The Invisible Hand in Clinical Research: The Study Coordinator's Critical Role in Human Subjects Protection

Hovde M. Seskin R. , “Selecting U.S. Clinical Investigators,” Applied Clinical Trials, 8 (1997): 34–42.

Department of Health and Human Services, Office of Inspector General, The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects, OEI-01-00-00190 (September 2001), available at <http://oig.hhs.gov/oei/reports/oei-01-00-00190.pdf>.

Annas G.J. , “Reforming Informed Consent to Genetic Research,” JAMA, 286 (2001): 2326–28.

King N. Henderson G. Stein J. , Beyond Regulations: Ethics in Human Subjects Research (Chapel Hill: University of North Carolina Press, 1999).

Papke A. , “The ACRP National Job Analysis of the Clinical Research Coordinator,” The Monitor, Winter (1996): 45–53, at 46.

Cooper J. Lomax J. , “The Role of the Research Nurse in Clinical Trials,” British Journal of Clinical Practice, 43 (1989): 167–68;.

Isaacman D.J. Reynolds E.A. , “Effect of a Research Nurse on Patient Enrollment in a Clinical Study,” Pediatric Emergency Care, 12 (1996): 340–42.

Good M. Schuler L. , “Subject Retention in a Controlled Clinical Trial,” Journal of Advanced Nursing, 26 (1997): 351–55.

McKinney J. Vermeulen W , “Research Nurses Play a Vital Role in Clinical Trials,” Oncology Nurse Forum, 27 (2000): 28–29, at 28.

Di Giulio P. , “Expanding the Role of the Nurse in Clinical Trials: The Nursing Summaries,” Cancer Nursing, 19 (1996): 343–47.

Hicks C. , “Nurse-Researcher: A Study of a Contradiction in Terms?,” Journal of Advanced Nursing, 24 (1996): 357–63;.

Johnson J.M. , “Clinical Trials: New Responsibilities and Roles for Nurses,” Nursing Outlook, 34 (1986): 149–53.

Gamache V. ,“Chasing Away Phantom Investigators,” CenterWatch, 8, no. 11 (2001): 1, 5–9 at 1.

Id.

Krueger R.A. , Focus Groups: A Practical Guide for Applied Research, 2d ed. (Thousand Oaks, California: SAGE Publications, 1994).

Merton R.K. Fiske M. Kendall P.L. , The Focused Interview: A Manual of Problems and Procedures, 2d ed. (New York: The Free Press, 1990).

Entwisle B. , “Designing Points of Convergence: Methods for Integrating Qualitative Approaches into Quantitative Analysis” (2002) (unpublished).

N5, QSR International Pty Ltd, Melbourne, Australia.

Annas G.J. , Standard of Care: The Law of American Bioethics (New York: Oxford University Press, 1993).

Ragin C. , The Comparative Method: Moving Beyond Qualitative and Quantitative Strategies (Berkeley: University of California Press, 1987).

See Grady , supra note 9;.

Di Giulio , supra note 9;.

Ecklund , supra note 10;.

Hicks , supra note 10;.

Johnson , supra note 10.

Seguin D.A. , “My Role as a Research Nurse Coordinator,” Critical Care Nursing, 12 (1990): 39–44.

Cooper Lomax , supra note 6;.

Isaacman Reynolds , supra note 6;.

Good Schuler , supra note 7;.

McKinney Vermeulen , supra note 8.

Abbott A. , The System of Professions (Chicago: University of Chicago Press, 1988).

See Johnson , supra note 10;.

Hubbard S.M. Donehower M.G. , “The Nurse in a Cancer Research Setting,” Seminars in Oncology, 7 (1980): 9–17.

National Institutes of Health, Required Education in the Protection of Human Research Participants, Notice OD-00-039 (June 5, 2000) (revised August 25, 2000), available at <http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html>.

Churchill L.R. , “Physician-Investigator/Patient-Subject: Exploring the Logic and the Tension,” Journal of Medical Philosophy, 5 (1980): 215–24;.

Katz J. , “Human Experimentation and Human Rights,” Saint Louis University Law Journal, 38 (1993): 7–54;.

Slatkoff S.F. Curtis P. Coker A. , “Patients as Subjects for Research: Ethical Dilemmas for the Primary Care Clinician-Investigator,” Journal of the American Board of Family Practice, 7 (1994): 196–201;.

Miller F.G. Rosenstein D.L. DeRenzo E.G. , “Professional Integrity in Clinical Research,” JAMA, 280 (1998): 1449–54;.

Elks M.L. , “Conflict of Interest and the Physician-Researcher,” Journal of Laboratory Clinical Medicine, 126 (1995): 19–23.

Reverby S.M. , ed., Tuskegee Truths: Rethinking the Tuskegee Syphilis Study (Chapel Hill: University of North Carolina Press, 2000).

See Gamache , supra note 11.