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  1. Article ; Online: Human Whole-Eye Donation for Research-Optimizing Clinical Trial Informed Consent.

    Bramstedt, Katrina A

    JAMA ophthalmology

    2024  

    Abstract: Importance: Posthumous whole-eye (globe) donations for research lack a mechanism that reinvolves the existing ophthalmic research team of the donor unless there is a preplanned donor directive. Disconnection between the deceased and their research team ... ...

    Abstract Importance: Posthumous whole-eye (globe) donations for research lack a mechanism that reinvolves the existing ophthalmic research team of the donor unless there is a preplanned donor directive. Disconnection between the deceased and their research team equates to lost opportunities for the research team to have a longitudinal view of the eyes that have been involved in their research.
    Objectives: To use the clinical trial informed consent process to create a posthumous research donation opportunity that directs the donation to the currently affiliated research team of the donors (preserving the longitudinal research experience).
    Evidence reviewed: Current globe donation pathways were reviewed. Additionally, published advice from the fields of ophthalmology, brain banking, and implantable medical devices were used as reference points.
    Findings: Globe donation represents a small but valuable type of ocular donation. Globe donation for research purposes is useful for investigators performing total human eye allotransplantation clinical trials, as well as for ophthalmic drug or device researchers. Results suggest that those performing invasive eye research should include the option of posthumous globe donation in their study protocols and informed consent forms to facilitate more opportunities for the generation of scientific knowledge.
    Conclusions and relevance: The longitudinal perspective can be valuable especially for eyes that have received long-term treatment with an investigational drug or device. This article poses a research-informed consent framework for posthumous globe donation.
    Language English
    Publishing date 2024-03-21
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2701705-9
    ISSN 2168-6173 ; 2168-6165
    ISSN (online) 2168-6173
    ISSN 2168-6165
    DOI 10.1001/jamaophthalmol.2024.0203
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: The Freelance Ethics Consultant: Practice Model and Opportunities.

    Bramstedt, Katrina A

    The Journal of clinical ethics

    2022  Volume 33, Issue 1, Page(s) 69–76

    Abstract: The first ethicists of the 1970s paved the way for the three most familiar models of clinical ethics consultation: (1) a single consultant, (2) a member of a hospital ethics committee, and (3) a member of a subcommittee of a hospital ethics committee. ... ...

    Abstract The first ethicists of the 1970s paved the way for the three most familiar models of clinical ethics consultation: (1) a single consultant, (2) a member of a hospital ethics committee, and (3) a member of a subcommittee of a hospital ethics committee. Within the single consultant model there are (A) the lone ethicist (a member of hospital staff, working alone when consulting) and (B) the independent ethicist (a freelance, external consultant, working alone). This article discusses the structure and opportunities offered by the freelance, independent ethicist model, and provides guidance for those who employ freelance, independent ethicists, as well as guidance for ethicists who are considering adopting this practice model.
    MeSH term(s) Consultants ; Ethicists ; Ethics Committees, Clinical ; Ethics Consultation ; Ethics, Clinical ; Humans
    Language English
    Publishing date 2022-03-18
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1122655-9
    ISSN 1046-7890
    ISSN 1046-7890
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 3456: Show issues Location:
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    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

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  3. Article ; Online: Arguments for 'ocular donation' as standardised terminology to reduce the 'ick factor' of 'eye donation'.

    Bramstedt, Katrina A

    Journal of medical ethics

    2022  Volume 48, Issue 11, Page(s) 935–936

    Abstract: This brief report presents the global problem of the shortfall of donor corneal tissue for transplantation, a potential root cause ('ick factor' language), and a potential solution (modification of 'ick factor' language). Specifically, use of the term ' ... ...

    Abstract This brief report presents the global problem of the shortfall of donor corneal tissue for transplantation, a potential root cause ('ick factor' language), and a potential solution (modification of 'ick factor' language). Specifically, use of the term 'eye donation' is a potential hurdle to ocular tissue donation as it can stimulate the 'ick factor.' Verbiage such as 'ocular (eye tissue)' could be a method of providing terminology that is less emotive than 'eye donor' or 'eye donation.' The field of transplantation has experienced terminology shifts over time; for example, 'cadaver' has been replaced with 'deceased donor,' 'harvest' has been replaced with 'recover,' and 'life support' has been replaced with 'ventilated.' Notably, only a small number of regions worldwide are using 'ocular' terminology, yet it could be an important step to enhancing the informed consent process and improving donation rates, potentially increasing transplant and optimising patient quality of life for those with treatable blindness.
    MeSH term(s) Humans ; Quality of Life ; Tissue and Organ Procurement ; Tissue Donors ; Cadaver ; Informed Consent
    Language English
    Publishing date 2022-01-07
    Publishing country England
    Document type Journal Article
    ZDB-ID 194927-5
    ISSN 1473-4257 ; 0306-6800
    ISSN (online) 1473-4257
    ISSN 0306-6800
    DOI 10.1136/medethics-2021-108003
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    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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  4. Article ; Online: Applying safeguards of research integrity to unethical organ donation and transplantation.

    Bramstedt, Katrina A

    Journal of medical ethics

    2020  Volume 46, Issue 10, Page(s) 685–686

    MeSH term(s) China ; Humans ; Organ Transplantation ; Tissue and Organ Procurement
    Language English
    Publishing date 2020-08-13
    Publishing country England
    Document type Journal Article ; Comment
    ZDB-ID 194927-5
    ISSN 1473-4257 ; 0306-6800
    ISSN (online) 1473-4257
    ISSN 0306-6800
    DOI 10.1136/medethics-2020-106535
    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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  5. Article ; Online: COVID-19 and the Death of Italy's Physicians.

    Bramstedt, Katrina A

    Progress in transplantation (Aliso Viejo, Calif.)

    2020  Volume 30, Issue 3, Page(s) 290–291

    MeSH term(s) Betacoronavirus ; COVID-19 ; Coronavirus Infections/epidemiology ; Humans ; Italy/epidemiology ; Pandemics ; Pneumonia, Viral/epidemiology ; SARS-CoV-2 ; Tissue and Organ Procurement/organization & administration ; Tissue and Organ Procurement/statistics & numerical data
    Keywords covid19
    Language English
    Publishing date 2020-07-02
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2864264-8
    ISSN 2164-6708 ; 1526-9248
    ISSN (online) 2164-6708
    ISSN 1526-9248
    DOI 10.1177/1526924820935412
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: Antibodies as Currency: COVID-19's Golden Passport.

    Bramstedt, Katrina A

    Journal of bioethical inquiry

    2020  Volume 17, Issue 4, Page(s) 687–689

    Abstract: Due to COVID-19, the fragile economy, travel restrictions, and generalized anxieties, the concept of antibodies as a "declaration of immunity" or "passport" is sweeping the world. Numerous scientific and ethical issues confound the concept of an antibody ...

    Abstract Due to COVID-19, the fragile economy, travel restrictions, and generalized anxieties, the concept of antibodies as a "declaration of immunity" or "passport" is sweeping the world. Numerous scientific and ethical issues confound the concept of an antibody passport; nonetheless, antibodies can be seen as a potential currency to allow movement of people and resuscitation of global economics. Just as financial currency can be forged, so too is the potential for fraudulent antibody passports. This paper explores matters of science, ethics, and identity theft, as well as the problems of bias and discrimination that could promulgate a world of pandemic "golden passports."
    MeSH term(s) Antibodies, Viral/blood ; COVID-19/epidemiology ; COVID-19/immunology ; Emigration and Immigration ; Employment/ethics ; Humans ; Pandemics/ethics ; Pandemics/prevention & control ; SARS-CoV-2/immunology ; Social Class ; Travel/ethics
    Chemical Substances Antibodies, Viral
    Keywords covid19
    Language English
    Publishing date 2020-08-25
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 2253038-1
    ISSN 1872-4353 ; 1176-7529
    ISSN (online) 1872-4353
    ISSN 1176-7529
    DOI 10.1007/s11673-020-09996-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: The carnage of substandard research during the COVID-19 pandemic: a call for quality.

    Bramstedt, Katrina A

    Journal of medical ethics

    2020  Volume 46, Issue 12, Page(s) 803–807

    Abstract: Worldwide there are currently over 1200 research studies being performed on the topic of COVID-19. Many of these involve children and adults over age 65 years. There are also numerous studies testing investigational vaccines on healthy volunteers. No ... ...

    Abstract Worldwide there are currently over 1200 research studies being performed on the topic of COVID-19. Many of these involve children and adults over age 65 years. There are also numerous studies testing investigational vaccines on healthy volunteers. No research team is exempt from the pressures and speed at which COVID-19 research is occurring. And this can increase the risk of honest error as well as misconduct. To date, 33 papers have been identified as unsuitable for public use and either retracted, withdrawn, or noted with concern. Asia is the source of most of these manuscripts (n=19; 57.6%) with China the largest Asian subgroup (n=11; 57.9%). This paper explores these findings and offers guidance for responsible research practice during pandemics.
    MeSH term(s) COVID-19/epidemiology ; Editorial Policies ; Global Health ; Humans ; Pandemics ; Research/organization & administration ; Research/standards ; Retraction of Publication as Topic ; SARS-CoV-2
    Keywords covid19
    Language English
    Publishing date 2020-10-01
    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-2020-106494
    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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  8. Article ; Online: Integrity watchdogs, lap dogs, and dead dogs.

    Bramstedt, Katrina A

    Accountability in research

    2020  Volume 28, Issue 3, Page(s) 191–195

    Abstract: Integrity officers working in academic and research settings can be termed "watchdogs" based on characteristics and behaviors that align with their role: alert, loyal to their training, responders, notifiers. These watchdogs have a difficult role that ... ...

    Abstract Integrity officers working in academic and research settings can be termed "watchdogs" based on characteristics and behaviors that align with their role: alert, loyal to their training, responders, notifiers. These watchdogs have a difficult role that involves being the receiver and transmitter of sensitive information that often relates to personal and corporate image, as well as funding. Academic and research organizations must operationalize their mission and vision with more than static policies and procedures about integrity and professionalism, or they risk their watchdogs being reduced to "lap dogs" with a diminutive and submissive presence who are merely loyal to the comfort zone of their employer. A lap dog role has several potential side effects including moral distress and moral injury for the integrity officer, as well as poor service quality for whistle-blowers and other service users. Organizations have a duty to ensure their integrity programs are meaningfully supported, including respecting the human constructs of the watchdog role.
    MeSH term(s) Animals ; Dogs ; Professionalism ; Whistleblowing
    Language English
    Publishing date 2020-09-15
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2069334-5
    ISSN 1545-5815 ; 0898-9621
    ISSN (online) 1545-5815
    ISSN 0898-9621
    DOI 10.1080/08989621.2020.1821370
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Luxembourg's approach to research integrity during the COVID-19 pandemic.

    Bramstedt, Katrina A

    Accountability in research

    2020  Volume 27, Issue 6, Page(s) 396–400

    Abstract: The COVID-19 pandemic has accelerated the pace of research from its routine marathon to a sprint, and this can increase the risk of both human error (mistakes) as well as research misconduct. In an effort to save time, researchers can be tempted to "cut ... ...

    Abstract The COVID-19 pandemic has accelerated the pace of research from its routine marathon to a sprint, and this can increase the risk of both human error (mistakes) as well as research misconduct. In an effort to save time, researchers can be tempted to "cut corners", discount ethical complexity, or use methods and approaches that fall outside of good research practice. Ethically, it is vital that research outputs during a pandemic be robust because clinical decision-making may reflect on these research results. Luxembourg, while a small European nation, is known for its well-ranked global research and innovation. Accordingly, Luxembourg's national organization for research integrity has taken several proactive measures to help researchers nationally and globally, foster robust research. This paper reports on these measures and encourages other nations to similarly assist the research community.
    MeSH term(s) Betacoronavirus ; Biomedical Research/ethics ; Biomedical Research/standards ; COVID-19 ; Coronavirus Infections/epidemiology ; Humans ; Luxembourg ; Pandemics ; Pneumonia, Viral/epidemiology ; Reproducibility of Results ; SARS-CoV-2
    Keywords covid19
    Language English
    Publishing date 2020-06-16
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2069334-5
    ISSN 1545-5815 ; 0898-9621
    ISSN (online) 1545-5815
    ISSN 0898-9621
    DOI 10.1080/08989621.2020.1778473
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Unicorn Poo and Blessed Waters: COVID-19 Quackery and FDA Warning Letters.

    Bramstedt, Katrina A

    Therapeutic innovation & regulatory science

    2020  Volume 55, Issue 1, Page(s) 239–244

    Abstract: Background: The COVID-19 pandemic has created a global setting of clinical crisis and human anxiety. Without available safe and effective vaccines and cures, an unscrupulous marketplace has emerged selling COVID-19 quackery (fraudulent misrepresentation ...

    Abstract Background: The COVID-19 pandemic has created a global setting of clinical crisis and human anxiety. Without available safe and effective vaccines and cures, an unscrupulous marketplace has emerged selling COVID-19 quackery (fraudulent misrepresentation of preventions and treatments).
    Methods: US Food and Drug Administration (FDA) Warning Letters issued from March 2020 to July 2020 were analyzed for themes pertaining to unapproved, adulterated, and misbranded COVID-19 products.
    Results: During this period, the FDA issued 3,139 Warning Letters of which 98 (3.14%) of these were focused on COVID-19-related drugs, devices, biologics, and dietary supplements (products and ingredients). Specifically, these Warning Letters revealed regulatory nonconformities involving 40 identified herbs, 22 minerals/compounds, 6 devices and biologicals, and 3 vitamins. Products included hand sanitizers; COVID-19 antibody test kits; herbal teas and tinctures; nasal gel; toothpaste; and 1 vaccine. Nine Warning Letters were issued for products being sold via the Amazon online shopping platform.
    Conclusion: A small percentage of FDA Warning Letters recently have been focused on COVID-19. These Letters expose the blatant and potentially harmful quackery of vendors across the world who prioritize financial gain over clinical beneficence. Patient history-taking should include queries about non-traditional and unapproved products to identify, document, and report potentially harmful quackery. FDA Warning Letters are a component of meaningful corrective action; however, greater effort in spreading awareness of such misrepresented, unapproved, and adulterated products is needed to deter purchases of such products.
    MeSH term(s) COVID-19 ; Correspondence as Topic ; Databases, Factual ; Fraud ; Government Regulation ; Humans ; Quackery ; SARS-CoV-2 ; United States ; United States Food and Drug Administration
    Keywords covid19
    Language English
    Publishing date 2020-10-01
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2708397-4
    ISSN 2168-4804 ; 2168-4790
    ISSN (online) 2168-4804
    ISSN 2168-4790
    DOI 10.1007/s43441-020-00224-1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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