A review of international and UK-based ethical guidelines for researchers conducting nontherapeutic genetic studies in developing countries

European Journal of Human Genetics

Volumn 14, Issue 1, 2006, Pages 9-16

  Choudhury, Shormila Roy ^a   Knapp, Leslie A ^a  

^a UNIVERSITY OF CAMBRIDGE   (United Kingdom)

Author keywords

Developing countries; Ethical guidelines; Informed consent; Nontherapeutic

Indexed keywords

ACCESS TO INFORMATION; BIOINFORMATICS; COMPENSATION; CONFIDENTIALITY; CULTURAL FACTOR; DEVELOPING COUNTRY; GENETIC POLYMORPHISM; GENOTYPE; HUMAN; HUMAN GENETICS; HUMAN RIGHTS; INFORMED CONSENT; PRACTICE GUIDELINE; PRIORITY JOURNAL; PRIVACY; PROFESSIONAL STANDARD; PROTECTION; REFUSAL TO PARTICIPATE; RESEARCH ETHICS; REVIEW; RISK BENEFIT ANALYSIS; SOCIAL ASPECT; UNITED KINGDOM;

CONSUMER PARTICIPATION; DEVELOPING COUNTRIES; ETHICS, RESEARCH; GENETIC RESEARCH; GREAT BRITAIN; GUIDELINES; HUMANS; INFORMED CONSENT; INTERNATIONAL COOPERATION; PUBLIC OPINION;

EID: 29644432124     PISSN: 10184813     EISSN: 14765438     Source Type: Journal    
DOI: 10.1038/sj.ejhg.5201497     Document Type: Review

References (50)

1. Nuffield Council on Bioethics: The ethics of research related to healthcare in developing countries. Nuffield Foundation, MRC & Wellcome Trust, 2002.
2. Shapiro HT, Meslin EM: Ethical issues in the design and conduct of clinical trials in developing countries. N Engl J Med 2001; 345: 139-142.
3. El Setouhy M, Agbenyega T, Anto F et al, Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries: Ethics. Fair benefits for research in developing countries. Science 2002; 298: 2133-2134.
4. Weijer C: Protecting communitiPs in research: philosophical and pragmatic challenges. Camb Q Healthc Ethics 1999; 8: 501-513.
5. Office for Human Research Protections (OHRP): Guidance on Research Involving Coded Private Information or Biological Specimens 2004. (Accessed December 2004). http://www.hhs.gov/ohrp/humansubjects/guidance/ cdebiol.pdf.
6. Nuremberg Code; In: Duncan AS, Dunstan GR, Welbourn RB (eds): The Dictionary of Medical Ethics [revised ed]. New York: Crossroad, 1981.
7. Shuster E: FiTty years later: the significance of the Nuremberg Code. N Engl J Med 1997; 337: 1436-1440.
8. World Medical Association: The Declaration of Helsinki, ethical principles for medical research involving human subjects. Amended by the WMA 52nd General Assembly, Edinburgh, 2000.
9. Council for International Organizations of Medical Sciences (CIOMS): Ethics and Research on Human Subjects. International Guidelines. Proceedings of the XXVIth CIOMS Conference, Geneva, Switzerland. 5-7th February 1992, Switzerland: CIOMS, 1993.
10. Council for International Organizations of Medical Sciences (CIOMS): International Ethical Guidelines for Biomedical Research Involving Human Subjects. Switzerland: CIOMS, 2002, (Accessed December 2004). http://www.cioms.ch/frame_guidelines_nov_2002.htm.
11. UNESCO, United Nations Educational, Scientific and Cultural Organization: International Declaration on Human Genetic Data 2003. Document Code: SHS.2004/DECLAR.BIOETHIQUECIB/4.
12. House of Commons UK: Human Tissue Bill. London: London Stationary Office, 2003.
13. Weijer C, Goldsand G, Emanuel E: Protecting Communities in research: current guidelines and limits of extrapolation. Nat Genet 1999; 23: 275-280.
14. Council of Europe, Steering Committee on Bioethics (CDBI)Evans I, Roscam Abbing H: Proposal for an instrument on the use of archived human biological materials in biomedical research, 2002a, (Accessed February 2005), http://www.coe.int/T/E/Legal_affairs/Legal_co-operation/Bioethics/ Activities/Biomedical_research/CDB1-INF(2002)5E.pdf.
15. Council of the Human Genome Organisation (HUGO): Statement of the Principled Conduct of Genetics Research 1996, (Accessed December 2004). http://www.gene.ucl.ac.uk/hugo/conduct.htm.
16. MeIical Research Council: Report: interim guidelines. Research involving human participants in developing societies; in: MRC (ed.): Ethical Guidelines for MRC-sponsored Studies. London: Medical Research Council, 1998.
17. Royal College of Physicians: Guidelines in the Practice of Ethics Committees in Medical Research Involving Human Subjects, 2nd edn., London: Royal College of Physicians, 1990.
18. WHO: Proposed international guidelines on ethical issues in medical genetics and genetic services. Report of a WHO meeting on ethical issues in medical genetics, Geneva, 15-16 December. Document code: WHO/HGN/GL/ ETH/98.1, 1997.
19. Bunch WH: Informed consent. Clin Orth Rel Res 2000; 378: 71-77.
20. de Sweemer-BP C: Informed consent: protecting the vulnerable; In: Bankowski Z, Levine RJ (eds): Ethics and Research on Human Subjects: International Guidelines. Switzerland: CIOMS, 1993, pp 36-43.
21. Gillon R: Ethical revAew procedures: a developed countries' perspective; In: Bankowski Z, Levine RJ (eds): Ethics and Research on Human Subjects: International Guidelines. Switzerland: CIOMS, 1993, pp 70-87.
22. Macklin R: Understanding Informed Consent. Acta Oncologica 1999; 38: 83-87.
23. Weijer C, Emanuel EJ: Ethics. Protecting communities in biomedical research. Science 2000; 289: 1142-1144.
24. Weijer C, Miller PB: Protecting communities in pharmacogenetic and pharmacogenomic research. Pharmacogenomics J 2004; 4: 9-16.
25. MeHical Research Council: Report: human tissue and biological samples for use in research. Operational and ethical guidelines. Medical Research Council, 2001.
26. Recommendations of the European Society of Human Genetics: Data Storage and DNA banking for biomedical research: Technical, social and ethical issues. Eur J Hum Genet 2003; 11 (Suppl 2): S8-S10.
27. Wellcome Trust & MRC: Report: Public perceptions of the collection of human biological samples. Wellcome Trust & MRC, 2000.
28. Marshall P: The Relevance of Culture for Informed Consent in U.S. Funded International Health Research; In: Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, Volume II: Commissioned Papers and Staff Analysis. NBAC, Bethesda, MD: National Bioethics Advisory Commission, 2001, pp C1-C38.
29. Wendler D, Shah S: Should children decide whether they are enrolled in nonbeneficial research? Am J Bioeth 2003; 3: 1-7.
30. Foster MW, Eisenbraun AJ, Carter TH: Communal discourse as a supplement to informed consent for genetic research. Nat Genet 1997; 17: 277-279.
31. Preziosi MP, Yam A, Ndiaye M, Simaga A, Simondon F, Wassilak SG: Practical experiences in obtaining informed consent for a vaccine trial in rural Africa. N Engl J Med 1997; 336: 370-373.
32. Coulibaly D, Msellati P, Dedy S, Welffens-Ekra C, Dabis F: Attitudes and behaviour of pregnant women towards HIV screening in Abidjan (Ivory Coast) in 1995 and 1996. Sante 1998; 8: 234-238.
33. White LJ, Jones JS, Felton CW, Pool LC: Informed consent for medical research: Common discrepancies and readability. Acad Emerg Med 1996; 3: 745-750.
34. Hamvas A, Madden KK, Nogee LM et al: Informed consent for genetic research. Arch Pediatr Adolesc Med 2004; 158: 551-555.
35. Council of Europe: Convention of Human Rights and Biomedicine 1997, (Accessed February 2005). http://conventions.coe.int/treaty/en/treaties/ html/164.html.
36. Working Group A: Informed consent; In: Bankowski Z, Levine RJ (eds): Ethics and Research on Human Subjects: International Guidelines. Switzerland: CIOMS, 1993, pp 56-61.
37. Austin MA: Ethical issues in human genoAe epidemiology: a case study based on the Japanese American family study in Seattle, Washington. Am J Epidemiol 2002; 155: 585-592.
38. Clayton EW Panel comment: why the use of anonymous samples for research matters. J Law Med Ethics 1995; 23: 375-377.
39. McPherson E: Ethical implications of the human genome diversity project. Nursing Connections 1995; 8: 36-43.
40. Reilly PR, Boshar MF, Holtzman SH: Ethical issues in genetic research: disclosure and informed consent. Nat Genet 1997; 15: 16-20.
41. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioural Research: Screening and Counselling for Genetic Conditions. Washington, DC: US Government Printing Office, 1983.
42. HUGO International Ethics Committee: Statement of DNA Sampling 1998, (Accessed February 2005). http://www.hugointernational.org/hugo/ sampling.html.
43. Hakimian R: Disclosure of Huntington's disease tT family members: the dilemma of known but unknowing parties. Genet Test 2000; 4: 359-364.
44. Council of Europe, Steering Committee on Bioethics (CDBI), Evans I, Roscam Abbing H: Draft Explanatory Report to the proposal for an instrument on the use of archived human biological materials in biomedical research 2002b, (Accessed February 2005). http://www.coe.int/T/E/Legal_affairs/Legal_co-operation/Bioethics/ Activities/Biomedical_research/CDB1-INF(2002)6E.pdf.
45. Medical Research Council: Personal information in medical research. MRC ethics series. Medical Research Council, 2000.
46. Nationaler Ethrikrat: Biobanken fur die Forshung. Stellungnahme. Berlin, 2004, (Accessed February 2005) http://www.ethikrat.org/themen/pdf/ Stellunnahme_Biobanken_04-03-17.pdf.
47. Gitanjali B, Raveendran R, Pandian DG, Sujindra S: Recruitment of subjects for clinical trials after informed consent: Does gender and educational status make a difference? J Postgrad Med 2003; 49: 109-113.
48. Weir RF, Horton JR: DNA banking and informed consent. Pt 1. IRB 1995; 17: 1-3.
49. Council of the Human Genome Organisation (HUGO): Statement on benefit-sharing 2000, (Accessed December 2004). http://www.gene.ucl.ac.uk/hugo/benefit.html.
50. Hoeyer K, Olofsson BO, Mjorndal T, Lynoe N: Informed consent and biobanks: A population-based study of attitudes towards tissue donation for genetic research. Scand J Public Health 2004; 32: 224-229.