Ethics Standards (HRPP) and Public Partnership (PARTAKE) to Address Clinical Research Concerns in India: Moving Toward Ethical, Responsible, Culturally Sensitive, and Community-Engaging Clinical Research.

Like other emerging economies, India's quest for independent, evidence-based, and affordable healthcare has led to robust and promising growth in the clinical research sector, with a compound annual growth rate (CAGR) of 20.4% between 2005 and 2010. However, while the fundamental drivers and strengths are still strong, the past few years witnessed a declining trend (CAGR -16.7%) amid regulatory concerns, activist protests, and sponsor departure. And although India accounts for 17.5% of the world's population, it currently conducts only 1% of clinical trials. Indian and international experts and public stakeholders gathered for a 2-day conference in June 2013 in New Delhi to discuss the challenges facing clinical research in India and to explore solutions. The main themes discussed were ethical standards, regulatory oversight, and partnerships with public stakeholders. The meeting was a collaboration of AAHRPP (Association for the Accreditation of Human Research Protection Programs)-aimed at establishing responsible and ethical clinical research standards-and PARTAKE (Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment)-aimed at informing and engaging the public in clinical research. The present article covers recent clinical research developments in India as well as associated expectations, challenges, and suggestions for future directions. AAHRPP and PARTAKE provide etiologically based solutions to protect, inform, and engage the public and medical research sponsors.

PARTAKE survey of public knowledge and perceptions of clinical research in India.

BACKGROUND: A public that is an informed partner in clinical research is important for ethical, methodological, and operational reasons. There are indications that the public is unaware or misinformed, and not sufficiently engaged in clinical research but studies on the topic are lacking. PARTAKE - Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment is a program aimed at increasing public awareness and partnership in clinical research. The PARTAKE Survey is a component of the program. OBJECTIVE: To study public knowledge and perceptions of clinical research. METHODS: A 40-item questionnaire combining multiple-choice and open-ended questions was administered to 175 English- or Hindi-speaking individuals in 8 public locations representing various socioeconomic strata in New Delhi, India. RESULTS: Interviewees were 18-84 old (mean: 39.6, SD ± 16.6), 23.6% female, 68.6% employed, 7.3% illiterate, 26.3% had heard of research, 2.9% had participated and 58.9% expressed willingness to participate in clinical research. The following perceptions were reported (% true/% false/% not aware): 'research benefits society' (94.1%/3.5%/2.3%), 'the government protects against unethical clinical research' (56.7%/26.3%/16.9%), 'research hospitals provide better care' (67.2%/8.7%/23.9%), 'confidentiality is adequately protected' (54.1%/12.3%/33.5%), 'participation in research is voluntary' (85.3%/5.8%/8.7%); 'participants treated like 'guinea pigs'' (20.7%/53.2%/26.0%), and 'compensation for participation is adequate' (24.7%/12.9%/62.3%). CONCLUSIONS: Results suggest the Indian public is aware of some key features of clinical research (e.g., purpose, value, voluntary nature of participation), and supports clinical research in general but is unaware of other key features (e.g., compensation, confidentiality, protection of human participants) and exhibits some distrust in the conduct and reporting of clinical trials. Larger, cross-cultural surveys are required to inform educational programs addressing these issues.

Public goods and procreation.

Procreation is the ultimate public goods problem. Each new child affects the welfare of many other people, and some (but not all) children produce uncompensated value that future people will enjoy. This essay addresses challenges that arise if we think of procreation and parenting as public goods. These include whether individual choices are likely to lead to a socially desirable outcome, and whether changes in laws, social norms, or access to genetic engineering and embryo selection might improve the aggregate outcome of our reproductive choices.

Studies on Understanding Individual Willingness to Disclose Genetic Information to Public and Private Stakeholders

While technologies for genetic sequencing have increased the promise of personalized medicine, they simultaneously pose threats to personal privacy. The public’s desire to protect itself from unauthorized access to information may limit the uses of this valuable resource. To date, there is limited understanding about the public’s attitudes toward the regulation and sharing of such information. We sought to understand the drivers of individuals’ decisions to disclose genetic information to a third party in a setting where disclosure potentially creates both private and social benefits, but also carries the risk of potential misuse of private information. We conducted two separate but related studies. First, we administered surveys to college students and parents, to determine individual attitudes toward and inter-generational influences on the disclosure decision. Second, we conducted a game-theory based experiment that assessed how participants’ decisions to disclose genetic information are influenced by societal and health factors. Key survey findings indicate that concerns about genetic information privacy negatively impact the likelihood of disclosure while the perceived benefits of disclosure and trust in the institution receiving the information have a positive influence. The experiment results also show that the risk of discrimination negatively affects the likelihood of disclosure, while the positive impact that disclosure has on the probability of finding a cure and the presence of a monetary incentive to disclose, increase the likelihood. We also study the determinants of individuals’ decision to be informed of findings about their health, and how information about health status is used for financial decisions.

TEACHING HIGH SCHOOL STUDENTS THE BEST CHORAL REPERTOIRE FROM THE GREAT COMPOSERS: MASTERWORKS AVAILABLE FOR IMMEDIATE, FREE ACCESS FROM THE CHORAL PUBLIC DOMAIN LIBRARY

Studying the choral works of the great composers of the past is always a worthy endeavor. For those aspiring to create an excellent high school choral program, it is critical to a student's musical foundation and heritage. Choral educators who teach high school are often bombarded with the most recently published new choral works, when they have a trove of excellent pieces right at their fingertips through websites like the Choral Public Domain Library (CPDL), all available at no cost. This project will explore the pedagogical reasons why this canon of public domain choral music should be taught at the high school level. A thorough guide to CPDL and an anthology of 200 works available on CPDL will provide the conductor with resources for programming this music. Though choral music in the public domain is free to all, publishers still publish this music and adhere copyright claims. This can create mistrust of legitimate editions on CPDL; why are they available at no cost when publishers are claiming copyright on similar editions? These issues will be thoroughly discussed in this project. For any given work on CPDL, there may be multiple editions available on the site. Choosing the right edition requires knowledge about basic editorial principles, especially for works written during the Renaissance period. A detailed discussion of these principles will provide the conductor with the tools needed to choose the best edition for his or her ensemble.

The tithe: Public research university STEM faculty perspectives on sponsored research indirect costs

This study sought to understand the phenomenon of faculty involvement in indirect cost under-recovery. The focus of the study was on public research university STEM (science, technology, engineering and mathematics) faculty, and their perspectives on, and behavior towards, a higher education fiscal policy. The explanatory scheme was derived from anthropological theory, and incorporated organizational culture, faculty socialization, and political bargaining models in the conceptual framework. This study drew on two key assumptions. The first assumption was that faculty understanding of, and behavior toward, indirect cost recovery represents values, beliefs, and choices drawn from the distinct professional socialization and distinct culture of faculty. The second assumption was that when faculty and institutional administrators are in conflict over indirect cost recovery, the resultant formal administrative decision comes about through political bargaining over critical resources. The research design was a single site, qualitative case study with a focus on learning the meaning of the phenomenon as understood by the informants. In this study the informants were tenured and tenure track research university faculty in the STEM fields who were highly successful at obtaining Federal sponsored research funds, with individual sponsored research portfolios of at least one million dollars. The data consisted of 11 informant interviews, bolstered by documentary evidence. The findings indicated that faculty socialization and organizational culture were the most dominant themes, while political bargaining emerged as significantly less prominent. Public research university STEM faculty are most concerned about the survival of their research programs and the discovery facilitated by their research programs. They resort to conjecture when confronted by the issue of indirect cost recovery. The findings direct institutional administrators to consider less emphasis on compliance and hierarchy when working with expert professionals such as science faculty. Instead a more effective focus might be on communication and clarity in budget processes and organizational decision-making, and a concentration on critical administrative support that can relieve faculty administrative burdens. For higher education researchers, the findings suggest that we need to create more sophisticated models to help us understand organizations dependent on expert professionals.

Expression, purification and X-ray crystallographic analysis of the Helicobacter pylori blood group antigen-binding adhesin BabA

Helicobacter pylori is a human pathogen that colonizes about 50% of the world's population, causing chronic gastritis, duodenal ulcers and even gastric cancer. A steady emergence of multiple antibiotic resistant strains poses an important public health threat and there is an urgent requirement for alternative therapeutics. The blood group antigen-binding adhesin BabA mediates the intimate attachment to the host mucosa and forms a major candidate for novel vaccine and drug development. Here, the recombinant expression and crystallization of a soluble BabA truncation (BabA^25-460) corresponding to the predicted extracellular adhesin domain of the protein are reported. X-ray diffraction data for nanobody-stabilized BabA^25-460 were collected to 2.25Å resolution from a crystal that belonged to space group P21, with unit-cell parameters a = 50.96, b = 131.41, c = 123.40Å, α = 90.0, β = 94.8, γ = 90.0°, and which was predicted to contain two BabA^25-460-nanobody complexes per asymmetric unit.

1960-1980. Het gouden tijdperk van de openbare werken. 1960-1980. L'âge d'or des travaux public

info:eu-repo/semantics/published

Risikowahrnehmung und psychologische Reaktionen in öffentlichen Krisensituationen am Beispiel von Terrorattentaten / Risk perception and psychological reactions in public crisis situations using the example of terror attacks

The reactions to the 9/11 terror attacks were immense in the western population. In the current review, the impact of terror attacks is presented with surveys, clinical interviews, and scientific polls, which were identified in a comprehensive literature search. Results show that the fear of further terror attacks is comparatively overestimated in the population and is associated with numerous psychological consequences and reactions. The overestimation of the probability of further terror attacks is related among other reasons to its unique features and its strong representation in the media. Several independent studies proved that the number of stress symptoms and psychiatric diagnoses is associated with a high risk perception in relation to terror attacks. This was not only the case for victims of terror attacks, but also for people indirectly exposed to the terror attacks. In addition, there is evidence that the number of the stress symptoms correlate with the duration of TV consumption of new findings about terror attempts. Methodologically, there is a critical lack of more in-depth analyses to explain the development of risk perceptions and its influence on mental and physical health. Because of the international importance and cross-cultural differences, an international standardization of research is desirable. [In German] Die Reaktionen auf die Terrorattentate vom 9. September 2001 in New York waren in der westlichen Bevölkerung immens. In der vorliegenden Übersichtsarbeit werden die Auswirkungen von Terrorattentaten durch Einbeziehung bevölkerungsrepräsentativer Untersuchungen, Surveys, klinischer Interviews und Einstellungsbefragungen dargestellt, die über eine deskriptive Literaturrecherche ermittelt wurden. Als Ergebnis des Reviews zeigt sich, dass die Angst vor weiteren Terrorattentaten in der Bevölkerung vergleichsweise hoch und mit zahlreichen psychologischen Folgen und Reaktionen assoziiert ist. Die Einschätzung der Auftretenswahrscheinlichkeit eines Terrorattentats hängt unter anderem mit den besonderen Charakteristika und der hohen medialen Präsenz des Themas zusammen. Die Anzahl der Stresssymptome bis hin zu psychiatrischen Diagnosen erwies sich in mehreren unabhängigen Untersuchungen mit einer hohen Risikowahrnehmung assoziiert. Dies ließ sich nicht nur bei den Opfern von Terrorattentaten, sondern auch bei indirekt Betroffenen zeigen. Darüber hinaus gibt es mehrfache Belege dafür, dass die Anzahl der Stresssymptome mit der Dauer des TV-Konsums über Neuigkeiten zu Terrorattentaten zusammenhing. Als methodische Kritik ist an den gegenwärtigen Untersuchungsszenarien einzuwenden, dass es derzeit keine tiefer gehenden Analysen zur Entwicklung der Risikowahrnehmung und zu ihrem Einfluss auf die Gesundheit gibt. Aufgrund der internationalen Bedeutung des Themas und der interkulturellen Unterschiede im Umgang mit Krisensituationen ist eine internationale Standardisierung von Untersuchungszugängen wünschenswert.

Public-public partnerships (PUPs) in water

A comprehensive global analysis of the use of public-public partnerships in water in over 60 countries.

A crisis for public-private partnerships (PPPs)?

The credit squeeze and recession are combining to make PPPs almost impossible to finance, anywhere in the world. Traditional government borrowing and procurement can still be used to implement infrastructure programmes.

Public-public partnerships (PUPs) in water

Water operators need to be efficient, accountable, honest public institutions providing a universal service. Many water services however lack the institutional strength, the human resources, the technical expertise and equipment, or the financial or managerial capacity to provide these services. They need support to develop these capacities. The vast majority of water operators in the world are in the public sector – 90% of all major cities are served by such bodies. This means that the largest pool of experience and expertise, and the great majority of examples of good practice and sound institutions, are to be found in existing public sector water operators. Because they are public sector, however, they do not have any natural commercial incentive to provide international support. Their incentive stems from solidarity, not profit. Since 1990, however, the policies of donors and development banks have focussed on the private companies and their incentives. The vast resources of the public sector have been overlooked, even blocked by pro-private policies. Out of sight of these global policy-makers, however, a growing number of public sector water companies have been engaged, in a great variety of ways, in helping others develop the capacity to be effective and accountable public services. These supportive arrangements are now called 'public-public partnerships' (PUPs). A public-public partnership (PUP) is simply a collaboration between two or more public authorities or organisations, based on solidarity, to improve the capacity and effectiveness of one partner in providing public water or sanitation services. They have been described as: “a peer relationship forged around common values and objectives, which exclude profit-seeking”.1 Neither partner expects a commercial profit, directly or indirectly. This makes PUPs very different from the public–private partnerships (PPPs) which have been promoted by the international financial institutions (IFIs) like the World Bank. The problems of PPPs have been examined in a number of reports. A great advantage of PUPs is that they avoid the risks of such partnerships: transaction costs, contract failure, renegotiation, the complexities of regulation, commercial opportunism, monopoly pricing, commercial secrecy, currency risk, and lack of public legitimacy.2 PUPs are not merely an abstract concept. The list in the annexe to this paper includes over 130 PUPs in around 70 countries. This means that far more countries have hosted PUPs than host PPPs in water – according to a report from PPIAF in December 2008, there are only 44 countries with private participation in water. These PUPs cover a period of over 20 years, and been used in all regions of the world. The earliest date to the 1980s, when the Yokohama Waterworks Bureau first started partnerships to help train staff in other Asian countries. Many of the PUP projects have been initiated in the last few years, a result of the growing recognition of PUPs as a tool for achieving improvements in public water management. This paper attempts to provide an overview of the typical objectives of PUPs; the different forms of PUPs and partners involved; a series of case studies of actual PUPs; and an examination of the recent WOPs initiative. It then offers recommendations for future development of PUPs.

Thinking inside the box: the World Bank position on the private and public sector

An analysis of how the World Bank has maintained a position supportive of mutlinational strategies for privatisation of water. (Brief version).

Developing “middle leaders” in the public services? The realities of management and leadership development for public managers

Purpose – This paper aims to assess the actual contribution to organisational change of management and leadership development (MLD) activity for middle managers (MMs) in public service organisations (PSOs). Design/methodology/approach – Using the case study approach, the paper compares the content and outcomes of management and leadership training interventions for MMs in two large PSOs. The organisations, a fire brigade and a train operating company, are leaders in their sectors with respect to management development and “modernisation” of their services. Findings – The paper demonstrates how, in one case, MM development was largely an exercise in regulatory compliance, with little effect on individual MMs' performance or organisational outcomes. The second case demonstrates how MMs were effectively trained to enforce specific human resource policies which contributed to the successful implementation of top-down strategy yet paid little attention to the potential leadership role of MMs. Research limitations/implications – The paper highlights the need for further contextualised research at organisational level into the outcomes of MLD, especially in terms of different public service contexts. Practical implications – The paper demonstrates the dangers of designing and implementing development programmes without sufficient regard to professional practice and the realities of managerial discretion in PSOs. Originality/value – The paper provides an in-depth and contextualised insight into the conditions for success and failure in management development interventions in PSOs.