Can vulnerable patients ever freely volunteer?

Good Clinical Practice Journal

Volumn 11, Issue 11, 2004, Pages 29-30

  Sharp, S Michael ^a  

^a EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; CLINICAL STUDY; DOCTOR PATIENT RELATION; INFORMED CONSENT; MEDICAL DECISION MAKING; MEDICAL DOCUMENTATION; MEDICAL ETHICS; NOTE; PATIENT CARE; PATIENT COMPLIANCE; PATIENT MONITORING; RISK ASSESSMENT; VOLUNTEER;

EID: 8644285384     PISSN: 13500961     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Note

References (11)

1. World Medical Association Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects. Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964 and last amended at the 52nd WMA General Assembly, Edinburgh, October 2002.
2. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of the Human Research Subjects of Research, National Institutes of Health, Bethesda, MD, 1979.
3. Department of Health and Human Services. 'Guideline for Good Clinical Practice. International Conference on Harmonization', Federal Register, pp25691-25709, May, 1997.
4. SM Sharp. 'Assuring informed consent documents are compliant with regulation', Research Practitioner, pp74-81, March/April, 2001.
5. E Estey, D Hotch, R Simon, S Marsoni, B Leyland- Jones, R Wittes. 'Therapeutic responce in Phase I trials of antineoplastic agents', Cancer Treatment Reports, pp1105-1115, September, 1986.
6. DD von Hoff, J Turner. 'Response rates, duration of response, and dose response effects in phase I studies of antineoplastic', Investigational New Drugs, pp115-122, February, 1991.
7. RD Pentz, AL Flamm, J Sugarman, et al. 'Study of the media's potential influence on prospective research participants' understanding of and motivations for participation in a high-profile Phase I trial', Journal of Clinical Oncology, pp3785-3791, September, 2002.
8. CK Daugherty, DM Banik, L Janish, MJ Ratain. 'Quantitative analysis of ethical issues in Phase I trials: A survey interview study of 144 advanced cancer patients', Institutional Review Board, pp6-14, May/June, 2000.
9. SM Sharp. 'Consent documents for oncology clinical trials: Does anybody read these things?', American Journal of Clinical Oncology, pp1-6, October, 2004.
10. E Kodish, M Eder, RB Noll, et al. 'Communication of randomization in childhood leukemia trials', Journal of the American Medical Association, pp470-475, January, 2004.
11. SM Sharp. 'Improving the process of informed consent', Applied Clinical Trials, pp32-38, January, 2001.