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Article ; Online: Decision aids for female BRCA mutation carriers: a scoping review protocol.

McGarrigle, Sarah A / Prizeman, Geraldine / Spillane, Carol / Byrne, Niamh / Drury, Amanda / Mockler, David / Connolly, Elizabeth M / Brady, Anne-Marie / Hanhauser, Yvonne P

BMJ open

2021 Volume 11, Issue 7, Page(s) e045075

Abstract: Introduction: Women who inherit a pathogenic mutation in Breast Cancer Susceptibility Genes 1 or 2 (BRCA1 or BRCA2) are at substantially higher risk of developing breast and ovarian cancer than the average woman. Several cancer risk management ... ...

Abstract	Introduction: Women who inherit a pathogenic mutation in Breast Cancer Susceptibility Genes 1 or 2 (BRCA1 or BRCA2) are at substantially higher risk of developing breast and ovarian cancer than the average woman. Several cancer risk management strategies exist to address this increased risk. Decisions about which risk management strategies to choose are complex, personal and multifactorial for these women. This scoping review will map evidence relevant to cancer risk management decision making in BRCA mutation carriers without a personal history of cancer. The objective is to identify and describe the features of patient decision aids that have been developed for BRCA mutation carriers. This information may be beneficial for designing new decision aids or adapting existing decision aids to support decision making in this population. Methods and analysis: This scoping review will be conducted according to the Joanna Briggs Institute's scoping review methodological framework. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist will be used for guidance. Studies on decision aids for women with a BRCA mutation who are unaffected by breast or ovarian cancer will be considered for inclusion. Five electronic databases will be searched (MEDLINE, EMBASE, Cochrane Library, CINAHL, Web of Science) with no restrictions applied for language or publication date. Studies for inclusion will be selected independently by two review authors. Data will be extracted using a predefined data extraction form. Findings will be presented in tabular form. A narrative description of the evidence will complement the tabulated results. Ethics and dissemination: Ethical approval for conducting this scoping review is not required as this study will involve secondary analysis of existing literature. Findings will be published in a peer-reviewed journal and presented at relevant conferences.
MeSH term(s)	Decision Support Techniques ; Female ; Genes, BRCA1 ; Genes, BRCA2 ; Humans ; Mutation ; Ovarian Neoplasms/genetics ; Research Design ; Review Literature as Topic ; Systematic Reviews as Topic
Language	English
Publishing date	2021-07-12
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2020-045075
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Article ; Online: Osteopoikilosis masquerading as osseous metastases in breast cancer.

McArdle, Adrian / O'Riordan, Conor / Connolly, Elizabeth M

Breast cancer (Tokyo, Japan)

2014 Volume 21, Issue 6, Page(s) 765–768

Abstract: Osteopoikilosis (OPK) is a rare, congenital bone disorder characterised by multiple round or ovoid radio densities appearing throughout the axial and appendicular skeleton. It is usually an asymptomatic condition diagnosed incidentally on radiological ... ...

Abstract	Osteopoikilosis (OPK) is a rare, congenital bone disorder characterised by multiple round or ovoid radio densities appearing throughout the axial and appendicular skeleton. It is usually an asymptomatic condition diagnosed incidentally on radiological imaging, and may mimic other bone disorders, including osseous metastases. In this case report, we present a patient with lobular breast cancer whose computed tomography findings were thought to be consistent with osseous cancer metastases. Radionuclide bone scintigraphy plays a key role in distinguishing OPK from osteoblastic bone metastases. This case demonstrates the importance of a clinical awareness of OPK to ensure that patients with potentially curable disease are properly diagnosed.
MeSH term(s)	Aged ; Bone Neoplasms/diagnosis ; Bone Neoplasms/secondary ; Breast Neoplasms/diagnosis ; Breast Neoplasms/pathology ; Breast Neoplasms/surgery ; Female ; Humans ; Osteopoikilosis/diagnosis ; Osteopoikilosis/pathology ; Positron-Emission Tomography/methods ; Tomography, X-Ray Computed
Language	English
Publishing date	2014-11
Publishing country	Japan
Document type	Case Reports ; Journal Article
ZDB-ID	2052429-8
ISSN	1880-4233 ; 1340-6868
ISSN (online)	1880-4233
ISSN	1340-6868
DOI	10.1007/s12282-011-0300-7
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Article: Anti-CTLA-4 based therapy elicits humoral immunity to galectin-3 in patients with metastatic melanoma.

Wu, Xinqi / Giobbie-Hurder, Anita / Connolly, Erin M / Li, Jingjing / Liao, Xiaoyun / Severgnini, Mariano / Zhou, Jun / Rodig, Scott / Hodi, F Stephen

Oncoimmunology

2018 Volume 7, Issue 7, Page(s) e1440930

Abstract: The combination of CTLA-4 blockade ipilimumab (Ipi) with VEGF-A blocking antibody bevacizumab (Bev) has demonstrated favorable clinical outcomes in patients with advanced melanoma. Galectin-3 (Gal-3) plays a prominent role in tumor growth, metastasis, ... ...

Abstract	The combination of CTLA-4 blockade ipilimumab (Ipi) with VEGF-A blocking antibody bevacizumab (Bev) has demonstrated favorable clinical outcomes in patients with advanced melanoma. Galectin-3 (Gal-3) plays a prominent role in tumor growth, metastasis, angiogenesis, and immune evasion. Here we report that Ipi plus Bev (Ipi-Bev) therapy increased Gal-3 antibody titers by 50% or more in approximately one third of treated patients. Antibody responses to Gal-3 were associated with higher complete and partial responses and better overall survival. Ipi alone also elicited antibody responses to Gal-3 at a frequency comparable to the Ipi-Bev combination. However, an association of elicited antibody responses to Gal-3 with clinical outcomes was not observed in Ipi alone treated patients. In contrast to being neutralized in Ipi-Bev treated patients, circulating VEGF-A increased by 100% or more in a subset of patients after Ipi treatment, with most having progressive disease. Among the Ipi treated patients with therapy-induced Gal-3 antibody increases, circulating VEGF-A was increased in 3 of 6 nonresponders but in none of 4 responders as a result of treatment. Gal-3 antibody responses occurred significantly less frequently (3.2%) in a cohort of patients receiving PD-1 blockade where high pre-treatment serum Gal-3 was associated with reduced OS and response rates. Our findings suggest that anti-CTLA-4 elicited humoral immune responses to Gal-3 in melanoma patients which may contribute to the antitumor effect in the presence of an anti-VEGF-A combination. Furthermore, pre-treatment circulating Gal-3 may potentially have prognostic and predictive value for immune checkpoint therapy.
Language	English
Publishing date	2018-03-13
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ZDB-ID	2645309-5
ISSN	2162-402X ; 2162-4011
ISSN (online)	2162-402X
ISSN	2162-4011
DOI	10.1080/2162402X.2018.1440930
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Article ; Online: Impact of progesterone receptor status on response to neoadjuvant chemotherapy in estrogen receptor-positive breast cancer patients.

Boland, Michael R / Ryan, Éanna J / Nugent, Timothy / Gilroy, Darina / Kelly, Michael E / Kennedy, John / Maguire, Aoife / Alazawi, Dhafir / Boyle, Terence J / Connolly, Elizabeth M

Journal of surgical oncology

2020 Volume 122, Issue 5, Page(s) 861–868

Abstract: Introduction: Breast cancer patients respond differently to neoadjuvant chemotherapy(NAC) based on receptor subtype. The aim of this study was to assess the impact of progesterone receptor (PgR) status on response to neoadjuvant chemotherapy (NAC) in ... ...

Abstract	Introduction: Breast cancer patients respond differently to neoadjuvant chemotherapy(NAC) based on receptor subtype. The aim of this study was to assess the impact of progesterone receptor (PgR) status on response to neoadjuvant chemotherapy (NAC) in estrogen receptor (ER)+, human epidermal growth factor receptor (HER)- breast cancer patients. Methods: ER+ and HER- patients receiving NAC over a 7-year period (2011-2017) were identified. The primary outcome was breast complete pathological response (pCR) rate. Secondary outcomes included axillary pCR, axillary/breast pCR and complete radiological response (cRR). Results: A total of 203 patients were identified (149 in the ER+, PgR+, and HER- group and 54 in the ER+, PgR-, and HER- group). Compared with the PgR+ group, PgR- patients were significantly associated with breast pCR (31.5% vs 7.4%; χ² test; P < .01). In multivariable analysis, PgR- status (odds ratio [OR], 4.58; 95% confidence interval [CI]: 1.58,13.28; P = .005), radiological size >50 mm (OR, 5.38; 95% CI: 1.07,27.04; P = .04) and grade (OR, 3.52;95% CI: 1.21,10.23;P = .02) were significant predictors of breast pCR. Only PgR- status was a significant predictor of cRR (OR, 6.234; 95% CI: 2.531, 15.355; P < .001). In node positive patients, PgR negativity was associated with a trend towards breast/axillary nodal pCR (22% vs 12.7%; χ² test; P = .055). Conclusion: Over 30% of ER+, PgR-, and HER- patients will have a breast pCR after NAC. PgR- is the only significant predictor of breast pCR/cRR in this tumor subtype. ER+, PgR-, and HER- patients should be considered for NAC.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Breast Neoplasms/diagnostic imaging ; Breast Neoplasms/drug therapy ; Breast Neoplasms/metabolism ; Breast Neoplasms/surgery ; Cohort Studies ; Female ; Humans ; Longitudinal Studies ; Lymphatic Metastasis ; Middle Aged ; Neoadjuvant Therapy ; Neoplasm Staging ; Receptor, ErbB-2/metabolism ; Receptors, Estrogen/metabolism ; Receptors, Progesterone/metabolism ; Retrospective Studies
Chemical Substances	Receptors, Estrogen ; Receptors, Progesterone ; ERBB2 protein, human (EC 2.7.10.1) ; Receptor, ErbB-2 (EC 2.7.10.1)
Language	English
Publishing date	2020-07-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	82063-5
ISSN	1096-9098 ; 0022-4790
ISSN (online)	1096-9098
ISSN	0022-4790
DOI	10.1002/jso.26096
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Zs.A 706: Show issues

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Article ; Online: The presentation of metabolic dysfunction and the relationship with energy output in breast cancer survivors: a cross-sectional study.

Guinan, Emer M / Connolly, Elizabeth M / Kennedy, M John / Hussey, Juliette

Nutrition journal

2013 Volume 12, Page(s) 99

Abstract: Background: Breast cancer prognosis can be adversely influenced by obesity, physical inactivity and metabolic dysfunction. Interventions aimed at improving surrogate markers of breast cancer risk such as insulin resistance may result in improved breast ... ...

Abstract	Background: Breast cancer prognosis can be adversely influenced by obesity, physical inactivity and metabolic dysfunction. Interventions aimed at improving surrogate markers of breast cancer risk such as insulin resistance may result in improved breast cancer outcomes. The design of such interventions may be improved through increased understanding of metabolic presentation in this cohort. This cross-sectional study aimed to characterise the metabolic profile of breast cancer survivors relative to abdominal obesity and insulin resistance. A secondary aim was to compare measures of energy output across these groups. Methods: Sixty-nine women (mean (SD) age 53.43 (9.39) years) who had completed adjuvant chemotherapy and radiotherapy for breast cancer were recruited. All measures were completed during one assessment conducted 3.1 (1.0) years post diagnosis. Body composition was measured by bioimpedance analysis and waist circumference (WC). Fasting (12 hour) blood samples were drawn to measure lipid profile, glucose, insulin, glycosylated haemoglobin A1c (HBA1c) and C-reactive protein (CRP). Insulin resistance was estimated by the homeostatic model assessment index (HOMA-IR)). Energy output was evaluated by resting metabolic rate (RMR) measured by indirect calorimetry and physical activity measured by accelerometry. Characteristics were compared across four groups (1. WC <80 cm, not insulin resistant; 2. WC 80-87.9 cm, not insulin resistant; 3. WC >88 cm, not insulin resistant; 4. WC >80 cm, insulin resistant) using ANOVA (p < 0.05). Results: Group 4 was characterised by significant disturbances in measures of glucose metabolism (glucose, insulin, HOMA-IR and HBA1c) and raised CRP compared to other groups. Group 4 also displayed evidence of dyslipidemia and higher body composition values compared to Groups 1 and 2. Both absolute and adjusted RMR were significantly higher in the Group 4 versus all other groups. Physical activity levels were similar for all groups. Conclusions: The results from this study suggest that participants who were both centrally obese and insulin resistant showed evidence of dyslipidemia, low-grade inflammation and glucose dysregulation. Metabolic profiles of participants who were centrally obese only were not significantly different from lean participants. Consideration of baseline metabolic presentation may be useful when considering the therapeutic targets for future interventions in this cohort.
MeSH term(s)	Adipose Tissue/metabolism ; Adult ; Basal Metabolism ; Blood Glucose/metabolism ; Body Composition ; Body Mass Index ; Body Weight ; Breast Neoplasms/blood ; Breast Neoplasms/complications ; Breast Neoplasms/metabolism ; C-Reactive Protein ; Cross-Sectional Studies ; Electric Impedance ; Energy Metabolism ; Female ; Glycated Hemoglobin A ; Health Behavior ; Humans ; Insulin/blood ; Insulin Resistance ; Life Style ; Middle Aged ; Motor Activity ; Obesity, Abdominal/blood ; Obesity, Abdominal/complications ; Survivors ; Waist Circumference
Chemical Substances	Blood Glucose ; Glycated Hemoglobin A ; Insulin ; C-Reactive Protein (9007-41-4)
Language	English
Publishing date	2013-07-15
Publishing country	England
Document type	Journal Article
ISSN	1475-2891
ISSN (online)	1475-2891
DOI	10.1186/1475-2891-12-99
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Article: Locomotor and energetic consequences of behavioral thermoregulation in the sanguivorous leech Hirudo verbana.

Hitchcock, Amanda C / Connolly, Erin M / Darakananda, Karin / Jeong, Janet W / Quist, Arbor J L / Robbins, Allison B / Ellerby, David J

Journal of thermal biology

2017 Volume 65, Page(s) 1–7

Abstract: Medicinal leeches (Hirudo verbana) thermoregulate with respect to their sanguivorous feeding behavior. Immediate postprandial preferences are for warmer than their initial acclimation temperature ( ... ...

Abstract	Medicinal leeches (Hirudo verbana) thermoregulate with respect to their sanguivorous feeding behavior. Immediate postprandial preferences are for warmer than their initial acclimation temperature (T
MeSH term(s)	Acclimatization ; Animals ; Body Temperature Regulation ; Cold Temperature ; Energy Metabolism ; Feeding Behavior ; Hirudo medicinalis/physiology ; Locomotion ; Swimming
Language	English
Publishing date	2017-04
Publishing country	England
Document type	Journal Article
ZDB-ID	1498364-3
ISSN	1879-0992 ; 0306-4565
ISSN (online)	1879-0992
ISSN	0306-4565
DOI	10.1016/j.jtherbio.2017.01.007
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Article ; Online: Breast reconstruction post mastectomy- Let's Google it. Accessibility, readability and quality of online information.

Lynch, Noel P / Lang, Bronagh / Angelov, Sophia / McGarrigle, Sarah A / Boyle, Terence J / Al-Azawi, Dhafir / Connolly, Elizabeth M

Breast (Edinburgh, Scotland)

2017 Volume 32, Page(s) 126–129

Abstract: Introduction: This study evaluated the readability, accessibility and quality of information pertaining to breast reconstruction post mastectomy on the Internet in the English language.: Methods: Using the Google: Results: The Web sites were ... ...

Abstract	Introduction: This study evaluated the readability, accessibility and quality of information pertaining to breast reconstruction post mastectomy on the Internet in the English language. Methods: Using the Google Results: The Web sites were difficult to read and comprehend. The mean Flesch Reading Ease scores were 55.5. The mean Gunning Fog Index scores was 8.6. The mean Michigan score was 34.8 indicating weak quality of websites. Websites with HoN certification ranked higher in the search results (p = 0.007). Website quality was influenced by organisation type (p < 0.0001) with academic/healthcare, not for profit and government sites having higher Michigan scores. 20% of sites met the minimum accessibility criteria. Conclusions: Internet information on breast reconstruction post mastectomy and procedures is poorly written and we suggest that Webpages providing information must be made more readable and accessible. We suggest that health professionals should recommend Web sites that are easy to read and contain high-quality surgical information. Medical information on the Internet should be readable, accessible, reliable and of a consistent quality.
MeSH term(s)	Adult ; Breast Neoplasms ; Comprehension ; Consumer Health Information/standards ; Female ; Health Literacy ; Humans ; Internet/standards ; Mammaplasty ; Mastectomy ; Middle Aged ; Search Engine/standards
Language	English
Publishing date	2017-04
Publishing country	Netherlands
Document type	Evaluation Studies ; Journal Article
ZDB-ID	1143210-x
ISSN	1532-3080 ; 0960-9776
ISSN (online)	1532-3080
ISSN	0960-9776
DOI	10.1016/j.breast.2017.01.019
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Zs.A 3620: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) 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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Article ; Online: A comprehensive exercise program for a young adult male with Down syndrome who experienced a stroke.

Casey, Amanda Faith / Mackay-Lyons, Marilyn / Connolly, Eilish Marie / Jennings, Craig / Rasmussen, Roy

Disability and rehabilitation

2014 Volume 36, Issue 17, Page(s) 1402–1408

Abstract: Purpose: Individuals with Down syndrome (DS) may be at heightened risk for stroke due to a combination of physiological conditions and lifestyle choices. There remains a lack of information regarding the effectiveness of exercise training on individuals ...

Abstract	Purpose: Individuals with Down syndrome (DS) may be at heightened risk for stroke due to a combination of physiological conditions and lifestyle choices. There remains a lack of information regarding the effectiveness of exercise training on individuals with DS post-stroke. This case report describes the effects of a comprehensive exercise program on an individual with DS who had sustained a stroke. Method: A 20-year-old male with DS recovering from a left hemorrhagic stroke 18 months previous underwent a 12-week land and water-based program 60 minutes/session, 5 sessions/week. Exercise sessions addressed specific limitations, including cardiorespiratory fitness, generalized muscle weakness, balance deficits, and reduced ambulatory ability in terms of speed, gait pattern and walking tolerance. Results: Between the baseline and 6-month follow-up assessments improvements were noted in peak oxygen consumption (VO2peak, 8% increase), one-repetition maximum (51%), community balance and mobility scale (54%), comfortable walking speed (42%), six-minute walk test (28%) and daily step count (21%). Conclusion: Improved cardiorespiratory fitness, strength, balance and mobility provide preliminary evidence of the trainability of individuals with both DS and stroke. Future studies are warranted to investigate the role of exercise in risk factor reduction for primary and secondary prevention of stroke in people with DS. Implications for Rehabilitation Individuals with Down syndrome (DS) may be at heightened risk of stroke due to a combination of physiological conditions and lifestyle choices which contribute to reduced exercise capacity, accelerated aging patterns, moyamoya syndrome and physical inactivity as well as high rates of obesity and related conditions. More intensive fitness programs may be particularly important for people with both DS and stroke. Participation in a comprehensive exercise program can be safe and effective in regaining pre-stroke levels of cardiorespiratory fitness, functional mobility and goal attainment. RESULTS suggest that a more intensive physical therapy regimen may be recommendable during out-patient rehabilitation for individuals with DS post-stroke.
MeSH term(s)	Acid-Base Equilibrium ; Cerebral Hemorrhage/epidemiology ; Cerebral Hemorrhage/physiopathology ; Cerebral Hemorrhage/prevention & control ; Cerebral Hemorrhage/rehabilitation ; Down Syndrome/epidemiology ; Exercise Therapy ; Gait ; Humans ; Male ; Oxygen Consumption ; Physical Fitness ; Risk Factors ; Social Behavior ; Stroke/epidemiology ; Stroke/physiopathology ; Stroke/prevention & control ; Stroke Rehabilitation ; Swimming ; Young Adult
Language	English
Publishing date	2014
Publishing country	England
Document type	Case Reports ; Journal Article
ZDB-ID	1104775-6
ISSN	1464-5165 ; 0963-8288
ISSN (online)	1464-5165
ISSN	0963-8288
DOI	10.3109/09638288.2013.833304
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Zs.A 1569: Show issues

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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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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
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