Regulatory and ethical principles in research involving children and individuals with developmental disabilities

Children and individuals with developmental disabilities (DD) compared to typical participants are disadvantaged not only by virtue of being vulnerable to risks inherent in research participation but also by the higher likelihood of exclusion from research altogether. Current regulatory and ethical guidelines although necessary for their protection do not sufficiently ensure fair distributive justice. Yet, in view of disproportionately higher burdens of co-occurring physical and mental disorders in individuals with DD, they are better positioned to benefit from research by equitable participation. Greater elucidation of this ethical dilemma is called for by researchers, institutional review boards, and funding agencies to urgently redress the imbalance. This article discusses many of the regulatory principles to ensure better research participation of children and individuals with DD: human rights, validity, distributive justice, beneficence/nonmaleficence, and autonomy.     

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.     

Reporting ethical practices in journal articles

Little attention has focused on the reporting of ethical research practices in journal articles. In Study 1, published articles in 2 psychopathology journals were reviewed to ascertain the types of ethical research information that were reported. In Study 2, a survey was sent to authors in Study 1 to determine which ethical practices they engaged in, if they reported this information, and reasons for not including this information in their article. In general, there is a great variability regarding the types of ethical research practices reported in journal articles. Commonly cited reasons for not including ethical research practice information in the articles included the need for brevity, belief that it was common practice, and lack of relevance for the project. These results suggest that there is no standard practice for reporting research practices in journal articles and great variability in the implementation of procedures that are generally considered standard.     

Deception by young children following noncompliance

A paradigm devised by M. Lewis, C. Stanger, and M. W. Sullivan (1989) was adapted to study deception and false-belief understanding. In Study 1, 3- and 5-year-olds were asked not to touch a toy in the experimenter's absence. Just over half of the children touched the toy, and of those children, the majority denied having done so. Of control children who were given permission to touch the toy, all touched it and admitted having done so. In Study 2, 3- and 5-year-olds were asked not to look in a box to identify its contents. Almost all children looked, most denied having looked, and a minority consistently feigned ignorance of the contents. False-belief understanding was linked to denial of looking but not to feigning ignorance. Of control children who were given permission to look, all acknowledged looking, and they almost always revealed their knowledge of the contents. The studies confirm that preschoolers deceive in the context of a minor misdemeanor but are less effective at feigning ignorance.     

Moral duties of parents and nontherapeutic clinical research procedures involving children

Shared views regarding the moral respect which is owed to children in family life are used as a guide in determining the moral permissibility of nontherapeutic clinical research procedures involving children. The comparison suggests that it is not appropriate to seek assent from the preadolescent child. The analogy with interventions used in family life is similarly employed to specify the permissible limit of risk to which children may be exposed in nontherapeutic research procedures. The analysis indicates that recent writers misconceive how certain moral principles, such as respect for personal autonomy, require us to act toward children. The results are also used to assess proposed federal regulations on research with children.     

Collaborative healthcare research: Some ethical considerations

This article reviews some of the ethical aspects of collaborative research. Scientific collaboration has known potential benefits but it’s a challenging task to successfully accomplish a collaborative venture on ethically sound grounds. Current trends in international healthcare research collaboration reflect limited benefits for the majority of world population. Research collaboration between scientists of academia and industry usually has financial considerations. Successful cross-cultural and international collaborations have to overcome many regional and global barriers. Despite these difficulties, many scientific collaborations usually begin with an informal meeting or contact. With advancement in global communications, scientists have greater responsibility towards the world community while considering the impact of their collaborative partnerships. I review the basic factors that are required for forging a collaborative partnership and responsible attitudes to sustain the relationship. Finally I conclude that scientists in healthcare research can play important roles beyond collaborations and contribute to bringing harmony, resolving differences across the nations and countries in today’s troubled world.     

Deception in research: distinctions and solutions from the perspective of utilitarianism

The use of deception in psychological research continues to be a controversial topic. Using Rawls's explication of utilitarianism, I attempt to demonstrate how professional organizations, such as the American Psychological Association, can provide more specific standards that determine the permissibility of deception in research. Specifically, I argue that researchers should examine the costs and benefits of creating and applying specific rules governing deception. To that end, I offer 3 recommendations. First, that researchers who use deception provide detailed accounts of the procedures they used to minimize the harm created by deception in their research reports. Second, that the American Psychological Association offer a definition of deception that describes techniques commonly used in research. Finally, I recommend that the informed consent procedure be revised to indicate that the researcher may use deception as part of the study.     

The role of educational psychologists in promoting ethical research conducted with children: an exploratory study

This study explored perceptions of educational psychologists on their role in promoting ethical research involving children. Participants were 10 South African educational psychologists (females = 60%; males = 40%) from mostly public services (90%). Data on their perceived roles in research ethics monitoring and implementation were collected through individual interviews and a brief questionnaire. The data were thematically analysed. Findings suggest that educational psychologists have a role in protecting children from harm during research participation while also monitoring benefits due to the children. A social justice perspective appears to explain the role of educational psychologists in research protection for children.     

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.     

Some ethical and legal issues in Germany involving informed consent and patenting

This paper elaborates on discussions in Germany regarding some of the ethical and legal issues in the area of the use and patenting of inventions involving human tissue. The issues discussed pertain to the benefits and problems regarding informed consent and the issue of property rights as they relate to the donation of cells and tissue. An earlier version of this paper was presented at an international conference, “The Ethics of Intellectual Property Rights and Patents,” held in Warsaw, Poland on 23–24 April, 2004.     

Delimiting the concept of research: an ethical perspective

It is important to be able to offer an account of which activities count as scientific research, given our current interest in promoting research as a means to benefit humankind and in ethically regulating it. We attempt to offer such an account, arguing that we need to consider both the procedural and functional dimensions of an activity before we can establish whether it is a genuine instance of scientific research. By placing research in a broader schema of activities, the similarities and differences between research activities and other activities become visible. It is also easier to show why some activities that do not count as research can sometimes be confused with research and why some other activities can be regarded only partially as research. Although the concept of research is important to delimit a class of activities which we might be morally obliged to promote, we observe that the class of activities which are regarded as subject to ethical regulation is not exhausted by research activities. We argue that, whether they be research or not, all the activities that are likely to affect the rights and interests of the individuals involved and impact on the rights and interests of other individuals raise ethical issues and might be in need of ethical regulation.