Reducing Regulatory Burdens on Research with Human Subjects: A Case Study of the Transition to the Final Common Rule at Boston Medical Center and Boston University Medical Campus.
Boston Medical Center/Boston University Medical Campus recently reduced certain requirements for human subjects research where this could be done without adversely affecting the rights and welfare of participants, in anticipation of changes in the Final Common Rule. Modifications affected exempt and...
| Publicado en: | Journal of Law, Medicine & Ethics Vol. 46; no. 1; pp. 164 - 180 |
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| Autor principal: | |
| Formato: | case study tables/charts Journal Article |
| Publicado: |
Cambridge University Press
Spring2018
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=128747363&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 128747363 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10731105 JME jtl: Journal of Law, Medicine & Ethics issn: 10731105 maglogo: N pubinfo: dt: Spring2018 vid: 46 iid: 1 pid: 15979 pub: Cambridge University Press artinfo: ui: 128747363 128747363 128747363 10.1177/1073110518766030 128747363 ppf: 164 ppct: 16 formats: tig: atl: Reducing Regulatory Burdens on Research with Human Subjects: A Case Study of the Transition to the Final Common Rule at Boston Medical Center and Boston University Medical Campus. aug: au: Ennever, Fanny K. affil: Fanny K. Ennever, Ph.D., is Chief Compliance Officer, Boston Medical Center. She holds an A.B. from Harvard University (Cambridge, MA), an M.S. from the Massachusetts Institute of Technology (Cambridge, MA), and a Ph.D. from Harvard University. sug: subj: Research Subjects Rules and Regulations Research, Medical Research Ethics Massachusetts Academic Medical Centers Organizational Policies Data Management Specimen Handling Consent (Research) Health Screening Institutional Review Research Subject Recruitment Special Populations ab: Boston Medical Center/Boston University Medical Campus recently reduced certain requirements for human subjects research where this could be done without adversely affecting the rights and welfare of participants, in anticipation of changes in the Final Common Rule. Modifications affected exempt and expedited categories, approval periods, ceding review, Quality Improvement/Quality Assessment activities, and some requirements for pregnant women, prisoners, and children. This case study may assist other institutions in responding to the Final Common Rule. pubtype: Academic Journal doctype: case study tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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