Are explanatory trials ethical? Shifting the burden of justification in clinical trial design

Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under “ideal” conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under “usual” conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is frustrating for everyone involved, and explains some of the challenges inherent in attempts to enhance knowledge translation and encourage evidence-based practice. The situation is more than simply frustrating, however; it is potentially unethical. Clinical trials must be socially valuable in order to (1) warrant the risks they impose on human research subjects and (2) fairly and efficiently assess new clinical interventions. Most bioethicists would agree that trials that have no social value, for instance, because their results do not have the potential to advance clinical care, should not be performed. What is less widely appreciated is that given limited research resources, trials that are more socially valuable should be preferred to trials that are less socially valuable when all else is equal. With respect to clinical trial design, I argue that while explanatory trials often have some social value, many have less social value than their pragmatic counterparts. On the basis of this general ethical assessment, I provide a preliminary defense of the position that clinical researchers should aim to conduct pragmatic trials, that is, that researchers face a burden of justification related to any idealizing elements added to trial designs.     

The Replication Crisis and Qualitative Research in the Psychology of Religion

ABSTRACT

This article forms a contribution to the discussion on the “replication crisis” in psychology from the qualitative research perspective and qualitative-oriented psychology of religion. The main theme of our article is, how should we deal, as qualitative-oriented psychologists of religion, with the issue of replicability? The introductory part of the article concentrates on validity criteria within qualitative-oriented research, and why qualitative-oriented psychologists of religion should take them into consideration in their research projects. Next, a typology of approaches (Intuitive, Field, Pragmatic, Synthetic), toward replication within qualitative studies is presented. Alongside discussing the possible ways of making qualitative research more replicable, examples of good practices in that matter are discussed. Some takeaway tips for qualitative-oriented psychologists of religion, that are to be used in order to make their research more replicable, are presented in the concluding part. Promoting CAQDAS, developing clear research protocols and procedures, describing the cultural context of the research in detail and discussing methodological issues and barriers/limitations of the study in a separate section are one of the main ideas postulated in the article, that should be included in the future qualitative studies on religion (s). The article concludes with a plea of sorts, that qualitative-oriented researchers do need to pay more attention to methodological issues while designing a research project, keeping in mind that it can (and should) be replicated in the future.     

Psychosocial treatment research with ethnic minority populations: ethical considerations in conducting clinical trials

Because of historical mistreatment of ethnic minorities by research and medical institutions, it is particularly important for researchers to be mindful of ethical issues that arise when conducting research with ethnic minority populations. In this article, we focus on the ethical issues related to the inclusion of ethnic minorities in clinical trials of psychosocial treatments. We highlight 2 factors, skepticism and mistrust by ethnic minorities about research and current inequities in the mental health care system, that researchers should consider when developing psychosocial interventions studies that include ethnic minorities.     

Ethical Considerations for Volunteer Recruitment of Visual Prosthesis Trials

With the development of visual prostheses research from the engineering phase to clinical trials, volunteer recruitment for the early visual prosthesis trials needs to be carefully considered. In this article, we mainly discuss several issues related to volunteer recruitment that had posed serious challenges to the visual prosthesis trials, such as low rates of participants, high expectations and underlying motivations to participate in the visual prosthesis trials as well as the importance of informed consent. When recruiting volunteers for visual prosthesis implants, it is critical that the visual prosthesis researchers should not only take into account the patient’s expectations and motivations, but also make the patients fully aware of the possible benefits and risks involved with their participation, and help patients establish realistic expectations for the early phase of visual prosthesis implantation. Based on these considerations to the challenges, eligible volunteers may be recruited in the preliminary stages of visual prosthesis trials.     

真实记忆与虚假记忆中的生命性效应研究

本研究采用DRM范式,探讨了生命性对真实和虚假记忆的影响。实验1使用类别呈现词语强化类别加工,实验2伪随机呈现词语弱化类别加工并进行即时及延时探测。结果发现：（1）当强化类别加工时,生命性和类别对击中率有相类似的促进效应;（2）当弱化类别加工并进行即时探测时,生命性对击中率的促进作用最强;（3）类别效应促进真实记忆和虚假记忆,但生命性效应仅促进了真实记忆,而不影响虚假记忆的产生;（4）在即时与延时探测中均发现类别效应和生命性效应。本研究证明了：（1）生命性效应的作用机制不同于类别效应;（2）生命性效应对真实和虚假记忆的作用机制不同;（3）类别效应和生命性效应的存在时效长达24小时,但是生命性效应的衰退速度较快。     

Learning a list for free recall: Selective reminding versus the standard procedure

Almost all free-recall experiments involve an acquisition phase in which the set of to-be-learned items is presented repeatedly in its entirety. Two experiments are described that pit this standard procedure against theselective reminding procedure (Buschke, 1973), wherein only items incorrect on trial n are presented again on trial n+ 1. The two methods were virtually identical in terms of (1) trials to reach an acquisition criterion of one errorless recall, (2) number of items correct on each recall trial during acquisition, (3) number of items correct on a 3-week delayed-recall test, (4) number of items correctly relearned after the 3-week retention interval, (5) extent of subjective organization on all retention tests, and (6) pattern of errors over all test trials. These results generalized to both single-category and random lists of 20 words, and were thoroughly consistent across the two experiments. However, the standard procedure required that many more items be presented over trials, and more subjects failed to learn the list within 1 h using the standard procedure. Because the selective reminding procedure is more efficient and has no apparent drawbacks, it is recommended that memory researchers switch to selective reminding as the preferred way to teach a subject a free-recall list.     

Advancing Developmental Science via Unmoderated Remote Research with Children

ABSTRACT

This article introduces an accessible approach to implementing unmoderated remote research in developmental science – research in which children and families participate in studies remotely and independently, without directly interacting with researchers. Unmoderated remote research has the potential to strengthen developmental science by: (1) facilitating the implementation of studies that are easily replicable, (2) allowing for new approaches to longitudinal studies and studies of parent-child interaction, and (3) including families from more diverse backgrounds and children growing up in more diverse environments in research. We describe an approach we have used to design and implement unmoderated remote research that is accessible to researchers with limited programming expertise, and we describe the resources we have made available on a new website (discoveriesonline.org) to help researchers get started with implementing this approach. We discuss the potential of this method for developmental science and highlight some challenges still to be overcome to harness the power of unmoderated remote research for advancing the field.     

扎根理论的运用：误区与策略

扎根理论在多学科研究中呈上升趋势,但运用误区和难点制约着研究质量。基于扎根理论的核心原则剖析常见的运用误区：忽视理论生成、将系统方法论窄化为编码程序、将理论抽样混同为目的性抽样或初始抽样;将理论等同于数据;重机械编码轻备忘录写作和持续比较。总结理论抽样、理论、适宜编码、备忘录撰写和持续比较的具体策略。最后提出扎根理论运用研究应秉承扎根、融合创新,注重系统性、规范性和灵活性。     

我国民族心理学研究的困境及出路

文章对我国民族心理学研究面临的困境进行了阐述,指出要成功走出目前的困境,在今后的研究中应融合多元方法,加强民族心理学研究中质与量的整合;加强民族心理学的理论建设;促进相邻学科的对话与合作,注重对综合性民族心理研究人才的培养;同时还要立足于我国民族的实际情况,加强对现实问题的研究,增强民族心理学研究的价值。     

Confining Choices: Should Inmates' Participation in Research be Limited?

Historically, prisoners in the United Stateshave served as an inexpensive and readilyavailable source of human subjects forresearch. Coinciding with the civil rightsmovement, however, was an emerging conceptionof prisoners' rights that led to the NationalCommission for the Protection of Human Subjectsof Biomedical and Behavioral Research beingcharged with investigating the use of prisonersas research subjects. The recommendations thatevolved and the subsequent guidelines that havebeen implemented by the Department of Healthand Human Services significantly curtail theuse of prisoners as research subjects. Whilethese measures are designed to protect inmatesfrom the abuses of the past, of particularconcern to many health care officials isexclusion of inmates from experimental HIV/AIDSand hepatitis treatments. This paper addresseswhether the vulnerability of prisoners in theUnited States due to their incarceration issufficient to prohibit them from participationin clinical trials that offer the possibilityof life-saving treatment. It first outlinesthe evolution in moral thinking that has led tolaws broadly prohibiting prisoners frombiomedical research studies and then analyzescases in the law to develop ethical argumentsin support of the view that prisoners should beallowed to participate in clinical trials. Theconclusion is that prisoners should be allowedto participate in such trials.     

Toward a New Generation of Cross-Cultural Research

ABSTRACT— In this article, we describe how cross-cultural research methodologies have evolved, with each phase of research addressing limitations of a previous one. We describe briefly the three previous phases and argue for embarking on a fourth phase that empirically establishes linkages between the active cultural ingredients hypothesized to cause between-country differences and the observed differences themselves. We discuss theoretical considerations and possible empirical methods to establish such linkages, and urge researchers to seriously consider incorporating these kinds of linkage studies in their programs of research.     

The Development of New Tests of Source Memory and a New Approach to the Testing of Equivalence of Parallel Versions

The principal aim of this study was to develop tests of source memory in both the verbal and visuo-spatial domains, which would be brief and easy to use in clinical and population settings. Source memory, that is, memory for context or attributes, is very vulnerable to the effects of ageing and to the early stages of dementia. Because longitudinal studies of cognitive function, including clinical trials, involve repeat testing, practice effects may hamper interpretation when identical tests are administered on each occasion. Accordingly, we developed parallel versions of each of the source memory tests. Rather than assuming equivalence by design, we tested the parallel versions to determine whether they were in fact equivalent in difficulty. We also explored the use of different analytic approaches to establishing equivalence. We report the results of a study in which we compared within- and between-subject performance on three parallel versions of visuo-spatial and verbal source memory tests, as well as three parallel versions of standard tests of episodic memory (word list recall) and executive function (letter fluency, category fluency, ideational fluency) in a sample of healthy elderly volunteers. Participants were tested on three occasions separated by 1 week, and test versions were counterbalanced across test sessions. We also examined performance in a group of participants tested on one occasion only, with test versions being allocated at random. We found that for a number of tests, versions which were designed to be parallel, failed to produce equivalent performance in our sample. We show how the results of this study may be of general use to researchers wishing to select particular versions of the tests in our battery. We also urge researchers to be cautious when using parallel versions of other tests. The careful matching or random allocation of items to parallel versions of a test is no guarantee that performance on the different versions will be equivalent.     

Challenging research on human subjects: justice and uncompensated harms

Ethical challenges to certain aspects of research on human subjects are not uncommon; examples include challenges to first-in-human trials (Chapman in J Clin Res Bioethics 2(4):1–8, 2011), certain placebo controlled trials (Anderson in J Med Philos 31:65–81, 2006; Anderson and Kimmelman in Kennedy Inst Ethics J 20(1):75–98, 2010) and “sham” surgery (Macklin in N Engl J Med 341:992–996, 1999). To date, however, there are few challenges to research when the subjects are competent and the research is more than minimal risk with no promise of direct benefit. The principal reason given for allowing research that is more than minimal risk without benefit is that we should respect the autonomy of competent subjects. I argue that though the moral intuitions informing respect for autonomy are sound, there is another set of intuitions regarding what we take to be just treatment of another when one agent knowingly causes or allows suffering on another agent. I argue that concerns generated by commutative justice serve as limitations on permissible research. I highlight our intuitions informing this notion of justice by appealing to work done on theodicy; what counts as a morally sufficient reason for God to allow suffering in humans is applicable also to the researcher-subject relationship. I conclude that all human subjects who are exposed to more than minimal risk research should enjoy the same actual protections (e.g., subpart D) as those given subjects who cannot consent.     

Cross-cultural social science research and questions of scientific medical imperialism

Concern for the rights and safety of individuals has caused clinical researchers to develop informed consent protocols for research involving human subjects. The applicapability of these regulations to social science research is often tenuous, since such research usually focuses on populations rather than individuals, and potential damage is apt to be political rather than personal. In cross-cultural social research, the protocols developed by Western clinical researchers may be not only ludicrously inapplicable, but intrusive and disruptive within the cultural context, raising questions of the intellectual imperialism of Western research ethics.     

A better stopping rule for conventional statistical tests

The goal of some research studies is to demonstrate the existence of an effect. Statistical testing, withp less than .05, is one criterion for establishing the existence of this effect. In this situation, the fixedsample stopping rule, in which the number of subjects is determined in advance, is impractical and inefficient. This article presents a sequential stopping rule that is practical and about 30% more efficient: Once a minimum number of subjects is tested, stop withp less than .01 or greater than .36; otherwise, keep testing. This procedure keeps alpha at .05 and can be adjusted to fit researchers’ needs and inclinations.     

Questionable research practices among Brazilian psychological researchers: Results from a replication study and an international comparison

Research on scientific integrity is growing in psychology, and questionable research practices (QRPs) have received more attention due to its harmful effect on science. By replicating the procedures of previous research, the present study aimed at describing the use of QRPs among Brazilian psychological researchers and to make an international comparison with previous studies in other countries—the US and Italy. Two hundred and thirty-two Brazilian researchers in the field of psychology answered questions related to 10 different QRPs. Brazilian researchers indicated a lower tendency to engage in two QRPs (failing to report all of a study's dependent measures; deciding whether to collect more data after looking to see whether the results were significant) when compared to their Italian and North American counterparts, but indicated a higher tendency to engage in two other QRPs (selectively reporting studies that “worked”; not reporting all of a study's conditions). Most of the sample did not admit integrity conflicts in their own research but indicated that others have integrity problems, as observed in previous studies. Those discrepancies could be attributed to contextual and systemic factors regarding different publication demands among the different nations. Further studies should focus on identifying the antecedents of QRPs.     

Implicit Learning in a Simple Cued Reaction-Time Task

Implicit learning tasks usually involve the learning of complex rules. While this does reduce the likelihood of subjects becoming aware of the relationship to be learned, it also raises the possibility of explaining improved performance in terms of explicit processes. The current experiments are an attempt to develop a task which shows evidence of implicit learning, but which involves the learning of a very simple rule and so avoids these alternative explanations. In two experiments, we exposed subjects to learning trials in which a target letter (or shape) was immediately preceded by a cue letter (or shape) in otherwise random nine-letter (or 15-shape) sequences. In a test phase, subjects responded more quickly to cued than uncued targets if the learning phase had involved reliable cue–target pairings, but not following random control pairings. This was true of subjects who were classified as aware and those classified as unaware of the cue–target relationship.     

End of Life Pediatric Research: What About the Ethics?

Clinical trials are required in order to develop new treatments and improve both patient life expectancy and quality of life. In this respect the last 10 years proved their efficiency. However clinical research shows one of the most difficult dilemmas from an ethical point of view. Patients included in clinical trials are submitted to known and unknown risks and hazards, but rarely benefit from the results. This is even more evident when clinical trials use children who are terminally ill. The core consideration becomes how far should we go with research when considering the child best interest.     

Inventing the wheel once more or learning from the history of psychotherapy research methodology: Reply to Gaudiano's comments on review

Gaudiano's criticism of one part of my review of ACT outcome research (Öst, 2008) is refuted on all issues but one. It is clear that the average amount of grant support for the ACT-studies was smaller than that of CBT-studies, even if the proportion of studies having grant support was not lower. However, that fact should only influence 25% (2 out of 8) of the methodology variables on which ACT-studies had lower mean scores than CBT-studies. It is not acceptable that a relatively new treatment, such as ACT, should be evaluated by more lenient criteria than already established therapies like CBT. If proponents of a new treatment wish to claim that their therapy is empirically supported then they have to accept to be evaluated by the APA Task Force criteria. It is time that ACT researchers start using the current psychotherapy research methodology.