A Randomized Controlled Trial of an Electronic Informed Consent Process

Rothwell, Erin; Wong, Bob; Rose, Nancy C.; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A.; Botkin, Jeffrey R.

doi:10.1177/1556264614552627

Cited by 55 publications

(76 citation statements)

References 22 publications

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“…Without medical or legal expertise, patients have been chronically misinformed as to the purpose, risks, benefits and procedures described on consent forms 5 . Most consent documents are worded for individuals with post-high school reading levels and are written in complex legal language.…”

Section: Introductionmentioning

confidence: 99%

“…A user-centered design approach 7 was selected to facilitate comprehension of the risks and benefits of consenting to HIE using interactive tools to improve decision making ability 5 . Findings from phase one of this study published elsewhere 8 suggested that there was: (1) limited understanding about HIE, (2) an inability to distinguish HIE from the Health Insurance Portability and Accountability Act (HIPAA) 9 , and (3) fragmented clinical workflow that prevented HIE consent from being discussed and obtained.…”

Section: Introductionmentioning

confidence: 99%

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User-Centered Design, Experience, and Usability of an Electronic Consent User Interface to Facilitate Informed Decision-Making in an HIV Clinic

Ramos

2017

CIN: Computers, Informatics, Nursing

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Health information exchange is the electronic accessibility and transferability of patient medical records across various health care settings and providers. In some states, patients have to formally give consent to allow their medical records to be electronically shared. The purpose of this study was to apply a novel user-centered, multi-step, multi-framework approach to design and test an electronic consent user interface, so patients with HIV can make more informed decisions about electronically sharing their health information. This study consisted of two steps. Step one was a cross-sectional, descriptive, qualitative study that employed user-centric design interviews to create the user interface. This informed step two. Step two consisted of a one group post-test to examine perceptions of usefulness, ease of use, preference and comprehension of a health information exchange electronic consent user interface. More than half of the study population had college experience, but challenges remained with overall comprehension regarding consent. The user interface was not independently successful, suggesting that in addition to an electronic consent user interface, human interaction may also be necessary to address the complexities associated with consenting to electronically share health information. Comprehension is a key factor in the ability to make informed decisions.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

User-Centered Design, Experience, and Usability of an Electronic Consent User Interface to Facilitate Informed Decision-Making in an HIV Clinic

Ramos

2017

CIN: Computers, Informatics, Nursing

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“…The study compared a simplified paper consent form only to a video plus the simplified paper consent form. The results demonstrated improved comprehension on some aspects of study specific details [33]. This intervention will be tested in the State of Michigan and the Michigan BioTrust on participant comprehension and uptake (NIH R01 HD082148-01A1).…”

Section: Education and Consent Approachesmentioning

confidence: 99%

Ethical and Regulatory Issues with Residual Newborn Screening Dried Bloodspots

Rothwell¹,

Botkin²

2015

OJPM

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After newborn screening is completed, most states retain leftover dried bloodspots. These dried bloodspots are stored for varying lengths of time among different state newborn screening programs. Dried bloodspots are a unique and valuable resource for the development of new newborn screening tests, quality assurance and biomedical research. Recent changes to the 2014 Newborn Screening Reauthorization Saves Lives Act require explicit parental consent for the retention and use of dried bloodspots in federally funded research. This has raised several ethical and regulatory issues and highlighted the challenges of respecting individual autonomy and public health goals. This article provides an overview of these issues and discusses methods for obtaining parental consent. These issues may be applicable to consent for the storage and use of biospecimens among other settings according to proposed changes to the Common Rule.

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“…Although there is little published evidence of this, it is our own local experience and that of other groups involving resource patients/parents. Information and consent for clinical research have often been reduced to the signing of a paper form, but the power of modern information technology is such that a web page, or an interactive web site, a video presentation, or other methods might well be more effective, and might well lead to better informed parents, and more representative samples being recruited [31, 32]. Parents may well prefer being met as a group, as opposed to the one-on-one traditional meeting with a member of the research team.…”

Section: Historymentioning

confidence: 99%

“…Parents may well prefer being met as a group, as opposed to the one-on-one traditional meeting with a member of the research team. The Seattle group have produced a series of videos that address issues around informed consent and randomization, which can be used to teach participants and parents about the meaning of many technical terms that are used [32]. Parents of babies in the NICU are also usually younger than the clinical researchers and are often more “tech-savvy” and may be more likely to interact with web-based methods of information and consent.…”

Section: Historymentioning

confidence: 99%

Integrating Parents in Neonatal and Pediatric Research

et al. 2019

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Background: Parents and their infants are the beneficiaries of neonatal and pediatric research, but in the past they have been excluded from most stages of research projects. As a result, many projects may fail to produce the most worthwhile information for parents and families. Lately, veteran resource parents and patients have been increasingly integrated in research initiatives. Methods: Benchmarking of neonatal and pediatric research initiatives where resource parents and/or ex neonatal patients have helped to optimize pediatric research. We review ways in which resource parents/patients can be involved in research, with examples and practical ideas of how to proceed. Results: Resource parents/patients can be collaborators in research and be integrated in many steps: prioritizing research projects, designing trials, determining the outcomes of interest, ethics review, developing and improving consent procedures, collection and interpretation of data, participation in data safety monitoring committees, publication of results, and presentation to peer groups. Some of the strategies for integration of stakeholders in clinical research are more complex, may involve risk and require more training than others. Conclusion: We suggest that groups wanting to involve parents in their research endeavors start with simpler tasks that entail less risk and develop teams of resource parents who have differing interests and abilities. Quality control of programs is essential, such as frequently giving and obtaining feedback from resource parents/patients and researchers. In the future, integration of resource parents/patients into every step of clinical research will be essential to ensure that parent and family important outcomes are examined.

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A Randomized Controlled Trial of an Electronic Informed Consent Process

Cited by 55 publications

References 22 publications

User-Centered Design, Experience, and Usability of an Electronic Consent User Interface to Facilitate Informed Decision-Making in an HIV Clinic

User-Centered Design, Experience, and Usability of an Electronic Consent User Interface to Facilitate Informed Decision-Making in an HIV Clinic

Ethical and Regulatory Issues with Residual Newborn Screening Dried Bloodspots

Integrating Parents in Neonatal and Pediatric Research

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