Consent For Use Research Articles

The Prevalence of Non-Alcoholic Fatty Liver Disease in Young Adults in the UK

Background: Crude estimates of non-alcoholic fatty liver disease (NAFLD) prevalence worldwide are 25% amongst all adults whilst prevalence in young adults remains unclear. We aim to estimate prevalence of NAFLD in young adults in a sample of 22-26year olds recruited through the Avon Longitudinal Study of Parents and Children (ALSPAC), using transient elastography (TE) and controlled attenuated parameter (CAP). Methods: 4021 participants attended clinic for fibroscan using the Echosens 502 Touch®; mean age 24yrs (+/- 0·8). Results with interquartile range/median ratio > 30% were excluded when analysing fibrosis, but not CAP. Data was collated on TE result, CAP score (S3 >66% hepatic steatosis), body mass index (BMI), serology including alanine transaminase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT). Findings: 3678 CAP scores were eligible for analysis. 780 (20·7%) participants had steatosis; 48·3% (n=377/780) had S3. ALT, AST and GGT all increased with CAP score (p<0·001). Overweight and obese BMI were positively associated with steatosis when adjusted for alcohol excess, social class and smoking (OR 5·17 [95%CI 4·11-6·50] and OR 27·27 [95%CI 20·54-36·19] respectively; p<0·001). 3600 TEs were eligible for fibrosis analysis. 104 participants (2·9%) had TE ≥7·9kPa. 9 participants had TE equivalent to F4 fibrosis. CAP score was positively associated with fibrosis on univariable regression (S3 OR 1·93 [95%CI 1·11-3·37]; p<0·001) but only individuals with harmful alcohol consumption and steatosis had increased fibrosis odds when adjusted for social class and smoking (OR 4·02 [95%CI 1·24- 13·02]; p=0·02). Interpretation: 1 in 5 young people had steatosis and 1 in 40 had evidence of fibrosis at 24yrs. The UK obesity epidemic is affecting young adults and requires greater public health interventions to prevent increasing health care burden due to NAFLD related advanced liver disease in later life. Funding Statement: The UK Medical Research Council and Wellcome (Grant ref: 102215/2/13/2) and the University of Bristol provide core support for ALSPAC. This work was undertaken with the support of the MRC and Alcohol Research UK (MR/L022206/1), and the David Telling Charitable Trust. The authors also acknowledge support from The Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), a UKCRC Public Health Research Centre of Excellence (joint funding (MR/KO232331/1) from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, the Welsh Government and the Wellcome Trust, under the auspices of the UK Clinical Research Collaboration), the NIHR School of Public Health Research, NIHR Health Protection Research Unit in Evaluation and NIHR Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol. Declaration of Interests: The authors stated: None to declare. Ethics Approval Statement: Ethical approval for the study was obtained from the ALSPAC Ethics and Law Committee and the Local Research Ethics Committees. Consent for biological samples has been collected in accordance with the Human Tissue Act (2004). Informed consent for use of data collected via questionnaires and clinics was obtained from participants following the recommendations of the ALSPAC Ethics and Law Committee at the time.

Review of a medical illustration department’s data processing system to confirm general data protection regulation (GDPR) compliance

This article reviews the clinical photography and video data processing and storage arrangements of the Medical Illustration Department (MID) at the Queen Elizabeth Hospital Birmingham National Health Service (NHS) Foundation Trust (QEHB), part of the University Hospitals Birmingham (UHB) NHS Foundation Trust umbrella group. This review suggests that the department’s current workflow and technical processing solution satisfies the requirements of the general data protection regulation (GDPR). At the time of writing, there were no additional financial costs or technical skills required for implementing GDPR regulations but this could change in future data processing systems. There are significant potential costs for non-compliance with GDPR. Brexit is unlikely to have any effect on complying with GDPR requirements. The GDPR gives the public the right to access information and be informed of how and why it is processed. It is recommended that improved administrative processing capability to accommodate this requirement should be included in future data processing designs. At the QEHB informed consent for use of photographs and videos is currently adequate to satisfy the common law of confidence.

Adapting Cord Blood Collection and Banking Standard Operating Procedures for HLA-Homozygous Induced Pluripotent Stem Cells Production and Banking for Clinical Application.

In this article, we will discuss the main aspects to be considered to define standard operation procedures (SOPs) for the creation of an induced pluripotent stem cell (iPSC) bank using cord blood (CB)—or similar cell type—bank guidelines for clinical aims. To do this, we adapt the pre-existing SOP for CB banking that can be complementary for iPSCs. Some aspects of iPSC manufacturing and the particular nature of these cells call for special attention, such as the potential multiple applications of the cells, proper explanation to the donor for consent of use, the genomic stability and the risk of genetic privacy disclosure. Some aspects of the iPSC SOP are solidly established by CB banking procedures, other procedures have good consensus in the scientific and medical community, while others still need to be further debated and settled. Given the international sharing vocation of iPSC banking, there is an urgent need by scientists, clinicians and regulators internationally to harmonize standards and allow future sample interchange between many iPSC bank initiatives that are springing up worldwide.

Peritumoral CD90 &lt;sup&gt;+&lt;/sup&gt;CD73 &lt;sup&gt;+&lt;/sup&gt; Cells Possess Immunosuppressive Features in Human Non-Small Cell Lung Cancer

Background: Although T cell abundance in solid tumors is associated with better outcomes, it also correlates with a stromamediated source of immune suppression driven by TGFβ1 and poor overall survival. Whether this also is observed in non-small cell lung cancer (NSCLC) is unknown. Methods: We utilized molecular analysis of The Cancer Genome Atlas (TCGA) NSLCC cohort to correlate immune activation (IA) gene expression and extracellular matrix/stromal (ECM/stromal) gene expression with patient survival. In an independent cohort of NSCLC samples, we used flow cytometry to identify mesenchymal subsets and ex vivo functional studies to characterize their immune regulatory function. Findings: We observed a high enrichment in a core set of genes defining an IA gene expression signature in NSCLC across TCGA Pan-cancer cohort. High IA signature score correlates with enrichment of ECM/stromal gene signature across TCGA NSCLC datasets. Importantly, higher ratio of ECM/stromal to IA gene signature score was associated with shorter overall survival. In tumors resected from a separate cohort of NSCLC patients, we identified Cd90+Cd73+ peritumoral cells that were enriched in the ECM/stromal gene signature, which was amplified by TGFβ1. IFNγ and TNFα-primed peritumoral Cd90+Cd73+ cells upregulate immune checkpoint molecules PD-L1 and IDO1 and secrete an array of cytokines/chemokines including TGFβ1. Finally, immune primed peritumoral Cd90+Cd73+ cells suppress T cell function, which was relieved following combined blockade of PD-L1, TGFβ1 and IDO1 but not PD-L1 alone. Interpretation: Our findings suggest that targeting PD-L1 together with independent biological features of the stroma may enhance host antitumor immunity in NSCLC. Funding Statement: LW and HY are supported by a 4-year China Scholarship Council award. This work was funded, in part, by a grant from the Cancer League of Bern, Switzerland to SRRH. Laser scanning microscopy imaging was funded by the R’Equip grant from the Swiss National Science Foundation Nr. 316030_145003. Declaration of Interests: The authors declare no potential conflicts of interest. Ethics Approval Statement: The study was approved by Ethics Commission of the Canton of Bern (KEK BE:042/2015). All patients gave informed written consent for use of surgical material for research purposes.

BNTRC: British Neurosurgical Trainee Research Collaborative Understanding Cauda Equina Syndrome

Introduction: Cauda equina syndrome (CES) is a rare but potentially devastating condition caused by compression of the cauda equina nerve roots. The clinical syndrome can include bilateral sciatica, saddle anaesthesia, bladder, bowel, and sexual dysfunction. The disabling nature of these symptoms has significant medical, social, and legal implications. Guidelines for the investigation and management of CES are based on evidence from small retrospective case series that include a range of presentations. Outcomes for those presenting with established loss of function may not be comparable to those with incipient symptoms. Arrangements for emergency imaging, patient transfer to specialist spinal units, and techniques for decompression also vary and could lead to differences in outcomes. Aims: This study aims to provide evidence for appropriate investigation and management of CES through: ascertaining the incidence of CES describing the clinical and radiological features of patients who are treated for CES establishing current practice in timing of investigations and choice of management of CES determining patient outcome and service usage following CES diagnosis Patients All patients over 18 years old treated for CES in a UK or Irish neurosurgical or orthopaedic spinal unit will be included. Patients will be identified via emergency admissions, and case ascertainment will be checked using coding records. Comparator: Outcomes and management will be stratified by presenting features and timing and type of surgical intervention. Outcome: Patient outcome will be assessed using validated patient reported outcome measures for back pain, leg pain, bladder, bowel, and sexual function. Health care services used over the following year will be recorded. Study design: This is a prospective cohort study with patients identified on admission to a spinal unit. Patients will be asked to consent for use of their data, contact for follow up assessments, and data linkage with existing NHS and surgical registries.

Identification and Verification of a Biomarker Panel for Early Diagnosis of Lung Cancer Patients

Background: Lung cancer is the most common cause of cancer related mortality worldwide, characterised by late clinical presentation (49-53% of patients are diagnosed at stage IV) and consequently poor outcomes. One challenge in identifying biomarkers of early disease is the collection of samples from patients prior to symptomatic presentation. An additional complication in determining differential biomarkers arises from protein expression change from non-specific systemic responses and co-morbidities such as Chronic Obstructive Pulmonary Disease (COPD). Methods: We employed isobaric tagging, relative quantification mass spectrometry to analyse protein markers that differed in blood entering and egressing from the tumour bearing lobe of the diseased lung immediately prior to lung resection surgery. These potential biomarkers were assessed as lung cancer early detection biomarkers using the orthogonal mass spectrometry (MS) technique Sequential window acquisition of all theoretical fragment ion spectra (SWATH) MS which we showed had equivalent quantification value to a selected reaction monitoring (SRM) approach. Findings: In a second cohort, SWATH-MS was used to measure 974 proteins in serum samples taken <50 months prior to and at lung cancer diagnosis. Two proteins found to increase in expression egressing from a tumour had value as biomarkers. SWATH-MS profiling followed by machine learning generated a predictive 13 protein panel resulted in a mean AUC of 0.80, an accuracy of 0.78, a sensitivity of 0.79 and a specificity of 0.78. Interpretation: Thus, whilst tumour egressing proteins did not contribute significantly to a MS early detection biomarker signature, SWATH-MS and machine learning have great potential value for early detection biomarker algorithms. Funding Statement: Mass spectrometry was supported with equipment grants from Bloodwise and Medical Research Council. This work was supported by the CRUK Manchester Centre award (C5759/A25254). CD and ADW are supported by the NIHR Manchester Biomedical Research Centre. CD is also supported via core funding to the CRUK Manchester Institute and via the CRUK Lung Cancer Centre of Excellence (C5759/A20465). The pulmonary vein study was funded by Roy Castle Lung Cancer Foundation (PC) and the North West Lung Centre Charity (PC). UKCTOCS was funded by the Medical Research Council (G9901012 and G0801228), Cancer Research UK (C1479/A2884), the Department of Health and with additional support from The Eve Appeal. Senior investigators at UCL supported by the NIHR University College London Hospitals (UCLH) Biomedical Research Centre. Declaration of Interests: The authors have no financial conflicts of interest. Ethics Approval Statement: UKCTOCS was approved by the UK North West Multicentre Research Ethics Committee (North West MREC 00/8/34) with site specific approval from the local regional ethics committees and the Caldicott guardians (data controllers) of the primary care trusts. All women gave written consent for use of samples and data in ethically approved secondary studies. The subset of samples used for the present study has been approved by the Yorkshire & The Humber - Sheffield Research Ethics Committee (REC Ref 15/YH/0044).

P3.01-78 The Cytology Samples and Plasma Specimens were Feasible for the EGFR Molecular Testing.

EGFR mutation detection with real-time PCR is standard method to identify eligible patients for EGFR-TKI treatments in daily routine practice. Surgically resected tissues or biopsy specimens are mainly used as the sample materials for testing. However, the biopsy samples sometimes have a certain limitation in their volume and so the cytology specimens are chosen for EGFR testing instead. Plasma has also become an option especially in EGFR-TKI resistant cases in which often have difficulties to obtain the adequate tumor yield. In this study, we evaluated the feasibilities of using cytology samples and plasma specimens for the EGFR molecular testing. Patients provided written informed consent for use of the samples were participated in this prospective research. Cytology samples were obtained from biopsy and cells were suspended into liquid-based cytology (LBC) media. Tumor contents in the samples were confirmed with Papanicolaou stained slides. Plasma samples were also collected from patients shortly before the tissue biopsy. EGFR mutations in these samples were analyzed by cobas EGFR Mutation Test v2. Also, EGFR testing result of tissue specimens of the patients corresponded were collected from the medical records measured by cobas EGFR Mutation Test v2 as reference. The feasibilities of both cytology and plasma specimen were evaluated comparing with the tissue samples. One-hundred fifty-eight patients were registered to this study. Among those patients, 77 patients with matched set of samples were enrolled to this study. EGFR mutation rates in tissue, cytology, and plasma were 37.7, 29.9 and 16.9 %, respectively. Overall agreement rate of the cytology specimens and the plasma specimens against the tissue samples were 87.0 and 75.3%, respectively. All eightT790M mutation positive cases were perfectly matched between tissue and cytology specimens. The results suggested that tissue specimen is the most suitable sample for detecting mutations. Since high specificities were confirmed in both cytology and plasma specimens, the results are reliable as long as the call is positive. Choosing cytology or plasma specimens for EGFR testing can be the considerations for the patients who have difficulties in collecting tissue samples in the real world setting.

Is Copyright Law Fit for Purpose in the Internet Era? An Economic and Legal Perspective

This paper asks the question: “Is copyright law fit for purpose in the Internet era?” to inform the debate on the development of a sustainable, online ecosystem from an economic and legal perspective This paper concludes that the application of exceptions to copyright that benefit intermediary business models - combined with the limitation on the liabilities of intermediaries made possible in the Digital Millennium Copyright Act [DMCA] in the USA and the eCommerce Directive in Europe - has led to the situation where rights holders are prevented from giving full consent for use of their works as required under copyright law and that this is damaging to the economy as a whole. This paper argues that the unintended consequences of legislation that establishes safe harbours are the: encouragement of parasitic growth; distortion of markets and investment; reduction of competition; creation of barriers to entry; and limitation of the overall economic growth of the cultural and creative industries both now and in the future. Society as a whole is therefore worse off than it would have been had rights holders’ full consent for the use of their works on the Internet been required or had their lack of consent been compensated. By examining the relationship between intermediaries and rights holders in the light of the Coase Theorem, four relevant scenarios for growth were identified. The first, “Pareto-efficient growth”, illustrates the role of copyright law in promoting economically efficient growth. If Pareto-efficient growth is to be achieved, it is necessary that creators have the option of granting their consent for the distribution of their works on the Internet. The second, “Parasitic growth”, describes the actual unintended effects of safe harbour, exposing the flaws in the safe harbour model. It suggests that under these conditions the economy may stagnate in a mode favouring copying and counterfeiting. The third, “Chilling effects”, reflects the concerns that led to the current framework for copyright law, in which intermediaries enjoy safe harbour in order to facilitate innovation. This argument often relies for its economic and legal justification upon a misinterpretation of Schumpeter’s characterisation of the nature of the competitive process in a market economy. The fourth, “No dispute” section highlights that copyright exceptions need to be limited to uses that do not create harm. Current exceptions in legislation are now too wide and unfit for the digital age. Growth of incomes, the development of suitable alternative institutional arrangements, together with falling transaction costs, and the lower costs of copying associated with the digital age all imply a more limited or narrow and reducing role for exceptions on a case-by-case basis is now appropriate. There is a range of policy options available to achieve Pareto-efficient growth, including: i) changing the law to oblige the intermediary, who currently benefits from safe harbour, to seek the full consent of rights holders by licence or contract; ii) implementing a mechanism under existing law that would enable the uploader to obtain the full consent of rights holders; iii) requiring the intermediaries to pay fair compensation, freely negotiated by and distributed to, all rights holders to compensate for the harm described in this paper. The contrasting fortunes of intermediaries and creators in the Internet economy provides testament to the balance of interests between the parties, having settled in a place where the absence of full consent of rights holders for the transformation, mass usage and distribution by intermediaries of copyright works (in original, amended, parodied or remixed music and video, through extracts of and links to news and thumbnails) not only impacts negatively the economics of creation and production, but also, through free-riding on the investment made by creators, damages the whole economy. This paper seeks to provide an economic and legal perspective on copyright law in the Internet era and policy recommendations lie deliberately outside its scope, but if Pareto-efficient growth is to be restored and overall welfare maximised, policymakers must address the present imbalance between the interests of intermediaries and creators.

Consentimiento informado bilingüe español-guaraní para su utilización en el consultorio odontológico

Consentimiento informado bilingüe español-guaraní para su utilización en el consultorio odontológico

Effect of MAF amplification on treatment outcomes with adjuvant zoledronic acid in early breast cancer: a secondary analysis of the international, open-label, randomised, controlled, phase 3 AZURE (BIG 01/04) trial

Adjuvant use of bisphosphonates can reduce the incidence of bone metastases in early breast cancer. Recurrence and survival seem to be improved only in postmenopausal patients, but the underlying mechanisms remain unclear. We investigated whether MAF amplification (a biomarker for bone metastasis) in primary tumours could predict the treatment outcomes of adjuvant zoledronic acid. The study population included patients enrolled in the international, open-label, randomised, controlled, phase 3 AZURE trial at eligible UK sites who had stage II or III breast cancer and who gave consent for use of their primary tumour samples. Patients were randomly assigned (1:1) to receive standard adjuvant systemic therapy alone (control group) or with zoledronic acid every 3-4 weeks for six doses, then every 3-6 months until the end of 5 years. Minimisation took into account the number of involved axillary lymph nodes, clinical tumour stage, oestrogen-receptor status, type and timing of systemic therapy, menopausal status, statin use, and treating centre. The primary endpoint was disease-free survival; the secondary endpoint, invasive-disease-free survival, was the primary disease endpoint for the analysis in this report. MAF amplification was assessed by fluorescence in-situ hybridisation of two cores of breast tumour tissue in a microarray, done in a central laboratory by technicians unaware of treatment assignment. We used multivariate analyses to assess disease outcomes by intention to treat. We also assessed interactions between MAF-positive status and menopausal status on efficacy of zoledronic acid. The AZURE trial is registered with the International Standard Randomised Controlled Trial Registry, number ISRCTN79831382. 1739 AZURE patients contributed primary tumour samples, of whom 865 (50%) had two assessable cores (445 in the control groups and 420 in the zoledronic acid group). 184 (21%) tumours were MAF positive (85 in the control groups and 99 in the zoledronic acid group) and the remaining tumours were MAF negative. At a median follow-up of 84·6 months (IQR 72·0-95·8), MAF status was not prognostic for invasive-disease-free survival in the control group (MAF-positive vs MAF-negative: hazard ratio [HR] 0·92, 95% CI 0·59-1·41), but was in the zoledronic acid group (0·52, 0·36-0·75). In patients with MAF-negative tumours, zoledronic acid was associated with higher invasive-disease-free survival than was control treatment (HR 0·74, 95% CI 0·56-0·98), but not in patients who had MAF-positive tumours. Additionally, among 121 patients not postmenopausal at randomisation with MAF-positive tumours, zoledronic acid was associated with lower invasive-disease-free survival (HR 2·47, 95% CI 1·23-4·97) and overall survival (2·27, 95% CI 1·04-4·93) than control treatment. MAF status can predict likelihood of benefit from adjuvant zoledronic acid and merits further investigation as a potential companion diagnostic. Novartis Global and Inbiomotion.

Ethical acceptability of using generic consent for secondary use of data and biological samples in medical research

The research idea starts from the previous identification of certain elements of generic consent for research activities found in informed consent (IC) forms used in therapeutic activities in hospitals that have the right to conduct medical research on human subjects in Northeast Romania. The paper questions the ethical acceptability of secondary use of data and biological samples in medical research, in the context of obtaining generic therapeutic consent from patients. The objective of the research is to analyze the Romanian context of using the IC obtained in therapeutic purposes as a starting point for the research activity. We wish to argue that the practice of obtaining a generic consent - for using the data obtained and the biological samples collected in the therapeutic process for secondary analysis - raises serious ethical issues regarding the validity and effectiveness of the IC.

Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial

SummaryBackgroundLocal cancer relapse risk after breast conservation surgery followed by radiotherapy has fallen sharply in many countries, and is influenced by patient age and clinicopathological factors. We hypothesise that partial-breast radiotherapy restricted to the vicinity of the original tumour in women at lower than average risk of local relapse will improve the balance of beneficial versus adverse effects compared with whole-breast radiotherapy.MethodsIMPORT LOW is a multicentre, randomised, controlled, phase 3, non-inferiority trial done in 30 radiotherapy centres in the UK. Women aged 50 years or older who had undergone breast-conserving surgery for unifocal invasive ductal adenocarcinoma of grade 1–3, with a tumour size of 3 cm or less (pT1–2), none to three positive axillary nodes (pN0–1), and minimum microscopic margins of non-cancerous tissue of 2 mm or more, were recruited. Patients were randomly assigned (1:1:1) to receive 40 Gy whole-breast radiotherapy (control), 36 Gy whole-breast radiotherapy and 40 Gy to the partial breast (reduced-dose group), or 40 Gy to the partial breast only (partial-breast group) in 15 daily treatment fractions. Computer-generated random permuted blocks (mixed sizes of six and nine) were used to assign patients to groups, stratifying patients by radiotherapy treatment centre. Patients and clinicians were not masked to treatment allocation. Field-in-field intensity-modulated radiotherapy was delivered using standard tangential beams that were simply reduced in length for the partial-breast group. The primary endpoint was ipsilateral local relapse (80% power to exclude a 2·5% increase [non-inferiority margin] at 5 years for each experimental group; non-inferiority was shown if the upper limit of the two-sided 95% CI for the local relapse hazard ratio [HR] was less than 2·03), analysed by intention to treat. Safety analyses were done in all patients for whom data was available (ie, a modified intention-to-treat population). This study is registered in the ISRCTN registry, number ISRCTN12852634.FindingsBetween May 3, 2007, and Oct 5, 2010, 2018 women were recruited. Two women withdrew consent for use of their data in the analysis. 674 patients were analysed in the whole-breast radiotherapy (control) group, 673 in the reduced-dose group, and 669 in the partial-breast group. Median follow-up was 72·2 months (IQR 61·7–83·2), and 5-year estimates of local relapse cumulative incidence were 1·1% (95% CI 0·5–2·3) of patients in the control group, 0·2% (0·02–1·2) in the reduced-dose group, and 0·5% (0·2–1·4) in the partial-breast group. Estimated 5-year absolute differences in local relapse compared with the control group were −0·73% (−0·99 to 0·22) for the reduced-dose and −0·38% (−0·84 to 0·90) for the partial-breast groups. Non-inferiority can be claimed for both reduced-dose and partial-breast radiotherapy, and was confirmed by the test against the critical HR being more than 2·03 (p=0·003 for the reduced-dose group and p=0·016 for the partial-breast group, compared with the whole-breast radiotherapy group). Photographic, patient, and clinical assessments recorded similar adverse effects after reduced-dose or partial-breast radiotherapy, including two patient domains achieving statistically significantly lower adverse effects (change in breast appearance [p=0·007 for partial-breast] and breast harder or firmer [p=0·002 for reduced-dose and p<0·0001 for partial-breast]) compared with whole-breast radiotherapy.InterpretationWe showed non-inferiority of partial-breast and reduced-dose radiotherapy compared with the standard whole-breast radiotherapy in terms of local relapse in a cohort of patients with early breast cancer, and equivalent or fewer late normal-tissue adverse effects were seen. This simple radiotherapy technique is implementable in radiotherapy centres worldwide.FundingCancer Research UK.

Clinicians\u2019 views and experiences of offering two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study

BackgroundThe Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. Preterm birth can be rapid and unexpected, allowing little time for the usual consent process. Therefore, in addition to the usual procedure for written consent, a two-stage pathway for consent for use when birth was imminent was developed. The aims of this study were to explore clinicians’ views and experiences of offering two consent pathways for recruitment to a randomised trial of timing of cord clamping at very preterm birth.MethodsThis was a qualitative study using semi-structured interviews. Clinicians from eight hospitals in the UK who had been involved in offering consent to the Cord Pilot Trial were invited to take part in an interview. Clinicians were interviewed in person or by telephone. Interviews were analysed using inductive systematic thematic analysis.ResultsSeventeen clinicians who had either offered usual written consent only (n = 6) or both the two-stage pathway (with oral assent before the birth and written consent after the birth) and usual written consent (n = 11) were interviewed. Six themes were identified: (1) team approach to offering participation; (2) consent form as a record; (3) consent and participation as a continual process; (4) different consent pathways for different trials; (5) balance between time, information, and understanding; and (6) validity of consent. Overall, clinicians were supportive of the two-stage consent pathway. Some clinicians felt that in time-critical situations oral assent presented an advantage over the usual written consent as they provided information on a “need to know” basis. However, there was some concern about how much information should be given for oral assent, and how this is understood by women when birth is imminent.ConclusionsThe two-stage pathway for consent developed for use in the Cord Pilot Trial when birth was imminent was acceptable to clinicians for comparable low-risk studies, although some concerns were raised about the practicalities of obtaining oral assent.Trial registrationISRCTN Registry, ISRCTN21456601. Registered on 28 February 2013.

The 'One in a Million' study: creating a database of UK primary care consultations.

BackgroundAround 1 million primary care consultations happen in England every day. Despite this, much of what happens in these visits remains a ‘black box’.AimTo create an archive of videotaped consultations and linked data based on a large sample of routine face-to-face doctor–patient consultations with consent for use in future research and training.Design and settingCross-sectional study in 12 general practices in the west of England, UK.MethodUp to two GPs from each practice took part in the study. Over 1 to 2 days, consecutive patients were approached until up to 20 eligible patients for each GP consented to be videotaped. Eligible patients were aged ≥18 years, consulting on their own behalf, fluent in English, and with capacity to consent. GP questionnaires were self-administered. Patient questionnaires were self-administered immediately pre-consultation and post-consultation, and GPs filled in a checklist after each recording. A follow-up questionnaire was sent to patients after 10 days, and data about subsequent related consultations were collected from medical records 3 months later.ResultsOf the 485 patients approached, 421 (86.8%) were eligible. Of the eligible patients, 334 (79.3%) consented to participate and 327 consultations with 23 GPs were successfully taped (307 video, 20 audio-only). Most patients (n = 300, 89.8%) consented to use by other researchers, subject to specific ethical approval.ConclusionMost patients were willing to allow their consultations to be videotaped, and, with very few exceptions, to allow recordings and linked data to be stored in a data repository for future use for research and training.

The use of human samples obtained during medicolegal autopsies in research: An introduction to current conditions and initiatives in Japan.

Background Leftover samples obtained during autopsies are extremely important basic materials for forensic research. However, there are no established practices for research-related use of obtained samples. Objective This study discusses good practice for the secondary use of samples collected during medicolegal autopsies. Methods A questionnaire was posted to all 76 departments of forensic medicine performing medicolegal autopsies in Japan, and 48 responses were received (response rate: 63.2%). As a secondary analysis, we surveyed information provided on department websites. Results Ethical reviews conducted when samples were to be used for research varied greatly among departments, with 21 (43.8%) departments reporting 'fundamentally, all cases are subject to review', eight (16.7%) reporting 'only some are subject to review' and 17 (39.6%) reporting 'none are subject to review'. Information made available on websites indicated that 11 departments had a statement of some type to bereaved families about the potential research use of human samples obtained during autopsies. Nine of these included a notice stating that bereaved families may revoke their consent for use. Several departments used an opt-out system. Conclusion There is no common practice in the field of legal medicine on the ethical use for medical research of leftover samples from medicolegal autopsies. The trust of not only bereaved families but also society in general is required for the scientific validity and social benefits of medical studies using leftover samples from medicolegal autopsies through the use of opt-out consenting and offline and online dissemination and public-relations activities.

Revised Common Rule Allows Broad Consent.

The U.S. Department of Health and Human Services has revised the Common Rule governing the protection of patients who donate biospecimens for research. The final rule eliminates a controversial proposal that would have required researchers to obtain renewed consent for use of donated samples beyond their original purpose.

ELBERTE v LATVIA: The To be or not to be question of Consent.

'Informed consent' is essentially an ethical and legal practice and has long been the central theme in the discussions over tissue research. This commentary discusses the case of Elberte v Latvia (Application no 61243/08, January 2015) which is a new direction in consent for use of tissues in health research. However it has offered lesser clarity in different ways. The case considers the importance of consent and also requires that the close relatives be given a right to consent under certain circumstances. This poses two important questions which will be dealt with under this commentary, one the factual right of the relatives to offer consent for another and secondly the impact such consent may have on tissue research.

Recommendations for Social Media Use in Hospitals and Health Care Facilities

Recommendations for Social Media Use in Hospitals and Health Care Facilities

82 - The Changing Ethical Landscape for Secondary Use of Human Biological Material: Implications for Stem Cell Banking and Research

The use of human biological material is essential for stem cell research. There is broad consensus that such use is ethically acceptable if two key conditions are satisfied: the wishes of the original donors of the material are respected and potential harms to them are minimized, in particular by protecting their privacy. What is less clear is how best to ensure that these conditions are satisfied without unduly impeding valuable research or imposing unreasonable burdens on researchers, oversight bodies, and institutions. The policies and regulations of various countries have taken slightly different approaches and some of these have been the subject of recent review and reform. For example, a notice of proposed changes to the U.S. “Common Rule” for human subjects research contains provisions that would require informed consent for use of human biospecimens, including even secondary use of non-identified material, although this could be a “broad consent” to future unspecified uses by means of an approved form. They would also require enhanced privacy and security protections for collection, storage and use of biospecimens.

Bi-linear mechanical property determination of acellular human patellar tendon grafts for use in anterior cruciate ligament replacement

Anterior cruciate ligament rupture is rising in its prevalence amongst the young and those with physically active lifestyles. Acellular human patellar tendon (PT) grafts offer a promising restoration solution, returning knee joint stability and overcoming some of the current disadvantages of autologous or allogeneic grafts. However, it is necessary to ensure that the decellularisation bio-processes involved do not cause structural changes in the microstructure of the tendon tissue that may adversely affect the mechanical properties, particularly with respect to the physiological range of loading.Sixteen cadaveric human PT grafts were sourced and processed from eight donors, with full ethical approval and consent for use in research. Eight specimens were allocated for decellularisation, while the remaining eight contralateral specimens were used as native controls. Testing consisted of 12 preconditioning cycles followed by uniaxial extension until failure occurred. Stress–strain data was then fitted to a bi-linear model using least squares regression by a custom-written Matlab script. The elastic moduli for the toe region and linear region of each specimen were determined, in addition to the transition point co-ordinates and strain energy density for increasing strain. No significant differences were found between groups for all of the parameters investigated. Hence, the shape and magnitude of the stress–strain profile was found to be the same for both groups throughout loading.The results of this study indicated that decellularisation appeared to have no effect on the material properties of human PT grafts under quasistatic conditions. Therefore, acellular human PT grafts can offer a viable additional solution for ACL replacement compared to current autologous and allogeneic treatment options.