The Library

Ethical issues in implementation research: a discussion of the problems in achieving informed consent

Tools

Hutton, Jane (Statistician), Eccles, Martin P. and Grimshaw, Jeremy M.. (2008) Ethical issues in implementation research: a discussion of the problems in achieving informed consent. Implementation Science, Vol.3 (No.52). ISSN 1748-5908

Preview

PDF
WRAP_Bugg_Ethical_Issues_1748-5908-3-52.pdf - Requires a PDF viewer such as GSview, Xpdf or Adobe Acrobat Reader
Download (246Kb)

Official URL: http://dx.doi.org/10.1186/1748-5908-3-52

Abstract

Background: Improved quality of care is a policy objective of health care systems around the world. Implementation research is the scientific study of methods to promote the systematic uptake of clinical research findings into routine clinical practice, and hence to reduce inappropriate
care. It includes the study of influences on healthcare professionals' behaviour and methods to enable them to use research findings more effectively. Cluster randomized trials represent the optimal design for evaluating the effectiveness of implementation strategies. Various codes of
medical ethics, such as the Nuremberg Code and the Declaration of Helsinki inform medical research, but their relevance to cluster randomised trials in implementation research is unclear. This paper discusses the applicability of various ethical codes to obtaining consent in cluster trials in implementation research.
Discussion: The appropriate application of biomedical codes to implementation research is not obvious. Discussion of the nature and practice of informed consent in implementation research cluster trials must consider the levels at which consent can be sought, and for what purpose it can be sought. The level at which an intervention is delivered can render the idea of patient level
consent meaningless. Careful consideration of the ownership of information, and rights of access to and exploitation of data is required. For health care professionals and organizations, there is a balance between clinical freedom and responsibility to participate in research.
Summary: While ethical justification for clinical trials relies heavily on individual consent, for
implementation research aspects of distributive justice, economics, and political philosophy underlie the debate. Societies may need to trade off decisions on the choice between individualized consent and valid implementation research. We suggest that social sciences codes could usefully inform the consideration of implementation research by members of Research Ethics Committees.

Item Type:

Journal Article

Subjects:

R Medicine > R Medicine (General)

Divisions:

Faculty of Science > Statistics

Library of Congress Subject Headings (LCSH):

Informed consent (medical law), Clinical trials

Journal or Publication Title:

Implementation Science

Publisher:

BioMed Central Ltd.

ISSN:

1748-5908

Official Date:

17 December 2008

Dates:

Date	Event
17 December 2008	Published

Volume:

Vol.3

Number:

No.52

Identification Number:

10.1186/1748-5908-3-52

Status:

Peer Reviewed

Access rights to Published version:

Open Access

References:

1. Grol R, Grimshaw J: From best evidence to best practice; about
effective implementation of change in patient care. Lancet
2003, 362:1225-30.
2. Grimshaw J, Thomas R, MacLennan G, Fraser C, Ramsay C, Vale L,
Whitty P, Eccles M, Matowe L, Shirren L, Wensing M, Dijkstra R,
Donaldson C: Effectiveness and efficiency of guideline dissemination
and implementation strategies. Health Technol Assess
2004, 8:.
3. Foy R, Eccles M, Grimshaw J: Why does primary care need more
implementation research? Family Practice 2001, 18:.
4. Eccles M, Grimshaw J, Campbell M, Ramsay C: Research designs
for studies evaluating the effectiveness of change and
improvement strategies. Qual Safety Health Care 2003, 12:47-52.
5. The Nuremberg Code: (1947) Brit Med J 1996, 313:1448 [http:/
/www.hhs.gov/ohrp/references/nurcode.htm].
6. World Medical Association Declaration of Helsinki: Ethical principles
for medical research involving human subjects 2000 1964 [http://
www.wma.net/].
7. Hutton JL: Are distinctive ethical principles required for cluster
randomised controlled trials? Statist Med 2001, 20:473-488.
8. International Statistical Institute: Declaration of Professional Ethics 1985
[http://isi.cbs.nl/ethics.htm]. Voorburg: International Statistical Institute
9. Royal Statistical Society: Code of Conduct London: The Royal Statistical
Society; 1993.
10. American Statistical Association: Ethical Guidelines for Statistical Practice
1999 [http://www.amstat.org/about/ethicalguidelines.cfm]. Alexandria:
ASA Committee on Professional Ethics
11. Edwards SJL, Braunholtz DA, Lilford RJ, Stevens AJ: Ethical issues in
the design and conduct of cluster randomised controlled trials.
Brit Med J 1999, 318:1407-1409.
12. Eccles M, Steen N, Grimshaw J, Thomas L, McNamee P, Soutter J,
Wilsdon J, Matowe L, Needham G, Gilbert F, Bond S: Effect of audit
and feedback, and reminder messages on primary-care radiology
referrals: a randomised trial. Lancet 2001, 357:1406-1409.
13. Eccles M, McColl E, Steen N, Rousseau N, Grimshaw J, Parkin D,
Purves I: Effect of computerised evidence based guidelines on
management of asthma and angina in adults in primary care:
cluster randomised controlled trial. Brit Med J 2002, 325:941-7.
14. Eccles MP, Whitty PM, Speed C, Steen IN, Vanoli A, Hawthorne GC,
Grimshaw JM, Wood LJ, McDowell D: A pragmatic cluster randomised
controlled trial of a Diabetes REcall And Management
system: the DREAM Trial. Implementation Science 2007,
2:6.
15. Council of the International Organisation of Medical Sciences: International
Guidelines for Biomedical Research Involving Human Subjects 2002
[Http://www.cioms.ch].
16. Hutton JL, Ashcroft RE: Some popular versions of uninformed
consent. Health Care Anal 2000, 8:41-52.
17. Doyal L: Informed consent in medical research: journals
should not publish research to which patients have not given
fully informed consent-with three exceptions. Brit Med J 1997,
314:1107.
18. Woodward B: Challenges to Human Subject Protections in
US Medical Research. J Am Med 1999, 282:1947-1952.
19. Briesacher B, Limcangco R, Simoni-Wastila L, Doshi J, Gurwitz J:
Evaluation of Nationally Mandated Drug Use Reviews to
Improve Patient Safety in Nursing Homes: A Natural Experiment
strategy. J Am Geriatr Soc 2005, 53:991-996.
20. Winkelmann R: Co-payments for prescription drugs and the
demand for doctor visits-Evidence from a natural experiment.
Health Econ 2004, 13:1081-1089.
21. Vahratian A, Zhang J, Hasling J, Troendle J, Klebanoff M, Thorp J: The
effect of early epidural versus early intravenous analgesia use
on labor progression: A natural experiment. Am J Obs Gyne
2004, 191:259-65.
22. Ashcroft RE, Chadwick DW, Clark SRL, Edwards RHT, Frith L, Hutton
JL: Implication of socio-cultural contexts for the ethics of
clinical trials. Health Technology Assessment 1997, 1(9):iv+65.
23. Tu J, Willison D, Silver F, Fang J, Richards J, Laupacis RA, Kapral M:
Impracticability of Informed consent in the Registry of the
Canadian Stroke Network. New Eng J Med 2004, 350:1414-1421.
24. MRC ethics series: Personal Information in Medical Research. [New guidance
on Health and Social Care Act 2001: 'Section 60' added-January
2003] London: Medical Research Council 2000.
25. Walley T: Using personal health information in medical
research. Brit Med J 2006, 332:130-1.
26. Ashcroft RE: Giving Medicine a Fair Trial. Brit Med J 2000,
320:1686.
27. Ward H, Cousens S, Smith-Bathgate B, Leitch M, Everington D, Will
R, Smith P: Obstacles to conducting epidemiological research
in the UK general population. Brit Med J 2004, 329:277-279.
28. Verity C, Nicoll A: Consent, confidentiality, and the threat to
public health surveillance. Brit Med J 2002, 324:1210-1213.
29. Iversen A, Liddell K, Fear N, Hotopf M, Wessely S: Consent, confidentiality,
and the Data Protection Act. Brit Med J 2006,
332:165-169.
30. Woolf S, Rothemich S, Johnson R, Marsland D: Selection bias from
requiring patients to give consent to examinst data for
Health Services Research. Arch Fam Med 2000, 9:1111-1118.
31. Baker R, Shiels C, Stevenson K, Fraser R, Stone M: What proportion
of patients refuse consent to data collection from their
records for research purposes? Br J Gen Pract 2000,
50(457):655-656.
32. Junghans C, Feder G, Heminway H, Timmis A, Jones M: Recruiting
patients to medical research: double-blind randomised trial
of 'opt-in' versus 'opt-out' strategies. BMJ 2005,
331(7522):940.
33. Blackstone S: Ethics: a very short introduction Oxford: Oxford University
Press; 2001.
34. Beauchap T, Childress J: Principles of Biomedical Ethics Oxford: Oxford
University Press; 2001.
35. Robling M, Hood K, Houston H, Pill R, Fay J, Evans H: Public attitudes
towards the use of primary care patient record data in
medical research without consent: a qualitative study. J Med
Ethics 2004, 30:104-109.
36. The British Sociological Association: Statement of Ethical Practice.
[http://www.socresonline.org.uk/info/ethguide.html]. Sociological
Research Online 2001
37. Thompson M: Professional ethics and the teacher: towards a General
Teaching Council Stoke-on-Trent: Trentham; 1997.
38. Burgess RG, Ed: The ethics of educational research Lewes: The Falmer
Press; 1989.
39. Raffe D, Bundell I, Bibby J: Ethics and tactics: issues arising from
an educational survey. In The ethics of educational research Edited
by: Burgess RG. Lewes: The Falmer Press; 1989:13-30.
40. Rogerson S: Ethical aspects of information technology. Volume
16. London: Institute of Business Ethics; 1998.