Research subject advocate: A new protector of research participants

Accountability in Research

Volumn 10, Issue 3, 2003, Pages 159-174

  Neill, Kathleen M ^a  

^a GEORGETOWN UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

General Clinical Research Center; Human subject experimentation; Institutional review board; Protection of human research participants; Qualitative analysis; Research subject advocate

Indexed keywords

ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CLINICAL TRIAL; EMPIRICAL APPROACH; HUMAN; HUMAN EXPERIMENT; INTERVIEW; LEGAL APPROACH; LEGAL ASPECT; NATIONAL CENTER FOR RESEARCH RESOURCES; ORGANIZATION AND MANAGEMENT; PATIENT ADVOCACY; PROFESSIONAL STANDARD; PUBLIC RELATIONS; RESEARCH SUBJECT; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH; EMPIRICAL APPROACH; LEGAL APPROACH; NATIONAL CENTER FOR RESEARCH RESOURCES;

CLINICAL TRIALS; ETHICS COMMITTEES, RESEARCH; HUMAN EXPERIMENTATION; HUMANS; INTERPROFESSIONAL RELATIONS; INTERVIEWS; PATIENT ADVOCACY; PROFESSIONAL ROLE; RESEARCH SUBJECTS; UNITED STATES;

EID: 1642633268     PISSN: 08989621     EISSN: 15455815     Source Type: Journal    
DOI: 10.1080/714906094     Document Type: Article

References (17)

1. Brass, E. (2002, April). The Harbor-UCLA GCRC Experience with Data and Safety Monitoring. Paper presented at the first annual meeting of Research Subject Advocates, Baltimore, MD. Available from RSA Web site, http://www.gcrconline.org
2. Croop, J. (2002, April). 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. Available from RSA Web site, http://www.gcrconline.org
3. 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.
4. Fagot-Largeault, A.M. (1988). Epistemological presuppositions involved in the programs of human research. In The Use of Human Beings in Research. H.T. Engelhardt, and S. F. Spiker (Eds.), Boston: Kluwer Academic Publishers, pp. 161-188.
5. Federman, D. D., Hanna, K. E., and Rodriguez, L. L. (eds.) and the Committee on Assessing the System for Protecting Human Research Participants (2002). Responsible Research: A Systems Approach to Protecting Research Participants. Washington, D.C.: National Academy Press.
6. Hardy, C., Palmer, I., and Phillips, N. (2000). Discourse as a strategic resource. Human Relations 53: 1227-1248.
7. 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.
8. 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.
9. Levinsky, N. G. (2002). Nonfinancial conflicts of interest in research. The New England Journal of Medicine 347: 759-761.
10. Meadows, L. M., and Morse, J. M. (2001). Constructing evidence within the qualitative project. In The Nature of Qualitative Evidence. J. M. Morse, J. M. Swanson, and A. J. Kuzel (Eds.), Thousand Oaks, CA: Sage Publications, pp. 187-200.
11. NCRR (2002). NCRR mission statement. Available from http://www.ncrr.nih.gov/about_ncrr/mission.asp
12. 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
13. Pellegrino, E. D. (1992). Beneficience, scientific autonomy, and self-interest: Ethical dimensions in clinical research. Cambridge Quarterly of Healthcare Ethics 4: 361-369.
14. Phillips, N., and Hardy, C. (2002). Discourse Analysis: Investigating Processes of Social Construction. Thousand Oaks, CA: Sage Publications.
15. Policy Guidelines by the Office for Human Research Protection (2003, February 7). Retrieved March 27, 2003, from http://ohrp.osophs.dhhs.gov/polasur.htm
16. Sandelowski, M. (1995). Sample size in qualitative research. Research in Nursing and Health, 18: 179-183.
17. Wajeeh, B. (2002, April) Role and Responsibilities of Research Subject Advocate. Paper presented at the first annual meeting of Research Subject Advocates, Baltimore, MD. Available from RSA Web site, http://www.gcrconline.org