BackgroundRandomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of (...) their methodology in a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data.MethodsThe development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial “long list” of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the “long list” and generate a “short list” of key items. In phase 4, these items will serve as the basis for an in-person consensus meeting to finalize a core set of items to be included in the reporting guideline and checklist. Phase 5 will involve drafting the checklist and elaboration-explanation documents, and dissemination and implementation of the guideline.DiscussionDevelopment of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data. (shrink)

Current UK legislation is impacting upon the feasibility and cost-effectiveness of medical record-based research aimed at benefiting the NHS and the public heath. Whereas previous commentators have focused on the Data Protection Act 1998, the Health and Social Care Act 2001 is the key legislation for public health researchers wishing to access medical records without written consent. The Act requires researchers to apply to the Patient Information Advisory Group for permission to access medical records without written permission. We present (...) a case study of the work required to obtain the necessary permissions from PIAG in order to conduct a large scale public health research project. In our experience it took eight months to receive permission to access basic identifying information on individuals registered at general practices, and a decision on whether we could access clinical information in medical records without consent took 18 months. Such delays pose near insurmountable difficulties to grant funded research, and in our case £560 000 of public and charitable money was spent on research staff while a large part of their work was prohibited until the third year of a three year grant. We conclude by arguing that many of the current problems could be avoided by returning PIAG’s responsibilities to research ethics committees, and by allowing “opt-out” consent for many public health research projects. (shrink)

Current UK legislation is impacting upon the feasibility and cost-effectiveness of medical record-based research aimed at benefiting the NHS and the public heath. Whereas previous commentators have focused on the Data Protection Act 1998, the Health and Social Care Act 2001 is the key legislation for public health researchers wishing to access medical records without written consent. The Act requires researchers to apply to the Patient Information Advisory Group for permission to access medical records without written permission. We present (...) a case study of the work required to obtain the necessary permissions from PIAG in order to conduct a large scale public health research project. In our experience it took eight months to receive permission to access basic identifying information on individuals registered at general practices, and a decision on whether we could access clinical information in medical records without consent took 18 months. Such delays pose near insurmountable difficulties to grant funded research, and in our case £560 000 of public and charitable money was spent on research staff while a large part of their work was prohibited until the third year of a three year grant. We conclude by arguing that many of the current problems could be avoided by returning PIAG’s responsibilities to research ethics committees, and by allowing “opt-out” consent for many public health research projects. (shrink)

Reactivity in qualitative data collection occurs when a researcher generates data about a situation with reactivity, that is, a situation in which the ongoing research affects the research participants such that they, say, diverge from their routines when the researcher is present, or tell the researcher what they think she wants to hear. In qualitative research, there are two basic approaches to reactivity. The traditional position maintains that data should ideally be collected in situations without any (...) reactivity. In other words, good data are reactivity free. By contrast, the more recent view holds that data from situations with reactivity are fine as long as the researcher is aware of the occurring reactivity so that she can take it into account when interpreting her data. In this fashion, good data are reactivity transparent. In this paper, I first spell out and defend the more recent approach to reactivity. I argue that qualitative data are reactivity transparent when conjoined with true reactivity assumptions and that, thus supplemented, data are informative about social life independently of its being studied. Next, I examine various issues raised by the requirement to put forth true reactivity assumptions. Lastly, I use my discussion of reactivity transparency as a basis for providing a framework for thinking about good qualitative data. (shrink)

BackgroundClinical trials should be as inclusive as possible to facilitate equitable access to research and better reflect the population towards which any intervention is aimed. Informed by the UK’s National Institute for Health and Care Research (NIHR) Innovations in Clinical Trial Design and Delivery for the Under-served (INCLUDE) guidance, we audited oncology trials conducted by the Clinical Trials and Statistics Unit at The Institute of Cancer Research, London (ICR-CTSU) to identify whether essential documents were overtly excluding any groups and whether (...) sufficient data were collected to assess diversity of trial participants from groups suggested by INCLUDE as under-served by research in the UK.MethodsThirty cancer clinical trials managed by ICR-CTSU and approved between 2011–2021 were audited. The first ethics approved version of each trial’s protocol, patient information sheet, and patient completed questionnaire, together with the first case report forms (CRFs) version were reviewed. A range of items aligned with the INCLUDE under-served groups were assessed, including age, sex and gender, socio-economic and health factors. The scope did not cover trial processes in participating hospitals.ResultsData relating to participants’ age, ethnic group and health status were well collected and no upper age limit was specified in any trials’ eligibility criteria. 23/30 (77%) information sheets used at least one gendered term to address patients. Most CRFs did not specify whether they were collecting sex or gender and only included male or female categories. The median reading age for information sheets was 15–16 years (IQR: 14–15 – 16–17). Socio-economic factors were not routinely collected and not commonly mentioned in trial protocols.ConclusionsNo systemic issues were identified in protocols which would explicitly prevent any under-served group from participating. Areas for improvement include reducing use of gendered words and improving readability of patient information. The challenge of fully assessing adequate inclusion of under-served populations remains, as socio-economic factors are not routinely collected because they fall beyond the data generally required for protocol-specified trial endpoint assessments. This audit has highlighted the need to agree and standardise demographic data collection to permit adequate monitoring of the under-served groups identified by the NIHR. (shrink)

KEY POINTS In Canada, commercial data brokers collect deidentified patient data from pharmacies, private drug insurers, the federal government and medical clinics without patient consent. Although pharmaceutical companies are the data brokers’ primary customers, academics and nonprofit and public entities also use commercial data sets, given the absence of a coordinated public approach to collecting these data across Canada. Risks of commercialized patient data include loss of anonymity, surveillance and marketing, discrimination and violation of (...) Indigenous data sovereignty. Coordinated infrastructure for the collection and coordination of health data across Canada and updated privacy legislation would protect individuals and communities and enable appropriate data uses. (shrink)

The increased use of information technology in every day health care creates vast amounts of stored health data that can be used for research. The secondary research use of routinely collected data raises questions about appropriate consent mechanisms for such use. One option is meta consent where individuals state their own consent preferences in relation to future use of their data, e.g. whether they want the data to be accessible to researchers under conditions of (...) specific consent, broad consent, blanket consent or not at all. This study investigates whether meta consent preferences can be successfully elicited by a smartphone application in the adult Danish population. A smartphone app was developed for the elicitation of meta consent preferences. An invitation to use the app was distributed to a stratified, representative sample of the Danish adult population. The meta consent choices, the use of the app, user experience data, and demographic data were logged and analysed statistically using IBM SPSS version 20. Of 1000 potential respondents 221 used the app. One hundred eighty-eight of the respondents were female and 103 male. The age range was 19 to 79 years with an average of 51 years. Most users indicate 1) that they find the choices they are asked to make easy to understand, 2) that the application is easy to use, and 3) that this kind of choice should be offered to people. It is possible to collect meta consent preferences in the general, adult population using a smartphone app. (shrink)

Social alliance is defined as the collaboration between for-profit and nonprofit organizations. Building on the insights derived from the resource-based theory, we develop a conceptual framework to explain how socially entrepreneurial nonprofit organizations can improve their social alliance performance by adopting strategic alliance management routines. We test our framework using the data collected from 203 UK-based SENPOs in the context of cause-related marketing campaign-derived social alliances. Our results confirm a positive relationship between social alliance management routines and social (...) alliance performance. We also find that relational mechanisms, such as mutual trust, relational embeddedness, and relational commitment, mediate the relationship between social alliance management routines and social alliance performance. Moreover, our findings suggest that different types of social alliance motivation can influence the impact of social alliance management routines on different types of the relational mechanisms. In general, we demonstrate that SENPOs can benefit from adopting social alliance management routines and, in addition, highlight how and when the social alliance management routines–social alliance performance relationship might be shaped. Our study offers important academic and managerial implications, and points out future research directions. (shrink)

BackgroundUse of routinely collected patient data for research and service planning is an explicit policy of the UK National Health Service and UK government. Much clinical information is recorded in free-text letters, reports and notes. These text data are generally lost to research, due to the increased privacy risk compared with structured data. We conducted a citizens’ jury which asked members of the public whether their medical free-text data should be shared for research for (...) public benefit, to inform an ethical policy.MethodsEighteen citizens took part over 3 days. Jurors heard a range of expert presentations as well as arguments for and against sharing free text, and then questioned presenters and deliberated together. They answered a questionnaire on whether and how free text should be shared for research, gave reasons for and against sharing and suggestions for alleviating their concerns.ResultsJurors were in favour of sharing medical data and agreed this would benefit health research, but were more cautious about sharing free-text than structured data. They preferred processing of free text where a computer extracted information at scale. Their concerns were lack of transparency in uses of data, and privacy risks. They suggested keeping patients informed about uses of their data, and giving clear pathways to opt out of data sharing.ConclusionsInformed citizens suggested a transparent culture of research for the public benefit, and continuous improvement of technology to protect patient privacy, to mitigate their concerns regarding privacy risks of using patient text data. (shrink)

IntroductionThis special issue brings together researchers from psychology and linguistics who apply the ethnomethodologically informed analytic technique of conversation analysis (henceforth CA) to examine a range of ethical issues as they emerge in transcribed recordings of interactions collected as part of routine research encounters. The data authors analyse are diverse, including naturalistic audio and video recordings of members’ everyday and professional practices (Mondada 2014), an ethnography of a gynaecology unit in a public hospital in Italy (Fatigante and Orletti (...) 2014), focus group interviews on domestic family life (Alby and Fatigante 2014), and semi-public meetings, recorded as part of an ethnography of ageing, poverty, and social exclusion (Paoletti 2014b). Noting that “ethical issues in research have seldom been the focus of ethnomethodological studies” (Paoletti 2014a: 174; see also Mondada 2014: 182–183), the primary aim of this special issue is to “open a debate on e. (shrink)

Background: Use of patients’ medical data for secondary purposes such as health research, audit, and service planning is well established in the UK. However, the governance environment, as well as public understanding about this work, have lagged behind. We aimed to systematically review the literature on UK and Irish public views of patient data used in research, critically analysing such views though an established biomedical ethics framework, to draw out potential strategies for future good practice guidance and inform (...) ethical and privacy debates. Methods: We searched three databases using terms such as patient, public, opinion, and electronic health records. Empirical studies were eligible for inclusion if they surveyed healthcare users, patients or the public in UK and Ireland and examined attitudes, opinions or beliefs about the use of patient data for medical research. Results were synthesised into broad themes using a framework analysis. Results: Out of 13,492 papers and reports screened, 20 papers or reports were eligible. While there was a widespread willingness to share patient data for research for the common good, this very rarely led to unqualified support. The public expressed two generalised concerns about the potential risks to their privacy. The first of these concerns related to a party’s competence in keeping data secure, while the second was associated with the motivation a party might have to use the data. Conclusions: The public evaluates trustworthiness of research organisations by assessing their competence in data-handling and motivation for accessing the data. Public attitudes around data-sharing exemplified several principles which are also widely accepted in biomedical ethics. This provides a framework for understanding public attitudes, which should be considered in the development in any guidance for regulators and data custodians. We propose four salient questions which decision makers should address when evaluating proposals for the secondary use of data. (shrink)

Biological samples are routinely collected and used in biomedical research. As Weir and Olick (2004) point out in their book The Stored Tissue Issue, there are four ways in which samples can be sto...

The task of data collection is becoming routine in many disciplines and this results in increased availability of data. This routinely collected data provides a valuable opportunity for analysis with a view to support evidence based decision making. In order to confidently leverage the data in support of decision making the most appropriate statistical method needs to be selected, and this can be difficult for an end user not trained in statistics. This paper outlines (...) an application of argumentation to support the analysis of clinical data, that uses Extended Argumentation Frameworks in order to reason with the meta-level arguments derived from preference contexts relevant to the data and the analysis objective of the end user. We outline a formalisation of the argument scheme for statistical model selection, its critical questions and the structure of the knowledge base required to support the instantiation of the arguments and meta-level arguments through the use of Z notation. This paper also describes the prototype implementation of argumentation for statistical model selection based on the Z specification outlined herein. (shrink)

The task of data collection is becoming routine in many disciplines and this results in increased availability of data. This routinely collected data provides a valuable opportunity for analysis with a view to support evidence based decision making. In order to confidently leverage the data in support of decision making the most appropriate statistical method needs to be selected, and this can be difficult for an end user not trained in statistics. This paper outlines (...) an application of argumentation to support the analysis of clinical data, that uses Extended Argumentation Frameworks in order to reason with the meta-level arguments derived from preference contexts relevant to the data and the analysis objective of the end user. We outline a formalisation of the argument scheme for statistical model selection, its critical questions and the structure of the knowledge base required to support the instantiation of the arguments and meta-level arguments through the use of Z notation. This paper also describes the prototype implementation of argumentation for statistical model selection based on the Z specification outlined herein. (shrink)

BackgroundChronic airway diseases are prevalent and costly conditions. Interdisciplinary rehabilitation programs that include Acceptance and Commitment-based components could be important to tackle the vicious circle linking progression of the disease, inactivity, and psychopathological symptoms.MethodsA retrospective evaluation of routinely collected data of an interdisciplinary rehabilitation program was performed. The program included group sessions including patient education, breathing exercise, occupational therapy and an ACT-based psychological treatment, and individual sessions of physical therapy. Demographic data, clinical characteristics of the patients (...) and the values of outcome variables before treatment, at discharge, at 3 months, and at 6 months were extracted from medical records. Multiple imputation was employed to address missing data. Linear mixed models were employed to assess changes over time. Multivariable logistic regression was performed to assess predictors of a minimum clinically important change of health status from baseline to the 6-months follow-up.ResultsData from 31 patients with chronic obstructive pulmonary disease and 12 patients with bronchiectasis were extracted. Health status improved from baseline to discharge to the 3 months follow-up, but not to the 6 months follow-up. Anxiety and depression improved across all the time points. Quality of life did not improve over time. Having a worse health status at baseline and fewer depressive symptoms were significantly associated with achieving a minimum clinically important change of health status at 6 months. The effects of the interdisciplinary program were not different for patients with COPD or with bronchiectasis.DiscussionInterdisciplinary programs including ACT-based components are promising treatments for the rehabilitation of patients with chronic airway diseases. (shrink)

Whether due to simplicity or hypocrisy, the question of access to patient data for biomedical research is widely seen in the public discourse only from the angle of patient privacy. At the same time, the desire to live and to live without disability is of much higher value to the patients. This goal can only be achieved by extracting research insight from patient data in addition to working on model organisms, something that is well understood by many patients. (...) Yet, most biomedical researchers working outside of clinics and hospitals are denied access to patient records when, at the same time, clinicians who guard the patient data are not optimally prepared for the data’s analysis. Medical data collection is a time- and cost-intensive process that is most of all tedious, with few elements of intellectual and emotional satisfaction on its own. In this process, clinicians and bioinformaticians, each group with their own interests, have to join forces with the goal to generate medical data sets both from clinical trials and from routinely collected electronic health records that are, as much as possible, free from errors and obvious inconsistencies. The data cleansing effort as we have learned during curation of Singaporean clinical trial data is not a trivial task. The introduction of omics and sophisticated imaging modalities into clinical practice that are only partially interpreted in terms of diagnosis and therapy with today’s level of knowledge warrant the creation of clinical databases with full patient history. This opens up opportunities for re-analyses and cross-trial studies at future time points with more sophisticated analyses of the same data, the collection of which is very expensive. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and (...) informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

Research Ethics, Volume 18, Issue 2, Page 151-162, April 2022. In today’s online data-driven world, people constantly shed data and deposit digital footprints. When individuals access health services, governments and health providers collect and store large volumes of health information about people that can later be retrieved, linked and analysed for research purposes. This can lead to new discoveries in medicine and healthcare. In addition, when securely stored and de-identified, the privacy risks are minimal and manageable. In many (...) jurisdictions, ethics committees routinely waive the requirement for researchers to obtain consent from data subjects before using and linking these datasets in an effort to balance respect for individuals with research efficiency. In this paper, I explore the ethical justification for using routinely collected health data for research without consent. I conclude that, not only is this morally justified but also that data subjects have a moral obligation to contribute their data to such research, which would obviate the need for ethics committees to consider consent waivers. In justifying this argument, I look to the duty of easy rescue, distributive justice and draw analogies with vaccination ethics. (shrink)

An emerging approach to complement randomised controlled trial (RCT) data in the development of radiotherapy treatments is to use routinely collected ‘real-world’ data (RWD). RWD is the data collected as standard-of-care about all patients during their usual cancer care pathway. Given the nature of this data, important questions remain about the permissibility and acceptability of using RWD in routine practice. We involved and engaged with patients, carers and the public in a two-day citizens’ (...) jury to understand their views and obtain decisions regarding two key issues: (1) preferred approaches to consent for the use of RWD within the context of patients receiving radiotherapy for lung cancer in RAPID-RT and (2) how RWD use should be best communicated to patients. Individual views were polled using questionnaires at various stages of the jury, whilst group discussion activities prompted further dialogue about the rationale behind choices of consent. Key decisions obtained from the jury include: (1) an opt-out approach to consent for the use of RWD; (2) the opt-out approach to consent should be informed. Furthermore, it was advised that information and communication regarding the consent process and use of RWD should be accessible, clear and available in a variety of formats. It is important that the consent process for patient data use is underpinned by principles of autonomy and transparency with clear channels of communication between those asking for and giving consent. Moreover, the process of seeking consent from patients should be proportionate to the risks presented from their participation. (shrink)

Background Improving the ways in which routinely-collected mental health data are shared could facilitate substantial advances in research and treatment. However, this process should only be undertaken in partnership with those who provide such data. Despite relatively widespread investigation of public perspectives on health data sharing more generally, there is a lack of research on the views of people with mental illness. Methods Twelve people with lived experience of mental illness took part in semi-structured interviews (...) via online video software. Participants had experience of a broad range of mental health conditions including anxiety, depression, schizophrenia, eating disorders and addiction. Interview questions sought to establish how participants felt about the use of routinely-collected health data for research purposes, covering different types of health data, what health data should be used for, and any concerns around its use. Results Thematic analysis identified four overarching themes: benefits of sharing mental health data, concerns about sharing mental health data, safeguards, and data types. Participants were clear that health data sharing should facilitate improved scientific knowledge and better treatments for mental illness. There were concerns that data misuse could become another way in which individuals and society discriminate against people with mental illness, for example through insurance premiums or employment decisions. Despite this there was a generally positive attitude to sharing mental health data as long as appropriate safeguards were in place. Conclusions There was notable strength of feeling across participants that more should be done to reduce the suffering caused by mental illness, and that this could be partly facilitated by well-managed sharing of health data. The mental health research community could build on this generally positive attitude to mental health data sharing by following rigorous best practice tailored to the specific concerns of people with mental illness. (shrink)

Archival data processing consists of cleaning and formatting data between the moment a dataset is deposited and its publication on the archive’s website. In this article, I approach data processing by combining scholarship on invisible labor in knowledge infrastructures with a Marxian framework and show the relevance of considering data processing as factory labor. Using this perspective to analyze ethnographic data collected during a six-month participatory observation at a U.S. data archive, I generate (...) a taxonomy of the forms of alienation that data processing generates, but also the types of resistance that processors develop, across four categories: routine, speed, skill, and meaning. This synthetic approach demonstrates, first, that data processing reproduces typical forms of factory worker’s alienation: processors are asked to work along a strict standardized pipeline, at a fast pace, without acquiring substantive skills or having a meaningful involvement in their work. It reveals, second, how data processors resist the alienating nature of this workflow by developing multiple tactics along the same four categories. Seen through this dual lens, data processors are therefore not only invisible workers, but also factory workers who follow and subvert a workflow organized as an assembly line. I conclude by proposing a four-step framework to better value the social contribution of data workers beyond the archive. (shrink)

The Mental Health Act 2007 introduced Deprivation of Liberty safeguards into the Mental Capacity Act 2005 with potentially far reaching resource implications. There appears to be no scientific data regarding the prevalence of deprivation of liberty in clinical settings such as hospitals and nursing homes. We examined how many patients across a whole Trust area in Wales were subject to some lack of capacity, how well documented this was and how many were potentially deprived of their liberty. We found (...) that no patient was deprived of their liberty, but 8% lacked capacity to make either basic or complex decisions; another 5% lacked capacity to make complex decisions. Documentation was good in mental health and community directorates, but there were gaps in documentation (not practice) in the medical and surgical directorates. Routine collection of data improved documentation regarding deprivation of liberty criteria. There is a high likelihood that senior nursing staff underestimate the number of patients who lack capacity. (shrink)

The COVID-19 pandemic has significantly changed university students' life routines, such as prolonged stay at home and learning online without prior preparation. Identifying factors influencing student online learning has become a great concern of educators and researchers. The present study aimed to investigate whether family wellbeing would significantly predict university students' online learning effectiveness indicated by engagement and gains. The mediational role of individual wellbeing such as life satisfaction and sleep difficulties was also tested. This study collected data (...) from 511 undergraduate students via an online survey. Structural equation modeling analysis revealed positive effects of family support on students' learning engagement and gains through the mediational effects of life satisfaction and sleep difficulties. In contrast to our expectation, family conflict during the pandemic also positively predicted students' learning gains, which, however, was not mediated by individual wellbeing. The findings add value to the existing literature by delineating the inter-relationships between family wellbeing, individual wellbeing, and online learning effectiveness. The study also sheds light on the unique meaning of family conflict, which needs further clarification in future studies. (shrink)

Massive amounts of data are collected and stored on a routine basis in virtually all domains of human activities. Such data are potentially useful to biomedicine. Yet, access to data for research purposes is hindered by the fact that different kinds of individual-patient data reside in disparate, unlinked silos. We propose that data cooperatives can promote much needed data aggregation and consequently accelerate research and its clinical translation. Data cooperatives enable direct control (...) over personal data, as well as more democratic governance of data pools. This model can realize a specific kind of data economy whereby citizens and communities are empowered to steer data use according to their motivations, preferences, and concerns. Policy makers can promote this model by recognizing citizens’ rights to access and to obtain a copy of their own data, and by funding distributed data infrastructures piloting new data aggregation models. (shrink)

Background The emergence of molecular HIV surveillance (MHS) and cluster detection and response (CDR) programs as key features of the United States (US) HIV strategy since 2018 has caused major controversies. HIV surveillance programs that re-use individuals’ routinely collected clinical HIV data do not require consent on the basis that the public benefit of these programs outweighs individuals’ rights to opt out. However, criticisms of MHS/CDR have questioned whether expanded uses of HIV genetic sequence data for (...) prevention reach beyond traditional public health ethics frameworks. This study aimed to explore views on consent within MHS/CDR among critical stakeholders.Methods In 2021 we interviewed 26 US HIV stakeholders who identified as being critical or concerned about the rollout of MHS/CDR. Stakeholders included participants belonging to networks of people living with HIV, other advocates, academics, and public health professionals. This analysis focused on identifying the range of positions among critical and concerned stakeholders on consent affordances, opt-outs, how to best inform people living with HIV about how data about them are used in public health programs, and related ethical issues.Results Participants were broadly supportive of introducing some forms of consent into MHS/CDR. However, they differed on the specifics of implementing consent. While some participants did not support introducing consent affordances, all supported the idea that people living with HIV should be informed about how HIV surveillance and prevention is conducted and how individuals’ data are used.Conclusions MHS/CDR has caused sustained controversy. Among critical stakeholders, consent is generally desirable but contested, although the right for people living with HIV to be informed was centrally supported. In an era of big data-driven public health interventions and routine uses of HIV genetic sequence data in surveillance and prevention, CDC and other agencies should revisit public health ethics frameworks and consider the possibility of consent processes. (shrink)

Background Outbreaks of infectious disease cause serious and costly health and social problems. Two new technologies – pathogen whole genome sequencing and Big Data analytics – promise to improve our capacity to detect and control outbreaks earlier, saving lives and resources. However, routinely using these technologies to capture more detailed and specific personal information could be perceived as intrusive and a threat to privacy. Method Four community juries were convened in two demographically different Sydney municipalities and two regional (...) cities in New South Wales, Australia to elicit the views of well-informed community members on the acceptability and legitimacy of: making pathogen WGS and linked administrative data available for public health researchusing this information in concert with data linkage and machine learning to enhance communicable disease surveillance systems Fifty participants of diverse backgrounds, mixed genders and ages were recruited by random-digit-dialling and topic-blinded social-media advertising. Each jury was presented with balanced factual evidence supporting different expert perspectives on the potential benefits and costs of technologically enhanced public health research and communicable disease surveillance and given the opportunity to question experts. Results Almost all jurors supported data linkage and WGS on routinely collected patient isolates for the purposes of public health research, provided standard de-identification practices were applied. However, allowing this information to be operationalised as a syndromic surveillance system was highly contentious with three juries voting in favour, and one against by narrow margins. For those in favour, support depended on several conditions related to system oversight and security being met. Those against were concerned about loss of privacy and did not trust Australian governments to run secure and effective systems. Conclusions Participants across all four events strongly supported the introduction of data linkage and pathogenomics to public health research under current research governance structures. Combining pathogen WGS with event-based data surveillance systems, however, is likely to be controversial because of a lack of public trust, even when the potential public health benefits are clear. Any suggestion of private sector involvement or commercialisation of WGS or surveillance data was unanimously rejected. (shrink)

Inadequate diet is the leading risk factor for morbidity and mortality worldwide. However, approaches to identifying inadequate diets in clinical practice remain inconsistent, and dietary interventions frequently focus on facilitating ‘healthy choices’, with limited emphasis on structural constraints. We examine the ethical implications of introducing a routine question in the medical history about ability to access food. Not collecting data on food security means that clinicians are unable to identify people who may benefit from support on an individual level, (...) unable to consider relevant dietary risk factors for disease and disease progression and unable to monitor population trends and inequalities in dietary access in order to design effective policy interventions. We argue that the current lack of routine screening for food insecurity is inconsistent with our approach to other health behaviours, as well as with doctors’ frequent informal role as gatekeepers to the food aid system, and recent calls for governmental action on food insecurity and health inequalities from individual clinicians and professional bodies. Potential ethical barriers to asking patients about food security are addressed, including concerns about stigma, limiting autonomy, fair resource allocation, unclear professional remits and clinicians’ ability to offer effective interventions. We suggest that there is an ethical imperative for doctors to ask patients about their ability to access healthy food. Gathering this data provides a valuable first step in re-framing the social determinants of health as modifiable risks, rather than inevitable inequities. No data are available. (shrink)

The General Data Protection Regulation (GDPR) was introduced in 2018 to harmonize data privacy and security laws across the European Union (EU). It applies to any organization collecting personal data in the EU. To date, service-level consent has been used as a proportionate approach for clinical trials, which implement low-risk, routine, service-wide interventions for which individual consent is considered inappropriate. In the context of public health research, GDPR now requires that individuals have the option to choose whether (...) their data may be used for research, which presents a challenge when consent has been given by the clinical service and not by individual service users. We report here on development of a pragmatic opt-out solution to this consent paradox in the context of a partner notification intervention trial in sexual health clinics in the UK. Our approach supports the individual’s right to withhold their data from trial analysis while routinely offering the same care to all patients. (shrink)

This paper outlines the approaches of two apparently competing schools of statistics. The criticisms made by supporters of Bayesian statistics about conventional Frequentist statistics are explained, and the Bayesian claim that their method enables research into new treatments without the need for clinical trials is examined in detail. Several further important issues are considered, including: the use of historical controls and data routinely collected on patients; balance in randomised trials; the possibility of giving information to patients; patient (...) choice and patient autonomy; and how widely the results of clinical trials can be used. It is concluded that good statistical techniques in the design and analysis of medical studies are essential, but the statistical school used in developing such techniques is relatively unimportant. (shrink)

Racial and ethnic variables are routinely used in health services research. However, there is a growing debate within nursing and other disciplines about the usefulness of these variables in research. A qualitative study was undertaken (July 2004 – November 2004) to ascertain how researchers conceptualize and operationalize racial and ethnic data. Data were derived from interviews with 33 participants in academic health centers in differing geographic regions. Content analyses extracted manifest and latent meanings to construct categories depicting (...) respondents' understandings of race and ethnicity in research. Race and ethnicity held several meanings but the subtext was often not clear because these terms were not operationalized. Measuring race and ethnicity quantitatively necessitated uniform classifications thus it was often necessary to impose a single racialized identity. Respondents recognized the problems with racial and ethnic variables but the majority still believed these variables were necessary and useful. Several researchers understood that racial and ethnic variables were used in ways that may stigmatize the populations studied. These respondents collected data on variables other than race and ethnicity to ascertain the causes of health differentials. The policy recommendation calls for a shift in thinking about how to use racial and ethnic variables in research. (shrink)

‘Aristocratic’ transactional relationships are widespread in Nigerian universities. Nigerian cultures positively sanction repressive sexual activities among single unmarried adolescents until the wedding night. Modernity has confronted this cultural prescription, as youths, particularly girls, engage in transactional exchange in different contexts. However, the literature on transactional sex in the ivory towers is not rich enough on client recruitment and management among female undergraduates in Nigeria. This study utilised in-depth interviews to collect data from 30 purposively selected female undergraduates. Findings show (...) that the prostitution label is substituted for ‘runs-girls’, as a distinct social category. Clients are recruited on and off campus through mastery of routine activities of ‘aristocrats’ on campus, connection and referrals. The ‘aristos’ include wealthy postgraduate students, politicians, business men, and military personnel, among others. The sex work is undertaken on and off campus, in hotels or in the private residences of ‘runs-girls’. ‘Aristocratic’ transactional sex is sustained by erotic capital, including dexterous bed skills, such as sucking and romance. Luxury possessions, such as cars, BlackBerry phones and social security (job placement) after school life are the perceived derivable benefits of the erotic association. Provision of part-time jobs for vulnerable students could positively reduce transactional sex in ivory towers. (shrink)

The COVID-19 pandemic has forced developmental researchers to rethink their traditional research practices. The growing need to study infant development at a distance has shifted our research paradigm to online and digital monitoring of infants and families, using electronic devices, such as smartphones. In this practical guide, we introduce the Experience Sampling Method – a research method to collect data, in the moment, on multiple occasions over time – for examining infant development at a distance. ESM is highly suited (...) for assessing dynamic processes of infant development and family dynamics, such as parent-infant interactions and parenting practices. It can also be used to track highly fluctuating family dynamics and routines. The aim of the current paper was to provide an overview by explaining what ESM is and for what types of research ESM is best suited. Next, we provide a brief step-by-step guide on how to start and run an ESM study, including preregistration, development of a questionnaire, using wearables and other hardware, planning and design considerations, and examples of possible analysis techniques. Finally, we discuss common pitfalls of ESM research and how to avoid them. (shrink)

The fossil record is paleontology’s great resource, telling us virtually everything we know about the past history of life. This record, which has been accumulating since the beginning of paleontology as a professional discipline in the early nineteenth century, is a collection of objects. The fossil record exists literally, in the specimen drawers where fossils are kept, and figuratively, in the illustrations and records of fossils compiled in paleontological atlases and compendia. However, as has become increasingly clear since the later (...) twentieth century, the fossil record is also a record of data. Paleontologists now routinely abstract information from the physical fossil record to construct databases that serve as the basis for quantitative analysis of patterns in the history of life. What is the significance of this distinction? While it is often assumed that the orientation towards treating the fossil record as a record of data is an innovation of the computer age, it turns out that nineteenth century paleontology was substantially “data driven.” This paper traces the evolution of data practices and analyses in paleontology, primarily through examination of the compendia in which the fossil record has been recorded over the past 200 years. I argue that the transition towards conceptualizing the fossil record as a record of data began long before the emergence of the technologies associated with modern databases (such as digital computers and modern statistical methods). I will also argue that this history reveals how new forms of visual representation were associated with the transition from seeing the fossil record as a record of objects to one of data or information, which allowed paleontologists to make new visual arguments about their data. While these practices and techniques have become increasingly sophisticated in recent decades, I will show that their basic methodology was in place over a century ago, and that, in a sense, paleontology has always been a “data driven” science. (shrink)

For the last ten years, within molecular life sciences, the reproducibility crisis discourse has been embodied as a crisis of trust in scientific images. Beyond the contentious perception of “questionable research practices” associated with a digital turn in the production of images, this paper highlights the transformations of gel electrophoresis as a family of experimental techniques. Our aim is to analyze the evolving epistemic status of generated images and its connection with a crisis of trust in images within that field.From (...) the 1980s to the 2000s, we identify two key innovations (precast gels and gel docs) leading to a “two‐tiered” gel electrophoresis with different standardization procedures, different epistemic statuses of the produced images and different ways of generating (dis)trust in images. The first tier, exemplified by differential gel electrophoresis (DIGE), is characterized by specialized devices processing images as quantitative data. The second tier, exemplified by polyacrylamide gel electrophoresis (PAGE), is described as a routine technique making use of image as qualitative “virtual witnessing.” The difference between these two tiers is particularly apparent in the ways images are processed, even though both tiers involve image digitization. Our account thus highlights different views on reproducibility within the two tiers. Comparability of images is insisted upon in the first tier while traceability is expected in the second tier. It is striking that these differences occur not only within the same scientific field, but even within the same family of experimental techniques. In the second tier, digitization entails distrust, whereas it implies a collective sentiment of trust in the first tier. (shrink)

One result of routine use in intensive care units of the medical apparatus known as the artificial ventilator has been the creation of human entities whose brains are diagnosed as irreversibly damaged, but whose bodies are kept alive by means of technological support. Such brain-dead bodies have potential value as a supply of human organs for transplant. This article, drawing primarily on ethnographic data collected in intensive care units, examines why procurement of organs from brain-dead bodies has been (...) fully institutionalized in North America for more than two decades, in contrast to Japan. It is argued that the basic medical discourse is essentially the same in both locations and that it is largely unexamined tacit knowledge formed from an amalgam of local values, discursive formations in law, medical guidelines, policy formulations and public commentary, that accountfor the difference. This situation, that has dramatically different effects on the transplant enterprise in the two locations, is not culturally determined and the respective dominant ideologies are widely disputed in both North America and Japan resulting in a situation of chronic flux. (shrink)

BackgroundThe diagnosis and treatment of cancer are associated with psychological distress that often leads to a significant reduction in emotional and physical well-being and quality of life. Early detection of psychological distress is therefore important. This study aims to assess the psychological distress of inpatient cancer patients using routine clinical data. Furthermore, variables and problems most strongly associated with psychological distress should be identified.Materials and MethodsN = 1,869 inpatients were investigated using the National Comprehensive Cancer Network Distress Thermometer and (...) problem checklist to assess distress as well as multiple possible problem areas. Visceral oncological cancer was the most common tumor diagnosis, followed by skin cancer and urological cancer.Results65.9% of the sample experienced high levels of distress. Female sex, stage 4 of disease, and visceral and head and neck cancer emerged as risk factors for high distress. A younger age was significantly correlated with higher distress. The most frequently self-reported problems were fears, worry, and fatigue. Patients with all 3 of these problems had 24 times higher risk [odds ratio = 23.9] for high levels of distress than patients without these problems. Women reported significantly more practical, emotional, and physical problems than men. Younger and middle-aged patients reported increased levels of practical, family, and emotional problems compared with older patients.DiscussionAlmost two-thirds of the sample reported high levels of distress. The most frequently reported problem areas were emotional and physical problems. These results can help to identify patients with high risk for psychological distress and, therefore, be used to optimize psychosocial and psycho-oncological care for patients with cancer. (shrink)

Collections of living organisms are reservoirs of biological knowledge that operate across times and places. From the mid-20th century, scientific institutions dedicated to the cultivation of such collections have routinized and professionalized their care. But “care,” for these collections, is focused not just on individual organisms—instead, a principal aim of a curator is to maintain the integrity of a reproducing “strain,” “variety,” “line,” or “stock,” and the composition of a collection as a whole. This paper explores the forms, the material (...) dimensions, the temporalities, and the values of that care, to recover the conditions under which scientist-custodians maintain continuity of research over many decades. This paper does so by focusing on two rather different kinds of scientific collection: that of Drosophila fruit flies on the one hand, and plant seeds on the other. Their comparison is valuable because their vastly different needs and life cycles engender very different practices of care. Comparing the materialities, life cycles, needs, and values of these divergent collections helps to draw attention to the routine and the apparently mundane. First, the paper asks: what kinds of work go into managing such collections—that is, the day-to-day management and cultivation, surveillance, and administration of information? Second, it asks: how do these practices maintain the integrity of the strains and stocks, and the collections themselves? What kinds of value does this work create? Third, what are the future imaginaries that are rhetorically drawn into the funding strategies of these collections, and how do they envision future use, ownership, and control? (shrink)

BackgroundImplementing the routine consultation of patient advance directives in hospital emergency departments and emergency medical services has become essential, given that advance directives constitute the frame of reference for care personalisation and respect for patients’ values and preferences related to healthcare. The aim of this study was to assess the levels and relationship of knowledge and attitudes of nursing and medical professionals towards advance directives in hospital emergency departments and emergency medical services, and to determine the correlated and predictor variables (...) of favourable attitudes towards advance directives.MethodsObservational, descriptive, and cross-sectional study. The study was conducted in the emergency department of a second-level hospital and in the emergency medical service. Data collection was performed from January 2019 to February 2020. The STROBE guidelines were followed for the preparation of the study.ResultsA total of 173 healthcare professionals responded to the questionnaire. Among them, 91.3% considered that they were not sufficiently informed about advance directives, and 74% acknowledged not having incorporated them into their usual practice. Multinomial analysis indicated a statistically significant relationship between the variable emergency medical service and having more favourable attitudes towards consulting the advance directives in their practical application (OR 2.49 [95% CI 1.06–5.88]; p = 0.037) and compliance in complex scenarios (OR 3.65 [95% CI 1.58 − 8.41]; p = 0.002). Working the afternoon and night shift was a predictor variable for obtaining a higher score with respect to attitudes in complex scenarios.ConclusionThere is an association between the level of knowledge that nursing and medical professionals have about advance directives and the scores obtained on the attitude scales at the time of practical implementation and in complex scenarios. This shows that the more knowledge professionals have, the more likely they are to consult patients' advance directives and to respect their wishes and preferences for care and/or treatment. (shrink)

This research study has done to identify and investigate the major factors behind the excessive usage of Facebook by the youth of Karachi and what kind of impacts they have to face on various aspects of their lives due to this much consumption of Facebook. In this research paper, the researcher has applied both types of methodology, Qualitative as well as Quantitative. The researcher has selected Karachi as the universe of the study. The data has collected in the (...) manner of survey forms filled by students of different universities and colleges of Karachi; aged from 18 to 30 and the sample size is 50 in which half of the population includes males and half females and 10 interviews are also conducted from teachers and parents of Facebook users. This research study raises major points related to the extreme usage of Facebook which includes the mental and physical conditions of adolescents, children’s progress in their academic lives, impacts on relationships and disturbance in routine works. The data has collected in a fair way. The results revealed that Facebook repercussion only happens when an individual is using it in an excessive amount. The researcher suggests that using Facebook could be beneficial only if people learns to use it in manageable levels and if they are able to create a balance between the virtual world and real world. (shrink)

BackgroundThis paper represents a portion of the findings from one of the first research studies eliciting the lived experience of adults with an early diagnosis of Phenylketonuria living in Ireland. Ireland has one of the highest prevalence rates of PKU in Europe, however, little is known about the experience of Irish adults with PKU. Furthermore, Ireland is one of the first countries in the world to introduce neonatal screening followed by the introduction of long-term dietary therapy over 50 years ago. (...) This study presents the first comprehensive assessment of the lived experience of Irish adults with PKU on long term dietary therapy.MethodsNarrative data was collected from eleven self-selected participants, using semi-structured interviews. The interviews were divided into five sections focused on eliciting a holistic understanding of the lived experience of adults with PKU living in Ireland. Thematic analysis was guided by Colaizzi's Framework in conjunction with NVivo qualitative data analysis software.FindingsFindings from the original research encompassed a broad understanding of the lived experience of adults with PKU living in Ireland, including factors influencing dietary therapy and managing PHE blood levels. The themes being discussed within this article are those which appear to be least represented within current literature: living with PKU, including reproductive health, the importance of self-management and establishing routine, support networks in adulthood and concerns regarding aging with PKU.ConclusionIt was evident from the findings that a diagnosis of PKU can influence how adults with PKU may experience aging and their own mortality. These findings offer new insight into the vulnerability attached to the experience of aging with PKU and may be beneficial to advocacy groups and for future development of policy and practice. (shrink)

In this paper, we describe the challenges of collecting data in the Māori population for automatic detection of schizophrenia using natural language processing (NLP). Existing psychometric tools for detecting are wide ranging and do not meet the health needs of indigenous persons considered at risk of developing psychosis and/or schizophrenia. Automated methods using NLP have been developed to detect psychosis and schizophrenia but lack cultural nuance in their designs. Research incorporating the cultural aspects relevant to indigenous communities is lacking (...) in the design of existing automatic prediction tools and one of the main reasons is the scarcity of data from indigenous populations. This paper explores the current design of the New Zealand health care system and its potential impacts on access and inequities in the Māori population and details the methodology used to collect speech samples of Māori at risk of developing psychosis and schizophrenia. The paper also describes the major obstacles faced during speech data collection, key findings, and probable solutions. (shrink)

Deliberative ways of dealing with ethical issues in health care are expanding. Moral case deliberation is an example, providing group-wise, structured reflection on dilemmas from practice. Although moral case deliberation is well described in literature, aims and results of moral case deliberation sessions are unknown. This research shows (a) why managers introduce moral case deliberation and (b) what moral case deliberation participants experience as moral case deliberation results. A responsive evaluation was conducted, explicating moral case deliberation experiences by analysing aims (...) (N = 78) and harvest (N = 255). A naturalistic data collection included interviews with managers and evaluation questionnaires of moral case deliberation participants (nurses). From the analysis, moral case deliberation appeals for cooperation, team bonding, critical attitude towards routines and nurses’ empowerment. Differences are that managers aim to foster identity of the nursing profession, whereas nurses emphasize learning processes and understanding perspectives. We conclude that moral case deliberation influences team cooperation that cannot be controlled with traditional management tools, but requires time and dialogue. Exchanging aims and harvest between manager and team could result in co-creating (moral) practice in which improvements for daily cooperation result from bringing together perspectives of managers and team members. (shrink)

Indirect observation is a recent concept in systematic observation. It largely involves analyzing textual material generated either indirectly from transcriptions of audio recordings of verbal behavior in natural settings (e.g., conversation, group discussions) or directly from narratives (e.g., letters of complaint, tweets, forum posts). It may also feature seemingly unobtrusive objects that can provide relevant insights into daily routines. All these materials constitute an extremely rich source of information for studying everyday life, and they are continuously growing with the burgeoning (...) of new technologies for data recording, dissemination, and storage. Narratives are an excellent vehicle for studying everyday life, and quantitization is proposed as a means of integrating qualitative and quantitative elements. However, this analysis requires a structured system that enables researchers to analyze varying forms and sources of information objectively. In this paper, we present a methodological framework detailing the steps and decisions required to quantitatively analyze a set of data that was originally qualitative. We provide guidelines on study dimensions, text segmentation criteria, ad hoc observation instruments, data quality controls, and coding and preparation of text for quantitative analysis. The quality control stage is essential to ensure that the code matrices generated from the qualitative data are reliable. We provide examples of how an indirect observation study can produce data for quantitative analysis and also describe the different software tools available for the various stages of the process. The proposed method is framed within a specific mixed methods approach that involves collecting qualitative data and subsequently transforming these into matrices of codes (not frequencies) for quantitative analysis to detect underlying structures and behavioral patterns. The data collection and quality control procedures fully meet the requirement of flexibility and provide new perspectives on data integration in the study of biopsychosocial aspects in everyday contexts. (shrink)

Digital tools may help to study socioeconomic aspects of agricultural development that are difficult to measure such as the effects of new policies and technologies on the intra-household allocation of time. As farm technologies target different crops and tasks, they can affect the time-use of men, women, boys, and girls differently. Development strategies that overlook such effects can have negative consequences for vulnerable household members. In this paper, the time-use patterns associated with different levels of agricultural mechanization during land preparation (...) in smallholder farming households in Zambia were investigated. A novel data collection method was used: a pictorial smartphone application that allows real-time recording of time-use, which eliminates recall bias. Existing studies analyzing the intra-household allocation of resources often focus on adult males and females. This study paid particular attention to boys and girls as well as adults. The study addressed seasonal variations. Compositional data analysis was used to account for the co-dependence and sum constraint of time-use data. The study suggests a strong gender differentiation for land preparation activities among mechanized households; for households using manual labor, such differentiation was not found. There is some evidence that the surplus time associated with mechanization is used for off-farm and domestic work. The study cannot confirm concerns about negative second-round effects: mechanized land preparation is not associated with a higher workload for women and children during weeding and harvesting/processing. The study provides a proof-of-concept that smartphone applications can be used to collect socioeconomic data that are difficult to measure but of high relevance. (shrink)

Constraints and dependencies among the elements of embodied cognition form patterns or microstrategies of interactive behavior. Hard constraints determine which microstrategies are possible. Soft constraints determine which of the possible microstrategies are most likely to be selected. When selection is non-deliberate or automatic the least effort microstrategy is chosen. In calculating the effort required to execute a microstrategy each of the three types of operations, memory retrieval, perception, and action, are given equal weight; that is, perceptual-motor activity does not have (...) a privileged status with respect to memory. Soft constraints can work contrary to the designer's intentions by making the access of perfect knowledge in-the-world more effortful than the access of imperfect knowledge in-the-head. These implications of soft constraints are tested in two experiments. In experiment 1 we varied the perceptual-motor effort of accessing knowledge in-the-world as well as the effort of retrieving items from memory. In experiment 2 we replicated one of the experiment 1 conditions to collect eye movement data. The results suggest that milliseconds matter. Soft constraints lead to a reliance on knowledge in-the-head even when the absolute difference in perceptual-motor versus memory retrieval effort is small, and even when relying on memory leads to a higher error rate and lower performance. We discuss the implications of soft constraints for routine interactive behavior, accounts of embodied cognition, and tool and interface design. (shrink)

Objectives -/- Surveys in various countries suggest 17% to 80% of doctors prescribe ‘placebos’ in routine practice, but prevalence of placebo use in UK primary care is unknown. Methods -/- We administered a web-based questionnaire to a representative sample of UK general practitioners. Following surveys conducted in other countries we divided placebos into ‘pure’ and ‘impure’. ‘Impure’ placebos are interventions with clear efficacy for certain conditions but are prescribed for ailments where their efficacy is unknown, such as antibiotics for suspected (...) viral infections. ‘Pure’ placebos are interventions such as sugar pills or saline injections without direct pharmacologically active ingredients for the condition being treated. We initiated the survey in April 2012. Two reminders were sent and electronic data collection closed after 4 weeks. Results -/- We surveyed 1715 general practitioners and 783 (46%) completed our questionnaire. Our respondents were similar to those of all registered UK doctors suggesting our results are generalizable. 12% (95% CI 10 to 15) of respondents used pure placebos while 97% (95% CI 96 to 98) used impure placebos at least once in their career. 1% of respondents used pure placebos, and 77% (95% CI 74 to 79) used impure placebos at least once per week. Most (66% for pure, 84% for impure) respondents stated placebos were ethical in some circumstances. Conclusion and implications -/- Placebo use is common in primary care but questions remain about their benefits, harms, costs, and whether they can be delivered ethically. Further research is required to investigate ethically acceptable and cost-effective placebo interventions. (shrink)

Phase 1 healthy volunteer clinical trials—which financially compensate subjects in tests of drug toxicity levels and side effects—appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on (...) phase 1 trials. We show how participant experiences shift attention from discrete exchanges, behaviors, and events in the research enterprise to the ongoing and dynamic patterns of serial participation in which individual decision-making is embedded in collective social and economic conditions and shaped by institutional policies. We argue in particular for the ethical significance of structurally diminished voluntariness, routine powerlessness in setting the terms of exchange, and incentive structures that may promote pharmaceutical interests but encourage phase 1 healthy volunteers to skirt important rules. (shrink)

Background: Rationing of various needed services, for example, nursing care, is inevitable due to unlimited needs and limited resources. Rationing of nursing care is considered an ethical issue since it requires judgment about potential conflicts between personal and professional values. Objectives: The present research sought to explore aspects of rationing nursing care in Iran. Research design: This study applied qualitative content analysis, a method to explore people’s perceptions of everyday life phenomena and interpret the subjective content of text data. (...) Data collection was performed through in-depth, unstructured, face-to-face interviews with open-ended questions. Participants and research context: The study population included Iranian nurses of all nursing positions, from clinical nurses to nurse managers. Purposive sampling was employed to select 15 female and 3 male nurses (11 clinical nurses, 3 supervisors, 1 matron, 1 nurse, and 2 members of the Nursing Council) working in hospitals of three cities in Iran. Ethical considerations: The study protocol was approved by Tehran University of Medical Sciences (91D1302870). Written informed consent was also obtained from all participants. Findings: According to the participants, rationing of nursing care consisted of two categories, that is, causes of rationing and consequences of rationing. The first category comprised three subcategories, namely, patient needs and demands, routinism, and VIP patients. The three subcategories forming the second category were missed nursing care, patient dissatisfaction, and nurses’ feeling of guilt. Conclusion: Levels at which healthcare practices are rationed and clarity of the rationing are important structural considerations in the development of an equal, appropriate, and ethical healthcare system. Moreover, the procedure of rationing is critical as it not only influences people’s lives but also reflects the values that dominate in the society. Therefore, in order to minimize the negative consequences of rationing of nursing care, further studies on the ethical dimensions of this phenomenon are warranted. (shrink)

A special report of The Hastings Center and the Association of American Medical Colleges addressed the ethical oversight of learning health systems, which seek to combine high‐quality patient care with routine data collection aimed at improving patient outcomes. The report contained two position papers, authored by a number of distinguished bioethicists, and several commentaries. The position papers urged two changes. First, they urged a rethinking of our approach to the regulation of human subjects research, so as to make it (...) easier in the future for learning health systems to function well. Second, they argued that the rethinking required dispensing with a strict distinction between research and therapy, which has been a major tenet of bioethics since the Belmont Report, which explicated basic ethical principles governing human subjects research. We fully support the objectives of the authors, and we agree that the learning health system is an important advance that serves patients well. Unnecessary regulatory burden ought not impede this progress. We disagree, however, that the best way to bring about these needed changes in the regulatory environment is to reject the basic distinction between research and treatment. Unfortunately, we find the arguments in favor of that strategy to be, in places, reminiscent of what we take to be basic conceptual errors that hampered the ethical understanding of human subjects research prior to adoption of the Belmont Report. To see why one need not reject the research‐treatment distinction in order to promote learning health systems, we first investigate in some detail the arguments offered for eliminating the distinction. We next turn to an issue not addressed by those authors, namely, the relationship between the physician or investigator and the patient or subject, to illustrate why the distinction is important and what is lost if it is jettisoned. (shrink)

Sociological studies of culture have made significant progress on conceptual clarification of the concept, while remaining comparatively quiescent on questions of measurement. This study empirically examines internal conflicts (or “infighting”), a ubiquitous phenomenon in political organizing, to propose a “resinous culture framework” that holds promise for redirection. The data comprise 674 newspaper articles and more than 100 archival documents that compare internal dissent across two previously unstudied lesbian and gay Marches on Washington. Analyses reveal that activists use infighting as (...) a vehicle to engage in otherwise abstract definitional debates that provide concrete answers to questions such as who are we and what do we want. The mechanism that enables infighting to concretize these cultural concerns is its coupling with fairly mundane and routine organizational tasks. This mechanism affords one way to release the culture concept, understood here as collective self-definitions, from being “an amorphous, indescribable mist which swirls around society members,” as it was once provocatively described. (shrink)