title: Research involving pediatric stem cell donors: A way forward.
abstract: The most suitable donor for younger patients who undergo hematopoietic stem cell transplantation in the research setting is frequently a minor sibling. These cases raise the question of whether minors who serve as stem cell donors for research subjects should be regarded as research subjects themselves. Regarding pediatric donors as research subjects ensures that an Institutional Review Boards reviews their involvement and determines whether it is appropriate. Yet, Institutional Review Boards must follow the US regulations for pediatric research, which were designed for patients and healthy volunteers, not for healthy donors. As a result, regarding pediatric donors as research subjects also can pose unnecessary obstacles to appropriate and potentially life-saving research. This article considers a new way to address this dilemma. The federal research regulations allow for waiver of some or all of the included requirements when they are unnecessary for a study or a class of studies. We argue that this option offers a way to ensure that the involvement of pediatric donors receives sufficient review and approval without inadvertently undermining valuable and potentially life-saving research.
authors.affiliation: Department of Bioethics, NIH Clinical Center, Bethesda, MD, USA dwendler@nih.gov.
authors.forename: David
authors.initials: D
authors.lastname: Wendler
authors.affiliation: Pediatric Oncology Branch, National Cancer Institute, Bethesda, MD, USA.
authors.forename: Nirali N
authors.initials: NN
authors.lastname: Shah
authors.affiliation: Keck School of Medicine of USC and Children's Hospital Los Angeles, Los Angeles, CA, USA.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Pulsipher
authors.affiliation: Pediatric Oncology Branch, National Cancer Institute, Bethesda, MD, USA.
authors.forename: Terry
authors.initials: T
authors.lastname: Fry
authors.affiliation: Department of Bioethics, NIH Clinical Center, Bethesda, MD, USA.
authors.forename: Christine
authors.initials: C
authors.lastname: Grady
mesh_terms: D000293:Adolescent; D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence; D002648:Child; D002675:Child, Preschool; D028744:Ethics Committees, Research; D018380:Hematopoietic Stem Cell Transplantation / Q000941:ethics* / Q000331:legislation & jurisprudence; D006801:Humans; D007223:Infant; D035842:Research Subjects; D057905:Stem Cell Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D009927:Tissue and Organ Procurement / Q000941:ethics* / Q000331:legislation & jurisprudence; D014481:United States
keywords: Transplantation; donor; pediatric; regulations