Ethical aspects of research into the etiology of autism

Advances in understanding autism and other developmental neuropsychiatric disorders will come from an integration of various research strategies including phenomenologic, functional neuroimaging, and pharmacologic methods, as well as epidemiologic approaches aimed at identifying genetic and environmental risk factors. The highly heritable nature of autism makes it scientifically valuable to involve parents and siblings as research participants. However, many studies on autism pose ethical challenges because they do not offer the prospect of direct benefit to subjects. In this article, we present an in-depth ethical analysis of current nontherapeutic research strategies that are common in autism research. The ethical analysis applies a proposed ethical framework for evaluating clinical research focusing on seven ethical requirements: (1) social or scientific value, (2) scientific validity, (3) fair subject selection, (4) favorable risk-benefit ratio, (5) independent review, (6) informed consent, and (7) respect for potential and enrolled research participants.     

Toward Honest Ethical Pluralism

I give the label “ethical pluralism” to the meta-ethical view that competing moral views are valid. I assume that validity is conferred on a moral view by its satisfying the relevant meta-ethical criteria in a maximally satisfactory way. If the relevant meta-ethical criteria are based on something roughly like the wide reflective equilibrium model, then ethical pluralism is likely to be correct. Traditional moral views do not grant exemptions from their own binding rules or principles to agents – should any exist – who adhere to a competing valid moral view. Given the usual conception of accepting a moral view, an ethical pluralist cannot honestly accept a traditional moral view. Consequently, I argue, an ethical pluralist is committed to the view that all traditional moral views are invalid. Given the likelihood of ethical pluralism, this conclusion is alarming. I set forth a weak conception of accepting a moral view that is designed to allow an ethical pluralist honestly to accept a traditional moral view. In particular, my conception is designed to explain how someone can (a) be guided by the view that she accepts; (b) accept her own moral view while rationally not accepting competing views that she thinks are equally valid; and (c) not be prepared to prescribe morally to those who are following other valid views. Central to my formulation are what I call a stance of modest respectful disapproval toward other people’s wrong behavior, together with acceptance of decisive moral reasons for oneself that are generated by the valid moral view that one accepts.     

Intervention Research with Youths at Elevated Risk for Suicide: Meeting the Ethical and Regulatory Challenges of Informed Consent and Assent

Intervention research with youths at elevated risk for suicidal behavior and suicide—a vulnerable and high risk population—presents investigators with numerous ethical challenges. This report specifically addresses those challenges involving the informed consent and assent process with parents/guardians and youths. The challenges are delineated in the context of pertinent laws and regulatory requirements, and guidelines are suggested for their practical resolution. These are illustrated with case examples from NIMH‐funded intervention trials. Through the sharing of such methodological information, intervention researchers can support each other in conducting ethical research in a manner that does not unduly compromise scientific rigor.     

The Ethical Foundations of Behavior Therapy

In this article, I am concerned with the ethical foundations of behavior therapy, that is, with the normative ethics and the meta-ethics underlying behavior therapy. In particular, I am concerned with questions concerning the very possibility of providing an ethical justification for things done in the context of therapy. Because behavior therapists must be able to provide an ethical justification for various actions (if the need arises), certain meta-ethical views widely accepted by behavior therapists must be abandoned: in particular, one must give up ethical subjectivism, ethical skepticism, and ethical relativism. An additional task is to show how it is possible to provide a nonsubjective, nonskeptical, and nonrelativistic moral justification for an ethical statement. Although this is a monumental task, I provide a rough sketch of such a model, one that is congenial to the value judgments underlying behavior therapy.     

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 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.     

The ethical foundations of behavior therapy

In this article, I am concerned with the ethical foundations of behavior therapy, that is, with the normative ethics and the meta-ethics underlying behavior therapy. In particular, I am concerned with questions concerning the very possibilty of providing an ethical justification for things done in the context of therapy. Because behavior therapists must be able to provide an ethical justification for various actions (if the need arises), certain meta-ethical views widely accepted by behavior therapists must be abandoned; in particular, one must give up ethical subjectivism, ethical skepticism, and ethical relativism. An additional task is to show how it is possible to provide a nonsubjective, nonskeptical, and nonrelativistic moral justification for an ethical statement. Although this is a monumental task, I provide a rough sketch of such a model, one that is congenial to the value judgments underlying behavior therapy.     

Deception research involving children: ethical practices and paradoxes

This commentary draws on the thoughtful contemplation and innovative procedures described in the special section articles as well as current professional codes and federal regulations to highlight ethical practices and paradoxes of deception research involving children. The discussion is organized around 4 key decision points for the conduct of responsible deception research involving children: (a) evaluating the scientific validity and social value of deception research within the context of alternative methodologies, (b) avoiding and minimizing experimental risk, (c) the use of child assent procedures as questionable ethical safeguards, and (d) debriefing as both remedy and risk.     

The meta-ethical significance of experiments about folk moral objectivism

The meta-ethical commitments of folk respondents – specifically their commitment to the objectivity of moral claims – have recently become subject to empirical scrutiny. Experimental findings suggest that people are meta-ethical pluralists: There is both inter- and intrapersonal variation with regard to people’s objectivist commitments. What meta-ethical implications, if any, do these findings have? I point out that current research does not directly address traditional meta-ethical questions: The methods used and distinctions drawn by experimenters do not perfectly match those of meta-ethicists. However, I go on to argue that, in spite of this mismatch, the research findings should be of interest to moral philosophers, including meta-ethicists. Not only do these findings extend the field of moral psychology with new data and hypotheses, but they also provide tentative evidence that touches on the adequacy of theses in moral semantics and moral metaphysics. Specifically, they put pressure on arguments in support of moral realism.     

Photography and Social Media Use in Community‐Based Participatory Research with Youth: Ethical Considerations

Community‐based participatory researchers increasingly incorporate photography and social media into their work. Despite its relative infancy, social media has created a powerful network that allows individuals to convey messages quickly to a widespread audience. In addition to its potential benefits, the use of social media in research also carries risk, given the fast pace of exchanges, sharing of personal images and ideas in high accessibility, low privacy contexts and continually shifting options and upgrades. This article contributes to the literature examining ethical considerations for photography and social media use in community‐based participatory research. We describe three key ethical dilemmas that we encountered during our participatory photography project with Latina/o youth: (a) use and content of images and risk; (b) incentives and coercion; and (c) social media activity and confidentiality. We provide our responses to these challenges, contextualized in theory and practice, and share lessons learned. We raise the question of how to contend with cultural shifts in boundaries and privacy. We propose that evaluating participant vulnerability versus potential empowerment may be more fitting than the standard approach of assessing risks and benefits. Finally, we recommend upholding the principles of participatory research by co‐producing ethical practices with one's participants.     

Intellectual Freedom and Editorial Responsibilities Within the Context of Controversial Research

Researchers studying depression often encounter research participants in serious preexisting distress. Examining investigators' ethical responsibilities to these subjects, Stanton and New (1988) found that depression researchers reported actions that ranged from doing nothing to contacting both the distressed subject and a significant other. By experimentally manipulating consent form information regarding potential treatment referral, we examined whether subjects (n = 357) adjusted their responses on depression measures as a function of the level of follow-up they expected to receive. Results reveal that subjects who potentially could receive the most intrusive intervention (i.e., experimenter contact with the subject and a significant other) were less likely to report depressive symptoms than were subjects who anticipated less intrusive follow-up. Willingness to report depressive symptoms in particular conditions varied in part as a function of subject sex. Thus, ethical safeguards used in studies with subjects in preexisting distress may have consequences for the validity of self-report depression measures.     

Effects of researcher follow-up of distressed subjects: tradeoff between validity and ethical responsibility

Researchers studying depression often encounter research participants in serious preexisting distress. Examining investigators' ethical responsibilities to these subjects, Stanton and New (1988) found that depression researchers reported actions that ranged from doing nothing to contacting both the distressed subject and a significant other. By experimentally manipulating consent form information regarding potential treatment referral, we examined whether subjects (n=357) adjusted their responses on depression measures as a function of the level of follow-up they expected to receive. Results reveal that subjects who potentially could receive the most intrusive intervention (i.e., experimenter contact with the subject and a significant other) were less likely to report depressive symptoms than were subjects who anticipated less intrusive follow-up. Willingness to report depressive symptoms in particular conditions varied in part as a function of subject sex. Thus, ethical safeguards used in studies with subjects in preexisting distress may have consequences for the validity of self-report depression measures.     

The Predictive Validity of Injury Proxies: Predicting Early Adolescent Injuries with Assessments of Minor Injuries

This study offers an initial step in establishing the predictive validity of injury proxies. Proxies are utilized frequently by injury researchers to overcome various methodological and ethical issues inherent in injury research, although psychometric data on proxies are limited. Using data from the NICHD Study of Early Child Care and Youth Development we found that minor injuries predicted adolescent injuries longitudinally, even in the context of well-established predictors of injury risk. This study is the first to demonstrate the predictive validity of minor injuries, a common proxy of pediatric injury risk. Findings are discussed with respect to implications for conceptual understanding of injury risk, future research, and prevention efforts.     

Ethical practices and beliefs of psychopathology researchers

Ethical guidelines are vague concerning how situations should be handled when researchers encounter participants in preexisting psychological distress. Ethical issues of beneficence, autonomy, and the nature of informed consent may arise in these situations. This study investigated the ethical practices and beliefs of 84 psychopathology researchers when confronting research participants in distress. Results indicated that psychopathology researchers in general engaged in diverse ethical practices in providing debriefing, treatment referrals, and providing for distressed participants. Characteristics of the designated studies and of the researchers accounted for significant differences in ethical practices. In addition, the type of psychopathology being assessed accounted for significant differences in ethical practices and beliefs. Guidelines are offered to aid researchers who encounter participants in preexisting distress.     

Ethical Practices and Beliefs of Psychopathology Researchers

Ethical guidelines are vague concerning how situations should be handled when researchers encounter participants in preexisting psychological distress. Ethical issues of beneficence, autonomy, and the nature of informed consent may arise in these situations. This study investigated the ethical practices and beliefs of 84 psychopathology researchers when confronting research participants in distress. Results indicated that psychopathology researchers in general engaged in diverse ethical practices in providing debriefing, treatment referrals, and providing for distressed participants. Characteristics of the designated studies and of the researchers accounted for significant differences in ethical practices. In addition, the type of psychopathology being assessed accounted for significant differences in ethical practices and beliefs. Guidelines are offered to aid researchers who encounter participants in preexisting distress.     

Being undone by research: an ethical obligation to togethering

I interviewed 24 women who participated in self-defense and handgun training classes who revealed lives that had been intentionally hidden, sharing the unspeakable experiences of incest, rape, child abuse, and domestic violence through stories of survival and resistance. In a poem to my participants, I reflect on my role as researcher and my desire to fulfill a commitment to my participants.

Hearing women’s stories of sexual and other violent assault, I not only experienced secondary trauma, but I have been charged with a mission of developing research products that will change policy. I wrote this poem as a way to communicate the complicated ethical issues that arise when conducting research with participants who reveal traumatic stories.     

Child abuse: is there a mandate for researchers to report?

During the past 20 years, states have increasingly expanded the lists of individuals who are obligated to report their suspicions of child abuse and neglect. These legal requirements are juxtaposed with ethical considerations in research and professional practice. The ethical issues include the obligation to maintain both confidentiality of information provided by human participants and the safety and protection of these participants. This article reviews the types of state child abuse reporting statutes and outlines the categories of mandated reporters. I develop a model of how individual researchers should approach deciding whether they are mandated reporters of child abuse and neglect.     

Ethical Issues in HIV/STD Prevention Research With High Risk Youth: Providing Help,Preserving Validity

Many preventive intervention studies with adolescents address high-risk behaviors such as drug and alcohol use, and unprotected sex. Randomized controlled trials (RCT) are the gold standard methodology used to test the effectiveness of these behavioral interventions. Interventions outside the rigidly described protocol are prohibited. However, there are ethical challenges to implementing inflexible intervention protocols, especially when the target population is young, experiences many stressful events, and lives in a resource-poor environment. Teens who are at high risk for substance use or sexual risk behaviors tend to be at risk for other problems such as exposure to violence, sexual and physical abuse, depression, and homelessness. How should investigators deal with the psychological and social needs of teenagers in prevention programs in an ethically appropriate way and at the same time preserve the validity of RCT results? We have identified program characteristics, participant characteristics, interaction with parents, and problems with adolescents not in the study as sources of ethical dilemmas in RCT with at-risk adolescents. As a result of our experience, we recommend that every behavioral intervention study develop an ethics protocol, which should include rules for providing help to participants, has contact information for experts to provide guidance, and an emergency procedure for dealing with life threatening situations. In addition, studies should have a resource manual, train research staff in these ethical issues, and work with a data safety and monitoring board or ethics committee.