Browsing by Author "Halverson, Colin"

Now showing 1 - 7 of 7
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    Adolescent Assent and Reconsent for Biobanking: Recent Developments and Emerging Ethical Issues
    (Frontiers Media, 2021-07-09) Kasperbauer, T. J.; Halverson, Colin; Medicine, School of Medicine
    Research biobanks that enroll minors face important practical, ethical, and regulatory challenges in reconsenting participants when they reach the age of 18. Federal regulations governing research in the United States provide minimal guidance and allow for a range of practices, including waiving the requirement to obtain reconsent. Some commentators have argued that institutional review boards should indeed grant such waivers, given the low risks of biobank-based research and the impracticality of contacting all participants when they turn 18. There is also significant ethical debate about the age at which adolescents can make authentic, autonomous decisions regarding their research participation. This paper reviews these issues in detail, describes the current state of the ethical discussion, and outlines evidence-based policies for enrolling minors into research biobanks.
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    Home testing for COVID-19: lessons from direct to consumer genetics
    (Springer Nature, 2020-06-16) Wilson, Theodore E.; Halverson, Colin; Medical and Molecular Genetics, School of Medicine
    On March 11th, 2020, COVID-19 was declared a worldwide pandemic. Publicly available testing has lagged, and tech entrepreneurs have quickly volunteered to fill this gap. Over the last two decades, genetic testing ordered outside of a clinic and without the involvement of a physician has been a way for the average individual to get genetic testing. In this commentary, we discuss the lessons learned from this parallel case from genetics and suggest regulatory caution in establishing direct-to-consumer COVID testing.
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    Patient Interest in the Development of a Center for Ehlers-Danlos Syndrome/Hypermobility Spectrum Disorder in the Chicagoland Region
    (Research Square, 2023-07-14) Wagner, Wendy; Doyle, Tom; Francomano, Clair; Knight, Dacre; Halverson, Colin; Medicine, School of Medicine
    Background: The Ehlers-Danlos Syndromes (EDS) are a set of connective tissue disorders that are hereditary in nature and characterized by joint hypermobility and tissue fragility. The complex nature of this unique patient population requires multidisciplinary care, but appropriate centers for such care do not exist in large portions of the country. Need for more integrated services has been identified in the Chicagoland region. In order to explore and begin to address barriers to seeking out appropriate care facing EDS patients in this region, we developed an online survey which we circulated through EDS social media groups for Chicagoland patients. Results: Three hundred and nine unique respondents participated. We found that there exists a strong medical need for and interest in the development of a center in the region, and participants reported that, if made available to them, that they would make extensive and regular use of such a facility. Conclusions: We conclude that the establishment of a collaborative medical center specializing in the diagnosis and treatment of EDS, HSD, and related disorders in the Chicagoland area would greatly benefit patients by providing comprehensive care, alleviate the burden on overworked healthcare providers, and generate revenue for medical facilities.
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    Patients’ views on variants of uncertain significance across indications
    (Springer, 2019-08-20) Clift, Kristin; Macklin, Sarah; Halverson, Colin; McCormick, Jennifer B.; Abu Dabrh, Abd Moain; Hines, Stephanie; Medicine, School of Medicine
    As genomic sequencing expands into more areas of patient care, an increasing number of patients learn of the variants of uncertain significance (VUSs) that they carry. Understanding the potential psychosocial consequences of the disclosure of a VUS can help inform pre- and post-test counseling discussions. Medical uncertainty in general elicits a variety of responses from patients, particularly in the growing field of medical genetics and genomics. It is important to consider patients’ responses to the ambiguous nature of VUSs across different indications and situational contexts. Genetic counselors and other providers ordering genetic testing should be prepared for the possibility of their patients’ misinterpretation of such results. Pre-test counseling should include a discussion of the possibility of VUSs and what it would mean for the patient’s care and its potential psychosocial impacts. When a VUS is found, post-test counseling should include additional education and a discussion of the variant’s implications and medical management recommendations based on the results. These discussions may help temper subjective interpretations, unrealistic views, and decisional regret.
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    Returning negative results from large-scale genomic screening: Experiences from the eMERGE III network
    (Wiley, 2021) Finn, Kelsey Stuttgen; Lynch, John; Aufox, Sharon; Bland, Sarah; Chung, Wendy; Halverson, Colin; Hebbring, Scott; Hoell, Christin; Holm, Ingrid; Jarvik, Gail; Kullo, Iftikhar; Leppig, Kathleen; Myers, Melanie; Prows, Cynthia; Rasouly, Hila Milo; Singh, Rajbir; Weisner, Georgia; Williams, Janet; Wynn, Julia; Smith, Maureen; Sharp, Richard; Medicine, School of Medicine
    Population-based genomic screening has the potential to improve health outcomes by identifying genetic causes of disease before they occur. While much attention has been paid to supporting the needs of the small percentage of patients who will receive a life-altering positive genomic screening result that requires medical attention, little attention has been given to the communication of negative screening results. As there are currently no best practices for returning negative genomic screening results, we drew on experiences across the electronic medical records and genomics (eMERGE) III Network to highlight the diversity of reporting methods employed, challenges encountered in reporting negative test results, and "lessons learned" across institutions. A 60-item survey that consisted of both multiple choice and open-ended questions was created to gather data across institutions. Even though institutions independently developed procedures for reporting negative results, and had very different study populations, we identified several similarities of approach, including but not limited to: returning results by mail, placing results in the electronic health record via an automated process, reporting results to participants' primary care provider, and providing genetic counseling to interested patients at no cost. Differences in procedures for reporting negative results included: differences in terminology used to describe negative results, definitions of negative results, guidance regarding the meaning of negative results for participants and their family members, and recommendations for clinical follow up. Our findings highlight emerging practices for reporting negative genomic screening results and highlight the need to create patient education and clinical support tools for reporting negative screening results.
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    Understanding the Return of Genomic Sequencing Results Process: Content Review of Participant Summary Letters in the eMERGE Research Network
    (MDPI, 2020-05-13) Lynch, John A.; Sharp, Richard R.; Aufox, Sharon A.; Bland, Sarah T.; Blout, Carrie; Bowen, Deborah J.; Buchanan, Adam H.; Halverson, Colin; Harr, Margaret; Hebbring, Scott J.; Henrikson, Nora; Hoell, Christin; Holm, Ingrid A.; Jarvik, Gail; Kullo, Iftikhar J.; Kochan, David C.; Larson, Eric B.; Lazzeri, Amanda; Leppig, Kathleen A.; Madden, Jill; Marasa, Maddalena; Myers, Melanie F.; Peterson, Josh; Prows, Cynthia A.; Kulchak Rahm, Alanna; Ralston, James; Milo Rasouly, Hila; Scrol, Aaron; Smith, Maureen E.; Sturm, Amy; Stuttgen, Kelsey; Wiesner, Georgia; Williams, Marc S.; Wynn, Julia; Williams, Janet L.; Medicine, School of Medicine
    A challenge in returning genomic test results to research participants is how best to communicate complex and clinically nuanced findings to participants in a manner that is scalable to the large numbers of participants enrolled. The purpose of this study was to examine the features of genetic results letters produced at each Electronic Medical Records and Genomics (eMERGE3) Network site to assess their readability and content. Letters were collected from each site, and a qualitative analysis of letter content and a quantitative analysis of readability statistics were performed. Because letters were produced independently at each eMERGE site, significant heterogeneity in readability and content was found. The content of letters varied widely from a baseline of notifying participants that results existed to more detailed information about positive or negative results, as well as materials for sharing with family members. Most letters were significantly above the Centers for Disease Control-suggested reading level for health communication. While continued effort should be applied to make letters easier to understand, the ongoing challenge of explaining complex genomic information, the implications of negative test results, and the uncertainty that comes with some types of test and result makes simplifying letter text challenging.
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    What is "Personal" About Personal Experience? A Call to Reflexivity for All
    (Taylor & Francis, 2023) Halverson, Colin; Halley, Meghan; Medicine, School of Medicine