Browsing by Subject "informed consent"

Now showing 1 - 10 of 23
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    Abortion and Compelled Physician Speech
    (Wiley, 2015) Orentlicher, David; Robert H. McKinney School of Law
    As states increasingly impose informed consent mandates on abortion providers, the required disclosures bring two well-established legal doctrines into conflict — the First Amendment’s freedom of speech and the physician’s duty to obtain informed consent. On one hand, the First Amendment precludes the government from forcing individuals to voice the government’s views. On the other hand, legislatures and courts can insist that physicians properly explain to patients about their medical conditions and potential treatments so patients can make informed decisions about their health care. When taking care of patients, doctors assume a duty to speak, as well as a duty to speak responsibly. Ordinarily, the doctrines of free speech and informed consent coexist without much difficulty. But as states have expanded the kinds of information that abortion providers must disclose to pregnant women, First Amendment concerns have become increasingly salient. In this article, I will use several examples of speech mandates for abortion and other health care services to identify principles for distinguishing between legitimate regulation of the informed consent process and illegitimate interference with the freedom of speech. First, speech mandates should be permissible when they provide material information to patients about their health care decisions. If the state is trying to ensure that patients are fully informed, the mandates should be allowed. As a corollary, the information must be truthful and not be misleading. The goal is to inform not to misinform. Second, speech mandates that pertain to moral considerations should not be permitted. Rather than informing the patient’s decision, these mandates force the physician or other health professional to espouse the state’s ideology. Courts and legal scholars have proposed other ways to distinguish permissible from impermissible mandates (e.g., whether the government takes sides, manipulates emotions, or uses graphic images). However, these additional distinctions raise their own concerns and should not be needed. If courts strictly apply the requirements that compelled speech pertain to medical facts about abortion and its alternatives rather than abortion ideology and that the compelled speech be truthful and not misleading, then the interests of pregnant women and their physicians should be protected.
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    Adolescent Self-Consent for Biomedical HIV Prevention Research: Implications for Institutional Review Board Approval and Implementation
    (Elsevier, 2015-07) Gilbert, Amy Lewis; Knopf, Amelia S.; Fortenberry, J. Dennis; Hosek, Sybil G.; Kapogiannis, Bill G.; Zimet, Gregory D.; IU School of Nursing
    Purpose The Adolescent Medicine Trials Network Protocol 113 (ATN113) is an open-label, multisite demonstration project and Phase II safety study of human immunodeficiency virus (HIV) preexposure prophylaxis with 15- to 17-year-old young men who have sex with men that requires adolescent consent for participation. The purpose of this study was to examine factors related to the process by which Institutional Review Boards (IRBs) and researchers made decisions regarding whether to approve and implement ATN113 so as to inform future biomedical HIV prevention research with high-risk adolescent populations. Methods Participants included 17 researchers at 13 sites in 12 states considering ATN113 implementation. Qualitative descriptive methods were used. Data sources included interviews and documents generated during the initiation process. Results A common process for initiating ATN113 emerged, and informants described how they identified and addressed practical, ethical, and legal challenges that arose. Informants described the process as responding to the protocol, preparing for IRB submission, abstaining from or proceeding with submission, responding to IRB concerns, and reacting to the outcomes. A complex array of factors impacting approval and implementation were identified, and ATN113 was ultimately implemented in seven of 13 sites. Informants also reflected on lessons learned that may help inform future biomedical HIV prevention research with high-risk adolescent populations. Conclusions The results illustrate factors for consideration in determining whether to implement such trials, demonstrate that such protocols have the potential to be approved, and highlight a need for clearer standards regarding biomedical HIV prevention research with high-risk adolescent populations.
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    Coordinated Evolution of Ontologies of Informed Consent
    (ICBO, 2018) Vajda, Jonathan; Otte, J. Neil; Stansbury, Cooper; Manion, Frank J.; Umberfield, Elizabeth; He, Yongqun; Harris, Marcelline; Obeid, Jihad; Brochhausen, Mathias; Duncan, William D.; Tao, Cui; Health Policy and Management, School of Public Health
    Informed consent, whether for health or behavioral research or clinical treatment, rests on notions of voluntarism, information disclosure and understanding, and the decisionmaking capacity of the person providing consent. Whether consent is for research or treatment, informed consent serves as a safeguard for trust that permissions given by the research participant or patient are upheld across the informed consent (IC) lifecycle. The IC lifecycle involves not only documentation of the consent when originally obtained, but actions that require clear communication of permissions from the initial acquisition of data and specimens through handoffs to, for example, secondary researchers, allowing them access to data or biospecimens referenced in the terms of the original consent.
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    Ethical Issues in Measuring Biomarkers in Children’s Environmental Health
    (2009-08) Sly, PD; Eskenazi, B; Pronczuk, J; Srám, R; Diaz-Barriga, F; Machin, DG; Carpenter, DO; Surdu, S; Meslin, Eric M.
    Background Studying the impact of environmental exposures is important in children because they are more vulnerable to adverse effects on growth, development, and health. Assessing exposure in children is difficult, and measuring biomarkers is potentially useful. Research measuring biomarkers in children raises a number of ethical issues, some of which relate to children as research subjects and some of which are specific to biomarker research. Objective As an international group with experience in pediatric research, biomarkers, and the ethics of research in children, we highlight the ethical issues of undertaking biomarker research in children in these environments. Discussion Significant issues include undertaking research in vulnerable communities, especially in developing countries; managing community expectations; obtaining appropriate consent to conduct the research; the potential conflicts of obtaining permission from an ethics review board in an economically developed country to perform research in a community that may have different cultural values; returning research results to participants and communities when the researchers are uncertain of how to interpret the results; and the conflicting ethical obligations of maintaining participant confidentiality when information about harm or illegal activities mandate reporting to authorities. Conclusion None of these challenges are insurmountable and all deserve discussion. Pediatric biomarker research is necessary for advancing child health.
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    Genetic Data Aren't So Special: Causes and Implications of Reidentification
    (Wiley, 2020-10-23) Kasperbauer, T.J.; Schwartz, Peter H.; Philosophy, School of Liberal Arts
    Genetic information is widely thought to pose unique risks of reidentifying individuals. Genetic data reveals a great deal about who we are and, the standard view holds, should consequently be treated differently from other types of data. Contrary to this view, we argue that the dangers of reidentification for genetic and nongenetic data—including health, financial, and consumer information—are more similar than has been recognized. Before different requirements are imposed around sharing genetic information, proponents of the standard view must show that they are in fact necessary. We further argue that the similarities between genetic and nongenetic information have important implications for communicating risks during consent for health care and research. While patients and research participants need to be more aware of pervasive data-sharing practices, consent forms are the wrong place to provide this education. Instead, health systems should engage with patients throughout patient care to educate them about data-sharing practices.
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    Incorporating Biobank Consent into a Healthcare Setting: Challenges for Patient Understanding
    (Taylor & Francis, 2021) Kasperbauer, T. J.; Schmidt, Karen K.; Thomas, Ariane; Perkins, Susan M.; Schwartz, Peter H.; Medicine, School of Medicine
    Biobank participants often do not understand much of the information they are provided as part of the informed consent process, despite numerous attempts at simplifying consent forms and improving their readability. We report the first assessment of biobank enrollees’ comprehension under an "integrated consent” process, where patients were asked to enroll in a research biobank as part of their normal healthcare experience. A number of healthcare systems have implemented similar integrated consent processes for biobanking, but it is unknown how much patients understand after enrolling under these conditions. Methods: We recruited patients who enrolled in a biobank while in a healthcare setting when receiving ordinary care. We assessed knowledge of consent materials using 11 true/false questions drawn from a well-known biobank knowledge test. After reviewing the results from 114 participants, we revised the consent form and repeated the knowledge assessment with 144 different participants. Results: Participants scored poorly on the knowledge test in both rounds, with no significant differences in overall scores or individual items between the rounds. In Phase 1, participants answered 53% of the questions correctly, 25% incorrectly, and 22% “I don’t know.” In Phase 2, participants answered 53% of questions correctly, 24% incorrectly, and 23% “I don’t know.” Participants scored particularly poorly on questions about data sharing and accessing medical records. Conclusions: Enrollees under an integrated consent model had significant misunderstandings that persisted despite an attempt to improve information specifically about those topics in a consent form. These results raise challenges for current approaches that attribute misunderstanding to overly complex consent forms. They also suggest that the pressures of the clinic may compound other problems with patient understanding of biobank consent. As health systems increasingly blend research and care, they may need to rethink their approach to educating patients about participation in a biobank.
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    Making health care decisions. [Chapter 1]
    (1982-10) United States. President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
    Studies the issues of informed consent regarding health care choices.
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    Making health care decisions. [Chapter 2]
    (1982-10) United States. President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
    Studies the issues of informed consent regarding health care choices.
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    Making health care decisions. [Chapter 3]
    (1982-10) United States. President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
    Studies the issues of informed consent regarding health care choices.
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    Making health care decisions. [Chapter 4(a)]
    (1982-10) United States. President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research
    Studies the issues of informed consent regarding health care choices.