Comparative evaluation of two superior stopping rules for hierarchical cluster analysis

A split-sample replication stopping rule for hierarchical cluster analysis is compared with the internal criterion previously found superior by Milligan and Cooper (1985) in their comparison of 30 different procedures. The number and extent of overlap of the latent population distributions was systematically varied in the present evaluation of stopping-rule validity. Equal and unequal population base rates were also considered. Both stopping rules correctly identified the actual number of populations when there was essentially no overlap and clusters occupied visually distinct regions of the measurement space. The replication criterion, which is evaluated by clustering of cluster means from preliminary analyses that are accomplished on random partitions of an original data set, was superior as the degree of overlap in population distributions increased. Neither method performed adequately when overlap obliterated visually discernible density nodes.This research was supported in part by NIMH grant 5R01 MH 32457 14.     

Problems for biomedical research at the academia-industrial interface

Throughout much of the world, universities have driven towards industrial partnerships. This collaboration, which, in the biochemical field at least, has to continue if potential benefits for patients are to be realised, has brought with it a number of problems. These include the neglect of long-term research in favour of short-term projects, the curtailing of free dissemination of research information within university departments and the biasing of results of clinical trials by the financial interests of the investigators. It is very important that governments, universities, and industry itself address these problems. Universities should monitor the amount of basic, curiosity-driven research that is being carried on, compared with that which is more short-term goal orientated. PhD students and post-doctoral fellows should be exposed to the principles of bioethics early on in their careers. Further work is necessary on the terms of research contracts to protect, on the one hand, the rights of individual scientists and, on the other, industry from rogue scientists. Where problems arise, procedures should be in place for independent reviews to be conducted by bodies such as the Medical Research Council in the UK or the National Institutes of Health in the USA. The conflict-of-interest rules recently introduced for publication in medical journals should be extended to all branches of science.     

A framework for risk-benefit evaluations in biomedical research

Essentially all guidelines and regulations require that biomedical research studies have an acceptable risk-benefit profile. However, these documents offer little concrete guidance for implementing this requirement and determining when it is satisfied. As a result, those charged with risk-benefit evaluations currently assess the risk-benefit profile of biomedical research studies in unsystematic ways, raising concern that some research participants are not being protected from excessive risks and that some valuable studies involving acceptable risk are being rejected. The present paper aims to address this situation by delineating the first comprehensive framework, which is based on existing guidelines and regulations as well as the relevant literature, for risk-benefit evaluations in biomedical research.     

Third-party payers and the cost of biomedical research

Four principal arguments have been offered in support of requiring public and private third-party payers to help fund medical research: (1) many of the costs associated with clinical trial participation are for routine care that would be reimbursed if delivered outside of a trial; (2) there is a need to promote scientific research and medical progress and lack of coverage is an impediment to enrollment; (3) to cover the costs of trials expands health care and treatment options for the sick; and (4) it is beneficial for private insurers to cover the costs associated with cancer clinical trials because doing so makes such companies more attractive to consumers. Although many see third-party-payer coverage as a victory for patients and for the future of research, requiring coverage of services provided in a trial beyond those that would be provided to a comparable patient outside the research context raises a number of concerns.     

Limits on risks for healthy volunteers in biomedical research

Healthy volunteers in biomedical research often face significant risks in studies that offer them no medical benefits. The U.S. federal research regulations and laws adopted by other countries place no limits on the risks that these participants face. In this essay, I argue that there should be some limits on the risks for biomedical research involving healthy volunteers. Limits on risk are necessary to protect human participants, institutions, and the scientific community from harm. With the exception of self-experimentation, limits on research risks faced by healthy volunteers constitute a type of soft, impure paternalism because participants usually do not fully understand the risks they are taking. I consider some approaches to limiting research risks and propose that healthy volunteers in biomedical research should not be exposed to greater than a 1% chance of serious harm, such as death, permanent disability, or severe illness or injury. While this guideline would restrict research risks, the limits would not be so low that they would prevent investigators from conducting valuable research. They would, however, set a clear upper boundary for investigators and signal to the scientific community and the public that there are limits on the risks that healthy participants may face in research. This standard provides guidance for decisions made by oversight bodies, but it is not an absolute rule. Investigators can enroll healthy volunteers in studies involving a greater than 1% chance of serious harm if they show that the research addresses a compelling public health or social problem and that the risk of serious harm is only slightly more than 1%. The committee reviewing the research should use outside experts to assess these risks.     

Protecting people in research: a comparison between biomedical and traffic research

Traffic research shares a fundamental dilemma with other areas of empirical research in which humans are potentially put at risk. Research is justified because it can improve safety in the long run. Nevertheless, people can be harmed in the research situation. Hence, we need to balance short-term risks against long-term safety improvements, much as in other areas of research with human subjects. In this paper we focus on ethical issues that arise when human beings are directly affected in the performance of research by examining how the ethical requirements in biomedical research can inform traffic research. After introducing the basic ethical requirements on biomedical research, each of the major requirements is discussed in relation to traffic research. We identify the main areas where biomedical research and traffic research differ, and where the ethical requirements from the former cannot easily be transferred to the latter. Finally, we argue that there is a need for systematic studies of the ethics of traffic research and point to some of the issues that need to be addressed.     

Data management and accountability in behavioral and biomedical research.

Regulations recently enacted by the Public Health Service and the National Science Foundation to address misconduct in scientific research were designed primarily to curtail deliberate forms of misconduct, such as fabrication or falsification of findings; however, researchers may also be held accountable for inadvertent deficiencies in data management. This article examines some of the problems in data quality control, documentation, and data retention that can occur when computers are used in scientific research. It focuses on deficiencies that could make it difficult to verify the integrity of research data or to reproduce statistical analyses. Strategies for prevention of data management problems are recommended.     

The design and analysis of state-trace experiments

State-trace analysis (Bamber, 1979) addresses a question of interest in many areas of psychological research: Does 1 or more than 1 latent (i.e., not directly observed) variable mediate an interaction between 2 experimental manipulations? There is little guidance available on how to design an experiment suited to state-trace analysis, despite its increasing use, and existing statistical methods for state-trace analysis are problematic. We provide a framework for designing and refining a state-trace experiment and statistical procedures for the analysis of accuracy data using Klugkist, Kato, and Hoijtink's (2005) method of estimating Bayes factors. The statistical procedures provide estimates of the evidence favoring 1 versus more than 1 latent variable, as well as evidence that can be used to refine experimental methodology.     

Animals in biomedical research: the undermining effect of the rhetoric of the besieged

It is correctly asserted that the intensity of the current debate over the use of animals in biomedical research is unprecedented. The extent of expressed animosity and distrust has stunned many researchers. In response, researchers have tended to take a strategic defensive posture, which involves the assertation of several abstract positions that serve to obstruct resolution of the debate. Those abstractions include the notions that the animal protection movement is trivial and purely anti-intellectual in scope, that all science is good (and some especially so), and the belief that an ethical consensus can never really be reached between the parties.     

顾炎武《易》音研究条例初探——顾氏《易音》"承其义则亦承其音"辨

顾炎武《易音》包含有六条易音研究条例,其中核心条例是"承其义则亦承其音"。这一关系原则中,"义"在"音"先,"义"是决定上下爻辞之间韵读关系成立的第一条件,在此基础上,音同或音近才能成为上下爻辞之间韵读关系成立的依据。通过对《易音》中的实例分析,发现此条例不仅贯穿其他条例,而且贯通顾氏整个易音研究。从清代易音研究的整体情况来看,可以说顾炎武易音研究条例成为易音研究的基本范式,并且具有丰富的易学内涵,对现代易学研究有着很好的方法论启示。     

Ethical issues in biomedical research: Perceptions and practices of postdoctoral research fellows responding to a survey

We surveyed 1005 postdoctoral fellows by questionnaire about ethical matters related to biomedical research and publishing; 33% responded. About 18% of respondents said they had taken a course in research ethics, and about 31% said they had had a course that devoted some time to research ethics. A substantial majority stated willingness to grant other investigators, except competitors, access to their data before publication and to share research materials. Respondents’ opinions about contributions justifying authorship of research papers were mainly consistent but at variance with those of many biomedical journal editors. More than half said they had observed what they considered unethical research practices. To increase the chances of getting a grant funded, 27% said they were willing to select or omit data to improve their results; to make publication of their work more likely or to benefit their career, 15% would select or omit data and 32% would list an undeserving author. Of respondents who thought they had been unfairly denied authorship on a paper, or been listed with or asked to list an undeserving author, 75% said they would be willing to list an undeserving author (P<0.001). Having taken a course dealing with research ethics had no effect on stated willingness to select or omit data or to fabricate data in the future, but was positively associated with willingness to grant undeserved authorship (P<0.04). Although these results do not controvert research demonstrating the effectiveness of ethics courses during professional education, they indicate that the research environment is a powerful component of a trainee’s experience and ethical development. Preliminary results of this work were presented in part as a poster at the forumEthics, Values, and the Promise of Science, presented by Sigma Xi, The Scientific Research Society, 25–26 February 1993 in San Francisco, California, USA.     

Conflict of interest in biomedical research: a view from Europe

In this paper I address the conflict of interest (CoI) issue from a legal point of view at a European level. We will see that the regulatory framework that exists in Europe does state the need for the independence of ethics committee involved in authorisation of research and clinical trials. We will see that CoI is an element that has to be closely monitored at National and International level. Therefore, Member States and Newly Associated States do have to address CoI in the authorisation process of research and clinical protocols of biomedicine. The opinions here expressed are personal and do not commit the European Commission. An earlier version of this paper was delivered at a Conference on Conflict of Interest and Its Significance in Science and Medicine, 5–6 April, 2002, Warsaw, Poland. The author is a Scientific Officer in the Programme Science and Society dealing with ethics and science (Unit C.3).     

The effect of dynamic social material conditions on cognition in the biomedical research laboratory

Phenomenology and the Cognitive Sciences - The modern biomedical research laboratory is increasingly defined by dynamic social material conditions requiring researchers to traverse multiple...     

Two factors to be considered in the design of experiments in anxiety and motor behavior

There are two aspects of Martens' paper which deserve comment. The first deals with experimental design and statistical power while the second concerns the distinction between performance and learning and the implications it has for research in anxiety and motor learning.