临床研究结果发布的伦理审查辨析

《涉及人的生命科学和医学研究伦理审查办法》对于临床研究结果的发布提出了伦理审查和知情同意告知的要求。探讨临床研究的结果发布可以最大程度实现临床研究的价值,包括有利于实现临床研究的透明性,有利于增强公众的信赖,有利于落实研究参与者的知情权,并分析了研究结果发布在隐私保护、发布形式、发布时间、科研诚信和学术不端方面带来的潜在伦理问题。建议伦理委员会从隐私风险最小化、发布形式规范化、发布时间合理化三方面进行伦理审查,同时给出了加强多部门协作和跟踪审查以及参与学术不端治理的伦理审查策略建议。

     

Human operant performance: Sensitivity and pseudosensitivity to contingencies

Undergraduates' button presses occasionally produced points exchangeable for money. Left and right buttons were initially correlated with multiple random-ratio (RR) and random-interval (RI) components, respectively. During interruptions of the multiple schedule, students filled out sentence-completion guess sheets describing the schedules, and points were contingent upon the accuracy of guesses. To test for sensitivity to schedule contingencies, schedule components were repeatedly reversed between the two buttons. Pressing rates were consistently higher in ratio than in interval components even when feedback for guesses was discontinued, demonstrating sensitivity to the difference between ratio and interval contingencies. The question was whether this sensitivity was based directly on the contingencies or whether it was rule-governed. For two students, when multiple RR RI schedules were changed to multiple RI RI schedules, rates became low in both components of the multiple RI RI schedule; however, subsequent prevention of point deliveries for the first few responses in any component produced high rates in that component. For a third student, response rates became higher in the RI component that provided the lower rate of reinforcement. In each case, performance was inconsistent with typical effects of the respective schedules with nonhuman organisms; it was therefore plausible to conclude that the apparently contingency-governed performances were instead rule-governed.     

AUDITORY SUCCESSIVE CONDITIONAL DISCRIMINATION AND AUDITORY STIMULUS EQUIVALENCE CLASSES

This paper describes an experimental demonstration of stimulus equivalence classes consisting entirely of auditory stimuli. Stimuli were digitized arbitrary syllables (e.g., “cug,” “vek”) presented via microcomputer. Training and testing were conducted with a two-choice auditory successive conditional discrimination procedure. On each trial, auditory samples and comparisons were presented successively. As each comparison was presented, a response location (a rectangle) appeared on the computer screen. After all stimuli for a trial were presented, subjects selected one of the response locations. Six subjects acquired the conditional discrimination baseline, 4 subjects demonstrated the formation of three-member auditory equivalence classes resulting from sample-S+ relations, and 1 subject demonstrated equivalence classes resulting from sample-S— relations. Four subjects received additional training and subsequently demonstrated expansion of the three-member classes to four members each.     

Non‐specific encoding of threat in social phobia and panic disorder

This study employs a release of proactive interference technique to explore encoding‐related processes in social phobia. Twenty‐six individuals with social phobia and 24 individuals with panic disorder participated in the memory task. Significant release of proactive interference was found when neutral and threat dimensions were encoded, but not when social and physical threat dimensions, or when positive and threat dimensions were presented. Threat was therefore differently encoded depending on the active encoding context in which semantic processing occurred. Individuals with social phobia or panic disorder did not differ in the release of proactive interference. The present experiment consequently yields little support for the specificity hypothesis in memory of anxious individuals. Instead, the findings generally demonstrate that threat encoding is similar for people with social phobia and those with panic disorder.     

Conditional discrimination in mentally retarded adults: the development of generalized skills.

The development of generalized conditional discrimination skills was examined in adults with retardation. Two subjects with histories of failure to acquire arbitrary matching under trial-and-error procedures were successful under procedures that trained one or more prerequisite skills. The successive discrimination between the sample stimuli was established by training the subjects to name the stimuli. The simultaneous discrimination between the comparison stimuli was established using either (a) standard simple discrimination training with reversals or (b) a procedure in which each of the two sample-comparison relations in the conditional discrimination was presented in blocks of trials, with the size of the blocks decreasing gradually until sample presentation was randomized. The amount of prerequisite training required varied across subjects and across successive conditional discriminations. After acquiring either two or three conditional discriminations with component training, both subjects learned new conditional discriminations under trial-and-error procedures. In general, each successive conditional discrimination was acquired more rapidly. Tests showed that conditional responding had become a generalized skill. Symmetry was shown for almost all trained relations. Symmetry trial samples were ultimately named the same as the stimuli to which they were related in training.     

Verbal self-reports about matching to sample: effects of the number of elements in a compound sample stimulus.

Adults' self-reports about their choices in a delayed matching-to-sample task were studied as a function of the number of elements (one, two, or three) in a compound sample stimulus. Signal-detection analyses were used to examine control of self-reports by the number of sample elements, by the speed and accuracy of choices reported about, and by several events contingent on self-reports. On each matching-to-sample trial, a sample element appeared as one of two comparison stimuli. Choice of the matching element, if made within 500 ms of the onset of the comparison stimuli, produced points worth money or chances in a drawing for money, depending on the subject. After each choice, subjects pressed either a "yes" or "no" button to answer a computer-generated query about whether the choice met the point contingency. The number of sample elements in the matching-to-sample task varied across trials, and events contingent on self-reports varied across experimental conditions. In Experiment 1, the conditions were defined by different combinations of feedback messages and point consequences contingent on self-reports, but self-reports were systematically influenced only by the sample-stimulus manipulation. Self-report errors increased with the number of sample elements. False alarms (inaccurate reports of success) were far more common than misses (inaccurate reports of failure), and false alarms were especially likely after choices that were correct but too slow to meet the point contingency. Sensitivity (A') of self-reports decreases as the number of sample elements increased. In addition, self-reports were more sensitive to choice accuracy than to choice speed. All subjects showed a pronounced bias (B'H) for reporting successful responses, although the bias was reduced as the number of sample elements increased and successful choices became less frequent. Experiment 2 demonstrated that the failure of point contingencies to influence self-reports in the first experiment was not due to a general ineffectiveness of the point consequences. Rates of inaccurate self-reports decreased when they resulted in point losses and increased when they resulted in point gains.     

Effects of self-generated rules on the development of schedule-controlled behavior.

College students responded under a multiple differential-reinforcement-of-low-rate 5-s fixed-ratio 8 schedule, with components alternating every 2 min. After 40 programmed minutes of acquisition and 12 min of maintenance, without notice, both schedules changed to extinction for 28 min. During acquisition, between alternations of the multiple schedule, some subjects were asked to develop rules describing the schedule contingencies. Other subjects were given these same rules between alternations, and a third group neither received nor were asked to develop rules. By the end of the acquisition phase, self-generated-rule subjects were more likely to show schedule-typical behavior than were subjects not asked to generate rules. The behavior of those given rules was similar to those asked to generate rules at the end of acquisition, but yoked-rule subjects acquired schedule-typical behavior at a quicker rate. By the end of extinction, during the period corresponding to the previous fixed-ratio interval, all no-rule subjects who had earned points during acquisition and maintenance were responding at a rate of less than 30 responses per minute. Only 3 of the 9 self-generated-rule subjects and 2 of the 5 yoked-rule subjects were similarly responding at this low rate. Results suggest that asking subjects to develop self-rules facilitates acquisition, but can retard extinction. Results also suggest that self-generated rules function similarly to external rules.     

Optimal temporal differentiation

In order to illuminate a light signaling a correct response, adult humans had to space their button presses according to a range of time requirements. In some conditions, the spacing needed only to exceed a minimum duration; in others, it had to fall between lower and upper bounds. Mean interresponse times always exceeded the lower limit, and decreased the more stringent were the upper bounds. Variability of interresponse times increased with larger lower bounds, but was unaffected by the size of the upper bound. Feedback about the direction of errors in conditions involving both upper and lower bounds did not affect the means, but it did reduce variability. Predictions were derived from optimality theory, based on the assumption that the critical factor was minimization of the time between correct responses. Without upper bounds, the theory overestimated the mean interresponse times by about 10%; with upper bounds, the theoretical predictions corresponded closely to the actual data. The results did not appear to reflect a scalar timing process. Optimality theory, in contrast to Weber's law, correctly predicted the variety of curves relating sensitivity to duration requirements.     

Effects of social context, reinforcer probability, and reinforcer magnitude on humans' choices to compete or not to compete.

In the first two experiments, subjects' choices to earn points (exchangeable for money) either by competing with a fictitious opponent or by not competing were studied. Buskist, Barry, Morgan, and Rossi's (1984) competitive fixed-interval schedule was modified to include a second response option, a noncompetitive fixed-interval schedule. After choosing to enter either option, the opportunity for reinforcers became available after the fixed-interval's duration had elapsed. Under the no-competition condition, points were always available after the interval had elapsed. Under the competition condition, points were available based on a predetermined probability of delivery. Experiments 1 and 2 examined how reinforcer probabilities and reinforcer magnitudes affected subjects' choices to compete. Several general conclusions can be made about the results: (a) Strong preferences to compete were observed at high and moderate reinforcer probabilities; (b) competing was observed even at very low reinforcer probabilities; (c) response rates were always higher in the competition component than in the no-competition component; and (d) response rates and choices to compete were insensitive to reinforcer-magnitude manipulations. In Experiment 3, the social context of this choice schedule was removed to determine whether the high levels of competing observed in the first two experiments were due to a response preference engendered by the social context provided by the experimenters through instructions. In contrast to the first two experiments, these subjects preferred the 60-s fixed-interval schedule (formerly the no-competition option), indicating that the instructions themselves were responsible for the preference to compete. This choice paradigm may be useful to future researchers interested in the effects of other independent variables (e.g., drugs, social context, instructions) on competitive behavior.     

Instructed versus shaped human verbal behavior: Interactions with nonverbal responding

Undergraduate students' presses on left and right buttons occasionally made available points exchangeable for money. Blue lights over the buttons were correlated with multiple random-ratio random-interval components; usually, the random-ratio schedule was assigned to the left button and the random-interval to the right. During interruptions on the multiple schedule, students filled out sentence-completion guess sheets (e.g., The way to earn points with the left button is to...). For different groups, guesses were shaped with differential points also worth money (e.g., successive approximations to “press fast” for the left button), or were instructed (e.g., Write “press slowly” for the left button), or were simply collected. Control of rate of pressing by guesses was examined in individual cases by reversing shaped or instructed guesses, by instructing pressing rates, and/or by reversing multiple-schedule contingencies. Shaped guesses produced guess-consistent pressing even when guessed rates opposed those characteristic of the contingencies (e.g., slow random-ratio and fast random-interval rates), whereas guesses and rates of pressing rarely corresponded after unsuccessful shaping of guesses or when guessing had no differential consequences. Instructed guesses and pressing were inconsistently related. In other words, when verbal responses were shaped (contingency-governed), they controlled nonverbal responding. When they were instructed (rule-governed), their control of nonverbal responding was inconsistent: the verbal behavior sometimes controlled, sometimes was controlled by, and sometimes was independent of the nonverbal behavior.