The gap between law and ethics in human embryonic stem cell research: Overcoming the effect of U.S. Federal policy on research advances and public benefit

Key ethical issues arise in association with the conduct of stem cell research by research institutions in the United States. These ethical issues, summarized in detail, receive no adequate translation into federal laws or regulations, also described in this article. U.S. Federal policy takes a passive approach to these ethical issues, translating them simply into limitations on taxpayer funding, and foregoes scientific and ethical leadership while protecting intellectual property interests through a laissez faire approach to stem cell patents and licenses. Those patents and licenses, far from being scientifically and ethically neutral in effect, virtually prohibit commercially sponsored research that could otherwise be a realistic alternative to the federal funding gap. The lack of federal funding and related data-sharing principles, combined with the effect of U.S. patent policy, the lack of key agency guidance, and the proliferation of divergent state laws arising from the lack of Federal leadership, significantly impede ethical stem cell research in the United States, without coherently supporting any consensus ethical vision. Research institutions must themselves implement steps, described in the article, to integrate addressing ethical review with the many legal compliance issues U.S. federal and state laws create. The opinions expressed in this article are the author’s own, and are not necessarily the opinions of others, including Children’s Hospital Boston. Portions of earlier versions of this article were previously published by the American Bar Association and the New York State Bar Association.     

Measuring Impulsivity in School-Aged Boys and Examining Its Relationship with ADHD and ODD Ratings

Seven different laboratory measures of impulsivity were administered to a group of 165 school-aged boys. Parents' and teachers' ratings of Attention Deficit and Hyperactivity Disorder and Oppositional/Defiant Disorder were also obtained. Factor analyses of impulsivity measures revealed the existence of a strong Inhibitory Control Factor including measures derived from Stop Task, the Continuous Performance Test, the Matching Familiar Figures Test, and the Circle Tracing Task. Other forms of impulsivity like resistance to interference, the Wisconsin Card Sorting Test and efficiency in the DRL Task loaded on a second independent factor. The Inhibitory Control factor was correlated with ADHD ratings, whereas the second factor was slightly related to the presence of ODD symptoms. Discussion is focused on the relevance of inhibitory control in impulsivity and ADHD research.     

The necessity and the value of placebo

The use of placebo in clinical trials has been repeatedly challenged as being unacceptable from an ethical point of view. The present paper responds to this criticism by taking up the issue in the light of the pertinent provisions of the Helsinki Declaration. Examples from different therapeutic areas are given that highlight the importance of placebo in situations in which its use is acceptable according to the Declaration. Particular emphasis is given to the question of active control trials, which, under conditions of low assay sensitivity, may become an ethically less acceptable approach than the use of a placebo control. An earlier version of 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.     

Adjustment to chronic low back pain--the relative influence of fear-avoidance beliefs, catastrophizing, and appraisals of control

The present study investigated the relative extent to which patients' adjustment to chronic low back pain (CLBP) was influenced by their fear-avoidance beliefs, their tendency to catastrophize, and their appraisals of control. Eighty-three CLBP patients completed a series of self-report measures before participating in a physical therapist-led intervention. Hierarchical multiple regression analyses revealed that patients' perceptions of their ability to decrease pain explained a small, but statistically significant, proportion of the variance in pain intensity. In addition, patients' levels of catastrophizing, as well as their fear-avoidance beliefs about both work and physical activity, were independently associated with levels of disability. Interestingly, however, when exploring the relative predictive utility of these three psychological factors, it became evident that fear-avoidance beliefs about physical activity (FABs-PA) were the only significant predictor of patients' disability. Specifically, those patients who exhibited higher levels of FABs-PA tended to report greater levels of disability, even after adjusting for age, sex and pain intensity.     

Cognitive defusion and self-relevant negative thoughts: examining the impact of a ninety year old technique

Cognitive defusion techniques are designed to reduce the functions of thoughts by altering the context in which they occur, rather than the attempting to alter the form, frequency, or situational sensitivity of the thoughts themselves. Applied technologies designed to produce cognitive defusion seem to lead to reductions in the believability of negative thoughts, but defusion techniques are generally only parts of complex packages and the role of defusion techniques per se is note yet known. The present study examined the impact of a cognitive defusion technique first described by Titchener nearly 90 years ago: rapidly repeating a single word. In series of eight single-case alternating treatment designs, this defusion technique was compared to a distraction task, and to a thought control task on reductions in the discomfort and believability of self-relevant negative thoughts. The cognitive defusion technique reduced both discomfort and believability more so than the comparison approaches. Control studies showed that the effect was probably not due to demand characteristics.     

Changes in the structure of children's isometric force variability with practice

This study examined the effect of age and practice on the structure of children's force variability to test the information processing hypothesis that a reduction of sensorimotor system noise accounts in large part for age-related reductions in perceptual-motor performance variability. In the study, 6-year-olds, 10-year-olds, and young adults practiced on 5 consecutive days (15 trials/day), maintaining for 15-s trials a constant level of force (5 or 25% of maximum voluntary contraction) against an object using a pinch grip (thumb and index finger). With increasing age, the amount of force error and variability decreased, but the sequential structure of variability increased in irregularity. With practice, children reduced the amount of variability by changing the structure of the force output so as to be more similar to that of their older counterparts. The findings provide further evidence that practice-driven changes in the structure of force output, rather than a decline in the amount of white noise, largely account for age-related reductions in the amount of force variability.     

The planning and execution of sequential eye movements: saccades do not show the one target advantage

The present experiment examined the one-target advantage (OTA) with regard to saccadic eye movements. The OTA, previously found with manual pointing responses, refers to the finding that movements are executed faster when the limb is allowed to stop on the target compared to the situation where it has to proceed and hit a second target. Using an adapted limb movement OTA task, saccades of 5 degrees and 15 degrees were made to (a) a single target (one-target), (b) one target and immediately to another target without a change in direction (two-target-extension), and (c) one target and immediately back to the start location (two-target-reversal). Unlike manual movements, the movement times for the initial saccade in the two-target-extension condition were not prolonged compared to either of the other two conditions. Moreover, this pattern of results was found for both the shorter and longer amplitude saccades. The results indicate that the OTA does not occur in the oculomotor system and therefore is not a general motor control phenomenon.     

Behavioral treatment of insomnia in older adults: an open clinical trial comparing two interventions

Fifty-five insomniacs, 60 years or above, participated in a behavioral treatment program, comparing two interventions (sleep hygiene+stimulus control vs sleep hygiene+relaxation tape). Half of the subjects were randomized to a waiting-list condition prior to treatment. No significant changes were observed during the waiting-list period. During the treatment period however, the subjects improved on several sleep parameters, and treatment gains were maintained at a 6-month follow-up. The effects of treatment were greater for nocturnal measures (e.g. sleep onset latency and total sleep time) as compared to daytime measures (e.g. life satisfaction, daytime alertness) and not-targeted behavior (medication use). There were no differences in treatment effects for the two interventions.     

The Meta-Cognitive Beliefs Questionnaire: development of a measure of obsessional beliefs

A 67 item self-report questionnaire called the Meta-Cognitive Beliefs Questionnaire (MCBQ) was developed to assess endorsement of beliefs about the importance of control and negative consequences associated with unwanted, ego-dystonic intrusive thoughts, images and impulses. The MCBQ and a battery of questionnaires that assessed symptoms and cognitions of worry, obsessive-compulsive disorder, anxiety, and depression were administered to large samples of undergraduate students. Beliefs about control of intrusive thoughts and perceived negative consequences due to uncontrolled mental intrusions had a unique significant relationship with obsessions, and to a lesser extent, worry. These findings are consistent with current cognitive behavioral theories that suggest an important role for meta-cognitive beliefs in the pathogenesis of obsessions.     

The effects of extinction,noncontingent reinforcement and differential reinforcement of other behavior as control procedures

Several techniques have been used in applied research as controls for the introduction of a reinforcement contingency, including extinction, noncontingent reinforcement (NCR), and differential reinforcement of other behavior (DRO). Little research, however, has examined the relative strengths and limitations of these "reversal" controls. We compared the effects of extinction with those of NCR and DRO in both multi-element and reversal designs, with respect to (a) rate and amount of response decrement, (b) rate of response recovery following reintroduction of reinforcement, and (c) any positive or negative side effects associated with transitions. Results indicated that extinction generally produced the most consistent and rapid reversal effects, with few observed negative side effects.