Ethical issues in the design of patient information sheets for research purposes

Pharmaceutical Medicine

Volumn 23, Issue 1, 2009, Pages 3-6

  Wells, Frank ^a,b  

^a European Forum for Good Clinical Practice Ethics Working Party   (United Kingdom)

^b European Forum for Good Clinical Practice Ethics Working Party   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT;

CANCER CHEMOTHERAPY; CANCER PATIENT; CANCER RADIOTHERAPY; CLINICAL RESEARCH; CLINICAL TRIAL; EDITORIAL; HEALTH CARE ORGANIZATION; HEALTH CARE POLICY; HUMAN; INFORMED CONSENT; METHODOLOGY; NEOPLASM; PATIENT CODING; PRACTICE GUIDELINE; PRIORITY JOURNAL; RESEARCH ETHICS;

EID: 66949121156     PISSN: 11782595     EISSN: None     Source Type: Journal    
DOI: 10.1007/bf03256742     Document Type: Editorial

References (13)

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2. International Conference on Harmonisation. Good clinical practice (ICH E6). ICH Steering Committee, 1996 June 10 [online]. Available from URL: http:// www.ich.org/LOB/media/MEDIA482.pdf [Accessed 2007 Jan 29]
3. EC clinical trials directive. Directive 2001/20/EC of the European Parliament and the council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use [online]. Available from URL: http:// www.eortc.be/Services/Doc/clinical-EU-directive-04-April-01.pdf [Accessed 2009 Jan 29]
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8. McCabe M, Morgan F, Curley H, et al. The informed consent process in a cross-cultural setting: is the process achieving the intended result? Ethn Dis 2005; 2 (15): 300-4
9. Caon M. Radiation information and informed consent for clinical trials. J Radiol Prot 2008; 28 (3): 415-22
10. Regulation (EC) No. 1901/2006of the European Parliament and of the Council of 20 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No. 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No. 726/2004. Off J EU 2006 Dec 27 [online]. Available from URL: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol- 1/ reg-2006-1901/reg-2006-1901-en.pdf [Accessed 2009 Jan 29]
11. Chappuy H, Doz F, Blanche S, et al. Children's views on their involvement in clinical research. Pediatr Blood Cancer 2008; 50 (5): 1043-46
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13. Stead M, Eadie D, Gordon D, et al. A qualitative exploration of patients' understanding of the science of clinical trials. J Med Ethics 2005; 31: 664-9