Pub Date : 2022-08-24DOI: 10.1101/2022.08.23.22279138
Krista L. Snyder, Jon F. Merz
Background The US Food and Drug Administration and National Institutes of Health adopted the Exception from Informed Consent (EFIC) rule in 1996, permitting waiver of informed consent for certain emergency research, including trials funded by the federal government. The rule requires that prospective consent be sought when practicable from patients or their Legally Authorized Representative(s) (LAR), and for those enrolled without consent, the patient or their LAR must be given information and an opportunity to opt-out from continued participation at the earliest opportunity. We sought to census the trials conducted under the EFIC rule to facilitate research to better understand how the rule is being used.
{"title":"A Census of Clinical Trials Conducted Under the US Exception from Informed Consent Rule","authors":"Krista L. Snyder, Jon F. Merz","doi":"10.1101/2022.08.23.22279138","DOIUrl":"https://doi.org/10.1101/2022.08.23.22279138","url":null,"abstract":"<strong>Background</strong> The US Food and Drug Administration and National Institutes of Health adopted the Exception from Informed Consent (EFIC) rule in 1996, permitting waiver of informed consent for certain emergency research, including trials funded by the federal government. The rule requires that prospective consent be sought when practicable from patients or their Legally Authorized Representative(s) (LAR), and for those enrolled without consent, the patient or their LAR must be given information and an opportunity to opt-out from continued participation at the earliest opportunity. We sought to census the trials conducted under the EFIC rule to facilitate research to better understand how the rule is being used.","PeriodicalId":501154,"journal":{"name":"medRxiv - Medical Ethics","volume":"61 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138511575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-04-16DOI: 10.1101/2022.04.11.22273710
Katinka Hooyer
Posttraumatic Stress Disorder continues to be a highly stigmatized disease for the veteran population and stigma continues to be identified as the main deterrent in treatment seeking. Little attention has been paid to how the process of obtaining service-connected disability status can amplify veterans’ perceptions of being stigmatized. The following ethnographic study identified how combat veterans experienced stigma in processing through Veterans Affairs care and the effects of linking a Posttraumatic Stress Disorder diagnosis with disability compensation to perceived stigmas. Stigma was identified in two inter-related areas: 1) the structural level in the Veterans Affairs disability claims process and 2) the individual level in interactions with Veterans Affairs service providers. Results based on veterans’ narratives suggest that the disability claims process, requiring multiple repetitions of personal trauma, coupled with perceptions of institutional stigmas of malingering, created bureaugenic effects: a worsening of symptoms caused by bureaucratic protocols intended to help veterans. This process influenced first time treatment users of the Veterans Affairs by deterring treatment-seeking behavior but was not found to affect veterans who had already initiated treatment. Despite the experience of stigma and commodification of their suffering through disability and diagnostic screening, veterans still sought disability compensation. Veterans viewed this compensation as acknowledgment of their loss and validation of their sacrifice.
{"title":"The “Trauma Pitch”: How stigma emerges for Iraq and Afghanistan veterans seeking disability compensation","authors":"Katinka Hooyer","doi":"10.1101/2022.04.11.22273710","DOIUrl":"https://doi.org/10.1101/2022.04.11.22273710","url":null,"abstract":"Posttraumatic Stress Disorder continues to be a highly stigmatized disease for the veteran population and stigma continues to be identified as the main deterrent in treatment seeking. Little attention has been paid to how the process of obtaining service-connected disability status can amplify veterans’ perceptions of being stigmatized. The following ethnographic study identified how combat veterans experienced stigma in processing through Veterans Affairs care and the effects of linking a Posttraumatic Stress Disorder diagnosis with disability compensation to perceived stigmas. Stigma was identified in two inter-related areas: 1) the structural level in the Veterans Affairs disability claims process and 2) the individual level in interactions with Veterans Affairs service providers. Results based on veterans’ narratives suggest that the disability claims process, requiring multiple repetitions of personal trauma, coupled with perceptions of institutional stigmas of malingering, created <em>bureaugenic effects</em>: a worsening of symptoms caused by bureaucratic protocols intended to help veterans. This process influenced first time treatment users of the Veterans Affairs by deterring treatment-seeking behavior but was not found to affect veterans who had already initiated treatment. Despite the experience of stigma and commodification of their suffering through disability and diagnostic screening, veterans still sought disability compensation. Veterans viewed this compensation as acknowledgment of their loss and validation of their sacrifice.","PeriodicalId":501154,"journal":{"name":"medRxiv - Medical Ethics","volume":"55 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138511578","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-04-16DOI: 10.1101/2022.04.08.22273613
Joseph Ochieng, Betty Kwagala, John Barugahre, Marlo Möller, Keymanthri Moodley
Background Genetics and genomics research (GGR) is associated with several challenges including, but not limited to, implications of sharing research findings with participants and their family members, issues of confidentiality, determining appropriate methods for providing genetic or genomic information to individuals tested, and ownership of DNA obtained from the samples. Additionally, GGR holds significant potential risk for social and psychological harms.
{"title":"Feedback of Individual Genetic and Genomics Research Results: A Qualitative Study Involving Grassroots Communities in Uganda","authors":"Joseph Ochieng, Betty Kwagala, John Barugahre, Marlo Möller, Keymanthri Moodley","doi":"10.1101/2022.04.08.22273613","DOIUrl":"https://doi.org/10.1101/2022.04.08.22273613","url":null,"abstract":"<strong>Background</strong> Genetics and genomics research (GGR) is associated with several challenges including, but not limited to, implications of sharing research findings with participants and their family members, issues of confidentiality, determining appropriate methods for providing genetic or genomic information to individuals tested, and ownership of DNA obtained from the samples. Additionally, GGR holds significant potential risk for social and psychological harms.","PeriodicalId":501154,"journal":{"name":"medRxiv - Medical Ethics","volume":"58 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138511577","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-02-08DOI: 10.1101/2022.02.07.22270434
Martin Haslberger, Susanne Gabriele Schorr, Daniel Strech, Tamarinde Haven
Research ethics committees (RECs) and regulatory agencies assess whether the benefits of a proposed early-stage clinical trial outweigh the risks based on preclinical studies reported in investigator’s brochures (IBs). Recent studies have indicated that preclinical evidence presented in IBs is reported in a way that does not enable proper risk-benefit assessment. We interviewed different stakeholders (regulators, REC members, industry representatives, preclinical and clinical researchers, ethicists, and metaresearchers) about their views on measures to increase the completeness and robustness of preclinical evidence reporting in IBs.
{"title":"Preclinical Efficacy in Investigator’s Brochures: Stakeholders’ views on measures to improve Completeness and Robustness","authors":"Martin Haslberger, Susanne Gabriele Schorr, Daniel Strech, Tamarinde Haven","doi":"10.1101/2022.02.07.22270434","DOIUrl":"https://doi.org/10.1101/2022.02.07.22270434","url":null,"abstract":"Research ethics committees (RECs) and regulatory agencies assess whether the benefits of a proposed early-stage clinical trial outweigh the risks based on preclinical studies reported in investigator’s brochures (IBs). Recent studies have indicated that preclinical evidence presented in IBs is reported in a way that does not enable proper risk-benefit assessment. We interviewed different stakeholders (regulators, REC members, industry representatives, preclinical and clinical researchers, ethicists, and metaresearchers) about their views on measures to increase the completeness and robustness of preclinical evidence reporting in IBs.","PeriodicalId":501154,"journal":{"name":"medRxiv - Medical Ethics","volume":"47 5","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138511583","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-02DOI: 10.1101/2021.08.25.21262155
Nora Hutchinson, Katarzyna Klas, Benjamin G. Carlisle, Jonathan Kimmelman, Marcin Waligora
Background Early in the SARS-CoV-2 pandemic, commentators warned that some COVID trials were inadequately conceived, designed and reported. Here, we retrospectively assess the prevalence of informative COVID trials launched in the first 6 months of the pandemic.
{"title":"How Informative Were Early SARS-CoV-2 Treatment and Prevention Trials? A longitudinal cohort analysis of trials registered on clinicaltrials.gov","authors":"Nora Hutchinson, Katarzyna Klas, Benjamin G. Carlisle, Jonathan Kimmelman, Marcin Waligora","doi":"10.1101/2021.08.25.21262155","DOIUrl":"https://doi.org/10.1101/2021.08.25.21262155","url":null,"abstract":"<strong>Background</strong> Early in the SARS-CoV-2 pandemic, commentators warned that some COVID trials were inadequately conceived, designed and reported. Here, we retrospectively assess the prevalence of informative COVID trials launched in the first 6 months of the pandemic.","PeriodicalId":501154,"journal":{"name":"medRxiv - Medical Ethics","volume":"59 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138511576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-09-22DOI: 10.1101/2021.09.16.21263493
Tamarinde Haven, Martin Holst, Daniel Strech
Background Concerns about research waste have fueled debate about incentivizing individual researchers and research institutions to conduct responsible research. Instead of looking at impact factors or grants, research institutions should be assessed based on indicators that pertain to responsible research. In this study, we showed stakeholders a proof-of-principle dashboard with quantitative metrics that visualized responsible research performance on a German University Medical Center (UMC) level. Our research question was: What are stakeholders’ views on a dashboard that displays the adoption of responsible research practices on a UMC-level?
{"title":"Stakeholders’ views on an institutional dashboard with metrics for responsible research","authors":"Tamarinde Haven, Martin Holst, Daniel Strech","doi":"10.1101/2021.09.16.21263493","DOIUrl":"https://doi.org/10.1101/2021.09.16.21263493","url":null,"abstract":"<strong>Background</strong> Concerns about research waste have fueled debate about incentivizing individual researchers and research institutions to conduct responsible research. Instead of looking at impact factors or grants, research institutions should be assessed based on indicators that pertain to responsible research. In this study, we showed stakeholders a proof-of-principle dashboard with quantitative metrics that visualized responsible research performance on a German University Medical Center (UMC) level. Our research question was: What are stakeholders’ views on a dashboard that displays the adoption of responsible research practices on a UMC-level?","PeriodicalId":501154,"journal":{"name":"medRxiv - Medical Ethics","volume":"70 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138511572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-09-22DOI: 10.1101/2021.09.16.21263690
Jetske van der Schaar, Leonie N.C. Visser, Femke H. Bouwman, Philip Scheltens, Annelien L. Bredenoord, Wiesje M. van der Flier
Introduction The NIA-AA research framework proposes a purely biological definition of Alzheimer’s Disease (AD). This implies AD can be diagnosed based on biomarker abnormalities. While this brings opportunities, it also raises challenges.
{"title":"Considerations regarding a diagnosis of Alzheimer’s Disease before dementia: a systematic review","authors":"Jetske van der Schaar, Leonie N.C. Visser, Femke H. Bouwman, Philip Scheltens, Annelien L. Bredenoord, Wiesje M. van der Flier","doi":"10.1101/2021.09.16.21263690","DOIUrl":"https://doi.org/10.1101/2021.09.16.21263690","url":null,"abstract":"<strong>Introduction</strong> The NIA-AA research framework proposes a purely biological definition of Alzheimer’s Disease (AD). This implies AD can be diagnosed based on biomarker abnormalities. While this brings opportunities, it also raises challenges.","PeriodicalId":501154,"journal":{"name":"medRxiv - Medical Ethics","volume":"49 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138511579","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-08-27DOI: 10.1101/2021.08.23.21262478
Maia Salholz-Hillel, Daniel Strech, Benjamin Gregory Carlisle
Objective To evaluate links between registration and publication across clinical trials led by German university medical centers (UMCs) and registered in either ClinicalTrials.gov or the German Clinical Trials Registry (DRKS). Inadequate links make trial publications and registrations less findable and compromise evidence synthesis and health policy decision making. The World Health Organization (WHO) and others call for better adoption of this straightforward transparency practice.
{"title":"Results publications are inadequately linked to trial registrations: An automated pipeline and evaluation of German university medical centers","authors":"Maia Salholz-Hillel, Daniel Strech, Benjamin Gregory Carlisle","doi":"10.1101/2021.08.23.21262478","DOIUrl":"https://doi.org/10.1101/2021.08.23.21262478","url":null,"abstract":"<strong>Objective</strong> To evaluate links between registration and publication across clinical trials led by German university medical centers (UMCs) and registered in either ClinicalTrials.gov or the German Clinical Trials Registry (DRKS). Inadequate links make trial publications and registrations less findable and compromise evidence synthesis and health policy decision making. The World Health Organization (WHO) and others call for better adoption of this straightforward transparency practice.","PeriodicalId":501154,"journal":{"name":"medRxiv - Medical Ethics","volume":"67 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138511573","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-07-30DOI: 10.1101/2021.01.19.21250091
Jean-Pierre Boissel, David Pérol, Hervé Décousus, Ingrid Klingmann, Marc Hommel
In order to propose a more precise definition and explore how to reduce ethical losses in randomized controlled clinical trials (RCTs), we set out to identify trial participants who do not contribute to demonstrating that the treatment in the experimental arm is superior to that in the control arm. RCTs emerged mid-last century as the gold standard for assessing efficacy, becoming the cornerstone of the value of new therapies, yet their ethical grounds are a matter of debate. We introduce the concept of unnecessary participants in RCTs, the sum of non-informative participants and non-responders. The non-informative participants are considered not informative with respect to the efficacy measured in the trial in contrast to responders who carry all the information required to conclude on the treatment’s efficacy. The non-responders present the event whether or not they are treated with the experimental treatment. The unnecessary participants carry the burden of having to participate in a clinical trial without benefiting from it, which might include experiencing side effects. Thus, these unnecessary participants carry the ethical loss that is inherent to the RCT methodology. On the contrary, responders to the experimental treatment bear its entire efficacy in the RCT. Starting from the proportions observed in a real placebo-controlled trial from the literature, we carried out simulations of RCTs progressively increasing the proportion of responders up to 100%. We show that the number of unnecessary participants decreases steadily until the RCT’s ethical loss reaches a minimum. In parallel, the trial sample size decreases (presumably its cost as well), although the trial’s statistical power increases as shown by the increase of the chi-square comparing the event rates between the two arms. Thus, we expect that increasing the proportion of responders in RCTs would contribute to making them more ethically acceptable, with less false negative outcomes.
{"title":"Using numerical modeling and simulation to assess the ethical burden in clinical trials and how it relates to the proportion of responders in a trial sample","authors":"Jean-Pierre Boissel, David Pérol, Hervé Décousus, Ingrid Klingmann, Marc Hommel","doi":"10.1101/2021.01.19.21250091","DOIUrl":"https://doi.org/10.1101/2021.01.19.21250091","url":null,"abstract":"In order to propose a more precise definition and explore how to reduce ethical losses in randomized controlled clinical trials (RCTs), we set out to identify trial participants who do not contribute to demonstrating that the treatment in the experimental arm is superior to that in the control arm. RCTs emerged mid-last century as the gold standard for assessing efficacy, becoming the cornerstone of the value of new therapies, yet their ethical grounds are a matter of debate. We introduce the concept of unnecessary participants in RCTs, the sum of non-informative participants and non-responders. The non-informative participants are considered not informative with respect to the efficacy measured in the trial in contrast to responders who carry all the information required to conclude on the treatment’s efficacy. The non-responders present the event whether or not they are treated with the experimental treatment. The unnecessary participants carry the burden of having to participate in a clinical trial without benefiting from it, which might include experiencing side effects. Thus, these unnecessary participants carry the ethical loss that is inherent to the RCT methodology. On the contrary, responders to the experimental treatment bear its entire efficacy in the RCT. Starting from the proportions observed in a real placebo-controlled trial from the literature, we carried out simulations of RCTs progressively increasing the proportion of responders up to 100%. We show that the number of unnecessary participants decreases steadily until the RCT’s ethical loss reaches a minimum. In parallel, the trial sample size decreases (presumably its cost as well), although the trial’s statistical power increases as shown by the increase of the chi-square comparing the event rates between the two arms. Thus, we expect that increasing the proportion of responders in RCTs would contribute to making them more ethically acceptable, with less false negative outcomes.","PeriodicalId":501154,"journal":{"name":"medRxiv - Medical Ethics","volume":"65 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138511574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-04-06DOI: 10.1101/2021.03.31.21254735
Benjamin Tolchin, Carol Oladele, Deron Galusha, Nitu Kashyap, Mary Showstark, Jennifer Bonito, Michelle C. Salazar, Jennifer L. Herbst, Steve Martino, Nancy Kim, Katherine A. Nash, Max Jordan Nguemeni Tiako, Shireen Roy, Karen Jubanyik
Background Sequential Organ Failure Assessment (SOFA) score predicts probability of in-hospital mortality. Many crisis standards of care use SOFA score to allocate medical resources during the COVID-19 pandemic.
{"title":"Racial Disparities in the SOFA Score Among Patients Hospitalized with COVID-19","authors":"Benjamin Tolchin, Carol Oladele, Deron Galusha, Nitu Kashyap, Mary Showstark, Jennifer Bonito, Michelle C. Salazar, Jennifer L. Herbst, Steve Martino, Nancy Kim, Katherine A. Nash, Max Jordan Nguemeni Tiako, Shireen Roy, Karen Jubanyik","doi":"10.1101/2021.03.31.21254735","DOIUrl":"https://doi.org/10.1101/2021.03.31.21254735","url":null,"abstract":"<strong>Background</strong> Sequential Organ Failure Assessment (SOFA) score predicts probability of in-hospital mortality. Many crisis standards of care use SOFA score to allocate medical resources during the COVID-19 pandemic.","PeriodicalId":501154,"journal":{"name":"medRxiv - Medical Ethics","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138531674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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