scholarly journals COVID-19 and consent for research: Navigating during a global pandemic

2020 ◽  
pp. 147775092097180
Author(s):  
Ran D Goldman ◽  
Luke Gelinas
Keyword(s):  
Clinical Practice ◽  
Informed Consent ◽  
Collaborative Research ◽  
Research Participation ◽  
Alternative Therapies ◽  
Urgent Care ◽  
Ethical Framework ◽  
Research Teams ◽  
Global Pandemic ◽  
Material Information

The modern ethical framework demands informed consent for research participation that includes disclosure of material information, as well as alternatives. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic (COVID-19) results in illness that often involves rapid deterioration. Despite the urgent need to find therapy, obtaining informed consent for COVID-19 research is needed. The current pandemic presents three types of challenges for investigators faced with obtaining informed consent for research participation: (1) uncertainty over key information to informed consent, (2) time and pressure constraints, and (3) obligations regarding disclosure of new alternative therapies and re-consent. To mitigate consenting challenges, primary investigators need to work together to jointly promote urgent care and research into COVID-19. Actions they can take include (1) prior plan addressing ways to incorporate clinical research into clinical practice in emergency, (2) consider patients vulnerable with early deliberation on the consent process, (3) seek Legally Authorized Representatives (LARs), (4) create a collaborative research teams, (5) aim to consent once, despite evolving information during the pandemic, and (6) aim to match patients to a trial that will most benefit them. The COVID-19 pandemic both exacerbates existing challenges and raises unique obstacles for consent that require forethought and mindfulness to overcome. While research teams and clinician-investigators will need to be sensitive to their own contexts and adapt solutions accordingly, they can meet the challenge of obtaining genuinely informed consent during the current pandemic.

scholarly journals Collaboration in Virtual Environments: Honouring the Métis Method of Visiting

2021 ◽  
Vol 63 (1) ◽  
Author(s):  
Fiona P. McDonald ◽  
Hanna M. Paul
Keyword(s):  
Informed Consent ◽  
Virtual Environments ◽  
Collaborative Research ◽  
Community Partners ◽  
Research Teams ◽  
Interdisciplinary Work ◽  
Research Protocols ◽  
Training And Research ◽  
Cultural Gaps

During COVID-19, many collaborative research teams and community partners pivoted to undertake their work in a virtual way. In this discussion, we capture the mechanics, logic, and situations under which virtual methods became relevant to applied interdisciplinary work. Using a shared voice, we chart the nuances of training and research through the redesign, the reimagining of research protocols, and the nuanced cultural gaps that exist between virtual connection and in-person visiting with community partners, Métis Knowledge Keepers, and experts. Through referencing our reflexive archive of experiences, emails, fieldnotes, and meeting minutes, we address how our attempt to simulate virtual informed consent has consequently provided insights into the value of co-creation and the importance of honouring visiting as a Métis method in virtual environments.

scholarly journals Is informed consent required for the diagnosis of brain death regardless of consent for organ donation?

2020 ◽  
pp. medethics-2020-106240
Author(s):  
Osamu Muramoto
Keyword(s):  
Clinical Practice ◽  
Informed Consent ◽  
Brain Death ◽  
Organ Donation ◽  
Point Of View ◽  
Ethical Framework ◽  
Donor Pool ◽  
Medical Diagnoses ◽  
Ethical Point ◽  
Maximum Comfort

In the half-century history of clinical practice of diagnosing brain death, informed consent has seldom been considered until very recently. Like many other medical diagnoses and ordinary death pronouncements, it has been taken for granted for decades that brain death is diagnosed and death is declared without consideration of the patient’s advance directives or family’s wishes. This essay examines the pros and cons of using informed consent before the diagnosis of brain death from an ethical point of view. As shared decision-making in clinical practice became increasingly indispensable, respect for the patients’ autonomous wishes regarding how to end their lives has a significant role in deciding how death is diagnosed. Brain death, as a fully technologically controlled death, may require a different ethical framework from the old one for traditional cardiac death. With emerging and proliferating options in end-of-life care for those who suffer from catastrophic brain injury, the traditional reasoning that ‘death gives no choice, hence no consent’ requires another examination. Patients facing imminent brain death now have options other than undergoing the diagnostic workup for brain death, such as donation after circulatory death and withdrawal of life-sustaining treatment with maximum comfort measures for death with dignity. Nevertheless, just as in the debate over opt-in versus opt-out organ donation policies, informed consent before the diagnosis of brain death faces fierce opposition from consequentialists urging the expansion of the donor pool. This essay examines these objections and provides constructive replies along with a proposal to accommodate this morally required consent.

Informed Consent in Clinical Practice

1990 ◽  
Vol 35 (1) ◽  
pp. 38-39
Author(s):  
Stephen L. Golding
Keyword(s):  
Clinical Practice ◽  
Informed Consent

Clinical genomics in the 21st century: The fine balance between ethics and science

2021 ◽  
pp. 147775092110366
Author(s):  
Terence YS Liew ◽  
Chun Y Khoo
Keyword(s):  
Clinical Practice ◽  
Informed Consent ◽  
21St Century ◽  
Preventive Medicine ◽  
Genomic Medicine ◽  
Traditional Practices ◽  
Current Clinical Practice ◽  
Common Goal ◽  
Clinical Genomics ◽  
Ethical Concerns

The 21st century has been revolutionary for the field of clinical genomics, with major advancements and breakthroughs over the years. It is now considered an instrumental tool in clinical and preventive medicine and has been used on a day-to-day basis to complement current clinical practice. However, with advancements in genomics comes greater bioethical concerns, which becomes increasingly complex with more cutting-edge technology. Some of the major ethical concerns include obtaining informed consent, possibility for genetic enhancements and eugenics, genomic equity and potential discrimination and cloning. It is imperative that we appreciate the benefits of genomic medicine in complementing traditional practices, identify and address the ethical concerns with relation to the practice of genomic medicine, and to ensure a common goal of improving human lives. With these in mind, the practice of genomics can have maximum impact in the collective health of the population, with greater benefit to all.

scholarly journals Ethical issues in genomics research on neurodevelopmental disorders: a critical interpretive review

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
S. Mezinska ◽  
L. Gallagher ◽  
M. Verbrugge ◽  
E.M. Bunnik
Keyword(s):  
Informed Consent ◽  
Neurodevelopmental Disorders ◽  
Cognitive Abilities ◽  
Social Impact ◽  
Mental Health Problems ◽  
Ethical Issues ◽  
Family Members ◽  
Genetic Diagnosis ◽  
Research Participation ◽  
Genomic Research

Abstract Background Genomic research on neurodevelopmental disorders (NDDs), particularly involving minors, combines and amplifies existing research ethics issues for biomedical research. We performed a review of the literature on the ethical issues associated with genomic research involving children affected by NDDs as an aid to researchers to better anticipate and address ethical concerns. Results Qualitative thematic analysis of the included articles revealed themes in three main areas: research design and ethics review, inclusion of research participants, and communication of research results. Ethical issues known to be associated with genomic research in general, such as privacy risks and informed consent/assent, seem especially pressing for NDD participants because of their potentially decreased cognitive abilities, increased vulnerability, and stigma associated with mental health problems. Additionally, there are informational risks: learning genetic information about NDD may have psychological and social impact, not only for the research participant but also for family members. However, there are potential benefits associated with research participation, too: by enrolling in research, the participants may access genetic testing and thus increase their chances of receiving a (genetic) diagnosis for their neurodevelopmental symptoms, prognostic or predictive information about disease progression or the risk of concurrent future disorders. Based on the results of our review, we developed an ethics checklist for genomic research involving children affected by NDDs. Conclusions In setting up and designing genomic research efforts in NDD, researchers should partner with communities of persons with NDDs. Particular attention should be paid to preventing disproportional burdens of research participation of children with NDDs and their siblings, parents and other family members. Researchers should carefully tailor the information and informed consent procedures to avoid therapeutic and diagnostic misconception in NDD research. To better anticipate and address ethical issues in specific NDD studies, we suggest researchers to use the ethics checklist for genomic research involving children affected by NDDs presented in this paper.

Commentary 1: Research with Persons Under Involuntary Commitment—Ethical Issues Surrounding Competence and Voluntariness

2019 ◽  
Vol 14 (5) ◽  
pp. 475-478
Author(s):  
Matthé Scholten ◽  
Jochen Vollmann
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Research Participation ◽  
Research Participant ◽  
Involuntary Commitment ◽  
Proxy Consent ◽  
Undue Influence ◽  
Research Participants ◽  
Manic Symptoms ◽  
Prospective Research

In this case commentary, we analyze ethical concerns that were raised in response to an interview with a woman with bipolar disorder who was under involuntary commitment. We focus on competence and voluntariness as two prerequisites for valid informed consent. We recommend that judgments of competence be based on whether prospective research participants sufficiently possess certain decision-making abilities. Based on this functional approach, we argue that manic symptoms need not undermine competence and that, even if we were to assume that the research participant became incompetent during the interview, this would not invalidate her consent retroactively. It would, however, compromise her ability to revoke her consent. We furthermore show that obtaining additional proxy consent for research participation may compromise the autonomy of service users who are competent to consent. Then we turn to the issue of voluntariness. Arguing that neither the great strength nor the external etiology of a desire compromises voluntariness, we propose that the voluntariness of a decision instead depends on whether the decision-maker endorses it on reflection. The researchers disclosed that prospective research participants’ decision about study participation would have no influence on the duration of the commitment or the quality of care. We contend that because of this neither coercion nor undue influence was exerted in the informed consent process. Nevertheless, there is an increased likelihood of perceived coercion and undue influence under conditions of involuntary commitment, and we close by suggesting some safeguards to prevent this.

scholarly journals Rapid implementation of virtual neurology in response to the COVID-19 pandemic

Neurology ◽  
2020 ◽  
Vol 94 (24) ◽  
pp. 1077-1087 ◽  
Author(s):  
Scott N. Grossman ◽  
Steve C. Han ◽  
Laura J. Balcer ◽  
Arielle Kurzweil ◽  
Harold Weinberg ◽  
...  
Keyword(s):  
Care Delivery ◽  
Mitigation Strategies ◽  
Urgent Care ◽  
Technology Infrastructure ◽  
Information Technology Infrastructure ◽  
Care Services ◽  
Global Pandemic ◽  
Specific Practice ◽  
Government Rules ◽  
Rapid Deployment

The COVID-19 pandemic is causing world-wide social dislocation, operational and economic dysfunction, and high rates of morbidity and mortality. Medical practices are responding by developing, disseminating, and implementing unprecedented changes in health care delivery. Telemedicine has rapidly moved to the frontline of clinical practice due to the need for prevention and mitigation strategies; these have been encouraged, facilitated, and enabled by changes in government rules and regulations and payer-driven reimbursement policies. We describe our neurology department's situational transformation from in-person outpatient visits to a largely virtual neurology practice in response to the COVID-19 pandemic. Two key factors enabled our rapid deployment of virtual encounters in neurology and its subspecialties. The first was a well-established robust information technology infrastructure supporting virtual urgent care services at our institution; this connected physicians directly to patients using both the physician's and the patient's own mobile devices. The second is the concept of one patient, one chart, facilitated by a suite of interconnected electronic medical record (EMR) applications on several different device types. We present our experience with conducting general teleneurology encounters using secure synchronous audio and video connections integrated with an EMR. This report also details how we perform virtual neurologic examinations that are clinically meaningful and how we document, code, and bill for these virtual services. Many of these processes can be used by other neurology providers, regardless of their specific practice model. We then discuss potential roles for teleneurology after the COVID-19 global pandemic has been contained.

Collaborative Research: Once More Into the Breach

PEDIATRICS ◽  
1988 ◽  
Vol 82 (3) ◽  
pp. 510-511
Author(s):  
EVAN CHARNEY
Keyword(s):  
Clinical Practice ◽  
Clinical Research ◽  
Collaborative Research ◽  
Molecular Level ◽  
Organ System ◽  
Biomedical Science ◽  
Memorial Hospital ◽  
Narrow Focus ◽  
Higher Power ◽  
Practice Based Research

In this issue, Christoffel and associates1 described a new program of practice-based research involving community pediatricians and the Department of Pediatrics at Children's Memorial Hospital in Chicago. In one sense, all clinical research is practice based and has a long and honorable history in medicine. What has changed is that the gap between those who conduct research and those in clinical practice has widened. As the pathophysiology of diseases is better understood, the frontier of biomedical science has moved from the whole patient to the organ system, the cell, and, now, the molecular level. It is as if each generation of researchers has snapped a progressively higher power lens under the microscope, with a deeper but more narrow focus.

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