Extended discussion of information for informed consent for participation in clinical trials

Cochrane Database of Systematic Reviews

Volumn 2017, Issue 8, 2012, Pages

  Hon, Yoon Khee ^a   Narayanan, Punithavathi ^b   Goh, Pik Pin ^a  

^a HOSPITAL KUALA LUMPUR   (Malaysia)

^b Penang Adventist Hospital   (Malaysia)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85017143734     PISSN: None     EISSN: 1469493X     Source Type: Journal    
DOI: 10.1002/14651858.CD009835.pub2     Document Type: Article

References (22)

1. Cohn E, Larson E. Improving participant comprehension in the informed consent process. Journal of Nursing Scholarship 2007;39:273-80.
2. Dodd MF, Mood DW. Chemotherapy: helping patients to know the drugs they are receiving and their possible side effects. Cancer Nursing 1981;4(4):311-18.
3. Edwards SJ, Lilford RJ, Thornton J, Hewison J. Informed consent for clinical trials: in search of the "best" method. Social Science and Medicine Dec 1998;47(11):1825-40.
4. Ellis P, Dowsett SM, Butow PN, Tattersall MHN. Attitudes to randomized clinical trials among outpatients attending a medical oncology clinic. Health Expectations 1999;2(1):33-43.
5. Elwyn G, Frosch D, Rollnick S. Dual equipoise shared decision making: definitions for decision and behaviour support interventions. Implementation Science 2009;4:75.
6. Erlen JA. Informed consent: revisiting the issues. Orthopaedic Nursing July/August 2010;29(4):276-80.
7. Fitzgerald DW, Marotte C, Verdier RI, Johnson WD Jr, Pape JW. Comprehension during informed consent in a less-developed country. Lancet 2002;360(9342):1301-2.
8. Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA 2004;292(13):1593-1601.
9. Gillies K, Skea Z, Politi MC, Brehaut JC. Decision support interventions for people making decisions about participation in clinical trials. Cochrane Database of Systematic Reviews 2012, Issue 3. [DOI: 10.1002/14651858.CD009736]
10. Harth SC, Thong YH. Parental perceptions and attitudes about informed consent in clinical research involving children. Social Science and Medicine 1995;41(12):1647-51.
11. Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions. The Cochrane Collaboration, 2011, updated March 2011, Version 5.1.0.
12. ICH topic E6(R1) Guideline for good clinical practice Step 5 note for guidance on good clinical practice. CPMP/ICH/135/95 July 2002.
13. Jenkins VA, Fallowfield L, Souhami A, Sawtell M. How do doctors explain randomized clinical trials to their patients?. European Journal of Cancer 1999;35(8):1187-93.
14. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 2001;358:1772-7.
15. Krynski MD, Tymchuk AJ, Ouslander JG. How informed can consent be? New light on comprehension among elderly people making decisions about enteral tube feeding. The Gerontologist 1994;34(1):36-43.
16. Lidz CW, Applebaum PS, Grisso T, Renaud M. Therapeutic misconception and appreciation of risks in clinical trials. Social Science and Medicine 2004;68:1689-97.
17. Llewellyn-Thomas HA, McGreal MJ, Thiel EC, Fine S, Erlichman C. Patients' willingness to enter clinical trials: measuring the association with perceived benefits and preference for decision participation. Social Science and Medicine 1991;32:35-42.
18. National Institutes of Health. Glossary. http://grants.nih.gov/grants/policy/hs/glossary.htm (accessed 28 March 2012) 2012.
19. Ryan R, Prictor M, McLaughlin KJ, Hill S. Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database of Systematic Reviews 2008, Issue 1. [DOI: 10.1002/14651858.CD003717.pub2]
20. Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence-based medicine: what it is and what it isn't. BMJ 13 Jan 1996;312(7023):71-2. [DOI: 10.1136/bmj.312.7023.71]
21. Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. World Health Organization WHO Technical Report Series, No. 850, Annex 3 1995.
22. Williams BF, French JK, White HD. Informed consent during clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study. Lancet 2003;361:918-22.