Informed consent for clinical anaesthesia research

Patients' rights for privacy and confidentiality extend to publications. This author describes how authors, reviewers, and editors can ensure patient confidentiality in manuscripts.

Increasing burden of institutional review in multicenter clinical trials of infertility: the Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies

In the context of research on medical practices, which includes comparative effectiveness research and pragmatic clinical trials, empirical studies have begun to raise questions about the extent to which institutional review boards' interpretations and applications of research regulations align with patients' values. To better understand the similarities and differences between these stakeholder groups, we compare and contrast two surveys: one of institutional review board professionals and one of patients, which examine views on consent for research on medical practices. We conducted online surveys of two target populations between July 2014 and March 2015. We surveyed 601 human subjects research professionals out of 1500 randomly selected from the Public Responsibility in Medicine and Research membership list (40.1% response rate), limiting analysis to 537 respondents who reported having had institutional review board experience. We also surveyed 120 adult patients out of 225 approached at subspecialty clinics in Spokane, Washington (53.3% response rate). Our survey questions probed attitudes about consent in the context of research on medical practices using medical record review and randomization. The patient survey included three embedded animated videos to explain these concepts. A majority of institutional review board professionals distinguished between consent preferences for medical record review and randomization, ranked clinicians as the least preferred person to obtain participant consent (54.6%), and viewed written or verbal permission as the minimum acceptable consent approach for research on medical practices using randomization (87.3%). In contrast, most patients had similar consent preferences for research on medical practices using randomization and medical record review, most preferred to have consent conversations with their doctors rather than with researchers for studies using randomization (72.6%) and medical record review (67.0%), and only a few preferred to see research involving randomization (16.8%) or medical record review (13.8%) not take place if obtaining written or verbal permission would make the research too difficult to conduct. Limitations of our post hoc analysis include differences in framing, structure, and language between the two surveys and possible response bias. Our findings highlight a need to identify appropriate ways to integrate patient preferences into prevailing regulatory interpretations as institutional review boards increasingly apply research regulations in the context of research on medical practices. Dialogue between institutional review boards and research participants will be an important part of this process and should inform future regulatory guidance.

In 2006, the National Institutes of Health (NIH), guided by the leadership of Elias Zerhouni, launched the Clinical and Translational Science Award (CTSA) program to jump-start transformative change in the nation’s research agenda to emphasize translating discovery from the bench to implementation in the community.1-5 Much of the funding for the CTSAs was garnered by rolling NIH funding of General Clinical Research Centers and educational K and T awards. Successful applicants were then asked to utilize these funds to (as stated in the Request for Applications) “transform the local, regional and national environments for clinical and translational science and to increase the safety, efficiency and speed of clinical and translational research.”4 Each of the 60 CTSA institutions has approached addressing this transformation in slightly different ways; however, it has become clear over the last 5 years that substantive changes, as a result of CTSA funding at academic institutions, are transforming medical research and the infrastructure that supports it. Each of the CTSA’s is required to address specific key functions to advance the consortium goals. These required key functions are (1) expertise in Biomedical Informatics, (2) a program in Research Education, Training, and Career Development, (3) a program in Community Engagement and Research, (4) an Evaluation component, (5) Pilot Projects in Translational and Clinical Studies, and (6) a Regulatory Knowledge and Support component. Optional CTSA key functions include (1) support of the Development of Novel Clinical and Translational Methodologies, (2) components or cores to support Research Design, Epidemiology, Biostatistics, and Clinical Research Ethics, (3) Clinical Research Resources and Facilities, and (4) components or cores that develop Translational Technologies and Resources. It is also encouraged for institutions to support research in Child Health. Addressing these key functions at the University of Michigan, for example, has led to transformational change in the structure and culture of the institution. After receiving a CTSA award in 2007, the University of Michigan (U-M) conducted a strategic assessment of the translational research enterprise through over 100 extensive interviews of faculty and staff providing the infrastructure for translational research, as well as the investigators conducting that research. The institution then conducted a survey of research team members involved in human subject research to identify and describe the current challenges facing translational research—specifically, the administrative processes associated with its planning and execution. In addition to identifying the issues, the team rated the technical and cultural/political levels of difficulty in implementing the solutions, as well as the corresponding impact each solution would potentially bring. These were then graphically mapped on a three-dimensional bubble chart (Figure 1). This stratification assisted in the planning, design, and prioritization of solutions, offering insights that guide the refinement efforts of a clinical research enterprise’s organization, business, and information technology (IT) processes. Bubble chart of implementation complexity. The chart orders tasks by level of execution difficulty—both technical and fiscal execution difficulty—as well as organizational and cultural complexity. The bubble size represents impact such that the bigger the bubble, the bigger the impact the change will have on improving translational research. For instance, enhancing study coordinator programs is relatively easy both technically and from an institutional buy-in perspective and was judged to provide a relatively large impact. Creating integrated informational technology systems involves significant investment, is more technically complex, requiring buy-in from multiple parties within the institution but is pivotal for achieving the goal of doing more effective translational research. The visual mapping provides context and definition to the challenge of enhancing the efficiency and effectiveness of translational research not only at the University of Michigan but all of the CTSAs. IT = Information Technology, CTSU = Clinical Trials Support Unit. Eight areas were identified as solution categories. The topics include organizational, procedural, financial, structural, educational, technological, and cultural elements. Transform and expedite study and contract approval process. The contract approval process, especially in regard to industry protocols, was recognized by the faculty as their number one area of discontent. The approval process was not clear to research team members and varied widely by unit and department as well as by type of sponsor. Educational and process improvement opportunities were identified. To address these issues, U-M has set a goal to expedite study approval process so that the contract and regulatory processes are executed within 60 days from submission for all studies and 45 days for industry-sponsored studies. The primary strategy to accomplish this aggressive goal was to create a team consisting of members of the units involved and to reengineer processes and conduct a demonstration project for feasibility within 1 year. Secondary strategies included increasing the transparency of contracting within the system to allow better tracking of proposals by the faculty and study teams, publishing desirable contract terms on a website for faculty and staff to use as protocols are developed, and to create an interactive, web-based research road map to guide faculty and staff through the necessary administrative steps to conduct translational research.6 Establish a clinical research support unit with best practice tools. The current translational research enterprise consists of multiple units with redundant functions of varying quality. The primary strategy was to create a leveraging of the resources of the CTSA to develop a franchisable model built on best practice modules that could then be easily adopted by other units throughout the university. Develop a customer friendly, transparent financial system that spans clinical trial budget creation to account reconciliation and study close out. The lack of transparent and integrated financial systems to track costs and other financial aspects of clinical research including budgeting and billing remains a challenge for study team members. The University of Michigan Office of Research has created the Calendar Review and Analysis Office (CRAO) to assist researchers with this process and is currently implementing a clinical study budget tool, eThority, to create standard billing calenders and processes across the organization. CRAO will also champion the evaluation of financial feasibility prior to proposal initiation; provide more assistance to PIs and research team members with study budgets, through increased training on best practices, budget negotiators, and standardized internal budget; and generate a new reconciliation report that will make study account statements more easily understood by research teams. Improve regulatory approval process and reduce Institutional Review Board (IRB) turn-around time. Significant gains have been made, resulting in a 40% improvement in IRB cycle time. Study teams will be advantaged by continuous improvements to the process. Embedded within the goal to expedite study approval is the goal to reduce IRB turnaround time (TAT) to 21 days for full convened board approval, including ancillary committees, and reduce no more than minimal risk studies to 5 days TAT. U-M is investigating strategies for greater IRB board participation of faculty, instituting another IRB board specifically for industry-based studies, as well as dedicating a board to minimal risk studies. The CTSA is also identifying various research teams to extract best practices. The CTSA has created an IND/IDE consultation and support team for researchers that have already helped over 100 investigators with IND/IDE applications. Create a home for study coordinators to promote education and sharing of best practices. A strong research team, anchored by a solid study coordinator, is critical to clinical research success. Study coordinator turnover was noted to be 18% a year. Of all study coordinators, 75% have been at U-M less than 3 years, compared to 44% of the rest of U-M staff and 56% of study coordinators nationally. Study coordinators noted that there was no coherent program or “home” for them within the system. Several strategies have been developed and are being enacted to address this problem. The CTSA created a virtual, web-based site for study coordinator support that will eventually include standardized resources such as workflow steps, templates, forms, and answers to common questions. A monthly study coordinator forum has been enacted to share challenges and best practices. Human resources has been engaged to develop uniform study coordinator job descriptions and to mentor the coordinators to develop a meaningful career path. Increase patient participation (enrollment) in research. The institution has set an ambitious goal to double patient participation in research in 5 years, while decreasing the number of studies that do not enroll a subject to 5%. A primary strategy to accomplish this was the creation of a web-based participant registry (UMclinicalstudies.org) to help match interested patients and volunteers with open studies. Currently, over 7,000 participants are registered. U-M is also investing in an electronic medical record system that better enables queries and “flags” potentially eligible patients. Further investigation by a study team is necessary to determine the underlying reasons for poor accrual to studies, whether due to missed competitive enrollment periods, rare disease studies that inherently will be challenged to accrue, registry studies with open enrollment, lack of ability to find enough patients within the patient population, or unwillingness to ask patients to participate. Understanding and addressing the underlying issues provides an opportunity for the CTSA to improve the quality, and potentially reduce “waste,” in the proposal and regulatory systems. Achieve efficiencies through integration of multiple, fragmented IT systems. More than 30 IT systems, as well as paper records, were identified that are currently utilized by investigators to perform clinical and translational research. Moreover, multiple IT service providers exist across the institution with poorly defined roles, responsibilities, and accountability. Alignment of key IT systems and personnel that support clinical and translational research is imperative. The CTSA is playing a central role in developing and leading a cohesive strategy that integrates IT for researchers’ benefits. For example, the institution is investing in a system-wide approach to develop an overall architecture that will create a clinical data repository. Evolve the culture of U-M to be more supportive and enthusiastic of clinical research. Like many academic institutions, the University of Michigan has struggled to value clinical research to the same extent as the basic sciences. In interviews and surveys, many faculty noted that choosing a career in clinical research can be seen as “falling between the cracks” or not as respected as a career in basic research. While improving infrastructure demonstrates value to these researchers, it is not enough. The CTSA has advocated to create a working group to make recommendations to University leadership to increase recognition for excellence in clinical research, to refine promotion and incentive criteria to value scholarly clinical activity and emphasize collaboration and innovation across all disciplines (team science). Furthermore, a plan is being developed to expand training programs to support training of those who want to become clinical and translational researchers, beyond the few slots that the CTSA (K and T programs) can currently support. The mission of the CTSA to enhance an investigator’s ability to conduct translational research at the University of Michigan has resulted in concrete organizational plans and investments to improve infrastructure of translational research and increase the satisfaction of participants, faculty, and staff who are engaged in these activities.7 Similar changes are occurring at CTSA institutions all over the country, validating the vision of Dr. Zerhouni and the investment in these vehicles of change by the NIH. Supported by UL 1RR024986 NIH/NCRR—Clinical and Translation Science Award.

US medical researchers brace themselves for budget cuts

In the new era of mobile technologies and social media, patient's privacy is at risk. Surgical patients have high visual appeal and may be vulnerable because a significant proportion of cases consist of emergency and trauma, in which patients are frequently unconscious. This study aims to identify the most vulnerable health providers to share patient's confidential data on social media in the surgical environment and their awareness of the confidentiality rules and laws. We surveyed medical graduates, surgical residents, and attending surgeons from a quaternary university hospital. Demographic data, usage and frequency of mobile apparatus, social media access, patient's data dissemination, and knowledge of laws and rules governing patient's privacy were recorded. One hundred fifty-six individuals (52 graduates, 51 residents, and 53 attending surgeons; mean age 24, 28, and 59 years, respectively) participated in the study. Patient's information was shared on social media by 53 per cent of the graduates, 86 per cent of the residents, and 32 per cent of the attending surgeons (P < 0.05). Confidentiality preservation policies were unknown to 69 per cent of graduates, 80 per cent of residents, and 62 per cent of attending surgeons (P = 0.124). Awareness of protocols to guide health-care professionals about safer use of social media was 0 per cent for graduates, 15 per cent for residents, and 22 per cent for attending surgeons (P = 0.002). Residents were the most vulnerable to share patient's information on social media compared with graduates and attending surgeons. Health institutions should promote continuing education in medical ethics, focussing on residents.

HANDBOOK FOR HEALTH CARE ETHICS COMMITTEES Linda Farber Post, Jeffrey Blustein, and Nancy Neveloff Dubler Baltimore: Johns Hopkins University Press, 2006, 327 pp., $29.95 (softcover). Scenarios created by the delivery of modern medical care increasingly present ethical quandaries too complex to be handled successfully just by the involved providers, patients, and families on their own. Although the direct participants in these complicated medical dramas often may need assistance to achieve clinically and morally satisfactory outcomes, formal resort to the judicial system for a legally definitive adjudication is very rarely desirable from anyone's perspective. Thus, the intermediate, voluntary but structured mechanism of institutional ethics committees (IECs) has developed. Emanating from a concept first proposed in the 1970s and spurred on by a number of well-publicized court decisions (summarized in part VI of the book under review), the IEC device has become a common and valuable fixture throughout the current American health care enterprise. potential virtues and shortcomings of IECs and the functions they seek to fulfill have generated a great deal of literature and discussion by experts in clinical care, health care administration, bioethics, and legal medicine. coauthors of Handbook for Health Care Ethics Committees have been significant contributors to the rapid growth and development of IECs, both as key players in the clinical ethics apparatus of Montefiore Medical Center in New York and as major national (indeed, inter-national) writers and educators about the topic. prior work of Post, Blustein, and Dubler (particularly the latter) is very familiar to those who have toiled for any length of time in the clinical ethics vineyards. In this new book, the authors assemble and share their substantial accumulated wisdom for the benefit of other health care institutions, their professional staffs, and especially their IEC members. intended audience is IEC members, to whom the authors speak directly in the second person: The goal of this handbook is to help your committee be a knowledgeable, skillful, and effective ethics resource for your institution (p. 12). This book certainly accomplishes that stated purpose. Moreover, despite the authors' disclaimer that they did not set out to produce a comprehensive textbook on clinical ethical principles and how they are applied in practice by IECs, this volume could serve as a very useful background tool for introductory instruction in bioethics, particularly for courses geared to health care professionals and students. Readers can either study this book as a whole (clearly the authors' intent) or chew on its separate parts. Following an introduction setting out the fundamental functions (case consultation, policymaking on both the individual bedside and broader organizational levels, and professional and public education) and structural possibilities of IECs, part I presents a foundational clinical ethics curriculum, consisting of some brief theoretical explanation as well as illustrative case vignettes, discussion questions, and suggested strategies. Both the ethical substance or principles (the what) implicated by a particular case and matters of decision-making process (the how) receive careful attention. Although not without a bit of moral hectoring in spots, the tone for the most part is instructional, persuasive, and practical, recognizing that all the parties to ethical discussions are real people characterized by the whole range of human biases, emotions, and weaknesses. ethical complexities are made manageable without undue simplification, reflecting the authors' prevailing attitude of optimism that consensus about good ethical responses to difficult conundrums almost always can be reached eventually. …

The ethics of global clinical trials: In developing countries, participation in clinical trials is sometimes the only way to access medical treatment. What should be done to avoid exploitation of disadvantaged populations?

Background: Patients are required to share information with their doctors to facilitate correct diagnosis and determination of treatment, especially to avoid adverse drug interactions. Despite efforts to fully implement and adopt Electronic Health Records System, there is limited attention to fully secure patients’ details. Issues of privacy and confidentiality still remain a major concern at health facilities mainly in developing countries like Uganda. This study aimed to determine what privacy and confidentiality mechanisms are used in the EHRs (Clinical Master and ICT4 M-Power systems Methods: The study used a design science research approach that adopted qualitative methods. Data Flow Diagrams were used to design the desired artifact while the development of the encryption and decryption tool, we used the Hypertext Pre-Processor(PHP) time platform, which is an object-oriented programming language and is a block component that is made up of Cascade Style Sheet (CSS) and HTML(hypertext markup language ) embedded in PHP for it to be fully functional and be able to connect to and run on the server where most of the records and details of the activities are stored in the database. Results: The respondents pointed at various current mechanisms for privacy and confidentiality that included; user credentials, segregation of roles, Physical access control, international access policies, interlocked interface screens, and training of users. Conclusion: The inclusion of encryption and decryption features are very vital to enhancing health facilities’ capacity and measures for establishing the privacy and confidentiality of patients’ data. Recommendation: The Ministry of Health, Uganda, and implementers of EHR should adopt the encryption and decryption tool for use at the health facilities as the second layer of security to ensure the privacy and confidentiality of patients’ data.

Purpose This study aims to diagnose the transformation of ethics into procedural compliance within institutional contexts and to propose a practice-oriented reconstruction termed “Real Ethics,” which preserves moral deliberation while maintaining essential safeguards, using clinical and AI ethics as emblematic cases within a broader institutional analysis. Design/methodology/approach The research employs a conceptual analysis informed by the works of Weber, Habermas, MacIntyre, Taylor, Tronto and Foucault, in conjunction with selected literature from clinical ethics, Institutional Review Boards, public health and artificial intelligence (AI) governance. Findings The findings indicate that institutional ethics frequently transitions from reasoned judgment to a focus on auditability and risk management, resulting in moral outsourcing, epistemic exclusion and moral distress. While procedural tools are crucial, they must serve as adaptable scaffolds firmly rooted in deliberative processes. Originality/value This study offers a unified institutional diagnosis of the proceduralization of ethics across multiple professional fields drawing on clinical and AI ethics as paradigmatic cases and presents actionable design principles for sustaining ethical agency across diverse institutional contexts.

A domain analysis model for eIRB systems: Addressing the weak link in clinical research informatics

Task Force 8: Pediatric Cardiology Fellowship Training in Research and Scholarly Activity. SPCTPD/ACC/AAP/AHA.

Clinical research encompasses a wide range of scientific investigations including case reports on a single patient, case series, retrospective studies, prospective studies, and multicenter randomized clinical trials. These activities aim to enhance our understanding of medical conditions with the intention of helping patients. Clinical research is time-consuming, challenging, and expensive, and with current practice pressures, it can be a daunting task. An increasing number of regulatory obstacles produce further challenges to performing clinical research. Both evidence and opinion indicate that these regulatory obstacles have adversely affected the conduct of clinical research. Ninety-one percent of the audience who attended the symposium at the 2007 Annual Meeting of the American Orthopaedic Association (AOA; a clinical meeting of senior orthopaedic surgeons) in Asheville, North Carolina, characterized this threat as moderate or severe. When the attendees were presented with three negative statements about their institutional review board, which described it as (1) cumbersome, bureaucratic, and difficult to deal with; (2) more interested in protecting the institution than the patient; and (3) causing delays and unnecessary costs, 66% felt that all three applied to their board. This reflects the deep sense of frustration many clinicians have with the current regulatory process and their belief that institutional review boards are clearly obstructive to clinical research. This symposium explores the barriers and obstacles to clinical research provided by the Health Insurance Portability and Accountability Act (HIPAA) and by institutional review boards and presents the position that change is necessary to minimize the problems and the expense they create. Clinical research requires substantial funding, particularly for large-scale multicenter trials, which limits the number and quality of these important clinical experiments. Issues related to the funding of orthopaedic trials from the perspective of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) are reviewed. Finally, high-quality clinical research needs clinician researchers trained in the methods of large clinical trials, and this type of expertise must be developed, mentored, and financially supported with protected time.

Institutional review boards (IRBs) and informed consent have recently come under increasing scrutiny. The provision of appropriate and understandable information and its comprehension are key elements of the informed consent process. This article examines how literacy and other factors might impact on comprehension of the information provided. Better understanding of these issues and how to best address them are crucial to allowing clinical research subjects to participate as well-informed and willing partners in scientific inquiry.

Introduction: Delay of hospital admission until completion of assessment by consultants is a major contributor to emergency department (ED) crowding. We measured emergency physicians’ (EP) ability to predict patient admission, and estimated potential time saved if EPs could request a bed at the time of consultation. Methods: This is a prospective cohort study in a tertiary care center over 4 months using a convenience sample of ED patients requiring consultation. We consecutively recruited patients from purposefully selected shifts to balance day of the week and time of day. We excluded patients younger than 18 years or those likely to be admitted (traumas, strokes, STEMI codes, and CTAS1). We asked EPs to predict patient disposition (admission or alternate disposition) just before consultation. We defined admission as: admission to any service, admission within 48 hours of ED discharge, patients held overnight without bed request, or if bed request was delayed by 12 or more hours, and alternate disposition as any other disposition. We present EP prediction test characteristics using sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with 95% confidence intervals (CI). The potential time saved was calculated from consultation to bed request for admitted patients. Results: Characteristics for the 454 included patients were: mean age 60.1 years, 48.4% male, 46.9% evening presentation, 69.4% were admitted (most commonly by Internal Medicine 26.9%), and median consult to bed request time was 3.5 hours (interquartile range 2.0 – 5.3 hours). Overall EP prediction sensitivity, specificity, PPV and NPV were 90.5% (95%CI 86.7-93.5), 84.2% (95%CI 77.0-89.8), 92.8% (95%CI 89.8-95.0) and 79.6% (95%CI 73.4-84.7) respectively. In other words, EPs correctly predicted 92.8% of patient admissions. The PPV for Internal Medicine was 95.7% (95%CI 89.7-98.4) and ranged from 78.9% (95%CI 53.9-93.0) for Psychiatry to 100% (95%CI 78.1-100) for Family Medicine. A total of 1113.5 hours of ED stretcher time (37.1 hours per shift) could have been saved if EPs initiated a concurrent bed request at time of consultation. Conclusion: EPs correctly predicted 92.8% of patient admissions across a broad field of disciplines. We estimate 1113.5 hours of ED stretcher time could have been saved over the study period if EPs triggered an inpatient bed request at the time of consultation, rather than waiting for the consultants’ disposition decision.