How to behave ethically in a world of fads

Although applied behavior analysis (ABA) has significant scientific support for treating people with autism spectrum disorders (ASDs), the field of autism treatment has been plagued with rapidly proliferating fad treatments subjecting people with ASD to various ineffective, pseudoscientific, and antiscientific treatments. To combat this, professionals must learn to make ethical treatment decisions, sometimes before research is conducted or published. Even when research is available negating fads, behavioral professionals must also overcome misperceptions about ABA. The purposes of this paper are to provide behavioral professionals with (a) a mechanism for making ethical treatment decisions (using sensory integration as an example) and (b) a method for responding to potential misperceptions and obstacles to using ABA. Copyright © 2010 John Wiley & Sons, Ltd.     

How Civil Society Organisations Changed the Regulation of Clinical Trials in India

ABSTRACT

In 2005 India changed its pharmaceutical and innovation policy that facilitated a dramatic increase in international clinical trials involving study sites in India. This policy shift was surrounded by controversies; civil society organisations (CSOs) criticised the Indian government for promoting the commercialisation of pharmaceutical research and development. Health social movements in India fought for social justice through collective action, and engaged in normative reasoning of the benefits, burdens and equality of research. They lobbied to protect trial participants from structural violence that occurred especially in the first 5–6 years of the new policy. CSOs played a major role in the introduction of new regulations in 2013, which accelerated a decline in the number of global trials carried out in India. This activism applied interpretations of global social justice as key ideas in mobilisation, eventually helping to institutionalise stricter ethical regulation on a national level. Like government and industry, activists believed in randomised controlled trials and comparison as key methods for scientific knowledge production. However, they had significant concerns about the global hierarchies of commercial pharmaceutical research, and their impact on the rights of participants and on benefits for India overall. Pointing to ethical malpractices and lobbying for stricter ethical regulations, they aimed to ensure justice for research participants, and developed effective strategies to increase controls over the business side of clinical research.     

Scientific rewards and conflicts of ethical choices in human subjects research.

The primary responsibility of the American Psychological Association's (APA) Committee on Standards in Research (CSR) is to advise the APA on issues and standards related to the protection of human participants in psychological research. A related goal is to enhance the use of good ethical practices by APA members. The purpose of this article is to foster the view of research ethics not as an affront to the integrity of sound research, but as opportunities for scientific rewards, including increased understanding of the meaning of data, enhanced recruitment, and the inclusion of more representative samples. Three ethical practices are discussed as examples of this general premise: respect for confidentiality, use of debriefing, and assurance that participants are noncoerced volunteers. The Committee's intent is to promote consideration of these issues, not to promulgate specific guidelines or procedures.     

Reporting and referring research participants: ethical challenges for investigators studying children and youth

Researchers studying at-risk and socially disenfranchised child and adolescent populations are facing ethical dilemmas not previously encountered in the laboratory or the clinic. One such set of ethical challenges involves whether to: (a) share with guardians research-derived information regarding participant risk, (b) provide participants with service referrals, or (c) report to local authorities problems uncovered during the course of investigation. The articles assembled for this special section address the complex issues of deciding if, when, and how to report or provide referrals for research participants who are minors (referred to hereafter as minor research participants). This paper focuses on two factors underlying these decisions: the validity of risk estimates and meta-ethical positions on scientific responsiblity. It is suggested that, before sharing information about minor research participants investigators should do the following: critically examine the diagnostic validity of developmental measures, include the scope and limitations of information sharing in informed consent procedures, and become familiar with state reporting laws. I discuss the impact of the traditionally accepted act utilitarian meta-ethical position on the investigator-participant relationship, and I recommend consideration of alternative positions as a step toward developing a research ethic of scientific responsibility and care.     

Discrete‐trial training performance of behavior interventionists with autism spectrum disorder: A systematic replication and extension

Further research is needed on strategies to improve employment outcomes for individuals with autism spectrum disorder (ASD). We replicated and extended prior research by examining the acquisition, maintenance, and generalization of discrete‐trial training (DTT) performance of adults with ASD who were interested in careers as behavior technicians. Three participants received training on how to implement DTT with children and we assessed the maintenance and generalization of DTT performance in the absence of feedback. Results indicated that procedural integrity generalized across children and targets and maintained for 6 to 17 session days without feedback. Results have implications for the successful employment of individuals with ASD as behavior technicians and for future research on strategies to enhance their performance on the job.     

Ethical and Legal Guidance for Mental Health Practitioners Who Wish to Conduct Research in a Private Practice Setting

Mental health practitioners, even when they have research training, rarely contribute to the scientific literature. One reason for this may be that they need help addressing the ethical and legal issues they encounter as they contemplate undertaking research in a clinical practice setting. To address that need, we offer several types of guidance for conducting research in a private practice setting in a way that meets high ethical and legal standards. We describe the situations in which ethical review of a research proposal by a federally registered institutional review board (IRB) is legally required, and identify alternate mechanisms that practitioners can use to obtain an ethical review when a formal IRB review is not required by law. We discuss legal and ethical requirements of conducting single-case studies in a practice setting. We provide a rationale, and free and inexpensive options, for obtaining a formal certificate of training in human subjects research. And we offer guidance for obtaining informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization from research participants. We conclude with a brief discussion of other legal and professional issues to consider when conducting research in private practice.     

The Ethical Standard of Care

The recent TeGenero phase I trial of a novel monoclonal antibody in healthy volunteers produced a drastic inflammatory reaction in participants receiving the experimental agent. Commentators on the ethics of the research have focused considerable attention on the role of financial considerations: the for-profit status of the biotechnology company and Contract Research Organization responsible respectively for sponsoring and conducting the trial and the amount of monetary compensation to participants. We argue that these financial considerations are largely irrelevant and distort ethical appraisal of this tragic research. Except for administering the antibody to all 6 participants nearly simultaneously, the trial appears to fulfill all of the critical ethical requirements for clinical research—social value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, and respect for enrolled participants.     

Training paraprofessionals to use behavioral strategies when educating learners with autism spectrum disorders across environments

Although the use of paraprofessionals in the education of young children with autism spectrum disorders (ASD) is a common practice, research on effective training procedures is scarce. The following study used a multiple‐baseline design across settings replicated by five paraprofessionals to evaluate their use of behavioral strategies with young children with, or at risk for, autism spectrum disorder. A training package consisting of a workshop and performance feedback by their supervising special education teacher served as the intervention. Results revealed that even though the paraprofessionals demonstrated skills in the use of behavioral strategies at the workshop, there was either no transfer or generalization to the preschool or home environments where they worked, or their use of skills decreased over time. When performance feedback was provided to all participants, their correct use of strategies increased. The training model evaluated in this study provides an example of one that could be employed in a typical public school classroom or early intervention program. Copyright © 2009 John Wiley & Sons, Ltd.     

Money and distorted ethical judgments about research: ethical assessment of the TeGenero TGN1412 trial

The recent TeGenero phase I trial of a novel monoclonal antibody in healthy volunteers produced a drastic inflammatory reaction in participants receiving the experimental agent. Commentators on the ethics of the research have focused considerable attention on the role of financial considerations: the for-profit status of the biotechnology company and Contract Research Organization responsible respectively for sponsoring and conducting the trial and the amount of monetary compensation to participants. We argue that these financial considerations are largely irrelevant and distort ethical appraisal of this tragic research. Except for administering the antibody to all 6 participants nearly simultaneously, the trial appears to fulfill all of the critical ethical requirements for clinical research--social value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, and respect for enrolled participants.     

The ethics of social science research

ABSTRACT Ethical thinking about social science research is dominated by a biomedical model whose salient features are the assumption that only potential harms to subjects of research are relevant in the ethical evaluation of that research, and in the emphasis on securing informed consent in order to establish ethical probity. A number of counter-examples are considered to the assumption, a number of defences against these counter-examples are examined, and an alternative model is proposed for the ethical evaluation of social science research: a model which can cope with the systemic harms (harms other than those to participants as participants) which have been identified. This model is based on John Rawls's idea of original position reasoning and treats social science research as an institutional feature of the basic structure of society.     

The Emergence of Clinical Research Ethics Consultation: Insights From a National Collaborative

The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards (IRBs), to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation (REC) services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to highlight four contexts in which REC can be a valuable resource. REC assists: 1) investigators before and after the regulatory review; 2) investigators, IRBs, and other research administrators facing challenging and novel ethical issues; 3) IRBs and investigators with the increasing challenges of informed consent and risk/benefit analysis; and 4) in providing flexible and collaborative assistance to overcome study hurdles, mediate conflicts within a team, or directly engage with research participants. Institutions that have established, or plan to establish, REC services should work to raise the visibility of their service and engage in open communication with existing clinical ethics consult services as well as the IRB. While the IRB system remains the foundation for the ethical review of research, REC can be a valuable service for investigators, regulators, and research participants aligned with the goal of supporting ethical research.     

Ethical Judgments of Counselors: Results From a Turkish Sample

The present study examined the ethical judgements of Turkish counselors (N = 767) using a translation of the Gibson and Pope (1993) ethical judgements survey. Items predominantly judged as ethical and unethical, and group differences regarding gender, taking ethics as a course, professional affiliation, and level of academic degree, were investigated. Chi-square analysis, Fishers’s exact test, and Fisher–Freeman–Halton tests were used in statistical analysis. Results revealed that participants predominantly judged breach of confidentiality in cases of child abuse and potential harm toward oneself or others as ethical. Items concerning sexual dual relationships were predominantly perceived as unethical, and male participants were more likely to judge items regarding sexual and nonsexual dual relationships as ethical. Implications for future research and practice are discussed.     

Behavior analysts' perceptions of the population specificity or comprehensiveness of autism treatments

The basic philosophy of radical behaviorism provides foundations for behavioral intervention applications in applied behavior analysis (ABA) across a variety of populations and human behaviors. However, as ABA increases in popularity for people with autism, many people perceive that ABA resembles other non‐research‐supported interventions which market themselves almost exclusively for autism. This study evaluated the extent to which behavior analysts perceived scientifically supported treatments (e.g., ABA) and non‐scientifically supported treatments as population‐specific or as comprehensively applicable across populations. Behavior analysts (N = 876) completed an online survey which indicated that approximately 3/4 of behavior analysts reported ABA as comprehensively effective for all people. Treatments without scientific support also were ranked more often or as effective as ABA for specific populations (i.e., intellectual and developmental disabilities, autism, severe behavior problems, adults, and children). Results indicated a continuing need to emphasize the education and requirements of radical behaviorism as the scientific foundations of ABA.     

Evaluating discrete trial teaching with instructive feedback delivered in a dyad arrangement via telehealth

Telehealth research in the field of applied behavior analysis (ABA) has focused on the training and supervision of others to implement various behavior analytic procedures. Current guidelines for practicing telehealth suggest that direct telehealth services may be appropriate for some individuals diagnosed with autism spectrum disorder, but more research is needed. This study evaluated the effects of discrete trial teaching with instructive feedback in a dyad arrangement delivered directly via telehealth to teach tact relations to 6 children diagnosed with autism spectrum disorder. All participants and the experimenter were located in different physical locations. All participants learned their primary and secondary targets, and 5 of the participants acquired the observational primary and secondary targets without direct teaching. Areas of future research and clinical implications are discussed in the context of telehealth service delivery.     

Ethical problems in research on risky behaviors and risky populations

The articles by Brooks-Gunn, Fisher, Hoagwood, Liss and Scott-Jones (all in this issue) present a panoply of real-world ethical issues in conducting scientific research on risky behaviors of children, adolescents, and their parents, particularly those from vulnerable populations. The universal, ethical principles of beneficence, justice, and respect for others are always applicable, but they do not resolve issues of child assent, parental consent, legal reporting requirements for illegal behaviors, and the special problems of studying risky behaviors in risky populations. Taken as a group, the articles raise some of the most interesting ethical problems that arise in developmental research. My discussion elaborates some issues and fails to resolve others. I hold the view that both science and ethics can be served by thoughtfully designed and implemented research on important social issues, but that the studies themselves cannot simultaneously solve the many societal problems of participants and be scientifically credible.     

Examination of efficacious,efficient, and socially valid error‐correction procedures to teach sight words and prepositions to children with autism spectrum disorder

Prior research shows that learners have idiosyncratic responses to error‐correction procedures during instruction. Thus, assessments that identify error‐correction strategies to include in instruction can aid practitioners in selecting individualized, efficacious, and efficient interventions. The current investigation conducted an assessment to compare 5 error‐correction procedures that have been evaluated in the extant literature and are common in instructional practice for children with autism spectrum disorder (ASD). Results showed that the assessment identified efficacious and efficient error‐correction procedures for all participants, and 1 procedure was efficient for 4 of the 5 participants. To examine the social validity of error‐correction procedures, participants selected among efficacious and efficient interventions in a concurrent‐chains assessment. We discuss the results in relation to prior research on error‐correction procedures and current instructional practices for learners with ASD.     

Animal ethical evaluation: an observational study of Canadian IACUCs

Three Canadian institutional animal care and use committees were observed over a 1-year period to investigate animal ethical evaluation. While each protocol was evaluated, the observer collected information about the final decision, the type of protocol (research vs. teaching), and the category of invasiveness. The observer also wrote down verbatim all verbal interventions, which were coded according to the following categories: scientific, technical, politics, human analog, reduction, refinement, and replacement. The data revealed that only 16% of the comments were devoted to the 3 explicit ethical categories (i.e., reduction, refinement, and replacement) and that most of the comments were technical. However, the analysis revealed that ethical concerns were implicit in both scientific and technical language, or some of the scientific and technical comments had an impact on the ethical treatment of animals. The results are discussed in relation to previous nonobservational research that identified potential pitfalls and bias in animal ethical evaluation.     

Improving Iranian Graduate Students’ Performance in Reading Scientific Articles in English Through Explicit Strategy Instruction

The purpose of this mixed-method investigation was to examine the effect of explicit instruction of cognitive strategies on the reading performance of Iranian graduate students and identify the cognitive strategies the participants used while reading a scientific article in English (L2). Prior to the study, the students completed a questionnaire and took part in a semi-structured interview providing information on the reading strategies they used while reading English texts. In order to also identify the participants’ improvement in reading English texts, they completed the reading section of the IELTS test prior to and following the treatment. During a 16-week course, students became familiar with cognitive strategies through explicit instruction. At the end of the course, the students were required to read a scientific article in English and think-aloud in order to identify the reading strategies they employed while reading. The quantitative results (paired-sample T-test) revealed that the participants’ reading comprehension significantly improved after explicit instruction of cognitive strategies. The qualitative data (think-aloud protocols) indicated that the participants used more cognitive strategies while reading scientific articles in English after receiving explicit instruction. Pedagogical implications are provided for further research.