Disclosing Conflicts of Interest in Clinical Research: Views of Institutional Review Boards, Conflict of Interest Committees, and Investigators

Strategies for disclosing investigators' financial interests to potential research participants have been adopted by many research institutions. However, little is known about how decisions are made regarding disclosures of financial interests to potential research participants, including what is disclosed and the rationale for making these determinations. We sought to understand the attitudes, beliefs, and practices of institutional review board chairs, conflict of interest committee chairs, and investigators regarding disclosure of financial interests to potential research participants. Several themes emerged, including general attitudes toward conflicts of interest, circumstances in which financial interests should be disclosed, rationales and benefits of disclosure, what should be disclosed, negative effects of and barriers to disclosure, and timing and presentation of disclosure. Respondents cited several rationales for disclosure, including enabling informed decision making, promoting trust in researchers and research institutions, and reducing legal liability. There was general agreement that disclosure should happen early in the consent process. Respondents disagreed about whether to disclose the amounts of particular financial interests. Clarifying the goals of disclosure and understanding how potential research participants use the information will be critical in efforts to ensure the integrity of clinical research and to protect the rights and interests of participants.     

Financial disclosure by clinical investigators; correction--FDA. Final rule; correction

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of February 2, 1998 (63 FR 5233). The document issued regulations requiring the sponsor of any drug, including a biological product, or device marketing application (applicant), to submit certain information covering the compensation to, and financial interests of, any clinical investigator conducting certain clinical studies. The document was published with an error. This document corrects that error.     

存款保險新機制下的銀行監管權

2013年9月11日,國務院總理李克強在回答世界經濟論壇主席施瓦布關於中國金融體制改革的問題時表示,中國將完善金融監管體系,增強金融監管機構的協調性,並且擇機推出存款保險制度。存款保險制度能夠強化對商業銀行的風險約束機制,從而有效地保護存款人利益,穩定金融秩序,因而很早就受到重視。早在1993年,我國已在《國務院關於金融體制改革的決定》中提出,要建立存款保險基金。此後,我國的立法者和專家學者都對此進行了大量研究。截至2013年6月底,我國人民幣存款餘額已逾百萬億。隨著存款的不斷增長,建設顯性的存款保險機制以防範銀行金融風險顯得尤為重要和迫切,醞釀已久的建立存款保險制度一事再度被提上日程。今年6、7月間,中國人民銀行接連表示,將積極研究制定《存款保險條例》,推進存款保險制度建設。本期特選取朱大旗教授、李慈強博士有關存款保險立法的文章,借鑒國外的成熟經驗,結合我國的具體實踐,探討中國國情下存款保險制度設計的路徑。     

Financial disclosure by clinical investigators--FDA. Final rule

The food and Drug Administration (FDA) is issuing regulations requiring the sponsor of any drug, including a biological product, or device marketing application (applicant), to submit certain information concerning the compensation to, and financial interests of any clinical investigator conducting certain clinical studies. This requirement will apply to any covered clinical study of a drug or device submitted in a marketing application that the applicant or FDA relies on to establish that the product is effective, including studies that show equivalence to an effective product, or that make a significant contribution to the demonstration of safety. This final rule requires applicants to certify to the absence of certain financial interests of clinical investigators and/or disclose those financial interests, as required, when covered clinical studies are submitted to FDA in support of product marketing. This regulation is intended to ensure that financial interests and arrangements of clinical investigators that could affect reliability of data submitted to FDA in support of product marketing are identified and disclosed by the sponsor of any drug, biological product, or device marketing application. If the applicant does not include certification or disclosure, or both, if required, or does not certify that it was not possible to obtain the information, the agency may refuse to file the application. FDA intends to propose to extend these requirements to submissions for marketing approval related to human foods, animal foods, and animal drugs in a subsequent issue of the Federal Register.     

Brief for bioethicists for privacy as amicus curiae supporting appellees

Amicus, an ad hoc group of philosophers, theologians, attorneys, and physicians, believe that adults should consult their doctor when making personal decisions. The doctor-patient relationship would be protected under the Constitution. In "Griswold v. Connecticut," the Supreme Court said that a state law which forbid married couples from using contraceptives was unconstitutional; that the couples should have a right to privacy. In "Roe," the Supreme Court recognized that a patient and her doctor should have privacy. In "Doe v. Bolton," the Supreme Court found that the State of Georgia was violating the patients' and physician's freedom. In "Planned Parenthood of Missouri v. Danforth," the Supreme Court said that a general informed consent provision was alright because it did not take away the abortion decision. The post- Roe state laws were ways to control doctors and patients so that a particular philosophical view could be imposed. The major question in Webster is whether personal decisions should be made by doctors and patients or the state. Both parties must agree to the decision. Section 188.205 of the Missouri law was before the Court in Webster. This section makes it illegal for public funds to be used to encourage a woman to have an abortion that wasn't necessary to save her life. There are medical conditions for which abortion is reasonable - Tay-Sachs disease, for instance. The child usually dies by 3 years of age. Without genetic screening, many at-risk couples would abort all pregnancies. 95% of all prenatal screenings are negative. State medical treatment decisions are arbitrary and impersonal. Having control over important personal decisions is necessary for freedom.     

论金融机构的适当性义务——基于行为要件的分析

金融机构适当性义务的作用不仅在于保护弱势交易主体,还在于克服金融交易中的信息不对称现象,实现交易中的义务与风险合理分配,进而通过买方的自主决定实现金融交易中的真实意思自治,构建金融市场公平公允的交易环境。为保证其作用发挥,有必要明确该义务的行为模式,使金融交易者明确自己的行为预期,促进交易者理性与市场效率提升。在目前阶段,适当性义务的预期行为模式应包括存在推荐服务时的了解产品、了解客户、适当性评估、记录保存行为,与指令交易中的警示与救援行为。     

Release on Recognizance: Substantive or Superficial Reform?

In the early 1960s, release on recognizance was hailed as a method through which inequities inherent in the system of monetary bail could be reduced. This goal was to be accomplished through the revision of the criteria on which pretrial release decisions were made; the defendant's ties to the local community and not his financial status were to be emphasized. Although the use of release on recognizance has become an accepted practice, these programs have escaped close examination. Using logit analysis, this article investigates the factors upon which release on recognizance was based in a western city. The findings suggest that decisions to release on recognizance were made more in accord with traditional criteria rather than those espoused by this reform movement.     

Family involvement, independence, and patient autonomy in practice

The legal debate about patient autonomy focuses mainly on mental capacity and provision of information. The influence of the family on the decisions of the competent adult patient has scarcely been discussed in English medical law. Dominated by the bioethical principle of individual autonomy, the law concentrates on the patient and takes an exclusionary stand regarding relatives. Hence, the aim of this article is to examine the attitude of English law towards the involvement of relatives when patients make decisions, and to investigate the views and experiences of patients and their relatives in reality. To fulfil this aim, a qualitative study was carried out in six NHS trusts in England. The study was based on in-depth interviews conducted with patients who suffer from long-term illnesses, and their relatives. In the interviews, patients stated that the relatives assisted them in making informed decisions about treatment. Patients said that relatives had an influence on the decision-making process and on the decision itself, but also reported that ultimately relatives left the final decision to the patient. The findings reflect a relational approach to patient autonomy. When making decisions about treatment, patients needed to know that their relatives would support them no matter what they decided. However, exceptional cases which demonstrated substantial familial influence suggest that the law should secure the patient's interest in making their own decisions. In light of these findings, it is argued that the current exclusionary attitude expressed in English medical law towards the role of relatives should be changed.     

疑难案件、司法判决与实质权衡

在疑难案件的审理中,经常可以发现,一些法律规则之外的因素影响了司法判决的做出。如何认识与评价这一现象？这些因素是否不可避免？如果是,这是否就意味着司法判决失去了客观性、确定性与合法性？文章通过考察几个中国司法实践中所出现的疑难案件,以及一些理论上的探讨,回答了上述问题,并得出结论：在疑难案件中,一个完整的法律论证必然要将某些法律之外的因素涵括进来;或者说,一个包含了法外因素的论证将更为真实、更为完整,从而也是更值得被接受的。     

The inhibiting factors that principal investigators experience in leading publicly funded research

Securing public funding to conduct research and leading it by being a principal investigator (PI) is seen as significant career development step. Such a role brings professional prestige but also new responsibilities beyond research leadership to research management. If public funding brings financial and infrastructure support, little is understood about the inhibiting factors that publicly funded PIs face given the research autonomy offered by publicly funded research. Our study finds that there are three key PI inhibiting factors (1) political and environmental, (2) institutional and (3) project based. Traditional knowledge, skills and technical know-how of publicly funded PIs are insufficient to deal with the increasing managerial demands and expectations i.e. growing external bureaucracy of public funding agencies. Public funding is no longer the ‘freest form of support’ as suggested by Chubin and Hackett (Peerless science: peer review and US science policy. Suny Press, New York, 1990) and the inhibiting factors experienced by publicly funded PIs limits their research autonomy. We also argue that PIs have little influence in overcoming these inhibiting factors despite their central role in conducting publicly funded research.     

Trámite legal para el pago de obligaciones pecuniarias impuestas al estado colombiano en decisiones sobre derechos humanos y derecho internacional humanitario

This article is one of the research results of the project “Impact of the Inter-American Court of Human Rights case law on Latin American High Courts rulings. Study about Brazil, Mexico and Colombia”. The author indicates how the Colombian State was seen compelled to send off a Law in the year 1996, through which, receiving a special procedure, he is included inside his internal code the guarantee of not repetition as mechanism of application of the decisions in matter of human rights and international human law in said country.     

Researching Private Security Consumption

This paper has two objectives: to provide an exploratory analysis of the rationalities and constraints that shape consumption of private security within organizations and to discuss some of the issues and questions that need to be addressed in future empirical studies of private security use by organizations. It is based largely on seven semi-directed interviews conducted with security managers, six of whom work in the private sector. While these security managers distanced themselves from responsibility for actual security consumption, arguing that they lack the capacity to make such decisions, they exercise considerable influence over the demand for private security within their organizations. Although all participants noted the relative ease with which they can convince their superiors to invest in security, they also indicated that security must have a demonstrated value-added component for the organization (often in money terms). Furthermore, executives expect security to be minimally intrusive and/or disruptive. This paper reports preliminary results of research on an under-investigated topic; it also builds on the methodological decisions and findings in this research to provide useful information to scholars interested in researching private security consumption in organizations.     

Roe v. Wade is constitutionally unprincipled and logically incoherent: a brief in support of judicial restraint

This "amicus curiae" brief was submitted by the Center for Judicial Studies and 56 members of Congress. They were concerned that "Roe" expands powers that belong to Congress and the states into the realm of federal government. Part I of the brief dealt with Missouri's claim that the laws that were at issue in "Webster" were permitted under "Roe" and shouldn't have been made invalid by lower courts. Most of the brief was in Part II. The thrust of it was that "Roe" was not based on any principle and is incoherent internally; "Roe" said that a privacy right existed under the US constitution. However, "Roe" didn't define this right of personal privacy. "Roe" cited a "line of decisions" to prove this point. However, none of the cases that "Roe" cited pretended to be based on the "right to privacy." They dealt with other issues. "Botsford" was said to be the beginning of the constitutional privacy right. It dealt with a "common law rule of evidence," not a right that was in the constitution. Therefore, it did not define the privacy right. "The process by which "Roe" moved from privacy to abortion was unfounded by judicial fiat." "Roe" said that it was protected by "the compelling interest standard," but did not give a reason why this was so. In "Roe," the woman';s interest in getting an abortion was analyzed in medical terms. But when talking about the State's interest in protecting potential human life, medical considerations were not controlling. Part III of the brief asked that "Roe" be overturned because it said that "a privacy right to abortion" was "devoid of any linkage to the text or history of the constitution." "Roe" should be abandoned because its "inadequacies" are "basic".     

Psychosocial concepts in juvenile law

This study was designed to clarify the types of information about juveniles and their families that are relevant for three types of juvenile court decisions: (a) the pretrial detention of juveniles; (b) their transfer for trial in criminal courts: and (c) disposition decisions after delinquency adjudication. Predominant legal standards for these decisions are described, information relevance for the decisions is defined, and why past studies have failed to clarify the information needs of juvenile court decision makers is explained. Results of a study involving a national sample of juvenile court personnel include an empirically derived domain of psychosocial and behavioral characteristics of juveniles and their families relevant for courts' interpretations of controlling legal standards; factor analysis of the domain, describing dimensions of the domain of information about juveniles and families; and an examination of the relation of these information categories to each legal standard controlling the decision areas in question. The interpretation of results may facilitate decision making by juvenile courts, evaluations by mental health professionals who assist juvenile courts, and further research by social scientists who study discretionary juvenile court decisions.This research was supported by grant No. MH-35090 from the Center for Studies of Antisocial and Violent Behavior, National Institute of Mental Health, DHHS. Portions of the study were conducted in collaboration with the National Juvenile Law Center, Inc. of St. Louis. The authors wish to acknowledge Martha Bellew-Smith, Marcia Conlin, and Robert Rust, who contributed substantially to the conduct of the study. Others who participated at various stages are Steve Bellus and Sandra Seigel     

ADOLESCENTS' VIEWS ON THE FAIRNESS OF PARENTING AND FINANCIAL ARRANGEMENTS AFTER SEPARATION

Interviews were conducted with 60 young people aged 12–19 in Australia, concerning their views about parenting and financial arrangements after separation. Half the young people reported that they had no say at all in where they would live after separation. A quarter said they were never able to see their nonresident parent when they wanted to. There was a strong relationship between young people's perceptions of the fairness of the parenting arrangements and the extent to which they were allowed to participate in making those arrangements. Half said that they did not have enough time with their nonresident parent. Having a continuing and meaningful relationship with both parents and with siblings was very important to them. More than a third favored arrangements of spending equal time with each parent. The young people were also very concerned with issues about fairness between first and second families, both in terms of time availability and financial provisions.     

Using market research to convert federal technology into marketable products

This paper discusses the need for a new market-research strategy to ensure timely applications of federally-developed technology in the private sector. It emphasizes the use of market research to facilitate the conversion of new technology into marketable new products and to guide decisions regarding future directions for technology research. Market research is a widely used source of information in the private sector, but historically it has been excluded from federal research programs.     

Webster and the fundamental right to make medical decisions

Members of the American Medical Association, the American Academy of Child and Adolescent Psychiatry, American Academy of Pediatrics, American College of Obstetricians and Gynecologists, American Fertility Society, American Medical Women's Association, American Psychiatric Association, and the American Society of Human Genetics have submitted an "amici curiae" brief in support of the appellees of "Webster." The brief did not endorse or oppose the view that the state's interest in fetal health is compelling as fetal viability. Instead, the brief said that: 1) everybody has the right to make medical decisions without the state interfering "up to the point where the state's compelling interest arises;" and 2) even after a compelling interest comes up, state rules must go along with good medical practices. Because some provisions of the Missouri law were not consistent with good medical practice, these provisions were not constitutional. The fetal viability testing requirement would increase risks to the woman and fetus without providing substantial information on viability. The counseling ban would prevent doctors from giving necessary information to pregnant women so that they could make informed decisions. The 1st section of the brief discussed "the medical background of pregnancy and abortion." The earliest age at which a fetus can survive has remained unchanged since "Roe." The medical complications and adverse health effects are fewer from than from childbirth. Abortions have become safer. The brief said that the "right of privacy" is broad enough so that a woman could decide whether or not to end her pregnancy. In "Roe," the Court found that if a woman was going to make a choice about pregnancy, this was the same as other private decisions which are protected in the Constitution. Individual medical decision making is "deeply rooted" in US "history and tradition." Accepted principles are reflected in the fact that the patient has a right to make these decisions based on the "liberty component of the Due Process Clause." Section 188.029 of the Missouri Law would make a doctor do certain tests for fetal viability. They would have no medical value, in most cases, and put a risk on the health of the mother. It was not related to any goal of the state, and was, therefore, unconstitutional. Section 188-205 of Missouri law - which says a doctor can't consult unless the mother's life is endangered was also unconstitutional.     

The council for national academic awards and legal studies

This is part one of a two-part paper. The papers outline the research for designing an m-learning (mobile phone) financial education game to counter financial exclusion. The paper will explain what led the researchers to use an m-learning game and what is unique about the design of the game compared to other serious games. The researchers will present the results of their 18-month project called “Innovation in Inclusion”, which teaches financial education to secondary school children aged between 13 and 15 years old, but which can be extrapolated into any type of interactive or m-learning method of teaching at any age. This game tested the hypothesis that if you increase financial education you can decrease the chances of being financially excluded in the future, by ensuring the people undertaking the learning aims can make effective financial decisions.     

Developing Codes of Conduct: Regulatory Conversations as Means for Detecting Institutional Change

The introduction of a new corporate governance code in Sweden, modeled after prevailing Anglo-Saxon norms of corporate governance, offers the opportunity to investigate global regulatory convergence. Using the metaphor of regulatory space, this article analyzes the positions of the parties who submitted formal responses to the introduction of "The Swedish Code of Corporate Governance—A Proposal from the Code Group." While the globalization of financial markets might forecast unconditional acceptance of the proposed code by business and financial interests, the analysis of who made comments, and what was said, reveals three categorically distinct groups: Swedish business "insiders" connected to the existing institutional framework who opposed changes that would erode traditional division of functions, including collective responsibility for the actions of company boards; "outsiders" (i.e., foreign investors and more marginal Swedish investors) aligned with Anglo-Saxon internationalization of the markets who would change the system of corporate accountability; and the professions (i.e., auditors), who advocated for their professional interests. Of the three groups, Swedish business insiders were most successful in gaining support for their positions. Although international financial and political interests were key to the introduction of the Code in the first place, the article demonstrates how the dynamics of national (local) culture and power structures influence the transfer of regulatory law across jurisdictions.