Considering Actionability at the Participant's Research Setting Level for Anticipatable Incidental Findings from Clinical Research

2015 ◽  
Vol 43 (3) ◽  
pp. 619-632
Author(s):  
Alberto (Betto) Ortiz-Osorno ◽  
Linda A. Ehler ◽  
Judith Brooks

Wolf et al. define an incidental finding (IF) as “... a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of the study...” Wolf et al. also propose that researchers “... should consider what kinds of IFs the protocol may produce and how rapidly the identification and evaluation process needs to proceed to provide timely information to the research participant and avoid harm.”Recently, the U.S. Presidential Commission for the Study of Bioethical Issues considered the matter of IFs. In the Commission's December 2013 report on this topic, “Anticipate and Communicate–Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts,” the panel further defines two categories of IFs, anticipatable and un-anticipatable, as well as introduces the concept of secondary findings. The commission recommends that researchers should develop plans to manage anticipatable IFs, and should consider to actively look for secondary findings.

2010 ◽  
Vol 38 (1) ◽  
pp. 117-126 ◽  
Author(s):  
Erica K. Rangel

With improved diagnostic capability and accuracy, the fields of medicine, neuroscience, psychiatry, and psychology have benefitted remarkably from the dramatic advancements in neuroimaging technology. Not only can surface and subsurface structures of the brain be mapped with incredible anatomical detail (with magnetic resonance imaging), now neural activity can be imaged across time as the brain responds to different stimuli (with functional magnetic resonance imaging). These sophisticated techniques have been a vital element in the recent increase in neuroimaging-based research. This increase, while producing new diagnostic techniques and improved treatment mechanisms for neurological disease, has also led to a new dilemma for human subjects researchers: how should incidental findings be managed? An incidental finding (IF) is a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of this study.


2020 ◽  
Vol 4 (6) ◽  
pp. 485-492
Author(s):  
Stephanie Schuckman ◽  
Lynn Babcock ◽  
Cristina Spinner ◽  
Opeolu Adeoye ◽  
Dina Gomaa ◽  
...  

AbstractIntroduction:Acute care research (ACR) is uniquely challenged by the constraints of recruiting participants and conducting research procedures within minutes to hours of an unscheduled critical illness or injury. Existing competencies for clinical research professionals (CRPs) are gaining traction but may have gaps for the acute environment. We sought to expand existing CRP competencies to include the specialized skills needed for ACR settings.Methods:Qualitative data collected from job shadowing, clinical observations, and interviews were analyzed to assess the educational needs of the acute care clinical research workforce. We identified competencies necessary to succeed as an ACR-CRP, and then applied Bloom’s Taxonomy to develop characteristics into learning outcomes that frame both knowledge to be acquired and job performance metrics.Results:There were 28 special interest competencies for ACR-CRPs identified within the eight domains set by the Joint Task Force (JTF) of Clinical Trial Competency. While the eight domains were not prioritized by the JTF, in ACR an emphasis on Communication and Teamwork, Clinical Trials Operations, and Data Management and Informatics was observed. Within each domain, distinct proficiencies and unique personal characteristics essential for success were identified. The competencies suggest that a combination of competency-based training, behavioral-based hiring practices, and continuing professional development will be essential to ACR success.Conclusion:The competencies developed for ACR can serve as a training guide for CRPs to be prepared for the challenges of conducting research within this vulnerable population. Hiring, training, and supporting the development of this workforce are foundational to clinical research in this challenging setting.


Author(s):  
Robin Lee ◽  
Karen Dahri ◽  
Tim T Y Lau ◽  
Stephen Shalansky

<p><strong>ABSTRACT</strong></p><p><strong>Background: </strong>Few studies have attempted to determine the proportion of Canadian hospital pharmacists involved in clinical research, despite a general consensus that research should be an essential component of a pharmacist’s professional role.</p><p><strong>Objectives: </strong>The primary objective was to characterize the involvement in clinical pharmacy research of hospital pharmacists in the 4 health authorities of the Lower Mainland of British Columbia (collectively known as the Lower Mainland Pharmacy Services). The secondary objective was to identify perceived barriers to conducting research.</p><p><strong>Methods: </strong>Pharmacists employed within Lower Mainland Pharmacy Services were invited to participate in an online cross-sectional survey, for completion in August and September 2015. Descriptive statistics were used to analyze the results. Groups of survey participants were compared to examine differences in measured outcomes.</p><p><strong>Results: </strong>A total of 534 pharmacists were surveyed, with a response rate of 16% (85/534). Overall, 77% (55/71) of the respondents reported having participated in research, and 87% (62/71) expressed interest in conducting future research. Chart reviews (78%, 36/46) and surveys (41%, 19/46) were the most common study designs used in prior research. Participants self-identified their research-related strengths as literature evaluation (46%, 27/59) and hypothesis generation (44%, 26/59). Conversely, 81% (48/59) of respondents self-identified statistical analysis as a weakness. Most respondents stated that personal satisfaction (82%, 49/60) and the opportunity to learn about disease states (78%, 47/60) were the driving factors for conducting research. The most commonly cited barrier to conducting research was lack of time (92%, 55/60). Opportunities to join existing teams (73%, 44/60) and mentorship programs (70%, 42/60) were identified as the most popular arrangements for encouraging future research.</p><p><strong>Conclusions: </strong>Most of the pharmacists who responded to this survey reported having participated in clinical pharmacy research, but a lack of dedicated time appears to be a major hurdle to greater research participation. A targeted program increasing exposure to existing research teams and mentorship opportunities is recommended for promoting future research.</p><p><strong>RÉSUMÉ</strong></p><p><strong>Contexte : </strong>Peu d’études ont cherché à déterminer la proportion de “pharmaciens d’hôpitaux canadiens qui contribuent à la recherché clinique, et ce, malgré un consensus voulant que la recherche doive être un élément essentiel du rôle professionnel des pharmaciens.</p><p><strong>Objectifs : </strong>L’objectif principal était d’offrir un portrait de la contribution à la recherche sur la pharmacie clinique des pharmaciens d’hôpitaux des quatre régies régionales des basses-terres continentales de la Colombie-Britannique (appelées collectivement <em>Lower Mainland Pharmacy Services</em>, c.-à-d. services de pharmacie des basses-terres continentales). L’objectif secondaire était de recenser les éléments perçus comme des obstacles à la réalisation de recherches.</p><p><strong>Méthodes : </strong>Les pharmaciens employés au sein des services de pharmacie des basses-terres continentales ont été invités à participer par voie électronique à une enquête transversale qui devait être complétée en août et en septembre 2015. Des statistiques descriptives ont été employées pour analyser les résultats. On a aussi comparé des groupes de participants à l’enquête afin d’examiner les différences entre les résultats mesurés.</p><p><strong>Résultats : </strong>Au total, 534 pharmaciens ont été sondés et le taux de réponse était de 16 % (85/534). Dans l’ensemble, 77 % (55/71) des répondants indiquaient avoir participé à des recherches et 87 % (62/71) souhaitaient faire de la recherche dans l’avenir. L’analyse de dossiers médicaux (78 %, 36/46) et les sondages (41 %, 19/46) représentaient les plans d’étude les plus utilisés par les répondants au cours de recherches antérieures. Les participants ont indiqué que leurs forces en lien avec la recherche étaient leur capacité d’évaluer la littérature (46 %, 27/59) et de formuler des hypothèses (44 %, 26/59). En revanche, 81 % (48/59) ont signalé l’analyse statistique comme leur point faible. La plupart des répondants croyaient que la satisfaction personnelle (82 %, 49/60) et la perspective d’acquérir des connaissances sur les maladies (78 %, 47/60) représentaient les principaux facteurs les motivant à faire de la recherche. Ce qui était évoqué le plus souvent comme un obstacle à la recherche était le manqué de temps (92 %, 55/60). Les occasions de se joindre à des équipes en place (73 %, 44/60) et les programmes de mentorat (70 %, 42/60) ont été désignés comme les dispositions les plus attrayantes pour encourager à poursuivre de futures recherches.</p><strong>Conclusions : </strong>La plupart des pharmaciens ayant répondu au sondage ont indiqué avoir contribué à des recherches en pharmacie clinique, mais le manque de temps réservé pour la recherche semblait être un obstacle important à une plus grande participation aux activités de recherche. Un programme ciblé multipliant les possibilités de fréquenter des équipes de recherche déjà établies et offrant plus d’occasions de mentorat serait une façon de promouvoir de futures recherches.


2017 ◽  
Vol 13 (7) ◽  
pp. e590-e601 ◽  
Author(s):  
Jada G. Hamilton ◽  
Elyse Shuk ◽  
Margaux C. Genoff ◽  
Vivian M. Rodríguez ◽  
Jennifer L. Hay ◽  
...  

Purpose: Tumor genomic profiling (TGP) can reveal secondary findings about inherited disease risks in a patient with cancer. Little is known about how patients with advanced cancer, currently the primary users of TGP, perceive the benefits and harms of secondary germline findings. Methods: We conducted semistructured interviews with 40 patients with advanced breast, bladder, colorectal, or lung cancer who had TGP. Qualitative interview data were evaluated by using a thematic content analysis approach. Results: Most participants expressed interest in the prospect of learning their secondary germline findings (57%), although a minority was equivocal (29%) or disinterested (14%). Reasons for these preferences varied but were influenced by participants’ perceptions of diverse benefits and harms of this information, which they regarded as relevant to themselves; their families; and other patients with cancer, medical science, and society. These attitudes were uniquely shaped by participants’ personal disease experiences and health status. Conclusion: Many patients with advanced cancer are interested in learning secondary germline findings and hold optimistic and perhaps unrealistic beliefs about the potential health benefits. Patients also have important concerns about clinical and emotional implications of this information. These perceptions are necessary to address to ensure that patients make informed decisions about learning secondary germline findings.


2019 ◽  
Vol 14 (2) ◽  
pp. 152-168
Author(s):  
Lucinda Manda-Taylor ◽  
Alice Liomba ◽  
Terrie E. Taylor ◽  
Kristan Elwell

Informed consent is an ethical requirement in clinical research. Obtaining informed consent is challenging in resource-constrained settings. We report results of a formative qualitative study that examined factors that facilitate and hinder informed consent for clinical research among critically ill children in Malawi. We argue that truly informed consent in a pediatric intensive care unit (PICU) is challenged by parental distress, time constraints when balancing care for critically ill patients with research-related tasks, and social hierarchies and community mistrust toward certain research procedures. We interviewed health care providers and parents of children attending a critical care unit to identify potential challenges and solicit strategies for addressing them. Providers and caregivers suggested practical solutions to enhance research participant understanding of clinical trial research, including the use of visual materials, community engagement strategies, and using patients as advocates in promoting understanding of research procedures.


2015 ◽  
Vol 41 (4) ◽  
pp. 568-616 ◽  
Author(s):  
Kayte Spector-Bagdady

The market for direct-to-consumer (DTC) health services continues to grow rapidly with former patients converting to customers for the opportunity to purchase varied diagnostic tests without the involvement of their clinician. For the first time a DTC genetic testing company is advertising health-related reports “that meet [Food and Drug Administration] standards for being clinically and scientifically valid.” Ethicists and regulatory agencies alike have recognized the need for a more informed transaction in the DTC context, but how should we classify a commercial transaction for something normally protected by a duty of care? How can we assure informed agreements in an industry with terms and conditions as varied as the services performed? The doctrine of “informed consent” began as an ethical construct building on the promise of beneficence in the clinical relationship and elevating the principle of autonomy—but in the DTC context should we hold providers to legal standards of informed consent and associated medical malpractice liability, or contractual obligations where consumers would seek remedy for breach?This Article analyzes the fine balance that must be struck in an industry where companies are selling services for entertainment or non-medical purposes that possess the capacity to produce serious and disquieting medical information. It begins by reviewing current standards of consent in the clinical setting from both a legal and ethical perspective and then lays forth current standards for DTC consent using two currently controversial case studies: that of keepsake fetal ultrasound and genetic testing.DTC keepsake ultrasound and genetic testing providers attempt to de-medicalize the devices used for these procedures from their intended medical uses to non-medical uses. But while keepsake ultrasound is marketed as “intended for entertainment purposes only,” it can provide medical information as an incidental finding. 23andMe currently purports to be the only DTC genetics service that “includes” reports that meet FDA qualifications, despite disclaimers of intent to “provide medical advice.” The attempted de-medicalization of these devices, therefore, has not been fully transformative, and DTC providers should have more robust ethical and legal duties than the average goods and services seller.This Article delineates these responsibilities, beginning with ethical duties surrounding marketing, entering into, and providing DTC services. It then turns to the legal paradigms necessary to enable, or at least allow for, DTC providers to meet these ethical obligations. While it argues that contractual, as opposed to fiduciary, requirements are most appropriate and that waivers of liability will likely be upheld, it also advocates for a heightened expectation of disclosure during contracting.


Author(s):  
A. L. Khokhlov ◽  
E. A. Polozova ◽  
V. A. Komissarova ◽  
N. V. Chudova ◽  
L. G. Tsyzman

Conducting of clinical trials is closely associated with the ethical justification, with ensuring the rights and safety of the subjects participating in them. Only through trials, it becomes possible to obtain reliable data for the inclusion of new drugs in practice, which are designed to save millions of lives. In the constantly developing field of clinical research, science does not stand still and it becomes necessary to conduct more and more new research: pediatric, geriatric, biomedical products and research involving acute social problems, and of course they all involve certain risks during their implementation. The question of the ethics of conducting research in the context of the COVID-19 pandemic is very relevant at the moment, when it is necessary to make quick decisions in the interests of all mankind, assessing all possible risks that they may entail.


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