title: US Government mandates for clinical and translational research.
abstract: This commentary is germane for clinical and translational researchers. Basic scientists may face different obstacles to developing their research careers. Over the past several years, the federal government has seen reductions in funding for extramural research. It seems that under the adverse economic forecasts, things are going to get worse. It might seem logical for the federal government to stretch whatever limited resources exist, by asking the institutions to cost-share greater fractions of the actual research costs, and as an incentive, avoid the imposition of unfunded mandates. But alas, although well intended, there have been expensive requirements imposed by the government, making it difficult for investigators and institutions to adequately fund and conduct their research and for scientific journals to maintain paying subscribers. Five prominent and costly changes, which are the focus of this commentary are (1) HIPAA, (2) http://ClinicalTrials.Gov, (3) Clinical and Translational Science Awards, (4) Upcoming rule changes for IRBs, and (5) PubMedCentral, each of which will be discussed in the ensuing paragraphs.
authors.affiliation: Department of Health Outcomes and Policy and Clinical and Translational Science Institute, College of Medicine, University of Florida, Gainesville, Florida, USA. shusterj@ufl.edu
authors.forename: Jonathan J
authors.initials: JJ
authors.lastname: Shuster
mesh_terms: D001363:Awards and Prizes; D002986:Clinical Trials as Topic / Q000191:economics / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research / Q000191:economics / Q000331:legislation & jurisprudence; D035082:Federal Government; D033161:Government Regulation; D020408:Health Insurance Portability and Accountability Act / Q000191:economics / Q000331:legislation & jurisprudence; D006801:Humans; D010506:Periodicals as Topic / Q000191:economics / Q000331:legislation & jurisprudence; D039781:PubMed / Q000191:economics / Q000331:legislation & jurisprudence; D012109:Research Support as Topic / Q000331:legislation & jurisprudence*; D057170:Translational Research, Biomedical / Q000191:economics* / Q000331:legislation & jurisprudence*; D014481:United States