e20 Comment (W Pvblhhed Drinx Deme15.1011 D0I:10 3295/50140 injury compensation systems that exist in most other industrialised nations.The Commission recommends that the US Government adopt a carefully designated set of standards forcompensation. Research supported by the US Government is subject to the same regulatory requirements domestically and internationally These requirements permit govemment agencies torecognise foreign procedures if theyprovide protections that are at least equivalent to federal rulesFor example,procedures for informed corsent in the UKmight be deemed *equivalent protections to those required by the US Govenment.However, US federal agencies have almost never exercised this authonty and often insist that all US rules be met even in foreigncountries where protections are equal to,or more stringent,than those inthe USA.The Commission recommends that the federalgovernment developa processforevaluatingrequestsfrom foreigngovernments and othernon-US institutions to determne if local laws and procedures can berecognised as provsding equivalent protectionstoresearchparticipants. The increasingly globalised nature of medicalresearch presents ethical challenges when study sites do not offer robust protections for volunteers orif the research subjects [are]being systematically selected because of their easy availabilty.their compromisedposition,or thesr manipulahilityThe Commission recognised the potential for exploitation in low-income communities and countries andrecommends thatresearchers and the proposed research sites demonstrate the capacity—or the ability to achieve the capacity when the researchis to be conducted-to protect all human participants. In addition,the Commission recommends that the US Governmentdevelopcriteria forethicalselectionof sites taking into consideration the extent to which sites can benefit the broadercommunity.TheCommission found thatmany of therisks of exploitation canbemitigated forexample,when a study s designed specifcally to respond to the healthneeds of thelocal community Good sciencerequires good ethicsand vice versa To do good science,indvidual investigators,along with the institutions that support andsponsor them,must assume responsibility to protect participants from MoralscienceandthePresidentialCommissionfortheStudy( Brejomn Fonkin. 1780 ofBioethical lssues Othatmoralsoencewerenasfarawayfmrovement, that men would cese to be wohes to one anothe, and that human bengs would at length leanwfat they now impropefly callhumanity!* Are human volunteers in tesearch sponsored by the US Government treated safely andethcally？President Barack Obama posed this fundamental question to the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission） in response to chilling accounts of unethicalresearch undertaken by the US Public Health Service in Guatemala during the 1940s inwhich vulnerable populations were deliberately exposed to sexually transmitted diseases wthout ther Ina report released on Dec 15.2011,the Bioethics Commission concluded that the curent US system provides“substantialpeotectionsforthehealth,rights and welfare of esearch subjects and protectsthemfrom harm or unethical treatmentAlthough confident that the currentsystemaffordssubstantial protectionstoresearch volunteers,theCommissionidentifed14specific changes tocurrentpoliciesthatcould furtherreduce the lkelihood ofharm orunethical treatment.These recommendations include development ofa compensation system for research participants who are injured during research studies;respecting equivalent ethicalstandards inforeign countries where US-funded research is conducted;and more elicitjustifications for site selection to prevent potential exploitation of foreignresearch volunteers. As noted by the Intemational Research Pane that advised the Bioethics Commission,the USAunlike manycountries-lacksacompehensivesystemto address potential harms connected to research participation Thus some research volunteers are left without any assurance of protection from personal fnanxial and physicalrisk when they take part inresearch that benefits society as a whole Although current US regulations require investigators to infomm research participants about anymedical care or compensationtobeprovided in theevent ofresearch-related injuriesnorulerequres free medical care or compensation to be provided. In this regardtheUS egulations diffe from the research wwwthanot com Vol 379 janary 28.2012 knowledge orconsent
柳叶刀_2012-January-28.pdf
【柳叶刀】2012-January-28.pdf 柳叶刀_The.Lancet.2012.January.28
柳叶刀_2012-January-28.pdf