Ethical challenges in neonatal research: Summary report of the ethics group of the newborn drug development initiative.

Ethical challenges in neonatal research: Summary report of the ethics group of the newborn drug development initiative. Research Abstract Details 

Research Abstract Table of Contents

Jump to the:

Ethical challenges in neonatal research: Summary report of the ethics group of the newborn drug development initiative. Abstract Text:

Gerri R Baer,Robert M Nelson, ,

BACKGROUND: The Newborn Drug Development Initiative (NDDI) was established to address the lack of substantive data supporting efficacy and safety of drugs in the neonate. OBJECTIVE: This commentary summarizes some of the ethical issues involved in neonatal drug development. METHODS: At the NDDI workshop held March 29 and 30, 2004, in Baltimore, Maryland, members of the Ethics Group were dispersed among the subspecialty groups before convening to discuss common ethical themes. The Ethics Group then met together to identify and discuss those ethical themes that were both important and shared among the groups. These themes are discussed and illustrated with the other NDDI group reports. This workshop was cosponsored by the National Institute of Child Health and Human Development and the US Food and Drug Administration. RESULTS: Neonatal drug research is scientifically and ethically necessary to establish the efficacy and safety of drugs widely used in newborn medicine. However, research involving neonates must be carefully designed to balance potential risks and benefits, with consideration given to the component analysis of risk. The protocols proposed by the NDDI groups would be considered greater than minimal risk and offering prospect for direct benefit, thus adhering to the Department of Health and Human Services' pediatric research regulations (Subpart D). The NDDI groups all proposed randomized controlled clinical trials, with careful attention to scientifically and ethically appropriate control groups. Multiple regulatory bodies have affirmed that in the absence of proven effective treatment or when a proven treatment offers marginal benefits, study designs with placebo controls are ethical. Obtaining parental permission is a complex issue, with a paucity of evidence describing the feasibility of informed and voluntary consent under conditions of duress and a short therapeutic window. The Subpart D regulations offer sufficient protection to critically ill neonates. The application of the revised Subpart B regulations would restrict the use of a waiver of consent for minimal risk research and for emergency research, and would not allow research that offers no direct benefit and no more than a minor increase over minimal risk. CONCLUSIONS: Multisite collaboration involving standards of care and institutional review board procedures may be important for establishing scientific and ethical consistency. Ongoing dialogue among researchers, clinicians, parents, and other interested parties is essential to promoting ethically and scientifically sound neonatal clinical research.

Ethical challenges in neonatal research: Summary report of the ethics group of the newborn drug development initiative. Publishing Authors By Initials

GR Baer,RM Nelson, ,

For similar abstracts research abstracts see: abstracts research

PUBMED ID PMID:

MEDLINE DATE:

Ethical challenges in neonatal research: Summary report of the ethics group of the newborn drug development initiative. Journal Published:

PUBLICATION TYPE: Review

Journal: Clinical therapeutics

VOLUME: 28

Page Numbers: 1399-407

Journal Abbreviation:

ISSN: 0149-2918

DAY: 3

MONTH: Sep

YEAR: 2006

Ethical challenges in neonatal research: Summary report of the ethics group of the newborn drug development initiative. Information

Number of References:

LANGUAGE: eng

NlmUniqueID: 7706726

Ethical challenges in neonatal research: Summary report of the ethics group of the newborn drug development initiative. Keywords Mesh Terms:

KEYWORDS: United States Food and Drug Administrati

MESH TERMS: ethics

Chemical & Substance for Abstract: Ethical challenges in neonatal research: Summary report of the ethics group of the newborn drug development initiative. Information

Substance Name:

Registry Number:

Grant and Affiliation Information for Ethical challenges in neonatal research: Summary report of the ethics group of the newborn drug development initiative.

AFFILIATION: Department of Pediatrics, Children's Hospital of Philadelphia and University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104, USA.

Country: United States

AGENCY: United States NINDS

GRANT: K01 NS02151

ACRONYM: NS

MEDLINETA: Clin Ther

REFSOURCE:

DATABASENAME:

ACCESSION NUMBER:

Number Hits: 0

Ethical challenges in neonatal research: Summary report of the ethics group of the newborn drug development initiative Related Publications

• Au(I)-catalyzed annulation of enantioenriched allenes in the enantioselective total synthesis of (-)-rhazinilam.
• CARBON DIOXIDE AS AN ATTRACTANT FOR CULICOIDES.
• CDK/GSK-3 inhibitors as a new approach for the treatment of proliferative renal diseases.
• CX3CR1+ interstitial dendritic cells form a contiguous network throughout the entire kidney.
• Catalytic asymmetric assembly of stereodefined propionate units: an enantioselective total synthesis of (-)-pironetin.
• Chronic binge ethanol consumption accelerates progression of simian immunodeficiency virus disease.
• Collapsing glomerulopathy.
• Common bacterial infections of the skin.
• Contrast-induced nephropathy in patients with chronic kidney disease undergoing computed tomography: a double-blind comparison of iodixanol and iopamidol.
• Determining global population distribution: methods, applications and data.
• Development of recombinant-based mass spectrometric immunoassay with application to resistin expression profiling.
• EPR and ENDOR study of radiation-induced radical formation in purines: hypoxanthine hydrochloride monohydrate crystals X-irradiated at 10 K.
• EPR and ENDOR study of radiation-induced radical formation in purines: sodium inosine crystals X-irradiated at 10 K.
• Effect of reproductive factors and postmenopausal hormone use on the risk of amyotrophic lateral sclerosis.
• Electron transfer in amino acid.nucleic acid base complexes: EPR, ENDOR, and DFT study of X-irradiated N-formylglycine.cytosine complex crystals.
• Ethical challenges in neonatal research: Summary report of the ethics group of the newborn drug development initiative.
• Feasibility of dynamic susceptibility contrast perfusion MR imaging at 3T using a standard quadrature head coil and eight-channel phased-array coil with and without SENSE reconstruction.
• Genome-wide analysis reveals new roles for the activation domains of the Saccharomyces cerevisiae heat shock transcription factor (Hsf1) during the transient heat shock response.
• HIV incidence among injection drug users in Baltimore, Maryland (1988-2004).
• Human cytomegalovirus attenuates interleukin-1beta and tumor necrosis factor alpha proinflammatory signaling by inhibition of NF-kappaB activation.
• Identifying and overcoming the barriers to high-quality palliative care in the intensive care unit.
• Maternal microchimerism in healthy adults in lymphocytes, monocyte/macrophages and NK cells.
• Mononuclear infiltrates in osteosarcoma and chemokine receptor expression.
• Neural bases and development of face recognition in autism.
• Phase I/II trial of an allogeneic cellular immunotherapy in hormone-naïve prostate cancer.
• Photoperiod differentially affects immune function and reproduction in collared lemmings (Dicrostonyx groenlandicus).
• Pregnancy and obesity: a review and agenda for future research.
• Social and photoperiod effects on reproduction in five species of Peromyscus.
• Surface plasmon resonance-enabled mass spectrometry arrays.
• [Sleeping position to prevent sudden infant death syndrome in Latin-american and Caribbean hospitals]