Publication Cover
Accountability in Research
Ethics, Integrity and Policy
Volume 10, 2003 - Issue 3
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Original Articles

Research Subject Advocate: A New Protector of Research Participants

Pages 159-174 | Published online: 08 Sep 2010

  • Brass , E. The Harbor-UCLA GCRC Experience with Data and Safety Monitoring . Paper presented at the first annual meeting of Research Subject Advocates . Baltimore, MD. April , Available from RSA Web site, http://www.gcrconline.org
  • Croop , J. Data and safety monitoring plans. Quality of DSM plans. Issues with multicenter trials . Paper presented at the first annual meeting of Research Subject Advocates . Baltimore, MD. April , Available from RSA Web site, http://www.gcrconline. org
  • DeVries , R. G. and Forsberg , C. P. 2002 . What do IRBs look like? What kind of support do they receive? . Accountability in Research , 9 : 199 – 216 .
  • Fagot-Largeault , A.M. 1988 . “ Epistemological presuppositions involved in the programs of human research ” . In The Use of Human Beings in Research , Edited by: Engelhardt , H.T. and Spiker , S. F. 161 – 188 . Boston : Kluwer Academic Publishers .
  • Federman , D. D. , Hanna , K. E. , Rodriguez , L. L. and the Committee on Assessing the System for Protecting Human Research Participants , eds. 2002 . Responsible Research: A Systems Approach to Protecting Research Participants. , Washing ton, D.C. : National Academy Press .
  • Hardy , C. , Palmer , I. and Phillips , N. 2000 . Discourse as a strategic resource. . Human Relations , 53 : 1227 – 1248 .
  • Hardy , C. , Phillips , N. and Clegg , S. 2001 . Reflexivity in organization and management theory: A study of the production of the research 'subject.' . Human Relations , 54 : 531 – 560 .
  • Institute of Medicine (IOM) Committee on Assessing the System for Protecting Human Research Participants . 2001 . Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (Executive Summary). , Washington, D.C. : National Academy Press .
  • Levinsky , N. G. 2002 . Nonfinancial conflicts of interest in research. . The New England Journal of Medicine , 347 : 759 – 761 .
  • Meadows , L. M. and Morse , J. M. 2001 . “ Constructing evidence within the qualitative project ” . In The Nature of Qualitative Evidence , Edited by: Morse , J. M. , Swanson , J. M. and Kuzel , A. J. 187 – 200 . Thousand Oaks, CA : Sage Publications .
  • NCRR . 2002 . NCRR mission statement . Available from http://www.ncrr.nih.gov/about_ncrr/mission.asp
  • NCRR . 2001 . Recommendations to General Clinical Research Centers (GCRCs) for Patient Safety in Clinical Research . Available from http://www.ncrr.nih.gov/clinical/gcrcpatientsafety20010622.asp
  • Pellegrino , E. D. 1992 . Beneficience, scientific autonomy, and self-interest: Ethical dimensions in clinical research. . Cambridge Quarterly of Healthcare Ethics , 4 : 361 – 369 .
  • Phillips , N. and Hardy , C. 2002 . Discourse Analysis: Investigating Processes of Social Construction. , Thousand Oaks, CA : Sage Publications .
  • 2003 . Policy Guidelines by the Office for Human Research Protection . February 7 Retrieved March 27, 2003, from http://ohrp.osophs.dhhs.gov/polasur.htm
  • Sandelowski , M. 1995 . Sample size in qualitative research. . Research in Nursing and Health , 18 : 179 – 183 .
  • Wajeeh , B. Role and Responsibilities of Research Subject Advocate . Paper presented at the first annual meeting of Research Subject Advocates . Baltimore, MD. April , Available from RSA Web site, http://www.gcrconline.org

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