Commentary: Can we facilitate the ethical approval of international observational studies?

International Journal of Epidemiology

Volumn 38, Issue 4, 2009, Pages 1108-1109

  Cuttini, Marina ^a   Saracci, Rodolfo ^b  

^a BAMBINO GESÙ CHILDREN S HOSPITAL   (Italy)

^b CNR   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

EPIDEMIOLOGICAL DATA; MEDICAL RESEARCH; MEDICAL SOCIETY; NOTE; OBSERVATIONAL STUDY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROFESSIONAL STANDARD; RESEARCH ETHICS;

ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; HUMANS; INTERNATIONAL COOPERATION; MULTICENTER STUDIES AS TOPIC; PRACTICE GUIDELINES AS TOPIC;

EID: 68849118470     PISSN: 03005771     EISSN: 14643685     Source Type: Journal    
DOI: 10.1093/ije/dyp238     Document Type: Note

References (7)

1. Claudot F, Alla F, Fresson J, Calvez T, Coudane H, Bonaïti-Pellié C. Ethics and observational studies in medical research: Various rules in a common framework. Int J Epidemiol 2009;38:1104-8.
2. Cuttini M, Marini C, Bruzzone S, Prati S, Saracci R. Protection of health information in Italy: A step too far? Int J Epidemiol 2008; doi:10.1093/ije/dyn185 [Epub 4 September 2008].
3. Greene SM, Geiger AM. A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval. J Clin Epidemiol 2006;59:784-90.
4. Council for International Organizations of Medical Sciences. International Ethical Guidelines for Epidemiological Studies. Geneva: CIOMS, 2009.
5. Council for International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical Research in Human Subjects. Geneva: CIOMS, 2002.
6. Federalwide Assurance for the Protection of Human Subjects, Section B FWA for International (non US) Institutions, para 3 Compliance with Laws, Regulations, Policies and Guidelines, item (e), http://www.hhs.gov/ ohrp/humansubjects/assurance/filasurt.htm (19 May 2009, date last accessed).
7. Directive 2001/20/EC of the European Parliament and of 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. Official Journal of the European Communities 1.5.2001, L121/34.