Carta Acesso aberto Revisado por pares

The OHRP and SUPPORT — Another View

2013; Massachusetts Medical Society; Volume: 369; Issue: 2 Linguagem: Inglês

10.1056/nejmc1308015

ISSN

1533-4406

Autores

Ruth Macklin, Lois Shepherd, Alice Dreger, Adrienne Asch, Françoise Βaylis, Howard Brody, Larry R. Churchill, Carl H. Coleman, Ethan Cowan, Janet L. Dolgin, Jocelyn Downie, Rebecca Dresser, Carl Elliott, M. Carmela Epright, Ellen K. Feder, Leonard H. Glantz, Michael A. Grodin, William Y. Hoffman, Barry Hoffmaster, David Hunter, Ana S. Iltis, Jonathan Kahn, Nancy M. P. King, Rory E. Kraft, Rebecca Kukla, Lewis A. Leavitt, Susan E. Lederer, Trudo Lemmens, Hilde Lindemann, Mary Faith Marshall, Jon F. Merz, Frances H. Miller, Margaret E. Mohrmann, Haavi Morreim, Meryl Nass, James Lindemann Nelson, John H. Noble, Elizabeth Reis, Susan M. Reverby, Anita Silvers, Aron Sousa, Roy G. Spece, Carson Strong, Judith P. Swazey, Leigh Turner,

Tópico(s)

Torture, Ethics, and Law

Resumo

Section A: The nature, duration and purpose of study.Your child is invited to participate in a single follow-up visit between the age of six years, four months and seven years, two months of age (school age) for children who were enrolled in the SUPPORT MRI study.As you may recall, that study did an extra brain ultrasound at the time that your child's near-term brain MRI was done for routine care.The purpose was to compare the findings of early and near-term ultrasounds and near-term MRI to determine if one way of imaging gives more useful information than the other.The primary purpose of the study is to examine the children at school age and determine whether near-term MRI is better than ultrasound in predicting developmental outcome.The second purpose is to evaluate the weight, height, body measurements and blood pressure.During the clinic visit, the interviews for you as a parent will take about 1 ½ -2 hours and the time to evaluate your child will take about 3½ hours, including breaks.The interviews with you will be at the same time your child is being tested so the whole visit will last about 3½ hours.SUPPORT school age follow-up, funded by the National Institutes of Health, is being conducted at Women and Infants Hospital and 14 other medical centers across the country.About 500 children and their parents are expected to participate.Sixty-one children are eligible to participate at Women and Infants Hospital.

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