Policies and quality assurance in the pharmaceutical industry 1

The pharmaceutical industry is engaged in a critical undertaking of research, development, and marketing of drugs to patients. In this complex process there are a number of important steps involving corporate policies that require adherence by top management and personnel. The clinical trials, especially phase I—where drugs are first introduced into man, is one of these key steps that requires careful ethical consideration. The generic problem of varied conflict of interest among the personnel and departments can be the main contributing factor to decline in faith and confidence in the industry. It is argued in this paper than an effective and comprehensive quality assurance program that depends on internal and external review process and augumented by periodic externally conducted data audit is essential for corporations in developing and marketing safe and effective drugs. External quality assurance programs and data audit can make recommendations to management to avoid conflict of interests. The comprehensive key points of a high quality assurance program is proposed.     

Proposed Legislation May Compromise Incentive to Present Unbiased Presentation of Research Data

This paper discusses some current issues and methods related to the detection of fraudulent financial reporting and draws potential implications for audit detection of fradulent scientific reporting. First, a brief history of auditor concern with fraud detection is presented. Then four issues are addressed: (1) How often does fraud occur? (2) What is fraud? (3) What are the general types of fraud? (4) How can auditors assess fraud risk and detect fraud?     

Care Management and Information Provision: Towards a Reasoned Method of Assessing the Range and Extent of Problems and Needs in Child-Care Social Work

Correspondence to Professor Michael Sheppard, Department of Social Policy and Social Work, University of Plymouth, Drake Circus, Plymouth, Devon PL4 8AA Summary The new managerialism associated with care management has, aswith other areas of health and welfare work, promoted ideasof efficient use of resources, quality assurance and the capacityto audit the work of welfare agencies. This approach placesa high premium on measurement, and emphazises a long-standingdesire to develop instruments the use of which would providethe basis for resource allocation. This paper presents a methodby which such data can be rigorously generated and analysed.It uses as its basis an instrument of established reliabilityand validity, designed to collect data on problems identifiedin clients in the child and family care social work group. Ituses a combination of principal component and cluster analysisto provide a clear picture of the nature and range of problemsand the grouping of cases with similar characteristics. Thesedata provide a quantitative basis upon which judgements aboutresource allocation can be made.     

The office of scientific integrity investigations: The importance of data analysis

Certified Public Accountants serve as independent auditors of financial statements. They perform information‐integrity testing for the economy and society, adding creditability to financial statements prepared by organizations’ management. Investors, creditors, and others rely on these financial statements and the audit report to make business decisions. Auditing work involves gathering evidence (research) and forming an opinion (reporting results) about the “fairness”; of financial statements according to regulatory, legal, and professional rules. As researchers, auditors are subject to a complex network of mechanisms to promote accountability in their work. These mechanisms exist at environmental, professional, and audit‐firm levels. They combine to influence the judgments of individual auditors.     

Data disclosure and data sharing in scientific research

Data sharing is examined for its bearing on (i) quality assurance and (ii) extensions of results in scientific research as well as (iii) part of a tradition of openness in science. It is suggested that sharing can be accomplished in a simple manner that is also sufficiently flexible to fit varying individual situations by asking authors of data dependent articles and grant proposals to footnote (a) whether they are willing to make their data available to others and, if so, (b) how the data may be accessed. Appendices report results from a survey of current policies and practices in professional societies and in Federal government fund granting agencies. Emphasis is on the social and management sciences.     

Auditing biochemical research data: A case study

There is little documentation in the literature of how to conduct a data audit of laboratory research. The purpose of such an audit is to verify the extent to which the published data agree with the corresponding laboratory notebook data and whether the data thus examined appear to be sufficient to justify the published conclusions. A case study is presented, which demonstrates a step by step approach towards conducting a data audit of a published research study.     

对我国是否出现两极分化的基本判断

中国的收入差距和收入分配矛盾已经达到了相当大的程度。不同的学者运用不同的分析方法和判断标准 ,对中国是否已经形成收入分配的两极分化得出了不同的结论。要对收入差距的状况做出客观认识 ,必须要有客观的标准。把静态标准、动态标准、居民心理承受力标准和政治标准综合起来分析后认为 ,尽管收入差距已经使贫富差别出现 ,并有继续扩大化的迹象 ,但是从总体上来说 ,仍在社会的可承受范围之内 ,并没有形成两极分化。当务之急 ,是积极采取各种措施 ,防止两极分化的产生     

Complaining Our Way to Quality: Complaints, Contracts and the Voluntary Sector

The research on which this paper is based is part of a wider study of quality assurance and the voluntary sector. The focus of this paper is on complaints procedures, as part of quality assurance mechanisms, where voluntary agencies are the contracted service providers. The authors argue that, with the introduction of contracting and particularly with its further development, the way in which complaints mechanisms currently operate will need to be revised if they are to be an effective part of the quality assurance process.     

Caregivers' use of spirituality in ethical decision-making

This qualitative study examined ethical dilemmas faced by female caregivers of frail elders as well as the dominant role of caregivers' spirituality in addressing these dilemmas. Dilemmas are difficult decisions that involve conflicting values, e.g., freedom versus safety. In-depth interviews were conducted with thirteen ethnically diverse caregivers recruited from a home health agency and its parent hospital. Purposive sampling was used to obtain variation among research participants. Focus group interviews of home health staff, key informant caregivers, and interviewees provided guidance for the research design, reflection on findings and development of implications. In order to deal with ethical dilemmas, all caregivers used spirituality as (1) a philosophy of life, e.g., "This is what you do when you're family," (2) an aid to decision-making, e.g., through the use of prayer; and/or, (3) a way to transcend dilemmas, e.g., "no choice is hard." Implications include the importance of caregiver-driven assessment, professional self-reflection, and sustained formal services for caregivers.     

Negotiating Tensions between Methodology and Procedural Ethics

In this commentary, I consider what can go wrong in research when tensions arise between methodology and procedural ethics. I recount difficulties negotiating and implementing a participant recruitment strategy during my doctoral research project, which aimed to explore the experiences of people affected by dementia in the United Kingdom who were disengaged from services. To access this hard-to-reach population, I intended to adopt an informal recruitment strategy, snowball sampling from personal contacts and striking up conversations in public places. The procedural ethics committee were unhappy with this approach, deeming it potentially coercive. They suggested a more formal recruitment strategy enacted via emailing community organisations and churches. This approach entailed practical consequences that ultimately weakened the study sample, data and findings. This case raises questions about the negotiation of tensions between methodology and procedural ethics in gerontological research.     

Realizing the potential of a strengths-based approach in family support with young people and their parents

This paper on a strengths-based approach (SBA) to practice is based on empirical research with stakeholders involved in an intensive support programme for young people at risk and their parents in Ireland. The Youth Advocate Programme (YAP) model provides wraparound support to respond to their needs by focusing on their competencies and their coping skills and building networks of community-based supports. The model includes parents or carers in the suite of support offered by advocates. An SBA to practice has been discussed for some time in academic literature and practice guidance. However, it tends to be considered primarily in relation to social work practice, and there is ongoing ambiguity as to what it actually involves in day-to-day engagement with individual family members. Insightful, rich accounts of SBAs as part of routine practice provided by young people, parents and practitioners form the basis to this paper and detail how these approaches support the development of hope-inspiring relationships and promote positive change. Relevant literature and research situates the debate on the experience of using SBA, the wider challenges faced by families, the impact of SBA in practice on those receiving the support service and its potential for use in the wider continuum of children and family services.     

Evaluating U.S. Medical Schools' Efforts to Educate Faculty Researchers on Research Integrity and Research Misconduct Policies and Procedures

This paper examines how well U.S. medical school institutions are doing to promote research integrity. It is an important question to ask in order to determine whether there are sufficient and adequate protections in place to protect the U.S. Public Health Service's (PHS) resources devoted to medical research. This paper focuses on 5,100 medical school researchers' knowledge of what constitutes research misconduct as well as their willingness to report it to the research integrity officer (RIO) and educate their Ph.D. trainees. We learned that 5.6% of researchers could correctly distinguish seven or more of the nine scenarios that depicted likely research misconduct, as defined by the PHS regulations, from scenarios describing other ethical issues. Instead, researchers had expansive definitions and often inappropriately identified infractions such as conflicts of interest, Institutional Review Board (IRB) violations, and other breaches in ethical standards to be research misconduct. In addition, researchers who correctly identified four instances of likely research misconduct in the test items were highly unlikely to report their observations to a RIO. Researchers also provided insight on the factors they believe influence their decision making process of whether to report research misconduct. In addition, this paper also reports on the guidance that faculty said they provided their trainees on research misconduct issues. We conclude with a discussion and recommendations on what institutional leaders might consider doing in order to enhance their research integrity efforts and protect their institution's reputation.     

Social assistance programs during the COVID-19 pandemic in Bangladesh: Does faith-based approach matters?

This paper aimed to examine the role of faith-based organizations (FBOs) in the distribution of social assistance (SA) during the COVID-19 pandemic in Bangladesh. The paper adopts a qualitative case-study approach to explore the best practices in the distribution of SA by five (5) organizations including FBOs, governmental organizations (GOs), Non-governmental organizations (NGOs), political groups, and private voluntary groups. In this study, 14 beneficiaries of SA were selected by stratified proportionate random sampling method, and five (5) key personnel were selected purposively based on their experiences in the management of SA distribution. The study found that “no-move, no touch” approach followed by FBOs is more likely to establish human rights and social justice and reduce the transmission of diseases. In contrast to the modern idea, which undermines the faith-based charity, the study proved that faith-based charity is gaining attraction as an effective approach combating global pandemic. The findings of this paper will be useful for policymakers, voluntary service workers, GO, and NGO workers to ensure the distribution of SA in a more productive and disciplined way during and after an emergency like the COVID-19 pandemic.     

Data Audit as a Way to Prevent/Contain Misconduct

Research misconduct is frequently in the media headlines. There is consensus among leading experts on research integrity that the prevalence of misconduct in research is at least 1%, and shoddy work may even go over 5%. Unfortunately, misconduct in research impacts all walks of life from drugs to human subject protections, innovations, economy, policy, and even our national security. The main method of detecting research misconduct depends primarily on whistleblowers. The current regulations are insufficient since dependence on whistleblowers manifests itself as an accidental hit or miss. No other endeavor in our society depends on such a poor system of discovery of misconduct to remedy it. Nearly a quarter of a century ago, I proposed data audit as a means to prevent/contain research misconduct. The audit has to protect the creative process and be non-obtrusive. Data audit evaluates the degree of correspondence of published data with the source data. The proposed data audit does not require any changes in the way researchers carry out their work.     

National,independent oversight: Reinforcing the safety net for human subjects research*

National, independent oversight is vital to resolve the problems and inconsistencies in oversight of human subjects research. Three key functions that must be considered in any proposal for such a mechanism are (1) issue spotting, (2) guidance on identified issues, and (3) sampling and follow‐up. The 1998 report and recommendations of the National Bioethics Advisory Commission concerning research involving persons with mental disorders that may affect decisionmaking capacity address these functions in part, but application is limited to a small segment of the research population. Incorporation of these three key functions in a formal, national, independent oversight process is necessary in order to ensure accountability and maintain public trust in research.     

Drugs and Technology in Pregnancy and Child-birth—Review of Literature

Literature on the use of drugs and technology in pregnancy and in child-birth is reviewed, giving the general trend of findings in the case of studies and surveys. Very little of the literature is unreservedly positive and much of it emphasizes the need for caution and the risks that exist in both the use of drugs and the use of most forms of technology applicable to investigations and procedures during pregnancy and child-birth. There is clearly an imperative need for research in this area, before expensive equipment is purchased for every centre which may be used for obstetric cases. There is also a need to educate women in this area to ensure that they can make informed decisions about what they will accept in treatment and what they will not accept.     

Factors Affecting the LGBT Population When Choosing a Surrogate Decision Maker

ABSTRACT

For individuals in the marginalized population of lesbian, gay, bisexual, and trans- gender persons (LGBT), choosing a health care surrogate to make medical decisions is an emotionally challenging task. These decisions become more difficult when compounded by issues of discrimination, lack of legal and social support, varying levels of relationship commitment, and complications of disclosure to family and medical professionals. Limited research exists regarding the social, legal, medical, and familial environments that impact the choice of a surrogate decision maker for an LGBT individual. This systematic review examines 14 articles to identify factors influencing individual surrogate choice and existing gaps in the literature. To remedy current research limitations, future research recommendations address the areas of design, sampling, data collection, and data analysis within diverse subgroups of the LGBT population. This review further identifies related areas of service required by members of the LGBT population relative to diversity, demographics, and social, legal, medical, and familial environments influencing their choice of a surrogate decision maker.     

Actuarial approaches to pension schemes

Do pension schemes which are referred to as “assessment schemes” or, to be more precise, those which provide for and take into account the adjustment of pensions, need the contribution of actuarial science? If so, what is its function? These questions were raised in the early 1930s by Albert Thomas, Director of the ILO, and his colleagues, especially by Adrien Tixier, Chief of the Social Insurance Section (later a Division). Since then, they have been the subject of extensive and remarkably high-level discussion. In this article, one of the people who contributed most to this discussion gives his personal answer to this question and bases it on the use of tables showing projections. Through its Permanent Committee of Actuaries and Statisticians, the ISSA has devoted great efforts to studying “demographic and financial projections in social security”. The subject remains on this Committee's programme of work and in going into it more thoroughly, the Committee proposes to limit itself to the invalidity, old-age and death risks. The present article forms part of this research work: it concentrates on schemes which provide for the adjustment of pensions.     

On the potential cost effectiveness of scientific audits

The rationale for the routine performance of scientific audits has been previously discussed, and it has been proposed that independent professionals audit scientific data just as certified public accountants in independent public accounting firms audit financial data (1–4). Scientific audits would typically require the examination of data in laboratory notebooks and other work sheets, upon which research publications are based. Examples of such audits have been publicized recently, although these represent audits which have been conducted relatively inefficiently, over periods of several years per audit, and which have only been conducted due to the persistence of whistleblowers suspecting scientific fraud (5, 6). A detailed report has also appeared on the results of an audit of the research activities of a particular individual, where the audit was limited solely to an examination of the research publications themselves for errors and discrepancies (7). It should be emphasized that the purpose of conducting scientific audits is not only to detect fabrication of experimental results but also to monitor presumably more prevalent, non‐fraudulent, inappropriate practices, such as misrepresentation of data, inaccurate reporting, and departure from institutional guidelines for handling hazardous materials, working with human subjects, etc.

Two concerns which have been raised concerning the performance of scientific audits relate to cost. What would they cost, and who would pay for them? These questions, however, may be turned around. What does it cost not to conduct such audits, and who pays for that? An assumption often made is that science is self‐correcting, that sooner or later the truth will be revealed because of the need to replicate experiments of others for independent verification of novel findings (8). Testimony recently presented at a U.S. congressional hearing suggests that the self‐correcting manner in which science advances represents a very slow and inefficient process for uncovering scientific fraud (5, 6, 9). Data from a survey of university scientists was also presented, indicating “. . . a reluctance to take prompt, corrective action not only when an investigator suspects another of misconduct but also should the investigator discover flaws in his or her own published reports‐whether the flaws were the result of honest error or fraud”; (10).

The uncritical acceptance by established scientists that the self‐correcting process works compounds the problem. The Editor of Science has written that”;. . . 99.9999 percent of reports are accurate and truthful. . .”; (8). If indeed only 0.0001% of published reports were inaccurate or untruthful, there would be little justification for scientific audits. However, congressional testimony from the National Institutes of Health (NIH) revealed that”;. . . the NIH Director's office has handled an average of 15–20 allegations and reports of misconduct annually in its extramural programs, which supports the work of approximately 50,000 scientists”; (11). As I shall attempt to demonstrate, since NIH alone receives fraud‐related complaints concerning the work of at least 0.03% of scientists it supports in other institutions, and since evidence indicates that the incidence of fraud is considerably greater than 0.03% (10, 12), the need to audit data is justifiable on the basis of being cost effective.