creation of clinical data warehouses, and data science initiatives provide unprecedented opportunities to harness existing data to advance research to improve human health. These new opportunities can present new challenges for obtaining and documenting informed consent
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