Biomaterial Database

Ethical issues in research involving infants. 2009

Douglas S Diekema

Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA. diek@u.washington.edu

The future health of infants and children is dependent on the performance of clinical research in which infants participate. Achieving a proper balance between this social good and the obligation to protect infants who participate in research is a significant challenge. As investigators design and implement research protocols, they should be aware of the ethical and legal requirements that govern research with infants. For research to satisfy ethical and legal requirements it must be scientifically sound and significant, subject selection must be fair, approaching families for enrollment must avoid pressure, the risks to participants cannot be excessive and must be minimized, risks must be justified by the benefits of the research, valid and voluntary informed consent must be obtained, enrolled subjects must be respected, and the protocol must have obtained approval of an independent ethical review board.

UI	MeSH Term	Description	Entries
D007231	Infant, Newborn	An infant during the first 28 days after birth.	Neonate,Newborns,Infants, Newborn,Neonates,Newborn,Newborn Infant,Newborn Infants
D007258	Informed Consent	Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment.	Consent, Informed
D009359	Neonatology	A subspecialty of Pediatrics concerned with the newborn infant.
D003219	Confidentiality	The privacy of information and its protection against unauthorized disclosure.	Patient Data Privacy,Privacy of Patient Data,Privileged Communication,Confidential Information,Secrecy,Communication, Privileged,Communications, Privileged,Data Privacy, Patient,Information, Confidential,Privacy, Patient Data,Privileged Communications
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D018570	Risk Assessment	The qualitative or quantitative estimation of the likelihood of adverse effects that may result from exposure to specified health hazards or from the absence of beneficial influences. (Last, Dictionary of Epidemiology, 1988)	Assessment, Risk,Benefit-Risk Assessment,Risk Analysis,Risk-Benefit Assessment,Health Risk Assessment,Risks and Benefits,Analysis, Risk,Assessment, Benefit-Risk,Assessment, Health Risk,Assessment, Risk-Benefit,Benefit Risk Assessment,Benefit-Risk Assessments,Benefits and Risks,Health Risk Assessments,Risk Analyses,Risk Assessment, Health,Risk Assessments,Risk Benefit Assessment,Risk-Benefit Assessments
D018579	Patient Selection	Criteria and standards used for the determination of the appropriateness of the inclusion of patients with specific conditions in proposed treatment plans and the criteria used for the inclusion of subjects in various clinical trials and other research protocols.	Patient Recruitment,Research Subject Recruitment,Selection Criteria,Research Subject Selection,Selection for Treatment,Selection of Research Volunteers,Selection of Subjects,Criteria, Selection,Recruitment, Patient,Recruitment, Research Subject,Recruitments, Research Subject,Research Subject Recruitments,Research Subject Selections,Research Volunteers Selection,Research Volunteers Selections,Selection for Treatments,Selection, Patient,Selection, Research Subject,Selections, Research Subject,Subject Recruitment, Research,Subject Recruitments, Research,Subject Selection, Research,Subject Selections, Research,Subjects Selection,Subjects Selections,Treatment, Selection for,Treatments, Selection for,Volunteers Selection, Research
D028744	Ethics Committees, Research	Hospital or other institutional committees established to protect the welfare of research subjects. Federal regulations (the "Common Rule" (45 CFR 46)) mandate the use of these committees to monitor federally-funded biomedical and behavioral research involving human subjects.	Institutional Review Boards,Board, Institutional Review,Boards, Institutional Review,Ethics Committee, Research,IRB,IRBs,Institutional Review Board,Research Ethics Committee,Research Ethics Committees,Review Board, Institutional,Review Boards, Institutional,Committee, Research Ethics,Committees, Research Ethics
D035843	Biomedical Research	Research that involves the application of the natural sciences, especially biology and physiology, to medicine.	Medical Research,Experimental Medicine,Investigational Medicine,Investigative Medicine,Research, Biomedical,Research, Medical,Medicine, Experimental,Medicine, Investigational,Medicine, Investigative