Balancing recruitment and protection: children as research subjects.
Since 1994, federal guidelines for research in the United States have called for the inclusion of special populations, among them, children, in clinical research (National Institutes of Health, 1998). While the guidelines are intended to assure the fair distribution of research benefits to children,...
| Publicado en: | Issues in Comprehensive Pediatric Nursing Vol. 24; no. 4; pp. 241 - 252 |
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| Autores principales: | , |
| Formato: | tables/charts Journal Article |
| Publicado: |
Taylor & Francis Ltd
Oct-Dec2001
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=106904466&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 106904466 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 01460862 B9E jtl: Issues in Comprehensive Pediatric Nursing issn: 01460862 maglogo: Y pubinfo: dt: Oct-Dec2001 vid: 24 iid: 4 pid: 377 pub: Taylor & Francis Ltd place: Philadelphia, Pennsylvania artinfo: ui: 106904466 106904466 2002030909 10.1080/014608601753260335 NLM11769209 106904466 ppf: 241 ppct: 11 formats: fmt: @attributes: type: P tig: atl: Balancing recruitment and protection: children as research subjects. aug: au: Meaux JB Bell PL affil: University of Central Arkansas, 201 Donaghey Ave, Dept of Nursing, Conway, AR 72035 sug: subj: Protection of Human Subjects Research Subject Recruitment In Infancy and Childhood Clinical Trials Consent (Research) In Infancy and Childhood Research Ethics United States Consent (Research) Legislation and Jurisprudence Legislation Age Factors Infant Child, Preschool Child Adolescence Infant: 1-23 months Child, Preschool: 2-5 years Child: 6-12 years Adolescent: 13-18 years ab: Since 1994, federal guidelines for research in the United States have called for the inclusion of special populations, among them, children, in clinical research (National Institutes of Health, 1998). While the guidelines are intended to assure the fair distribution of research benefits to children, this federal mandate has created an ethical dilemma for researchers. Health professionals involved in research with children are called on to balance improving access and recruitment of children for clinical trials with the need to protect this very vulnerable population. Given this balancing act, it is important for nurse-researchers to be familiar with the issues of informed consent and assent with children. Our article reviews instances of exploitation of children in research, laws and federal regulations on informed consent and assent designed to protect children, and research on factors that affect children's capacity to consent/assent. We conclude with recommendations to assure a proper balance between the need to recruit children into clinical trials and the need to protect their rights as human subjects. pubtype: Academic Journal doctype: tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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