title: Who's watching the watchdogs? Responding to the erosion of research ethics by enforcing promises.
abstract: For more than thirty years, federal regulations--collectively known as the "Common Rule"--have governed all federally funded medical research involving human subjects. The Common Rule requires, inter alia, that any research facility receiving federal funds submit a Federal Wide Assurance (FWA) to the department or agency from which funding is sought. The FWA is a contract in which the research facility promises to abide by the Common Rule for all its research that involves human subjects, whether it is privately or federally funded. Drawing upon other instances in which third-party beneficiaries have successfully enforced government contracts, this Note argues that, upon discovery that a contract of assurance has been breached in the course of federally or privately funded research, a research subject should be able to maintain an action against the research institution as a third-party beneficiary to that contract.
authors.forename: Lori A
authors.initials: LA
authors.lastname: Alvino
mesh_terms: D002986:Clinical Trials as Topic / Q000009:adverse effects; D016265:Conflict of Interest; D032982:Contracts / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research; D035082:Federal Government; D005380:Financing, Government; D033161:Government Regulation; D019983:Guideline Adherence / Q000331:legislation & jurisprudence*; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D016365:Liability, Legal; D017149:Private Sector; D035842:Research Subjects / Q000331:legislation & jurisprudence; D012109:Research Support as Topic; D014481:United States