title: Children as hematopoietic cell donors in research: when is it approvable?
abstract: With increasing frequency, allogeneic hematopoietic cell transplantation involving children is being performed in the research setting. Allogeneic hematopoietic cell transplantation, however, cannot be performed without a hematopoietic stem cell (HSC) donor. This donor is often a sibling of the recipient and may also be a child. In such circumstances, it is unclear whether or how the federal regulations for pediatric research apply to the minor donors. This introductory paper reviews the issues to be considered while evaluating studies that use HSCs obtained from minor donors and identifies areas where further research is needed. In the era of increasing applicability for donor-derived cellular therapies, we provide a suggested framework for determining when minor donors qualify as human research subjects and when their participation can be approved under the federal regulations.
authors.affiliation: Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
authors.forename: N N
authors.initials: NN
authors.lastname: Shah
authors.affiliation: 1] Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA [2] Children's Center for Cancer and Blood Diseases, Children's Hospital of Los Angeles, University of Southern California, Los Angeles, CA, USA.
authors.forename: A S
authors.initials: AS
authors.lastname: Wayne
authors.affiliation: Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD, USA.
authors.forename: C
authors.initials: C
authors.lastname: Grady
authors.affiliation: Pediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
authors.forename: T
authors.initials: T
authors.lastname: Fry
authors.affiliation: Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD, USA.
authors.forename: D
authors.initials: D
authors.lastname: Wendler
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000941:ethics / Q000331:legislation & jurisprudence; D006412:Hematopoietic Stem Cells; D006801:Humans; D019520:Living Donors / Q000941:ethics / Q000331:legislation & jurisprudence; D008297:Male