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  1. Article ; Online: Consent in the time of COVID-19.

    Turnham, Helen Lynne / Dunn, Michael / Hill, Elaine / Thornburn, Guy T / Wilkinson, Dominic

    Journal of medical ethics

    2020  Volume 46, Issue 9, Page(s) 565–568

    Abstract: The COVID-19 pandemic crisis has necessitated widespread adaptation of revised treatment regimens ... for both urgent and routine medical problems in patients with and without COVID-19. Some of these alternative ... a nuanced discussion about treatments that would be considered in other times but currently unavailable ...

    Abstract The COVID-19 pandemic crisis has necessitated widespread adaptation of revised treatment regimens for both urgent and routine medical problems in patients with and without COVID-19. Some of these alternative treatments maybe second-best. Treatments that are known to be superior might not be appropriate to deliver during a pandemic when consideration must be given to distributive justice and protection of patients and their medical teams as well the importance given to individual benefit and autonomy. What is required of the doctor discussing these alternative, potentially inferior treatments and seeking consent to proceed? Should doctors share information about unavailable but standard treatment alternatives when seeking consent? There are arguments in defence of non-disclosure; information about unavailable treatments may not aid a patient to weigh up options that are available to them. There might be justified concern about distress for patients who are informed that they are receiving second-best therapies. However, we argue that doctors should tailor information according to the needs of the individual patient. For most patients that will include a nuanced discussion about treatments that would be considered in other times but currently unavailable. That will sometimes be a difficult conversation, and require clinicians to be frank about limited resources and necessary rationing. However, transparency and honesty will usually be the best policy.
    MeSH term(s) Beneficence ; Betacoronavirus ; COVID-19 ; Coronavirus Infections/epidemiology ; Coronavirus Infections/virology ; Disclosure/ethics ; Ethics, Medical ; Health Care Rationing ; Humans ; Informed Consent/ethics ; Pandemics ; Personal Autonomy ; Physicians ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/virology ; SARS-CoV-2 ; Social Justice ; Standard of Care
    Keywords covid19
    Language English
    Publishing date 2020-06-10
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 194927-5
    ISSN 1473-4257 ; 0306-6800
    ISSN (online) 1473-4257
    ISSN 0306-6800
    DOI 10.1136/medethics-2020-106402
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1163: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  2. Article: Modeling consent in the time of COVID-19.

    Knoppers, Bartha Maria / Beauvais, Michael J S / Joly, Yann / Zawati, Man H / Rousseau, Simon / Chassé, Michaël / Mooser, Vincent

    Journal of law and the biosciences

    2020  Volume 7, Issue 1, Page(s) lsaa020

    Abstract: ... In this article, we propose a tripartite approach to consent to create resources for research relating to COVID-19 ... Effective responses to the COVID-19 pandemic require novel solutions for research and responsible ... data sharing. Biobanking presents itself as a key priority in furthering our understanding of COVID-19 ...

    Abstract Effective responses to the COVID-19 pandemic require novel solutions for research and responsible data sharing. Biobanking presents itself as a key priority in furthering our understanding of COVID-19. In this article, we propose a tripartite approach to consent to create resources for research relating to COVID-19. The approach aims to link three levels of participation: COVID-19 patients, respiratory/infectious disease patients, and longitudinal study participants. We explore the potential approaches that can be taken to consent processes with these three participant groups. We furthermore describe an access model for both single-site and multi-site data and sample storage. Through dealing with these topics at a high level, the model may be adapted to local legal and ethical requirements while still pursuing its ultimate goal: the creation of a research infrastructure that supports transparent, strong, and open science.
    Keywords covid19
    Language English
    Publishing date 2020-05-08
    Publishing country England
    Document type Journal Article
    ZDB-ID 2756090-9
    ISSN 2053-9711
    ISSN 2053-9711
    DOI 10.1093/jlb/lsaa020
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Time to modify informed consent in the COVID-19 era!

    Gulia, Abhity / Gupta, Anju / Sharma, Prateek / Gupta, Nishkarsh

    Indian journal of cancer

    2021  Volume 58, Issue 1, Page(s) 143–144

    MeSH term(s) COVID-19/diagnosis ; COVID-19/epidemiology ; COVID-19/prevention & control ; Humans ; Informed Consent/standards ; Perioperative Period ; Risk ; SARS-CoV-2
    Language English
    Publishing date 2021-03-05
    Publishing country India
    Document type Letter
    ZDB-ID 410194-7
    ISSN 1998-4774 ; 0019-509X
    ISSN (online) 1998-4774
    ISSN 0019-509X
    DOI 10.4103/ijc.IJC_694_20
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.B 581: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

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  4. Article ; Online: Consent in the time of COVID-19

    Turnham, Helen Lynne / Dunn, Michael / Hill, Elaine / Thornburn, Guy T / Wilkinson, Dominic

    Journal of Medical Ethics

    2020  Volume 46, Issue 9, Page(s) 565–568

    Abstract: The COVID-19 pandemic crisis has necessitated widespread adaptation of revised treatment regimens ... for both urgent and routine medical problems in patients with and without COVID-19. Some of these alternative ... a nuanced discussion about treatments that would be considered in other times but currently unavailable ...

    Abstract The COVID-19 pandemic crisis has necessitated widespread adaptation of revised treatment regimens for both urgent and routine medical problems in patients with and without COVID-19. Some of these alternative treatments maybe second-best. Treatments that are known to be superior might not be appropriate to deliver during a pandemic when consideration must be given to distributive justice and protection of patients and their medical teams as well the importance given to individual benefit and autonomy. What is required of the doctor discussing these alternative, potentially inferior treatments and seeking consent to proceed? Should doctors share information about unavailable but standard treatment alternatives when seeking consent? There are arguments in defence of non-disclosure; information about unavailable treatments may not aid a patient to weigh up options that are available to them. There might be justified concern about distress for patients who are informed that they are receiving second-best therapies. However, we argue that doctors should tailor information according to the needs of the individual patient. For most patients that will include a nuanced discussion about treatments that would be considered in other times but currently unavailable. That will sometimes be a difficult conversation, and require clinicians to be frank about limited resources and necessary rationing. However, transparency and honesty will usually be the best policy.
    Keywords Health Policy ; Arts and Humanities (miscellaneous) ; Issues, ethics and legal aspects ; Health(social science) ; covid19
    Language English
    Publisher BMJ
    Publishing country uk
    Document type Article ; Online
    ZDB-ID 194927-5
    ISSN 1473-4257 ; 0306-6800
    ISSN (online) 1473-4257
    ISSN 0306-6800
    DOI 10.1136/medethics-2020-106402
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    Full text online

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    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 1163: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  5. Article: Consent in the time of COVID-19

    Turnham, Helen Lynne / Dunn, Michael / Hill, Elaine / Thornburn, Guy T / Wilkinson, Dominic

    J Med Ethics

    Abstract: The COVID-19 pandemic crisis has necessitated widespread adaptation of revised treatment regimens ... for both urgent and routine medical problems in patients with and without COVID-19. Some of these alternative ... a nuanced discussion about treatments that would be considered in other times but currently unavailable ...

    Abstract The COVID-19 pandemic crisis has necessitated widespread adaptation of revised treatment regimens for both urgent and routine medical problems in patients with and without COVID-19. Some of these alternative treatments maybe second-best. Treatments that are known to be superior might not be appropriate to deliver during a pandemic when consideration must be given to distributive justice and protection of patients and their medical teams as well the importance given to individual benefit and autonomy. What is required of the doctor discussing these alternative, potentially inferior treatments and seeking consent to proceed? Should doctors share information about unavailable but standard treatment alternatives when seeking consent? There are arguments in defence of non-disclosure; information about unavailable treatments may not aid a patient to weigh up options that are available to them. There might be justified concern about distress for patients who are informed that they are receiving second-best therapies. However, we argue that doctors should tailor information according to the needs of the individual patient. For most patients that will include a nuanced discussion about treatments that would be considered in other times but currently unavailable. That will sometimes be a difficult conversation, and require clinicians to be frank about limited resources and necessary rationing. However, transparency and honesty will usually be the best policy.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #596572
    Database COVID19

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  6. Book ; Online: Consent in the time of COVID-19

    Turnham, Helen Lynne / Dunn, Michael / Hill, Elaine / Thornburn, Guy T / Wilkinson, Dominic

    2020  

    Abstract: The COVID-19 pandemic crisis has necessitated widespread adaptation of revised treatment regimens ... for both urgent and routine medical problems in patients with and without COVID-19. Some of these alternative ... a nuanced discussion about treatments that would be considered in other times but currently unavailable ...

    Abstract The COVID-19 pandemic crisis has necessitated widespread adaptation of revised treatment regimens for both urgent and routine medical problems in patients with and without COVID-19. Some of these alternative treatments maybe second-best. Treatments that are known to be superior might not be appropriate to deliver during a pandemic when consideration must be given to distributive justice and protection of patients and their medical teams as well the importance given to individual benefit and autonomy. What is required of the doctor discussing these alternative, potentially inferior treatments and seeking consent to proceed? Should doctors share information about unavailable but standard treatment alternatives when seeking consent? There are arguments in defence of non-disclosure; information about unavailable treatments may not aid a patient to weigh up options that are available to them. There might be justified concern about distress for patients who are informed that they are receiving second-best therapies. However, we argue that doctors should tailor information according to the needs of the individual patient. For most patients that will include a nuanced discussion about treatments that would be considered in other times but currently unavailable. That will sometimes be a difficult conversation, and require clinicians to be frank about limited resources and necessary rationing. However, transparency and honesty will usually be the best policy.
    Keywords Current controversy ; covid19
    Language English
    Publishing date 2020-09-01 00:00:00.0
    Publisher BMJ Publishing Group Ltd
    Publishing country us
    Document type Book ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    Full text online

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  7. Article: Rethinking informed consent in the time of COVID-19: An exploratory survey.

    De Sutter, Evelien / Lalova-Spinks, Teodora / Borry, Pascal / Valcke, Peggy / Kindt, Els / Negrouk, Anastassia / Verhenneman, Griet / Derèze, Jean-Jacques / Storme, Ruth / Huys, Isabelle

    Frontiers in medicine

    2022  Volume 9, Page(s) 995688

    Abstract: ... previously enrolled research participants upon study amendments or to obtain consent from COVID-19 patients ... Background: Owing to the infectious nature of COVID-19, alternative solutions, such as electronic ... is rarely available. The results also showed that the COVID-19 pandemic brought additional challenges ...

    Abstract Background: Owing to the infectious nature of COVID-19, alternative solutions, such as electronic informed consent (eIC), needed to be implemented to inform research participants about study-related information and to obtain their consent. This study aimed to investigate stakeholders' experiences with alternative consenting methods as well as their views on any regulatory or legal guidelines for eIC implementation in clinical research. Results may serve as the cornerstone to rethink the informed consent process in clinical research.
    Materials and methods: This study consisted of an online survey among three stakeholder groups across European Union (EU) Member States and the United Kingdom. The stakeholder groups included (i) investigators, (ii) data protection officers (DPOs) or legal experts working in the pharmaceutical industry, academia, and academic biobanks, and (iii) ethics committee (EC) members. Data collection occurred between April and December 2021. The data collected were analyzed using descriptive and inferential statistics.
    Results: The online survey was completed by 191 respondents, of whom 52% were investigators. Respondents were active in 24 out of the 27 EU Member States and the United Kingdom. The majority of each stakeholder group considered validated electronic methods moderately or extremely useful to re-consent previously enrolled research participants upon study amendments or to obtain consent from COVID-19 patients. Nevertheless, this exploratory survey identified that only 13% of DPOs/legal experts, 26% of investigators, and 41% of EC members had experience with eIC. In addition, results suggest that the legal acceptance of eIC across EU Member States and the United Kingdom is variable and that a definition of eIC, issued by national law or policy, is rarely available. The results also showed that the COVID-19 pandemic brought additional challenges to inform participants and to obtain their consent; for example, related to travel restrictions.
    Conclusion: A number of alternative consenting methods were recommended, for example by the European Medicines Agency, to ensure clinical study continuation during the COVID-19 pandemic. Although stakeholders support the use of eIC in clinical research, it seems that the experience with eIC is low. To harmonize eIC practices as much as possible, further investments in multi-stakeholder, multi-national guidance are needed.
    Language English
    Publishing date 2022-09-27
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2775999-4
    ISSN 2296-858X
    ISSN 2296-858X
    DOI 10.3389/fmed.2022.995688
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Modelling Consent in the Time of COVID-19

    Knoppers, Bartha Maria / Beauvais, Michael J S / Joly, Yann / Zawati, Ma'n H / Rousseau, Simon / Chassé, Michaël / Mooser, Vincent

    J Law Biosci

    Abstract: ... In this article, we propose a tripartite approach to consent to create resources for research relating to COVID-19 ... Effective responses to the COVID-19 pandemic require novel solutions for research and responsible ... data sharing. Biobanking presents itself as a key priority in furthering our understanding of COVID-19 ...

    Abstract Effective responses to the COVID-19 pandemic require novel solutions for research and responsible data sharing. Biobanking presents itself as a key priority in furthering our understanding of COVID-19. In this article, we propose a tripartite approach to consent to create resources for research relating to COVID-19. The approach aims to link three levels of participation: COVID-19 patient, respiratory/infectious disease patients, and longitudinal study participants. We explore the potential approaches that can be taken to consent processes with these three participant groups. We furthermore describe an access model for both single-site and multi-site data and sample storage. Through dealing with these topics at a high level, the model may be adapted to local legal and ethical requirements while still pursuing its ultimate goal: the creation of a research infrastructure that supports transparent, strong, and open science.
    Keywords covid19
    Publisher PMC
    Document type Article ; Online
    DOI 10.1093/jlb/lsaa020
    Database COVID19

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  9. Article: Modeling consent in the time of COVID-19

    Knoppers, Bartha Maria / Beauvais, Michael J. S. / Joly, Yann / Zawati, Man H. / Rousseau, Simon / Chassé, Michaël Mooser / Vincent,

    Journal of law and the biosciences

    Abstract: ... In this article, we propose a tripartite approach to consent to create resources for research relating to COVID-19 ... Effective responses to the COVID-19 pandemic require novel solutions for research and responsible ... data sharing Biobanking presents itself as a key priority in furthering our understanding of COVID-19 ...

    Abstract Effective responses to the COVID-19 pandemic require novel solutions for research and responsible data sharing Biobanking presents itself as a key priority in furthering our understanding of COVID-19 In this article, we propose a tripartite approach to consent to create resources for research relating to COVID-19 The approach aims to link three levels of participation: COVID-19 patients, respiratory/infectious disease patients, and longitudinal study participants We explore the potential approaches that can be taken to consent processes with these three participant groups We furthermore describe an access model for both single-site and multi-site data and sample storage Through dealing with these topics at a high level, the model may be adapted to local legal and ethical requirements while still pursuing its ultimate goal: the creation of a research infrastructure that supports transparent, strong, and open science
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #690685
    Database COVID19

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    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

  10. Article ; Online: Modeling consent in the time of COVID-19

    Knoppers, Bartha Maria / Beauvais, Michael J S / Joly, Yann / Zawati, Man H / Rousseau, Simon / Chassé, Michaël / Mooser, Vincent

    Journal of Law and the Biosciences

    2020  Volume 7, Issue 1

    Abstract: ... of COVID-19. In this article, we propose a tripartite approach to consent to create resources for research ... Abstract Effective responses to the COVID-19 pandemic require novel solutions for research and ... relating to COVID-19. The approach aims to link three levels of participation: COVID-19 patients ...

    Abstract Abstract Effective responses to the COVID-19 pandemic require novel solutions for research and responsible data sharing. Biobanking presents itself as a key priority in furthering our understanding of COVID-19. In this article, we propose a tripartite approach to consent to create resources for research relating to COVID-19. The approach aims to link three levels of participation: COVID-19 patients, respiratory/infectious disease patients, and longitudinal study participants. We explore the potential approaches that can be taken to consent processes with these three participant groups. We furthermore describe an access model for both single-site and multi-site data and sample storage. Through dealing with these topics at a high level, the model may be adapted to local legal and ethical requirements while still pursuing its ultimate goal: the creation of a research infrastructure that supports transparent, strong, and open science.
    Keywords covid19
    Language English
    Publisher Oxford University Press (OUP)
    Publishing country uk
    Document type Article ; Online
    ZDB-ID 2756090-9
    ISSN 2053-9711
    ISSN 2053-9711
    DOI 10.1093/jlb/lsaa020
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

    Full text online

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