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NIH Mar 23, 2006 | R01
Protecting Human Subjects in Genetic Enhancement Research
Institution: CASE WESTERN RESERVE UNIVERSITY
FOA Number: PA-00-133
Abstract
Researchers and bioethicists have developed guidelines to protect human subjects in clinical experiments involving genetic technologies. However, these rules were developed for investigations of therapeutic interventions and do not address the risks involved in the potential use of genetic technologies for enhancement purposes. Society has reached a clear consensus against attempting germ-line genetic interventions in humans, but genetic knowledge could still be used for enhancement purposes in other ways, such as the somatic use of biosynthetic growth hormone to increase stature, or studies to identify genetic mutations associated with non-disease traits. In the absence of guidelines that explicitly address the special issues of enhancement research, subjects could be exposed to risks that would be acceptable in the case of therapeutic research but unacceptable in the case of enhancement research. Moreover, the absence of explicit enhancement research policy is likely to drive this type of research into the realm of 'underground' illicit or off-label use and self-experimentation, which could cause serious harm to research subjects and to society. To address this policy gap, this project will identify ethically relevant differences between therapeutic and enhancement genetic research and analyze these differences in terms of the ethical principles that govern human subjects research, in order to determine whether current rules and regulations adequately restrict enhancement research, and, if not, propose changes to existing rules and regulations so that society can respond effectively to possible future attempts to conduct genetic enhancement research using human subjects.
FUNDING AGENCY:
Funder:
NIHInstitute:
NATIONAL HUMAN GENOME RESEARCH INSTITUTEFunding Type:
R01Project Number:
R01HG003879Start Date:
Mar 23, 2006End Date:
Jan 31, 2008PROJECT TERMS:
Autoexperimentation, base, Bioethics Consultants, Clinical, Clinical Research, Clinical Trials, Conceptions, condition, Consensus, design, Development, disability, Disease, Enhancement Technology, falls, Future, gene mutation, gene therapy, Gene Transfer, Genetic Enhancement, Genetic Research, Genetic screening method, genetic technology, Germ Lines, Goals, Guidelines, Hand, Human, Human Genetics, human subject, Human Subject Research, improved, Innovative Therapy, Intervention, Investigation, Knowledge, Label, Light, Modality, Normalcy, Participant, Pharmaceutical Preparations, Policies, Policy Maker, Policy Research, Purpose, Recombinant DNA, Regulation, Research, Research Ethics, Research Personnel, research study, Research Subjects, Resistance, Risk, Safety, Science Policy, Societies, Somatotropin, spelling, Standards of Weights and Measures, System, Taboo, Therapeutic, Therapeutic Human Experimentation, Therapeutic Intervention, trait, Vulnerable Populations