Unnecessary Bureaucracy Research Articles

The advance of research governance in psychiatry: one step forward, two steps back

Purpose. To investigate the reasons behind difficulties in recruiting patients to randomized controlled trials (RCTs) in psychiatry and to examine a database of RCTs for differences between studies in mental health and other specialities. Methods. A discussion of recent changes in research governance in the UK and Europe followed by an examination of the database of all trials supported by the Health Technology Assessment programme of the National Institute of Health Research in the UK between 1993 and 2007 to determine if three different measures, (i) time between grant approval and study start date, (ii) percentage of additional time given to extend recruitment and (iii) percentage of planned recruitment achieved, changed over the time period studied and differed between mental health, cancer and other medical disciplines. Findings. Despite attempts in the UK to accelerate the process of clinical trials in recent years, there was a significant increase in the extension time for trials to be completed (p=0.038) and the percentage of planned recruitment to mental health studies (71%) was significantly less than for cancer (90.3%) and other studies (86.1%) (p=0.032). Summary. These results suggest that, despite the priority afforded to the advancement of RCTs in healthcare, such studies are encountering increasing difficulty in recruiting to time and target. We suggest that this difficulty can be attributed, at least in part, to the excessively byzantine regulation and governance processes for health research in the UK, and unnecessary bureaucracy in the current National Health Service system. Mental health studies appear particularly vulnerable to delay and better systems to facilitate recruitment are required urgently for the evidence base to be improved and facilitate new cost-effective interventions.

Evaluation of an established learning portfolio

The trainee-held learning portfolio is integral to the foundation programme in the UK. In the Northern Deanery, portfolio assessment is standardised through the Annual Review of Competence Progression (ARCP) process. In this study we aimed to establish how current trainees evaluate portfolio-based learning and ARCP, and how these attitudes may have changed since the foundation programme was first introduced. Deanery-wide trainee attitudes were surveyed by an electronic questionnaire in 2009 and compared with perceptions recorded during the pilot phase (2004-2005). Many trainees continue to view the e-portfolio negatively. Indeed, significantly fewer trainees in 2009 thought that the e-portfolio was a 'good idea' or a 'worthwhile investment of time' than in 2005. Trainees remain unconvinced about the educational value of the e-portfolio: fewer trainees in 2009 regarded it as a tool that might help focus on training or recognise individual strengths and weaknesses. Issues around unnecessary bureaucracy persist. Current trainees tend to understand how to use the e-portfolio, but many did not know how much, or what evidence to collect. Few supervisors were reported to provide useful guidance on the portfolio. ARCP encouraged portfolio completion but did not give meaningful feedback to drive future learning. Continued support is needed for both trainees and supervisors in portfolio-building skills and in using the e-portfolio as an educational tool. Trainee-tailored feedback is needed to ensure that portfolio-based assessment promotes lifelong, self-directed and reflective learners.

Overcoming executive bureaucracy in the application of administrative justice to foreigners in South Africa

This article examines the various problems being faced by foreigners on a daily basis in order to obtain the necessary permits to work and reside in South Africa. The article highlights that the major obstacle is unnecessary bureaucracy by the officials of the Home Affairs who are responsible for the processing of permits. The article also examines how executive bureaucracy is affecting administrative actions and what the courts are doing in order to ensure that foreigners receive just administrative actions on the applications made. The article concludes that with proper oversights on the low ranking officials, bureaucracy will be drastically minimized and this will serve as solution to the plight of foreigners especially the skilled workers in South Africa. Key words: Executive bureaucracy, administrative justice, rights of foreigners, work permits, home affairs, officials of home affairs.

Field trials and tribulations—making sense of the regulations for experimental field trials of transgenic crops in Europe

Transgenic plants that are being developed for commercial cultivation must be tested under field conditions to monitor their effects on surrounding wildlife and conventional crops. Developers also use this opportunity to evaluate the performance of transgenic crops in a typical environment, although this is a matter of commercial necessity rather than regulatory compliance. Most countries have adapted existing regulations or developed new ones to deal specifically with transgenic crops and their commodities. The European Union (EU) is renowned, or perhaps notorious, for having the broadest and most stringent regulations governing such field trials in the world. This reflects its nominal adherence to the precautionary approach, which assumes all transgenic crops carry an inherent risk. Therefore, field trials in the EU need to demonstrate that the risk associated with deploying a transgenic crop has been reduced to the level where it is regarded as acceptable within the narrowly defined limits of the regulations developed and enforced (albeit inconsistently) by national and regional governments, that is, that there is no greater risk than growing an equivalent conventional crop. The involvement of national and regional competent authorities in the decision-making process can add multiple layers of bureaucracy to an already-intricate process. In this review, we use country-based case studies to show how the EU, national and regional regulations are implemented, and we propose strategies that could increase the efficiency of regulation without burdening developers with further unnecessary bureaucracy.

Editorial

In England health services are very much in the news at the moment. The Government’s National Health Service reforms seem a little like an attempt to throw everything up into the air and see where it all lands. The abolition of Primary Care Trusts and the transfer of commissioning to general practitioners were originally sold as an assault on unnecessary bureaucracy and a return to control of resources to clinicians working with patients. To many of those who work in the health service it seems like yet another top down reform which is one of the things that the government assured everyone would not happen. Despite some excellent examples people with learning disabilities as a group have not fared well within the existing health service. This is highlighted in Andrew Holman’s interview with Dame Jo Williams that features in this edition of the Journal. As Chief Executive of Mencap Dame Jo oversaw the work that led to publication of Death by Indifference (Mencap 2007) that drew attention to poor healthcare of people with learning disabilities. This, along with the associated campaign seemed to have an impact on government thinking and led to an ombudsman’s investigation (Health Service Ombudsman, 2009) and Department of Health inquiry led by Sir Michael (2008). The reports demonstrated that there were significant issues in relation to the healthcare of people with learning disabilities. The publications were welcomed by those people in learning disability services who had been working for some years to improve health services for people with learning disabilities. With this evidence it is easy to become insular in learning disability services and to think that poor services only affect the people we work with. The recent report by the ombudsman on older people in hospitals (Health Service Ombudsman, 2011) tells us that where there are problems they are not restricted to people with learning disabilities. It seems as if some parts of the health service have problems with working with people who have difficulties in communication, or who have complex needs that involve more than one intervention or impact on long term conditions. It is also tempting to emphasise the things that have gone wrong at the expense of the positive stories in healthcare. General satisfaction rates with the health service appear to have been going up in recent years and it is clear that some things have been going well, including for some people with learning disabilities. I have certainly talked to many families who report excellent relationships with their general practitioners and I also know people whose stay in hospital has gone really well. To improve things further there needs to be clear recognition that some people are not being served well by current services. For example the hospital service is now so conditioned to deal with acute phases of an illness that it struggles with either long term care or the transition from the acute to rehabilitation stages, these are precisely the problems that many people with learning disabilities have. Simple examples such as people being discharged from acute hospitals on a Friday with community services finding out the following Monday are still far from uncommon and lead to disjointed services, emergency admissions and considerable anxiety. It is possible that a change in commissioning will help address some of these problems. For people with learning disabilities it is important that some of the key issues such as time, communication skills, respect for individuals, disjointed services and an understanding of consent to treatment are addressed. For this to take place people with learning disabilities and their families and supporters are going to have to understand how to gain influence in what will be a new commissioning system. Dame Jo Williams, in her new job as Chair of the Care Quality Commission will be central to the drive to raise and maintain standards in the health service. Her task is unenviable because the responsibilities of the Care Quality Commission have expanded hugely as they now have the responsibility for regulation of standards in both health and social care. The combination of health and social care services for regulatory purposes is an encouraging bit of joined up thinking in a service that otherwise remains divided. People with learning disabilities have an ally in Jo Williams and it is hoped that she will be an effective influence in raising standards across services in England.

Maturity assessment models: a design science research approach

In order to ascertain and measure dedicated aspects of social and technical systems ‘maturity’, a wide range of maturity assessment models have been developed by both, practitioners and academics over the past years. In spite of its broad proliferation, the concept has not been untroubled by criticism. Unnecessary bureaucracy, poor theoretical foundation, and the impression of a falsified certainty to achieve success are just a few examples for that. As there is still a significant lack of knowledge on how to design theoretically sound and widely accepted maturity assessment models, it is the aim of this paper to discuss the typical phases of maturity model development and application by taking a design science research perspective. Given that both, development and application are intimately connected, different decision parameters are identified that are relevant in respect to rigour and relevance of the maturity assessment model.

Leadership for self-organisation: complexity theory and communicative action

Complexity theory suggests that leaders must create the conditions for self-organised emergence and emergent order, both of which value bottom-up development and move an organisation away from excessive or inhibiting bureaucracy and hierarchy. Communication, as a central feature of complexity theory, can facilitate the creation of the conditions for self organised emergence and order. Communication in complexity-theory-based leadership to reduce unnecessary bureaucracy and hierarchy and to foster openness to unpredictable futures is argued to be illocutionary rather than perlocutionary. The nature of such communication is found in Habermas's 'ideal speech situation' and his theory of communicative action. Self-organisation, emergence and emergent order have to be considered in terms of desirability, morality and ethics. The illocutionary force of Habermas's 'ideal speech situation' addresses these in relation to communication, reducing unnecessary bureaucracy and hierarchy in an organisation. The paper argues that leaders can embrace the tenets of Habermas's ideal speech situation and theory of communicative action in order to create the conditions for desired, morally and ethically defensible emergent, self-organised, feedback-informed order.

EC Competition Law vs. Greek Competition Law: Conscious Parallelism or Unconscious Competition?

On April 30, 2009, one day before the 5th anniversary of the entry into force of Regulation 1/2003 on the reform of EC competition law procedural rules, the Commission of the European Communities published a Report on the functioning of the Regulation. In this Report, the Commission outlines its decision-making practices over the last five years and examines the impact of the new procedural arrangements on its productivity and duration of proceedings. Furthermore, the Commission describes its experience from its cooperation with National Competition Authorities (“NCAs”) and National Courts. One of the most radical reforms that Council Regulation 1/2003 brought about was the abolishment of the prior notification system of agreements for individual exemption under Art. 81(3) and the introduction of the “self-assessment” system, which allowed the parties to decide whether their agreement qualified for an exemption and was therefore legal. The main purpose of such reform, which rendered Art. 81 (3) directly applicable, was to reduce the Commission workload associated with hundreds of notifications — many of which concerned agreements without any anticompetitive effects — and allow it to “concentrate its resources on curbing the most serious infringements, while also relieving undertakings from considerable costs.” According to the Commission Report, this aim has been largely fulfilled, unnecessary bureaucracy has been reduced, and the Commission has been able to focus its resources on important competition issues requiring extensive analysis. The Report also points out that the majority of Member States have followed the model of Regulation 1/2003 and abolished the notification system of their national competition law; to date, national competition laws of more than 20 Member States operate without any notification obligation. A further success of Regulation 1/2003, pursuant to the Commission Report, was the creation of the European Network of Competition Authorities (“ECN”), which allowed NCAs and the Commission to effectively cooperate towards the uniform application of competition law within EEA — a very challenging goal of the Modernization Package which has created concerns as to its feasibility. Such concerns are acknowledged by the Commission, which notes in its Report that there are still areas which merit improvement, such as the negative impact of national divergences in the NCAs’ fining powers, procedural rules, and treatment of unilateral conduct. The aforementioned Commission Report has major importance for Greece as it coincided with the presentation of a Bill aimed at reforming the existing national competition law, namely C.L. 703/1977. The Bill has two main goals, according to its preamble: a) to reinforce the role of the Hellenic Competition Commission (“HCC”) and b) to harmonize the Greek Competition Law to the acquis communautaire. The current legal regime indeed presents quite many discrepancies with the EC legislation; the main ones are stated below:

Thinking in Terms of Design Decisions When Developing Maturity Models

To measure dedicated aspects of “maturity”, a range of maturity models have been developed in the field of information systems by practitioners and academics over the past years. Despite its broad proliferation, the concept has not escaped criticism. Unnecessary bureaucracy, poor theoretical foundation, and the impression of a falsified certainty to achieve success are a few examples. As there is a significant lack of knowledge on how to design theoretically sound and widely accepted maturity models, in this paper, the author opens the discussion on design decisions when developing these models. Based on analogy and informed arguments, the author synthesizes a generic but adjuvant framework that consists of five common design steps and eighteen decision parameters that help practitioners as well as researchers in the development of maturity models.

Clinical pharmacology: a declaration of intent

Clinical pharmacology: a declaration of intent

South Africa's governance challenges: assessing the South Africa–China mineral case

The past 50 years of Africa's history have been blighted by a lack of good governance, which has hindered economic growth and political stability. The continent continues to maintain weak states which are clearly evident in the persistent corruption, unconstitutional behaviour, inefficiency, waste and unnecessary bureaucracy that remain widely practised. However, owing to emerging markets such as China and India that have promoted foreign direct investment in developing countries, a lot of speculation has arisen regarding the impact of the Forum for Cooperation between Africa and China on continental governance. The speculation tends to focus on whether the multilateral trade agreement between Africa and China will be mutually beneficial, or promote bad governance practices such as corruption. This paper argues that in order for any multilateral agreement to become economically beneficial in Africa, the continental elites must first implement good governance best practices. Furthermore, the onus is on the African states, not their regional or trading partners, to implement economic institutional change.

Proposal for using a studio format to enhance institutional advancement

Universities today need to become quicker on their toes. They must continually scan the environment and seize emerging opportunities – and institutional advancement must lead this effort. An unfortunate number of institutional advancement operations are ill equipped for the task at hand. Many suffer from high staff turnover and overly hierarchical systems that reflect excessive fragmentation and compartmentalization. They inadvertently perpetuate stifling and unnecessary bureaucracy. Organizing advancement efforts around the metaphor of the design studio or creative workshop promises to (a) pool talent, (b) cultivate collaboration, and (c) align diverse but related interests in order to promote fruitful advancement. By shifting the way personnel and leaders conceptualize their work, institutional advancement can overcome a number of challenges that currently hinder its efforts. The Institutional Advancement Atelier described in this paper can improve advancement's overall productivity and its ability to see and harness opportunities in a quickly changing environment – and increase employee satisfaction in the process.

Payment to healthcare professionals for patient recruitment to trials: systematic review and qualitative study.

To review UK guidelines regarding the use of financial incentives for healthcare professionals to become involved in clinical trials, and to survey perceptions and current practice. Electronic databases were searched from inception to June 2006. Interviews were held with NHS healthcare professionals, research managers from the pharmaceutical industry and members of the public. From the searches, 634 identified studies were assessed for inclusion in the systematic review, but only three met the criteria for data extraction. Fifty-eight individuals were interviewed: 38 chief investigators, six non-research active clinicians, eight public and six pharmaceutical managers. Investigators were selected from those funded by the HTA Programme, the other by 'snowballing' and personal contact. The evidence from the literature was limited and inconclusive. In UK guidelines, the issues around payments to clinicians or patients were implied rather than stated, usually linked to discussion of conflict of interest and disclosure of any such conflicts. Developments in NHS research governance had led to increased transparency in all payments for research participation and for payments to be made to NHS Trusts rather than individual clinicians. While reimbursement of costs incurred by research was strongly supported by the interviewees, payments to incentivise recruitment were not. A code of practice was suggested for payments in publicly funded trials, which was closely linked to the principles of Good Clinical Practice in research. Factors such as interest in the topic, scope for patient benefit and good communication were considered more important than payment. Interviews with the general public indicated low levels of awareness of the existence of payments to clinicians linked to patient recruitment in trials, and unanimous support for full disclosure. Interviews with managers in the pharmaceutical industry showed greater familiarity with payments for research involvement. GPs were seen as the only group for whom scope existed for individual payments. Concerns were expressed by the pharmaceutical company interviewees at the rising cost of research and unnecessary bureaucracy. The ethical stances outlined in Good Clinical Practice in research were widely endorsed by the three groups interviewed. These allow reasonable payments to clinicians, subject to disclosure of any possible conflicts of interest. The potential for incentivising clinicians to recruit was limited as any payments should be based on the cost of inputs and should not be made to individuals but to their host organisation. NHS professionals were concerned that payments could damage the quality of research and also considered full disclosure to patients as challenging. Patients and members of the public favoured full disclosure and payment of expenses to patients involved in research. Pharmaceutical company interviewees viewed payment to the NHS for all research activities as normal and highly regulated. They complained that the prices charged were high and so variable that they required benchmarking. Considerable scope exists for compiling data on the factors that help and hinder the progress of clinical trials and also for experimenting with different incentives to encourage involvement in clinical research. Further research should focus on improved reporting of those organisational aspects of trials that are known to affect recruitment; retrospective analysis of the factors associated with different levels of recruitment to RCTs; prospective comparative research on trial recruitment; qualitative research on participants' experiences of being involved in different kinds of trials, and proposals to include within trials experiments with payments methods.

Better Regulation in Europe

“Better Regulation” is afoot in Europe. After several transatlantic regulatory topics such as the precautionary principle, genetically mod climate change, Europe and America now appear to be converging on for regulation. In a process of hybridization, European institutions are b Regulation” reforms from both the US approach to regulatory review usin analysis and from European member states’ initiatives on administrative co simplification; in turn the European Commission is helping to spread t among the member states. In many respects, the Better Regulation initia salutary reforms, such as wider use of regulatory impact assessments and a unnecessary bureaucracy. In other respects, the European initiative spea Procrustean deregulation than of better regulation. Meanwhile the Europ still needs to establish the institutional infrastructure needed to succeed. Th argues that the European program of “Better Regulation” is well-founde even better if it adopted several strategies: enlarging the scope of benefit-cost analysis toward a broader, “warmer” and more evenha these tools, with greater attention to multiple risks; moving beyond a narrow cutting administrative costs or simplification for their own sake, tow Better Regulation in Europe – J.B. Wiener – draft of 17 September2006. Forthcoming in Current Legal Problems (2006) Better Regulation in Europe

Health research and the Data Protection Act 1998.

The 1998 Data Protection Act in the UK largely restates existing good practice: individuals have a right to know what data are held about them and why; and those processing data have a duty to proceed with fairness and transparency, maintain high data quality and keep data secure. Some health researchers have criticised the Act, seeing it as a legal minefield, unnecessary bureaucracy and interference from the European Union. This is largely based on misconceptions. Recent guidance from the Information Commissioner aims to assist researchers by advising how legal requirements can be met through anonymisation of data, attention to data-processing methods and fair collection of data. The Act provides a clear framework of rights and responsibilities that should be embraced with enthusiasm rather than with the reluctance of a person forced to carry out a meaningless chore.

Circular Arguments: Teachers and texts

Statutory regulation of national curricula has presented a series of challenges for primary educators. Circular 4/98 prescribed for the first time the English subject knowledge that should be delivered by initial teacher education programmes. The detail of this prescription resulted in less emphasis on texts for children and analysis of their possible meanings. The consultation on changes to Circular 4/98 presents an opportunity to reassert the central importance of children's literature as part of students' subject knowledge. However, there are considerable dangers evident from the consultation documents which could lead to a continuation of bleak reductionism and unnecessary bureaucracy.

ISO 9000 standards: perceptions and experiences in the UK construction industry

With the adoption by construction firms of BS EN ISO 9000 there has been much debate concerning its effectiveness and value as a quality management system. In spite of the reported benefits of ISO 9000 certification, however, concerns regarding its overall benefit to construction firms due to unnecessary bureaucracy and paperwork, increased costs, stifling of innovation, etc. still persist in the industry. This paper reports on the results of a research carried out on the implementation of BS EN ISO 9000 as a continuation of BS5750 in the UK construction industry from the view point of the experiences and perceptions of quality assurance managers of selected construction firms.

Elementos relacionados con la efectividad y eficiencia del trabajo del médico de familia: un estudio Delphi en la provincia de Alicante

[corrected] To detect factors that more directly restrict effectiveness and efficiency of the family physician's work in the health center. Made proposals for change which will contribute to increase this efficiency and effectiveness. Consensus method by Delphi technique. Thirty experts, from different settings of the National Health System at the province of Alicante, were requested for participate in this study: 15 health center co-ordinators, 7 directors of district primary care services and 8 chairmen of internal medicine hospital services. Twenty-four experts maintained their participation in all phases of the project, that means 80% of participation. The factors identified with a larger consensus (supported by at least 83% of the participants) were: difficulties in the relationship and communication between primary and secondary care levels; lack of incentives or motivation in manpower policy; vertical health programs not realistic and not well co-ordinated; a society each time more medicalized; deficiencies in the makeup of the general practitioners patients listś; political influences in management; excessive bureaucracy on consultations; deficiencies in continuing medical education; lack of prefixed aims and previously set criteria of standards; different training and involvement levels among professionals; limited access to diagnostic tests and a limited health education level among the population. The solutions proposed with a larger consensus (supported by at least 92% of the participants) were: to improve and increase communication between primary and secondary care levels; to makeup the patient list of every general practitioner and to adjust the staff of the health centers according to sociodemographic population variables and professional duties (practice, management, teaching, research,.); to design programs of continuing medical education with obligatory attendance for professionals; to incentive and to motivate professionals; to professionalize and depoliticize management; reduction of unnecessary bureaucracy on consultations by computing some tasks; to establish guidelines in practice; to introduce the Individual Health Card; self-management in health centers; to increase the primary care capacity in solving health problems; freedom of choice of the specialist consultant by the general practitioner; to release the access for the general practitioners to certain diagnostic tests; to improve certain social services and to increase the time that health center co-ordinators devote to managerial tasks. Most of the problems identified and the solutions proposed were linked either with organisational or managerial factors or with human resources management. The essences of the new primary care model are not questioned. Other Spanish publications which investigated the opinion of health professional as well, have identified similar problems and proposed similar solutions. This coincidence and the high degree of agreement reached by the participants in designing problems and in proposing solutions, may indicate that factors that most restrict the effectiveness and the efficiency of the family physicians work in health centers are clearly explained and it is necessary to deal with the solutions resolutely.

Anatomy of an OPTI: Part I. Form, function, and relationships.

In July 1995, the American Osteopathic Association (AOA) Board of Trustees passed new regulations for the accreditation of osteopathic graduate medical education (GME) programs by establishing the Osteopathic Postdoctoral Training Institutions (OPTI) system, to be implemented over 4 years. The resulting changes include requirements for college cosponsorship of GME programs and the establishment of standards for the minimum number of residency programs, interns, and residents. The OPTIs will be subject to AOA inspections at least every 5 years. Proponents of the OPTI system claim it will strengthen the profession by promoting educational collaboration, raising academic standards, and requiring appropriate resources to support osteopathic medical education. Opponents fear that it will be too resource intensive, create an additional layer of unnecessary bureaucracy, and have a negative impact on small colleges, hospitals, and states. Despite the controversy, a process for applying for OPTI status has been developed by the AOA, and a number of hospitals and colleges are already developing OPTIs. This article, the first in a two-part series, identifies issues and barriers to be considered in the formation of OPTIs and articulates principles underlying successful collaborations. In Part 2 these issues, principles, and barriers will be reinforced by describing the process used to form a large OPTI--the Ohio University College of Osteopathic Medicine (OU-COM) Centers for Osteopathic Regional Education (CORE) System.

La eficiencia del trabajo del médico en el centro de salud

Factors that most directly restrict the efficiency and effectiveness of the family doctor's work in primary care are analyzed. They are the following: excessive bureaucracy, lack of motivation and incentives for a job well-done, a gradual decrease in resources available for primary care in comparison with specialized care, difficulties in primary care work management, lack of communication between medical specialized services and primary care, and the difficulty of measuring the primary care output. There will be proposed the following changes: a reduction of unnecessary bureaucracy, rationalitation opposite to rationing in the management of resources, to increase the participation of the family doctor in the management of resources, promotion and incentives for increasing the cooperation between primary care and medical specialized services sponsored by Public Health Administration, to define and establish criteria to evaluate the primary care output, and a policy of encouraging medical training through the development of a professional career in primary care sponsored by Public Health Administration.