Children clinical research

L D. The principle of justice is a relevant consideration when subjects are selected for clinical research. It requires that members of a vulnerable population, such as institutionalized patients with mental retardation, not be exploited. The principle of autonomy would be most relevant to the parents ability to consent or refuse on the child s behalf, something Dr. Martin thinks is handled satisfactorily. Dr. Martin believes risks have been minimized and the overall study drug is likely to help the participants, so the study has satisfied the principles of nonmaleficence and beneficence. The principle of medical priority is not mentioned in the chapter and pertains to treating the most medically needy patients first, which is not at issue here. 

Cohen, DJ. (1986) Research in child psychiatry lines of personal, institutional and career development. In Pincus, H.A. and Pardes, H., eds. Clinical Research Careers in Child Psychiatry. Washington, DC. American Psychiatric Association, p. 74. 

This work was supported by a NARSAD Young Investigator Award to Peter Milev and by a K12 Clinical Research Career Development Award from the National Institutes of Health, National Institute of Child Health and Human Development (NIH, NICHHD), Grant number 5K12RR023247-03. 

National Institute on Drug Abuse. Drug Dependence in Pregnancy Clinical Management of Mother and Child. Services Research Monograph Series. NIDA, DHEW Publication, No. ADM 79-678. 

And the child with a BLL of only 1 unit isn t safe either. In fact, as far as we can tell, there s no threshold of safety for lead in the blood, no concentration below which lead is harmless to the child s developing brain. The only safe concentration is zero. That s the consensus of clinical researchers and pediatricians in America and around the world. 

Parents have different reasons for allowing their children to participate in clinical research. A researcher should understand these factors and take them into account in trial design and parent/patient education. The aim is to improve the recruitment rate, on the one hand, and parentsVpatients satisfaction, on the other. Less well-informed parents may misconstrue that their child will get better treatment or will get a novel treatment in a randomised trial and will be disappointed when the result or randomisation does not correspond to their perception. Fundamentally, such a misunderstanding threatens their ability to make an informed choice. 

Most studies on parental perception have been carried out within 72 hours of research participation decisions (Zupancic et al., 1997 Hoehn et al., 2005) others are retrospective or prospective questionnaire studies (van Stuijvenberg et ah, 1998). Factors that influence parental decisions are societal benefit, personal benefit, risk perception and perceived lack of harm. The logistic factors that influence parental perception of risks are the amount of information given, the trust in the institution and the time required for the decision-making. Parents who perceived benefit, either personal or societal, were more likely to participate than if they perceived risk (Tait et al., 2004 Hoehn et al., 2005). Societal benefit is the most frequently cited reason for participation in clinical research. Parents with a critically ill child have an altruistic view to help future children in similar conditions (Langley et ah, 1998 van Stuijvenberg et ah, 1998 Schmidt et ah, 1999 Mason and Allmark, 2000 Hoehn et ah, 2005). 

Burgess E, Singhal N, Amin H, et al. (2003). Consent for clinical research in the neonatal intensive care unit, a retrospective survey and a prospective smdy. Arch Dis Child Fetal Neonatal Ed 88 F321-F323. 

Tennant FS, Tarver AL, Rawason RA (1983) Clinical evaluation of mecamylamine for withdrawal from nicotine dependence. In Harris LS (ed) Problems of drug dependence, NIDA Research Monograph 49. USDHHS publication no, 84-1316, pp 239-246 Tercyak KP, Herman C, Audrain J (2002) Association of attention-deficit/hyperactivity disorder symptoms with levels of cigarette smoking in a community sample of adolescents, J Am Acad Child Adolesc Psychiatry 41 799-805... 

Jensen, P.S., Bhatara, V.S., Vitiello, B., Hoagwood, K., Feil, M., and Burke, L.B. (1999) Psychoactive medication prescribing practices for U.S. children gaps between research and clinical practice. J Am Acad Child Adolesc Psychiatry 38 557-565. 

Sharp, W, Walter, J., Marsh, W., Ritchie, G., Hamburger, S., and Castellanos, X. (1999) ADHD in girls clinical comparability of a research sample. J Am Acad Child Adolesc Psychiatry 38 40-47. 

Carlson, G.A. (2000) Very early onset bipolar disorder. Does it Exist in Childhood In Rapoport, J, ed. Onset of Adult Psychopathology—Clinical and Research Advances. APPI Press, pp. 303-332. Carlson, G.A., Bromet, E.J., and Lavelle, J. (1999) Medication treatment in adolescents vs adults with psychotic mania. / Child Adolesc Psychopharmacol 9 221-231. 

Mounting a clinical trial in child psychopharmacology requires the integration of considerable clinical and research expertise. Attention must be paid to multiple design and methodological aspects, and scientific goals... 

As a result of these efforts, more research is under way in child and adolescent clinical psychopharmacoiogy than ever before. The full impact of this increased research activity will take several years to be realized owing to the lag time between initiating and completing a research program in clinical psychopharmacoiogy. 

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