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One of the significant modifications to the Common Rule is the requirement that prospective participants be given information sufficient for a "reasonable person." However, research is limited on what types of information patients, caregivers, and providers consider "key information." Although certain aspects of informed consent (IC) may be considered standard, considering the individualized needs and preferences of patients is necessary for patient-centered consent. In this study, we qualitatively examined the specific types of information that patients and caregivers involved in hematopoietic cell transplantation (HCT), as well as their providers, believe to be important and necessary as part of the IC process to make a decision about participating in clinical research; and further, how these perspectives are aligned. Our findings suggest opportunities for improving the IC document and process by emphasizing information of importance to patients, such as the benefits to others and contributions to science that are associated with participation in clinical research. Furthermore, increasing patient engagement during the IC process may allow providers to streamline information that is aligned with patient information needs and preferences., (Copyright © 2017 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.)

Background: Michigan's BioTrust for Health, a public health research biobank comprised of residual dried bloodspot (DBS) cards from newborn screening contains over 4 million samples collected without written consent. Participant-centric initiatives are IT tools that hold great promise to address the consent challenges in biobank research., Methods: Working with Private Access Inc., a pioneer in patient-centric web solutions, we created and pilot tested a dynamic informed consent simulation, paired with an educational website, focusing on consent for research utilizing DBSs in Michigan's BioTrust for Health., Results: Out of 187 pilot testers recruited in 2 groups, 137 completed the consent simulation and exit survey. Over 50% indicated their willingness to set up an account if the simulation went live and to recommend it to others. Participants raised concerns about the process of identity verification and appeared to have little experience with sharing health information online., Conclusions: Applying online, dynamic approaches to address the consent challenges raised by biobanks with legacy sample collections should be explored, given the positive reaction to our pilot test and the strong preference for active consent. Balancing security and privacy with accessibility and ease of use will continue to be a challenge., (© 2014 S. Karger AG, Basel.)

Purpose: Some large population biobanks that house biospecimens and health information for research seek broad consent from participants, whereas others reconsent for specific new studies. Understanding research participants' attitudes and preferences about broad and narrow consent may improve recruitment, retention, and public support., Methods: An online survey was conducted among a representative sample of 4,659 US adults to examine relationships between consent preferences and demographic factors, beliefs about privacy and the value of research, and the perceived trustworthiness of researchers., Results: Participants preferred broad consent (52%) over study-by-study consent models (48%). Higher preferences for study-by-study consent observed among black non-Hispanic respondents and respondents with lower income and education were explained by differences in the prevalence of one or more beliefs about the study. Respondents with fears about research and those who would feel respected if asked for permission for each research use preferred study-by-study consent. Preference for broad consent was related to the desire not to be bothered with multiple requests and the belief that the study could lead to improved treatments, cures, and lives saved., Conclusion: These data suggest that support for broad consent is contingent on sufficient information about data use. Work with research participants and community leaders to understand, respond to, and influence opinions about a given, ongoing study may improve uptake of broad consent.

Introduction Methods Results Conclusion Sharing patient health information and biospecimens can improve health outcomes and accelerate breakthroughs in medical research. But patients generally lack understanding of how their clinical data and biospecimens are used or commercialized for research. In this mixed methods project, we assessed the impact of communication materials on patient understanding, attitudes, and perceptions.Michigan Medicine patients were recruited for a survey (n = 480) or focus group (n = 33) via a web‐based research study portal. The survey assessed the impact of mode of communication about health data and biospecimen sharing (via an informational poster vs. a news article) on patient perceptions of privacy, transparency, comfort, respect, and trust. Focus groups provided in‐depth qualitative feedback on three communication materials, including a poster, FAQ webpage, and a consent form excerpt.Among survey respondents, the type of intervention (poster vs. news) made no statistically significant difference in its influence on any characteristic. However, 95% preferred that Michigan Medicine tell them about patient data and biospecimen research sharing versus hearing it from the news. Focus group participants provided additional insights, discussing values and perceptions of altruism and reciprocity, concerns about commercialization, privacy, and security; and the desire for consent, control, and transparency.Developing our understanding of patient data‐sharing practices and integrating patient preferences into health system policy, through this work and continued exploration, contributes to building infrastructure that can be used to support the development of a learning health system across hospital systems nationally. [ABSTRACT FROM AUTHOR]