Ethics in behavioral genetics research

As research in behavioral genetics uncovers the genetic contribution to human behavior, it will undoubtedly further our understanding of normal human variation in many behavioral traits, such as personality, intelligence, and sexuality. This research also shows great potential for the diagnosis, treatment, and prevention of mental illnesses. Recent findings underscore this potential and document the increasing validity of research methods--methods that in the past have led to mistaken inferences about genes "for" violent behavior and homosexuality. Although all research with human subjects requires adequate attention to its ethical aspects, certain ethical issues involved with behavioral genetics are particularly acute and deserve careful attention. This article reviews these selected major ethical issues arising in (1) the conduct of behavioral genetics research; and (2) the application of its research findings. While some of the ethical concerns in the latter category are likely to be of substantial importance and animate considerable popular concern, they currently fall outside the realm of traditional research review. Determining how to deal with these concerns should be a focus of future scholarly work.     

Ethics and research assessing the relative roles of genes and the environment

Research on the interaction of genes and the environment is revealing that many human diseases have both genetic and environmental components. Even traditional "environmental" diseases, such as infections, appear to interact with genetic components in the human host. Environmental genetics research will inevitably increase understanding of individual susceptibilities to toxic exposures in the environment and harmful side effects of medications; therefore, it has great promise for improving the prevention and treatment of human diseases. However, realizing the benefits of this research requires careful attention to ethical issues that are particularly relevant in this context. This article reviews some of the most pressing issues related to research design and methods, as well as from the application of research results (e.g., workplace genetic screening and legal toxic torts, personal medical responsibility, and the relationship between genetics and public health measures).     

Ethics and Research Assessing the Relative Roles of Genes and the Environment*

Research on the interaction of genes and the environment is revealing that many human diseases have both genetic and environmental components. Even traditional “environmental” diseases, such as infections, appear to interact with genetic components in the human host. Environmental genetics research will inevitably increase understanding of individual susceptibilities to toxic exposures in the environment and harmful side effects of medications; therefore, it has great promise for improving the prevention and treatment of human diseases. However, realizing the benefits of this research requires careful attention to ethical issues that are particularly relevant in this context. This article reviews some of the most pressing issues related to research design and methods, as well as from the application of research results (e.g., workplace genetic screening and legal toxic torts, personal medical responsibility, and the relationship between genetics and public health measures).     

What a tangled web we weave: ethical and legal implications of deception in recruitment

Deception in human subject research is neither uncommon nor prohibited. The use of deception in the recruitment phase of clinical research has received relatively little attention. Given that informed consent is foundational to human subject research, the practice of misrepresenting the study purpose in clinical research would seem to contradict one of the fundamental tenets of ethical human subjects research. Using the example of prodromal psychosis, this article the ethical and legal implications of deception in recruitment and the sufficiency of current guidance on the practice when the study involves a stigmatizing condition, the collection of genetic samples, or both. I conclude that when these two elements are present, deception should only be used when absolutely necessary and, if used, researchers should be required to debrief participants before the collection of genetic samples and give particular attention to minimizing risks of privacy breaches.     

What a Tangled Web We Weave: Ethical and Legal Implications of Deception in Recruitment

Deception in human subject research is neither uncommon nor prohibited. The use of deception in the recruitment phase of clinical research has received relatively little attention. Given that informed consent is foundational to human subject research, the practice of misrepresenting the study purpose in clinical research would seem to contradict one of the fundamental tenets of ethical human subjects research. Using the example of prodromal psychosis, this article the ethical and legal implications of deception in recruitment and the sufficiency of current guidance on the practice when the study involves a stigmatizing condition, the collection of genetic samples, or both. I conclude that when these two elements are present, deception should only be used when absolutely necessary and, if used, researchers should be required to debrief participants before the collection of genetic samples and give particular attention to minimizing risks of privacy breaches.     

Response to Commentaries:

It is time to bring nature (genetics) together with nurture (environment) in the study of social development. Following a brief overview of behavioral genetic theory and methods, three examples are described of new genetic research especially relevant to social developmentalists. First, initial research findings on three key domains of social development (attachment, empathy, and social competence) suggest that genetic factors contribute to individual differences in social development. Second, research on widely used measures of social environment implicates a genetic contribution, which opens up new directions for research at the interface of nature and nurture in social development. Third, by the turn of the century, it is predicted that behavioral genetic research will be conducted using DNA markers that assess genetic variation among individuals directly rather than resorting to indirect estimates based on twin and adoption methods. This will revolutionize behavioral genetic research and make it more accessible and applicable to developmentalists. As a first step in the direction of behavioral genetics, social developmentalists are encouraged to include siblings in their research.     

Parenting is genetically influenced: What does that mean for research into child and adolescent social development?

Individual differences in child and adolescent social development are due to a combination of variation in genetic propensity and environmental conditions. That is, variation in social domains like bullying-victimization, loneliness and pro- and antisocial behaviour is genetically influenced to a substantial extent. That is not to say that social contexts also do not play an important role in shaping social development. Indeed, parenting and parent–child relationship quality have been associated with various aspects of social development. What complicates matters is that environmental conditions – including parenting – are under genetic influence as well. Genetic influence on parenting has not received sufficient attention in the literature on social development although it likely biases estimates of parental effects on offspring social development. To change this situation, I review recent twin and molecular research on genetic influence on parenting and discuss why genetically-informed studies improve and enrich contemporary research into social development. The aim of this topic review is to provide an accessible introduction to genetics of parenting and encourage genetically-informed research into social development.     

Assessing the educational literature in the responsible conduct of research for core content

To determine core content for RCR instruction, content analysis was conducted using key instructional resources for ORI's nine RCR "core instructional areas". Topics discussed in these key RCR resources were identified and their frequency across resources was tabulated. Topics covered most frequently were judged to be core content. Although key educational resources cited a variety of references, specific topics and issues addressed were generally consistent across the materials examined. Nonetheless, key resources varied in organization and depth of coverage for core instructional areas. Recent resources were more systematic and comprehensive than earlier works. This was particularly evident in materials about human participant research, conflicts of interest, and data management and sharing. Key resources presented additional "non-core" issues, such as scientific values, ethical principles, creativity and objectivity, moral reasoning, genetics, epidemiological issues, and scientists' societal roles, suggesting that ORI's core instructional areas should be reconfigured or expanded. Because educational material available on RCR and professionalism was so comprehensive, we recommend that ORI consider research integrity, not research misconduct, as one core instructional area. We also recommend that compliance with research regulations be restored as a core instructional area to accentuate ethical, financial and legal requirements related to acceptance of federal funding.     

Empirically supported ethical research practice: the costs and benefits of research from the participants' view

Researchers and institutional review boards are routinely called upon to evaluate the cost-benefit status of proposed research protocols that involve human participants. Often these assessments are based on subjective judgments in the absence of empirical data. This reliance on subjective judgments is of particular concern for studies involving clinical samples where unfounded assumptions may adversely affect research progress or clinical outcomes. The Reactions to Research Participation Questionnaire (RRPQ) was designed to address this shortcoming and to help promote ethical decision making about research practice. The present study describes development of the RRPQ and presents a series of exploratory and confirmatory analyses investigating its structure. Based on these findings, a revised version of the instrument and suggestions for future research are presented. This approach provides a foundation for scientifically informed protection of human subjects.     

Clinical trials of drugs used off-label in neonates: ethical issues and alternative study designs

The use of drugs for indications unapproved by the Food and Drug Administration (FDA), often called "off label use, "is widespread in children, including neonates. The widespread off-label use of drugs in neonates presents ethical and safety challenges. Since the passage of the Best Pharmaceuticals for Children Act (BPCA) in 2002, both the FDA and National Institutes of Health (NIH) have taken initiatives to facilitate and encourage research to achieve the necessary labeling for drugs routinely used in infants and children. Federal regulations provide broad rules and guidance for the protection of human subjects in research. However, there are ethical issues that a physician may face when designing clinical trials of drugs in neonates that are routinely used off-label and widely believed to be beneficial. We attempt to describe these ethical challenges and provide recommendations, including alternative study designs, to resolve them in an ethical framework that takes into account the Belmont Report, the statement of the World Medical Association (WMA), and federal regulations.     

Clinical Trials of Drugs Used Off-Label in Neonates: Ethical Issues and Alternative Study Designs

The use of drugs for indications unapproved by the Food and Drug Administration (FDA), often called “off-label use,” is widespread in children, including neonates. The widespread off-label use of drugs in neonates presents ethical and safety challenges. Since the passage of the Best Pharmaceuticals for Children Act (BPCA) in 2002, both the FDA and National Institutes of Health (NIH) have taken initiatives to facilitate and encourage research to achieve the necessary labeling for drugs routinely used in infants and children. Federal regulations provide broad rules and guidance for the protection of human subjects in research. However, there are ethical issues that a physician may face when designing clinical trials of drugs in neonates that are routinely used off-label and widely believed to be beneficial. We attempt to describe these ethical challenges and provide recommendations, including alternative study designs, to resolve them in an ethical framework that takes into account the Belmont Report, the statement of the World Medical Association (WMA), and federal regulations.     

Research ethics review for the use of anonymized samples and data: A systematic review of normative documents

While the anonymization of biological samples and data may help protect participant privacy, there is still debate over whether this alone is a sufficient safeguard to ensure the ethical conduct of research. The purpose of this systematic review is to examine whether the review of an ethics committee is necessary in the context of anonymized research, and what the considerations in said ethics review would be. The review of normative documents issued by both national and international level organizations reveals a growing concern over the ability of anonymization procedures to prevent against reidentification. This is particularly true in the context of genomic research where genetic material’s uniquely identifying nature along with advances in technology have complicated previous standards of identifiability. Even where individual identities may not be identifiable, there is the risk of group harm that may not be protected by anonymization alone. We conclude that the majority of normative documents support that the review of an ethics committee is necessary to address the concerns associated with the use of anonymized samples and data for research.     

Addressing procedural challenges of ethical review system: Towards a better ethical quality of clinical trials review in Malaysia

The review of clinical trials with human participants in Malaysia is governed by a decentralized control system. The clinical trial protocols are reviewed by 13 registered research ethics committees (RECs) in Malaysia. A governmental body, the National Pharmaceutical Control Bureau, is responsible for the inspection and oversight of these registered RECs to ensure that they comply with the regulatory requirements. However, this study highlights that each REC in Malaysia has a different standard operating procedure and ethical review process. Other procedural challenges identified include inadequate membership, poor mechanism for research monitoring after ethical approval, and insufficient resources. Establishments of a national standard of REC and a central ethics committee are suggested to ensure procedural compliance in the oversight of clinical trials in Malaysia. While there is a growing concern that procedural compliance may not have a direct impact on the protection of human subjects, our key point is that an ethical review system compliant with the national standards could serve as a strong framework to support and enhance the ethical quality of decision-making and judgement. We believe that being aware of how influential procedural compliance can be would help committees improve the ethical quality of their research review.     

Empirically supported ethical research practice: The costs and benefits of research from the participants’ view

Researchers and institutional review boards are routinely called upon to evaluate the cost‐benefit status of proposed research protocols that involve human participants. Often these assessments are based on subjective judgments in the absence of empirical data. This reliance on subjective judgments is of particular concern for studies involving clinical samples where unfounded assumptions may adversely affect research progress or clinical outcomes. The Reactions to Research Participation Questionnaire (RRPQ) was designed to address this shortcoming and to help promote ethical decision making about research practice. The present study describes development of the RRPQ and presents a series of exploratory and confirmatory analyses investigating its structure. Based on these findings, a revised version of the instrument and suggestions for future research are presented. This approach provides a foundation for scientifically informed protection of human subjects.     

Ethical guidelines for research with children: A review of current research ethics documentation in New Zealand

Abstract

Children's rights to participate in matters affecting them, including research, have gained increasing recognition over recent decades. This recognition, and the growth in research with children as participants, has given rise to greater attention from researchers to ethical issues related to child research. This article reviews the current ethics documentation in New Zealand. The findings indicate that considerable variation exists between ethical codes and guidelines in relation to research with children. The dominant focus is on attending to issues of consent and protection from harm, at the outset of the research, rather than recognition of the ongoing nature of ethical issues throughout the research process. Although the findings indicate an increase in the consideration of ethical issues, the existing documentation is inconsistent and inadequate in attending to specific child‐related issues. Suggestions are made to enhance children's participation in research and demonstrate a respect for their participation rights.     

Research on environmental health interventions: ethical problems and solutions

This article reviews a variety of ethical issues one must consider when conducting research on environmental health interventions on human subjects. The paper uses the Kennedy Krieger Institute lead abatement study as well as a hypothetical asthma study to discuss questions concerning benefits and risks, risk minimization, safety monitoring, the duty to warn, the duty to report, the use of control groups, informed consent, equitable subject selection, privacy, conflicts of interest, and community consultation. Research on environmental health interventions can make an important contribution to our understanding of human health and disease prevention, provided it is conducted in a manner that meets prevailing scientific, ethical, and legal standards for research on human subjects.     

Research on Environmental Health Interventions: Ethical Problems and Solutions

This article reviews a variety of ethical issues one must consider when conducting research on environmental health interventions on human subjects. The paper uses the Kennedy Krieger Institute lead abatement study as well as a hypothetical asthma study to discuss questions concerning benefits and risks, risk minimization, safety monitoring, the duty to warn, the duty to report, the use of control groups, informed consent, equitable subject selection, privacy, conflicts of interest, and community consultation. Research on environmental health interventions can make an important contribution to our understanding of human health and disease prevention, provided it is conducted in a manner that meets prevailing scientific, ethical, and legal standards for research on human subjects.     

International research: Ethical imperialism or ethical pluralism? 1

Conflicts have arisen in international research when countries in which research is being carried out lack the ethical rules or mechanisms for review employed in the United States and Europe. It is objected that a requirement to adhere to regulations promulgated by the US government constitutes “ethical imperialism.”; But if researchers in some countries need not be bound by ethical standards widely accepted in the conduct of research, it could open the door to an ethical relativism allowing virtually any standard a country desires to accept. One example is the variations in informed consent, especially in countries that accord lesser importance to the individual than do the US and Europe. A recent controversy centered on a series of placebo‐controlled, HIV/AIDS trials sponsored by the United States and conducted in several developing countries. These trials could not ethically be carried out in the United States because a proven effective treatment exists. Attempts to avoid similar controversies in forthcoming HIV/AIDS vaccine trials have been initiated by the joint United Nations AIDS program, with a process of regional consultations in the countries where the research will be conducted.     

Ethics,Gender, and Ethnicity in Single-Case Research and Evaluation

Social work practitioners and students are now being encouraged to do single-case research or at least, to evaluate their practice outcomes objectively. Ethical issues in both endeavors, including issues related to clients' gender and ethnicity, need more attention than they have been given. This article explores a number of ethical issues in single-case research and evaluation, with special attention to possible gender and ethnic bias in selecting clients or target problems to monitor. Guidelines for reducing bias, seeking informed client consent, and use of human subjects review are proposed.     

Ethics of research design

Discussions of ethical issues in research involving human subjects most usually provoke concerns about valid informed consent procedures. However, considering the recognized limitations of informed consent, arguably the way a study is designed is a more consequential concern for subject well‐being. This paper summarizes ethical issues in the design of clinical research, with reference to historic and current guidelines. Special attention is given to randomized clinical trials (RCTs) and psychiatric research.