Managing financial conflicts of interest in clinical research

Upholding public trust in clinical research necessitates that human subjects be protected from avoidable harm and that the design, interpretation and reporting of research results be shielded from avoidable bias. On both counts, managing financial conflicts of interest is critically important, especially in the modern era when the opportunities for investigators to benefit personally from the commercialization of their intellectual property are overtly encouraged and rapidly expanding. Efforts are underway in the United States to provide more useful guidance to universities and medical schools for purposes of strengthening the oversight and management of financial conflicts of interest in clinical research. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Placebo: Its action and place in health research today

The place for the placebo in human clinical research is addressed in this paper. The World Medical Association which is comprised of some 80 National Medical Associations uses much of its resources to address medical ethics and human rights issues. It adopted the Declaration of Helsinki in June 1964 which addressed the protection of individuals in clinical trials. The use of placebos assumes an important role in this document. Five Revisions of the Declaration of Helsinki have occurred and the most recent was adopted in October 2000. The provisions on placebo are now in Paragraph 29 which reads as follows: “The benefit, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic methods exists.” The reactions to the newly revised version of the Declaration of Helsinki were numerous and rapid, not the least of which was the paragraph I quoted above. At the direction of the WMA Council, a small group of experts together with the WMA workgroup studied the Paragraph 29 to ensure that no ethically sound research was being restricted by the revision. The outcome was approved by the Council and later the WMA General Assembly in October 2000. This gives a note of clarification as to the appropriate use of placebos. Numerous papers and statements over the last several years have described positions very much in line with the Note of Clarification cited above. This paper was presented at an international conference, “Placebo: Its Action and Place in Health Research Today,” held in Warsaw, Poland on 12–13 April, 2003.     

Are readers of our face readers of our minds? Dogs (<Emphasis Type="Italic">Canis familiaris</Emphasis>) show situation-dependent recognition of human’s attention

The ability of animals to use behavioral/facial cues in detection of human attention has been widely investigated. In this test series we studied the ability of dogs to recognize human attention in different experimental situations (ball-fetching game, fetching objects on command, begging from humans). The attentional state of the humans was varied along two variables: (1) facing versus not facing the dog; (2) visible versus non-visible eyes. In the first set of experiments (fetching) the owners were told to take up different body positions (facing or not facing the dog) and to either cover or not cover their eyes with a blindfold. In the second set of experiments (begging) dogs had to choose between two eating humans based on either the visibility of the eyes or direction of the face. Our results show that the efficiency of dogs to discriminate between attentive and inattentive humans depended on the context of the test, but they could rely on the orientation of the body, the orientation of the head and the visibility of the eyes. With the exception of the fetching-game situation, they brought the object to the front of the human (even if he/she turned his/her back towards the dog), and preferentially begged from the facing (or seeing) human. There were also indications that dogs were sensitive to the visibility of the eyes because they showed increased hesitative behavior when approaching a blindfolded owner, and they also preferred to beg from the person with visible eyes. We conclude that dogs are able to rely on the same set of human facial cues for detection of attention, which form the behavioral basis of understanding attention in humans. Showing the ability of recognizing human attention across different situations dogs proved to be more flexible than chimpanzees investigated in similar circumstances.     

The association between implicit theories of personality and the attributional process

The influence of implicit theories of personality (entity vs. incremental theorists; see Dweck, Chiu and Hong, 1995) on the stages of the Sequential Operations Model of attribution (Gilbert, Pelham, and Krull, 1988) was investigated. Two hundred eighty Norwegian participants were given a Norwegian translation of the implicit personality theories measure. Participants then read two essays, one advocating the pro-life position and the other advocating the pro-choice position on the abortion issue. The essay positions were ostensibly assigned rather than freely chosen by the author. After each essay, participants were asked to rate the essay position and the true attitude of the author. Entity and incremental theorists showed no differences in their ratings of the essay position; however, entity theorists made significantly stronger correspondent inferences about the author's attitude than did incremental theorists. These results support the contention that entity theorists engage in less attributional correction than incremental theorists.     

卜筮与《周易》

《周易》包括古经与《易传》两个有机组成部分。古经为一诞生于西周时期的卜筮之书,但却内蕴着"人的发现"的时代主题。《易传》则对卜筮进行了创造性的哲学转化,充分揭示了人在天地人物相融为一的整个世界中的主体性地位,令古经"人的发现"的意蕴,得到了空前的最高哲学层面上的丰富、深化与升华,即此而确立起易学天人之学的哲学品格。其中也透显出宗教巫术的非理性信仰向理性的转化过程。     

Gene therapy: ethical issues

To discern the ethical issues involved incurrent gene therapy research, to explore theproblems inherent in possible future genetherapies, and to encourage debate within thescientific community about ethical questionsrelevant to both, we surveyed American Societyof Human Genetics scientists who engage inhuman genetics research. This study of theopinions of U.S. scientific experts about theethical issues discussed in the literature ongene therapy contributes systematic data on theattitudes of those working in the field as wellas elaborative comments. Our survey finds thatrespondents are highly supportive of thepotential use of somatic cell gene therapy tocure serious diseases in adults and children aswell as prospective offspring. A clearmajority, however, believe that using suchgenetic techniques for enhancement purposes isunacceptable. Delineating the line betweendisease/disorder and improvement/enhancementposes a problem not easily resolved and oneconducive to the growth of slippery-slopeapprehensions. The majority of respondents alsoadvocate germ-line therapy, in theory at least,and under similar restrictions, but theyrecognize the roadblock that the existence ofunanticipated negative consequences currentlypresents. Another complex matter involvestrying to determine appropriate reasons forchoosing target diseases for research, forwhich the dichotomy between rare single-geneand common multifactorial diseases reveals anongoing dilemma.     

On medicine as a human science

All the powerful influences exertedby the subjective-interpersonal dimension onthe organic or technical-functional dimensionof sickness and health do not make anintersubjective test concerning medicaltherapeutic results impossible. Theseinfluences are not arbitrary; on the contrary,they obey laws that are de facto sufficientlystable to allow predictions and explanationssimilar to those of experimental sciences.While, in this respect, the rules concerninghuman action are analogous to the scientificlaws of nature, they can at any time be revokedby becoming aware of them. Law-like andreproducible regularities in the sciences ofman are by no means separated from a patient'spersonal-hermeneutic mediation. This makes itpossible for human beings to modify, improve orsometimes even entirely (or better almostentirely) suspend these psychological,sociological, ethnological, medical,regularities. For this reason the sciences ofman including medicine are under the obligationof constantly inspecting the continuingvalidity of the rules on which theirpredictions and explanations are based, namelyby indirect, statistical methods. Thisrequires a synergistic collaboration ofextra-clinical and clinical tests through whichmedicine can obtain a good level ofintersubjective testability.     

B. F. Skinner's Science and Human Behavior: its antecedents and its consequences

Skinner's Science and Human Behavior marked a transition from a treatment of behavior that took physics as its reference science to one that emphasized behavior as a fundamental part of the subject matter of biology. The book includes what may be Skinner's earliest statement about the similarity of operant selection to Darwinian natural selection in phylogeny. Other major topics discussed in the book included multiple causation, private events, the self, and social contingencies. Among the important antecedents were Skinner's own Behavior of Organisms and Keller & Schoenfeld's Pincinples of Psychology. Current developments in education, behavioral economics, and some behavior therapies can be attributed at least in part to Skinner's seminal work. The effective behavioral analysis of governmental and religious systems will probably depend on elaborations of our understanding of verbal behavior.     

Free to blame? Belief in free will is related to victim blaming

The more people believe in free will, the harsher their punishment of criminal offenders. A reason for this finding is that belief in free will leads individuals to perceive others as responsible for their behavior. While research supporting this notion has mainly focused on criminal offenders, the perspective of the victims has been neglected so far. We filled this gap and hypothesized that individuals’ belief in free will is positively correlated with victim blaming—the tendency to make victims responsible for their bad luck. In three studies, we found that the more individuals believe in free will, the more they blame victims. Study 3 revealed that belief in free will is correlated with victim blaming even when controlling for just world beliefs, religious worldviews, and political ideology. The results contribute to a more differentiated view of the role of free will beliefs and attributed intentions.