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  1. Article ; Online: A roadmap to precision treatments for familial pulmonary fibrosis.

    Hurley, Killian / Ozaki, Mari / Philippot, Quentin / Galvin, Liam / Crosby, David / Kirwan, Mary / Gill, Deborah R / Alysandratos, Konstantinos-Dionysios / Jenkins, Gisli / Griese, Matthias / Nathan, Nadia / Borie, Raphael

    EBioMedicine

    2024  Volume 104, Page(s) 105135

    Abstract: Interstitial lung diseases (ILDs) in adults and children (chILD) are a heterogeneous group of lung disorders leading to inflammation, abnormal tissue repair and scarring of the lung parenchyma often resulting in respiratory failure and death. Inherited ... ...

    Abstract Interstitial lung diseases (ILDs) in adults and children (chILD) are a heterogeneous group of lung disorders leading to inflammation, abnormal tissue repair and scarring of the lung parenchyma often resulting in respiratory failure and death. Inherited factors directly cause, or contribute significantly to the risk of developing ILD, so called familial pulmonary fibrosis (FPF), and monogenic forms may have a poor prognosis and respond poorly to current treatments. Specific, variant-targeted or precision treatments are lacking. Clinical trials of repurposed drugs, anti-fibrotic medications and specific treatments are emerging but for many patients no interventions exist. We convened an expert working group to develop an overarching framework to address the existing research gaps in basic, translational, and clinical research and identified areas for future development of preclinical models, candidate medications and innovative clinical trials. In this Position Paper, we summarise working group discussions, recommendations, and unresolved questions concerning precision treatments for FPF.
    Language English
    Publishing date 2024-05-07
    Publishing country Netherlands
    Document type Journal Article ; Review
    ZDB-ID 2851331-9
    ISSN 2352-3964
    ISSN (online) 2352-3964
    DOI 10.1016/j.ebiom.2024.105135
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

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  2. Article ; Online: GDPR: an impediment to research?

    Clarke, Niamh / Vale, Gillian / Reeves, Emer P / Kirwan, Mary / Smith, David / Farrell, Michael / Hurl, Gerard / McElvaney, Noel G

    Irish journal of medical science

    2019  Volume 188, Issue 4, Page(s) 1129–1135

    Abstract: Background: The recent introduction of the General Data Protection Regulation and Health Research Regulations has been an area of significant concern for those engaged in clinical research. These European regulations, following subsequent interpretation ...

    Abstract Background: The recent introduction of the General Data Protection Regulation and Health Research Regulations has been an area of significant concern for those engaged in clinical research. These European regulations, following subsequent interpretation by Ireland's Department of Health, now place Ireland in a unique position which differs substantially from other European countries and may prove a significant impediment to Irish clinical research, depriving Irish patients of timely access to potentially life-saving treatments and making Ireland less attractive to pharmaceutical companies engaged in this area. At the very least, the regulations, as applied in Ireland, will place a significant extra burden of work on Ireland's clinical researchers and at their worst will force individuals and institutions out of the clinical research field, which will result in significant loss to the Irish knowledge economy and lead to the detriment of patient care.
    Aim: In this article, we explore what exactly is proposed by Europe's GDPR and by Ireland's Health Research Regulations. We look at the challenges presented to clinical researchers, and we highlight those areas, which need clarification by the Department of Health and by the Data Protection Commissioner.
    Conclusions: We propose five recommendations, which would ameliorate some of the more restrictive impositions of these regulations. This review was commissioned by the Irish Academy of Medical Science.
    MeSH term(s) Computer Security/legislation & jurisprudence ; Europe ; Humans ; Ireland
    Language English
    Publishing date 2019-02-08
    Publishing country Ireland
    Document type Journal Article
    ZDB-ID 390895-1
    ISSN 1863-4362 ; 0021-1265
    ISSN (online) 1863-4362
    ISSN 0021-1265
    DOI 10.1007/s11845-019-01980-2
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  3. Article ; Online: What GDPR and the Health Research Regulations (HRRs) mean for Ireland: a research perspective.

    Mee, Blanaid / Kirwan, Mary / Clarke, Niamh / Tanaka, Aoife / Manaloto, Lino / Halpin, Emma / Gibbons, Una / Cullen, Ann / McGarrigle, Sarah / Connolly, Elisabeth M / Bennett, Kathleen / Gaffney, Eoin / Flanagan, Ciaran / Tier, Laura / Flavin, Richard / McElvaney, Noel G

    Irish journal of medical science

    2020  Volume 190, Issue 2, Page(s) 505–514

    Abstract: Background: Irish Health Research Regulations (HRRs) were introduced following the European Union (EU) General Data Protection Regulation (GDPR) in 2018. The HRRs described specific supplementary regulatory requirements for research regarding governance, ...

    Abstract Background: Irish Health Research Regulations (HRRs) were introduced following the European Union (EU) General Data Protection Regulation (GDPR) in 2018. The HRRs described specific supplementary regulatory requirements for research regarding governance, processes and procedure that impact on several facets of research. The numerous problems that the HRRs and particularly "explicit consent" inadvertently created were presented under the auspices of the Irish Academy of Medical Sciences (IAMS) on November 25, 2019, at the Royal College of Surgeons in Ireland.
    Aims: The objective of this review was to obtain feedback and to examine the impact of GDPR and the HRRs on health research in Ireland in order to determine whether the preliminary feedback, presented at the IAMS meetings, was reflected at a national level.
    Methods: Individuals from the research community were invited to provide feedback on the impact, if any, of the HRRs on health research. Retrospective patient recruitment and consent outside a hospital setting for a multi-institutional Breast Predict study (funded by the Irish Cancer Society) were also analysed.
    Results: Feedback replicated the issues presented at the IAMS with additional concerns identified. Only 20% of the original target population (n = 1987) could be included in the Breast Predict study.
    Conclusions: Our results confirm that the HRRs have had a significantly negative impact on health research in Ireland. Urgent meaningful engagement between patient advocate groups, the research community and legislators would help ameliorate these impacts.
    MeSH term(s) Biomedical Research/legislation & jurisprudence ; Computer Security/legislation & jurisprudence ; Female ; Government Regulation ; Humans ; Ireland ; Male ; Research Design/legislation & jurisprudence ; Retrospective Studies
    Language English
    Publishing date 2020-07-29
    Publishing country Ireland
    Document type Journal Article
    ZDB-ID 390895-1
    ISSN 1863-4362 ; 0021-1265
    ISSN (online) 1863-4362
    ISSN 0021-1265
    DOI 10.1007/s11845-020-02330-3
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  4. Article ; Online: What GDPR and the Health Research Regulations (HRRs) mean for Ireland: "explicit consent"-a legal analysis.

    Kirwan, Mary / Mee, Blanaid / Clarke, Niamh / Tanaka, Aoife / Manaloto, Lino / Halpin, Emma / Gibbons, Una / Cullen, Ann / McGarrigle, Sarah / Connolly, Elisabeth M / Bennett, Kathleen / Gaffney, Eoin / Flanagan, Ciaran / Tier, Laura / Flavin, Richard / McElvaney, Noel G

    Irish journal of medical science

    2020  Volume 190, Issue 2, Page(s) 515–521

    Abstract: Background: Irish Health Research Regulations (HRRs) were introduced following the commencement of the General Data Protection Regulation (GDPR) in 2018. The HRRs set out supplementary regulatory requirements for research. A legal analysis presented ... ...

    Abstract Background: Irish Health Research Regulations (HRRs) were introduced following the commencement of the General Data Protection Regulation (GDPR) in 2018. The HRRs set out supplementary regulatory requirements for research. A legal analysis presented under the auspices of the Irish Academy of Medical Sciences (IAMS) on April 8 and November 25, 2019 at the Royal College of Surgeons in Ireland welcomed the introduction of GDPR and the HRRs. The analysis found the GDPR "explicit consent" introduced by the HRRs is problematic. A call was made to regulate informed consent in line with the common law as an achievable alternative safeguard, bringing Ireland in line with other EU Member States.
    Aims: This article aims to review academic papers, legal opinion, EU opinion and advice and data protection law in relation to research and explicit consent, in order to examine the legal burden of GDPR and the HRRs on health research in Ireland and to determine whether the analysis presented at the IAMS meetings is reflected more widely in legal text.
    Methods: Legal literature review of academic papers, legal opinion, EU opinion and advice and data protection legislation.
    Results: The legal literature review overwhelmingly supports the concerns raised.
    Conclusions: Our results confirm the GDPR explicit consent requirement of the HRRs is having had a significantly negative and far-reaching impact on the conduct of health research in Ireland. Urgent review of the HRRs and meaningful engagement between the health research community and legislators in healthcare is required.
    MeSH term(s) Biomedical Research/legislation & jurisprudence ; Computer Security/legislation & jurisprudence ; Female ; Government Regulation ; Humans ; Informed Consent/legislation & jurisprudence ; Ireland ; Male ; Research Design/legislation & jurisprudence
    Keywords covid19
    Language English
    Publishing date 2020-07-30
    Publishing country Ireland
    Document type Journal Article
    ZDB-ID 390895-1
    ISSN 1863-4362 ; 0021-1265
    ISSN (online) 1863-4362
    ISSN 0021-1265
    DOI 10.1007/s11845-020-02331-2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Transition to blended learning: experiences from the first year of our blended learning Bachelor of Nursing Studies programme.

    Sweeney, Mary-Rose / Kirwan, Anne / Kelly, Mary / Corbally, Melissa / O Neill, Sandra / Kirwan, Mary / Hourican, Susan / Matthews, Anne / Hussey, Pamela

    Contemporary nurse

    2016  Volume 52, Issue 5, Page(s) 612–624

    Abstract: Background: The School of Nursing at Dublin City University offered a new blended learning Bachelor of Nursing Studies programme in the academic year 2011.: Aim: To document the experiences of the academic team making the transition from a face-to- ... ...

    Abstract Background: The School of Nursing at Dublin City University offered a new blended learning Bachelor of Nursing Studies programme in the academic year 2011.
    Aim: To document the experiences of the academic team making the transition from a face-to-face classroom-delivered programme to the new blended learning format.
    Method: Academics who delivered the programme were asked to describe their experiences of developing the new programme via two focus groups.
    Results: Five dominant themes were identified: Staff Readiness; Student Readiness; Programme Delivery and Student Engagement; Assessment of Module Learning Outcomes and Feedback; and Reflecting on the First Year and Thinking of the Future. Face-to-face tutorials were identified as very important to both academics and students. Reservations about whether migrating the programme to an online format encouraged students to engage in additional practices of plagiarism were expressed by some. Student ability/readiness to engage with technology-enhanced learning was an important determinant of their own success academically.
    Discussion: In the field of nursing blended learning is a relatively new and emerging field which will require huge cultural shifts for staff and students alike.
    MeSH term(s) Adult ; Attitude to Computers ; Computer-Assisted Instruction/methods ; Education, Nursing, Baccalaureate/methods ; Female ; Focus Groups ; Humans ; Internet ; Ireland ; Male ; Nursing Education Research ; Qualitative Research ; Students, Nursing/psychology ; Young Adult
    Language English
    Publishing date 2016-10
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1491361-6
    ISSN 1839-3535 ; 1037-6178
    ISSN (online) 1839-3535
    ISSN 1037-6178
    DOI 10.1080/10376178.2016.1197781
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    In stock of ZB MED Cologne/Königswinter

    Zs.A 5103: Show issues Location:
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    Jg. 1995 - 2021: Lesesall (2.OG)
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  6. Article: What GDPR and the Health Research Regulations (HRRs) mean for Ireland: "explicit consent"-a legal analysis

    Kirwan, Mary / Mee, Blanaid / Clarke, Niamh / Tanaka, Aoife / Manaloto, Lino / Halpin, Emma / Gibbons, Una / Cullen, Ann / McGarrigle, Sarah / Connolly, Elisabeth M / Bennett, Kathleen / Gaffney, Eoin / Flanagan, Ciaran / Tier, Laura / Flavin, Richard / McElvaney, Noel G

    Ir. j. med. sci

    Abstract: BACKGROUND: Irish Health Research Regulations (HRRs) were introduced following the commencement of the General Data Protection Regulation (GDPR) in 2018. The HRRs set out supplementary regulatory requirements for research. A legal analysis presented ... ...

    Abstract BACKGROUND: Irish Health Research Regulations (HRRs) were introduced following the commencement of the General Data Protection Regulation (GDPR) in 2018. The HRRs set out supplementary regulatory requirements for research. A legal analysis presented under the auspices of the Irish Academy of Medical Sciences (IAMS) on April 8 and November 25, 2019 at the Royal College of Surgeons in Ireland welcomed the introduction of GDPR and the HRRs. The analysis found the GDPR "explicit consent" introduced by the HRRs is problematic. A call was made to regulate informed consent in line with the common law as an achievable alternative safeguard, bringing Ireland in line with other EU Member States. AIMS: This article aims to review academic papers, legal opinion, EU opinion and advice and data protection law in relation to research and explicit consent, in order to examine the legal burden of GDPR and the HRRs on health research in Ireland and to determine whether the analysis presented at the IAMS meetings is reflected more widely in legal text. METHODS: Legal literature review of academic papers, legal opinion, EU opinion and advice and data protection legislation. RESULTS: The legal literature review overwhelmingly supports the concerns raised. CONCLUSIONS: Our results confirm the GDPR explicit consent requirement of the HRRs is having had a significantly negative and far-reaching impact on the conduct of health research in Ireland. Urgent review of the HRRs and meaningful engagement between the health research community and legislators in healthcare is required.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #684428
    Database COVID19

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