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  1. Article ; Online: Consent during a pandemic.

    Vasant, R / Haigh, A

    British dental journal

    2020  Volume 228, Issue 11, Page(s) 809

    MeSH term(s) COVID-19 ; Humans ; Informed Consent ; Pandemics
    Keywords covid19
    Language English
    Publishing date 2020-06-09
    Publishing country England
    Document type Letter
    ZDB-ID 218090-x
    ISSN 1476-5373 ; 0007-0610
    ISSN (online) 1476-5373
    ISSN 0007-0610
    DOI 10.1038/s41415-020-1711-7
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    In stock of ZB MED Cologne/Königswinter

    Ul III Zs.143: Show issues Location:
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    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 447: Show issues

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  2. Article: Informed Consent in COVID-19-Research: An Ethical Analysis of Clinical Studies Performed during the Pandemic.

    Voit, Katja / Skuban-Eiseler, Tobias / Orzechowski, Marcin / Steger, Florian

    Healthcare (Basel, Switzerland)

    2023  Volume 11, Issue 12

    Abstract: ... studies. Aspects of research ethics, such as obtaining informed consent (IC), can be complicated. We are ... Health crises such as the current COVID-19 pandemic pose challenges to the conduct of clinical ...

    Abstract Health crises such as the current COVID-19 pandemic pose challenges to the conduct of clinical studies. Aspects of research ethics, such as obtaining informed consent (IC), can be complicated. We are concerned with whether or not the proper IC procedures were followed in the context of clinical studies at Ulm University in the years 2020 to 2022. We identified all protocols of clinical studies dealing with COVID-19 that the Research Ethics Committee of Ulm University has reviewed and voted on in the years 2020 to 2022. We then performed a thematic analysis regarding the following aspects: study type, handling of IC, type of patient information, means of communication, applied security precautions, and the approach to participants from vulnerable groups. We identified n = 98 studies that dealt with COVID-19. In n = 25 (25.51%), IC was obtained traditionally in written form, in n = 26 (26.53%) IC was waived, in n = 11 (11.22%) IC was obtained delayed, and in n = 19 (19.39%) IC was obtained by proxy. No study protocol was accepted that waived IC in case IC would have been required in times outside of pandemics. It is possible to obtain IC even in times of severe health crises. In the future, it is necessary to address in greater detail and with legal certainty which alternative methods of obtaining IC are possible and under which circumstances IC can be waived.
    Language English
    Publishing date 2023-06-17
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2721009-1
    ISSN 2227-9032
    ISSN 2227-9032
    DOI 10.3390/healthcare11121793
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  3. Article: Surgical Consent during COVID Pandemic: COVID Times-Surgical Consent Checklist.

    Jose, Toney / Joy, Arya

    The Indian journal of surgery

    2020  Volume 82, Issue 5, Page(s) 918–920

    Abstract: ... services is made. It also acts as a documentation of the discussions carried out during the consenting ... to the routine surgical consent, to ensure that the patients are able to make informed decisions. The first ever ... COVID-specific checklist for surgical consent 'COVID times-surgical consent checklist' is introduced ...

    Abstract COVID-19 caused many countries to stop their elective procedures to allow preservation of resources for COVID-19 care. With restriction being gradually lifted, the surgical services have to face the pending burden of elective cases alongside the pandemic. The true impact of the pandemic and the COVID-19 on perioperative outcomes is still being discovered. This demands a COVID-specific consenting process in addition to the routine surgical consent, to ensure that the patients are able to make informed decisions. The first ever COVID-specific checklist for surgical consent 'COVID times-surgical consent checklist' is introduced. This checklist enables the surgeon to ensure that a discussion detailing the impact of COVID-19 on surgical services is made. It also acts as a documentation of the discussions carried out during the consenting process.
    Keywords covid19
    Language English
    Publishing date 2020-08-03
    Publishing country India
    Document type Journal Article
    ZDB-ID 138063-1
    ISSN 0972-2068 ; 0019-5650
    ISSN 0972-2068 ; 0019-5650
    DOI 10.1007/s12262-020-02544-w
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    In stock of ZB MED Cologne/Königswinter

    Zs.B 334: Show issues Location:
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  4. Article: Is written informed consent 'cast in iron' even during a pandemic?

    Gupta, Pooja / Naeem, Syed Shariq / Mohan, Prafull / Banerjee, Amitav

    Medical journal, Armed Forces India

    2020  Volume 76, Issue 4, Page(s) 367–369

    Keywords covid19
    Language English
    Publishing date 2020-10-29
    Publishing country India
    Document type Editorial
    ZDB-ID 196342-9
    ISSN 0377-1237
    ISSN 0377-1237
    DOI 10.1016/j.mjafi.2020.10.007
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    In stock of ZB MED Cologne/Königswinter

    Zs.A 6511: Show issues Location:
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    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

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  5. Article: Surgical Consent during COVID Pandemic: COVID Times-Surgical Consent Checklist

    Jose, Toney / Joy, Arya

    Indian J Surg

    Abstract: ... services is made. It also acts as a documentation of the discussions carried out during the consenting ... to the routine surgical consent, to ensure that the patients are able to make informed decisions. The first ever ... COVID-specific checklist for surgical consent 'COVID times-surgical consent checklist' is introduced ...

    Abstract COVID-19 caused many countries to stop their elective procedures to allow preservation of resources for COVID-19 care. With restriction being gradually lifted, the surgical services have to face the pending burden of elective cases alongside the pandemic. The true impact of the pandemic and the COVID-19 on perioperative outcomes is still being discovered. This demands a COVID-specific consenting process in addition to the routine surgical consent, to ensure that the patients are able to make informed decisions. The first ever COVID-specific checklist for surgical consent 'COVID times-surgical consent checklist' is introduced. This checklist enables the surgeon to ensure that a discussion detailing the impact of COVID-19 on surgical services is made. It also acts as a documentation of the discussions carried out during the consenting process.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #692149
    Database COVID19

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  7. Article ; Online: The Use of Electronic Consent for COVID-19 Clinical Trials: Lessons for Emergency Care Research During a Pandemic and Beyond.

    Jaton, Eric / Stang, Jamie / Biros, Michelle / Staugaitis, Abbey / Scherber, Julie / Merkle, Florian / Mohr, Nicholas M / Streib, Christopher / Klein, Lauren / Puskarich, Michael A

    Academic emergency medicine : official journal of the Society for Academic Emergency Medicine

    2020  Volume 27, Issue 11, Page(s) 1183–1186

    Keywords covid19
    Language English
    Publishing date 2020-11-03
    Publishing country United States
    Document type Letter
    ZDB-ID 1329813-6
    ISSN 1553-2712 ; 1069-6563
    ISSN (online) 1553-2712
    ISSN 1069-6563
    DOI 10.1111/acem.14141
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    In stock of ZB MED Cologne/Königswinter

    Zs.A 4479: Show issues Location:
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    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

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  8. Article ; Online: Care of women and application of the principle of informed consent to interventions during birth in the COVID-19 pandemic period.

    Liepinaitienė, Alina / Bujaitė, Izabelė / Galkontas, Aurimas / Jotautis, Vaidas / Dėdelė, Audrius

    European journal of midwifery

    2024  Volume 8

    Abstract: ... as possible. The application of the principle of informed consent to interventions during the COVID-19 ... of relatives during childbirth, and consent was often not asked for vaginal examination. ... in Lithuania to reveal the care of women who gave birth during the COVID-19 pandemic and the application ...

    Abstract Introduction: In the early phases of the COVID-19 pandemic, inadequate intrapartum care protocols were in place. Many organizations have responded promptly and recognized the importance of adherence to appropriate guidelines. The International Confederation of Midwives issued an official statement on 29 March 2020, which states that every woman has the right to information, to give consent, to refuse consent, and to have her choices and decisions respected and upheld. No research has been conducted in Lithuania to reveal the care of women who gave birth during the COVID-19 pandemic and the application of informed consent to interventions.
    Methods: This study is quantitative of cross-sectional design. An anonymous questionnaire survey method was used. One hundred fifty-two women who gave birth in Lithuania during the COVID-19 pandemic (March 2020 - May 2022) and had COVID-19 infection during childbirth, participated in the study. Statistical data analysis was performed.
    Results: During the COVID-19 pandemic, women's care was characterized by always or almost always adequate information from health professionals on all issues to minimize the stress of new procedures necessitated by the COVID-19 pandemic and allowing them to stay with newborns as long as possible. The application of the principle of informed consent to interventions during the COVID-19 pandemic was not always applied to the performance of transvaginal examination manual compression of the uterine fundus to facilitate the expulsion period.
    Conclusions: Most women said that they were properly informed by healthcare professionals about all questions related to the new procedures that became necessary due to the COVID-19 pandemic and felt included in their own choice. However, mothers felt the need of relatives during childbirth, and consent was often not asked for vaginal examination.
    Language English
    Publishing date 2024-05-01
    Publishing country Greece
    Document type Journal Article
    ISSN 2585-2906
    ISSN (online) 2585-2906
    DOI 10.18332/ejm/186069
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Monitoring advances including consent: learning from COVID-19 trials and other trials running in UKCRC registered clinical trials units during the pandemic.

    Love, Sharon B / Armstrong, Emma / Bayliss, Carrie / Boulter, Melanie / Fox, Lisa / Grumett, Joanne / Rafferty, Patricia / Temesi, Barbara / Wills, Krista / Corkhill, Andrea

    Trials

    2021  Volume 22, Issue 1, Page(s) 279

    Abstract: ... required for the conduct of clinical trials during the pandemic; this paper describes many of the learnings ... Informed consent is included as a specific issue within this paper, as review of completed consent documentation is ... workable solutions can be found using only central or central and remote monitoring. eConsent, consent ...

    Abstract The COVID-19 pandemic has affected how clinical trials are managed, both within existing portfolios and for the rapidly developed COVID-19 trials. Sponsors or delegated organisations responsible for monitoring trials have needed to consider and implement alternative ways of working due to the national infection risk necessitating restricted movement of staff and public, reduced clinical staff resource as research staff moved to clinical areas, and amended working arrangements for sponsor and sponsor delegates as staff moved to working from home.Organisations have often worked in isolation to fast track mitigations required for the conduct of clinical trials during the pandemic; this paper describes many of the learnings from a group of monitoring leads based in United Kingdom Clinical Research Collaboration (UKCRC) Clinical Trials Unit (CTUs) within the UK.The UKCRC Monitoring Task and Finish Group, comprising monitoring leads from 9 CTUs, met repeatedly to identify how COVID-19 had affected clinical trial monitoring. Informed consent is included as a specific issue within this paper, as review of completed consent documentation is often required within trial monitoring plans (TMPs). Monitoring is defined as involving on-site monitoring, central monitoring or/and remote monitoring.Monitoring, required to protect the safety of the patients and the integrity of the trial and ensure the protocol is followed, is often best done by a combination of central, remote and on-site monitoring. However, if on-site monitoring is not possible, workable solutions can be found using only central or central and remote monitoring. eConsent, consent by a third person, or via remote means is plausible. Minimising datasets to the critical data reduces workload for sites and CTU staff. Home working caused by COVID-19 has made electronic trial master files (TMFs) more inviting. Allowing sites to book and attend protocol training at a time convenient to them has been successful and worth pursuing for trials with many sites in the future.The arrival of COVID-19 in the UK has forced consideration of and changes to how clinical trials are conducted in relation to monitoring. Some developed practices will be useful in other pandemics and others should be incorporated into regular use.
    MeSH term(s) COVID-19 ; Clinical Trials as Topic ; Humans ; Informed Consent ; Pandemics ; United Kingdom
    Language English
    Publishing date 2021-04-14
    Publishing country England
    Document type Journal Article
    ZDB-ID 2040523-6
    ISSN 1745-6215 ; 1468-6694 ; 1745-6215
    ISSN (online) 1745-6215
    ISSN 1468-6694 ; 1745-6215
    DOI 10.1186/s13063-021-05225-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Informed consent and trial prioritization for clinical studies during the COVID-19 pandemic. Stakeholder experiences and viewpoints.

    Weigold, Stefanie / Schorr, Susanne Gabriele / Faust, Alice / Woydack, Lena / Strech, Daniel

    PloS one

    2024  Volume 19, Issue 4, Page(s) e0302755

    Abstract: ... response strategies for informed consent and study prioritization in a pandemic setting.: Methods ... We performed semi-structured interviews with German stakeholders involved in clinical research during the COVID ... strategies for effective and efficient translation of informed consent and study prioritization in times ...

    Abstract Background: Very little is known about the practice-oriented challenges and potential response strategies for effective and efficient translation of informed consent and study prioritization in times of a pandemic. This stakeholder interview study aimed to identify the full spectrum of challenges and potential response strategies for informed consent and study prioritization in a pandemic setting.
    Methods: We performed semi-structured interviews with German stakeholders involved in clinical research during the COVID-19 pandemic. We continued sampling and thematic text analysis of interview transcripts until thematic saturation of challenges and potential response strategies was reached.
    Results: We conducted 21 interviews with investigators, oversight bodies, funders and research support units. For the first topic informed consent we identified three main themes: consent challenges, impact of consent challenges on clinical research, and potential strategies for consent challenges. For the second topic prioritization of clinical studies, we identified two main themes: perceived benefit of prioritization and potential strategies for prioritization. All main themes are further specified with subthemes. A supplementary table provides original quotes from the interviews for all subthemes.
    Discussion: Potential response strategies for challenges with informed consent and study prioritization partly share common ground. High quality procedures for study prioritization, for example, seem to be a core response strategy in dealing with informed consent challenges. Especially in a research environment with particularly high uncertainty regarding potential treatment effects and further limitations for valid informed consent should the selection of clinical trials be very well justified from a scientific, medical, and ethics viewpoint.
    MeSH term(s) Humans ; COVID-19/epidemiology ; COVID-19/psychology ; Informed Consent/ethics ; Pandemics ; Clinical Trials as Topic/ethics ; SARS-CoV-2 ; Stakeholder Participation ; Germany ; Interviews as Topic
    Language English
    Publishing date 2024-04-30
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2267670-3
    ISSN 1932-6203 ; 1932-6203
    ISSN (online) 1932-6203
    ISSN 1932-6203
    DOI 10.1371/journal.pone.0302755
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