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Biomedical subjects

Celia B Fisher

Publications and source records attributed to Celia B Fisher.

At least 19 recordsLinked to original sources
PubMed2006

Capacity of persons with mental retardation to consent to participate in randomized clinical trials.

OBJECTIVE: Adults with mental retardation have histories of cognitive and adaptive deficits posing unique ethical challenges for research consent assessment. This study examined the capacity of persons with mental retardation to consent to participate in randomized clinical trials. METHOD: A total of 150 adults (50 each with mild and moderate mental retardation and 50 comparison subjects without mental retardation) responded to a set of consent questions for a hypothetical randomized clinical trial testing a medication for aggressive disorders. Intelligence, adaptive behavior, medical treatment history, and consent history were evaluated. Univariate and multivariate methods were used to compare performance across and within groups. RESULTS: Comparison subjects scored significantly higher on measures of consent capacity than participants with mild mental retardation, who scored higher than those with moderate mental retardation. Most subjects with mental retardation were able to make a participation choice, and many understood research methods and appreciated the protagonist's disorder and the consequences of participation. Almost half of those with mild mental retardation understood human subject protections. Performance was weakest on understanding the purpose of research and reasoning about whether to participate, suggesting vulnerability to the therapeutic misconception. Psychiatric and experiential factors did not predict consent capacity. CONCLUSIONS: While adults with mental retardation as a group showed consent deficits, many attained consent capacity scores comparable to those of comparison subjects. Investigators should consider individual differences and a consent format suited to deficits in language, memory, and attention before restricting consent opportunities for persons with mental retardation.

Adult↗
PubMed2006

Privacy and ethics in pediatric environmental health research-part I: genetic and prenatal testing.

The pressing need for empirically informed public policies aimed at understanding and promoting children's health has challenged environmental scientists to modify traditional research paradigms and reevaluate their roles and obligations toward research participants. Methodologic approaches to children's environmental health research raise ethical challenges for which federal regulations may provide insufficient guidance. In this article I begin with a general discussion of privacy concerns and informed consent within pediatric environmental health research contexts. I then turn to specific ethical challenges associated with research on genetic determinants of environmental risk, prenatal studies and maternal privacy, and data causing inflicted insight or affecting the informational rights of third parties.

Child↗
PubMed2006

Privacy and ethics in pediatric environmental health research-part II: protecting families and communities.

BACKGROUND: In pediatric environmental health research, information about family members is often directly sought or indirectly obtained in the process of identifying child risk factors and helping to tease apart and identify interactions between genetic and environmental factors. However, federal regulations governing human subjects research do not directly address ethical issues associated with protections for family members who are not identified as the primary "research participant." Ethical concerns related to family consent and privacy become paramount as pediatric environmental health research increasingly turns to questions of gene-environment interactions. OBJECTIVES: In this article I identify issues arising from and potential solutions for the privacy and informed consent challenges of pediatric environmental health research intended to adequately protect the rights and welfare of children, family members, and communities. DISCUSSION: I first discuss family members as secondary research participants and then the specific ethical challenges of longitudinal research on late-onset environmental effects and gene-environment interactions. I conclude with a discussion of the confidentiality and social risks of recruitment and data collection of research conducted within small or unique communities, ethnic minority populations, and low-income families. CONCLUSIONS: The responsible conduct of pediatric environmental health research must be conceptualized as a goodness of fit between the specific research context and the unique characteristics of subjects and other family stakeholders.

Child↗
PubMed2005

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.

Behavioral Research↗
PubMed2004

Informed consent and clinical research involving children and adolescents: implications of the revised APA ethics code and HIPAA.

In 2003, 2 new sets of rules and regulations affecting the conduct of clinical research involving children and adolescents went into effect: the revised American Psychological Association's (APA) Ethical Principles of Psychologists and Code of Conduct (APA, 2002; effective June 1, 2003) and the Privacy Rule (45 CFR Part 160 and A and E of Part 164; effective April; 14, 2003) of the Health Insurance Portability and Accountability Act (HIPAA: Public Law 104-191). This article highlights those APA ethical standards and HIPAA regulations relevant to clinical research involving children and adolescents and discusses how psychologists can apply these rules in ways that will ensure ethical and legal compliance.

Adolescent↗
PubMed2003

Goodness-of-fit ethic for informed consent to research involving adults with mental retardation and developmental disabilities.

This article reviews current theory and research on informed consent policies for adults with mental retardation within a relational ethics framework that re-conceptualizes consent vulnerability in terms of the goodness-of-fit between participant decisional capacities and the specific consent context. Conceptualizing informed consent competence as a product of the relationship between person and consent context shifts assessment of decisional capacity away from an exclusive focus on a research participant's cognitive deficiencies to (a) an examination of those aspects of the consent setting that are creating or exacerbating consent vulnerability and (b) consideration of how the setting can be modified to produce a consent process that best reflects and protects the hopes, values, concerns, and welfare of adults with developmental disabilities.

Adult↗
PubMed2003

Developing a code of ethics for academics. Commentary on 'Ethics for all: differences across scientific society codes' (Bullock and Panicker).

This article discusses the possibilities and pitfalls of constructing a code of ethics for university professors. Professional, educational, legal, and policy questions regarding the goals, format, and content of an academic ethics code are raised and a series of aspirational principles and enforceable standards that might be included in such a document are presented for discussion and debate.

Administrative Personnel↗
PubMed2003

Adolescent and parent perspectives on ethical issues in youth drug use and suicide survey research.

The contribution of adolescent and parent perspectives to ethical planning of survey research on youth drug use and suicide behaviors are highlighted through an empirical examination of 322 7th-12th graders' and 160 parents' opinions on questions related to 4 ethical dimensions of survey research practice: (a) evaluating research risks and benefits, (b) establishing guardian permission requirements, (c) developing confidentiality and disclosure policies, and (d) using cash incentives for recruitment. Generational and ethnic variation in response to questionnaire items developed from discussions within adolescent and parent focus groups are described. The article concludes with a discussion of the potential contributions and challenges of adolescent and parent perspectives for planning scientifically valid and ethically responsible youth risk survey research.

Adolescent↗
PubMed2003

Health care decision-making by adults with mental retardation.

Abilities of adults with mild, moderate, or no mental retardation to understand hypothetical treatments was investigated using the Assessment of Consent Capacity-Treatment developed for this study based on Appelbaum and Roth's psycholegal consent standards. Performance in all groups decreased with increasing psycholegal complexity of consent decision-making. Most adults with mild and no mental retardation and almost half of adults with moderate mental retardation were able to make and justify treatment choices and fully or partially understand treatment information. Most adults without mental retardation, 50% with mild, and 18% with moderate mental retardation were able to partially appreciate relevance of treatment choice to patient's situation and weigh treatment risks against benefit. Implications of findings for patient rights are discussed.

Adult↗
PubMed2002

Research ethics for mental health science involving ethnic minority children and youths.

In response to U.S. Public Health Service projects promoting attention to disparities in the outcomes of mental health treatments, in July 2001, the American Psychological Association, the National Institute of Mental Health, and the Fordham University Center for Ethics Education convened a group of national leaders in bioethics, multicultural research, and ethnic minority mental health to produce a living document to guide ethical decision making for mental health research involving ethnic minority children and youths. This report summarizes the key recommendations distilled from these discussions.

Adolescent↗
PubMed1994

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.

Adolescent↗