With thanks to: Sue Allen PCRN research nurse – development , direction and script; Cassi Duffin, City College, Norwich – production and pre –production; Teele Killing, City College, Norwich – post production, editing and artwork; Heather Leishman – PCRN co-ordinator – actor; Libby Aitchison – lecturer CCN – actor; Isabel Schoppe – film voiceover. Primary Care Research Network, East of England (PCRn EoE); National Institute of Health Research (NIHR); NHS Norfolk and Waveney – Research and Development (R&D); City College, Norwich (CCN); Norfolk and Suffolk Comprehensive Local Research Network ( N&SCLRN); Innovations East

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RCN Informed Consent guidance - Bibliography

Baum, M. (1990). The ethics of clinical research. London, King's Fund.

Beauchamp, T. & Childress, J. (1994). Principles of biomedical ethics. 4th edition. New York, Oxford University Press

Benson, AB, Pregler, JP, Bean, JA et al (1991) ‘Oncologists reluctance to accrue patients into clinical trials: An Illinois Cancer Center Study’. Journal of Clinical Oncology. 9: 2067-2075.

Bottomley, A. (1997). “To randomise or not to randomise: methodological pitfalls of the RCT design in psychosocial intervention studies.” European Journal of Cancer Care 6: 222-230.

Bryan, J. (2000). “Have you got the trials habit?” Cancer Services Insight January: 4-5.

Cox, K. (1999). A means to an end? A study of patients' experiences of participation in phase I and II anti-cancer drug trials. Unpublished PhD thesis. Nottingham, University of Nottingham.

Dongen, J A V & van der Velde, CJ. (1996). “The benefits of participation in clinical trials.” European Journal of Surgical Oncology 22: 561-562.

Freedman, B. (1990) ‘Cohort-specific consent: An honest approach to phase 1 clinical cancer studies’. IRB. 12: 5-7

Gotay, CC. (1991). “Accrual to cancer clinical trials: Directions from the research literature.” Social Science and Medicine 33(5): 569-

Hart, J. (1993). “Recruitment to randomised controlled trials. Letter.” The Lancet 341: 1539.

Kardinal, CG & Cupper, HT. (1979) ‘Hope, consent and clinical research’. Forum on Medicine. 1(8): 48-49.

Kemp, N, Skinner, E & Toms, J. (1984) ‘Randomised controlled trials in cancer treatment- a public opinion survey’. Clinical Oncology. 10: 155-161.

Llewellyn-Thomas, H. A.,McGreal, M J., Theil, E.C., Fine, S. & Erlichman, C. (1991). “Patients' willingness to enter clinical trials: measuring the association with perceived benefit and preference for decision participation.” Social Science and Medicine 32: 35-42.

Maslin-Prothero S E (2000) Factors affecting recruitment to breast cancer clinical trials: An examination of the British Association of Surgical Oncology II trial and the International Breast Cancer Intervention Study. Unpublished PhD thesis. Nottingham, University of Nottingham

Peto, R. & Baigent, C (1998). “Trials: the next 50 years.” British Medical Journal 7167: 1170-1171.

Schwartz, D., Flamant, R. & Lellouch, J. (1980). Clinical Trials. London, Academic Press.

Stephenson, T. & Walker D (1996). “Gaining Patients' Consent - Telling parents all relevant details might reduce recruitment of children to trials.” British Medical Journal 313 (7053): 362-363.

Stiller, C. (1992). “Survival of patients in clinical trials and at specialist centres”. In: Williams, C. J. (Ed) Introducing new treatments for cancer: practical, ethical and legal problems. Chichester, Wiley.

Stiller, C. A. (1994). “Centralised treatment, entry to trials and survival.” British Journal of Cancer 70: 352-362.

Tannock, I. (1995). “The recruitment of patients into clinical trials.” British Journal of Cancer 71: 1134-1135.

Taylor, KM, Feldstein, ML, Skeel, RT, Pandya, KJ, Ng, P. & Carbone, PP. (1994). “Fundamental dilemmas of the randomised clinical trial process: Results of a survey of the 1737 Eastern Cooperative Oncology Group Investigators.” Journal of Clinical Oncology 12 (9): 1796-1805.

Thornton, H. (1997). “The Voice of the Breast Cancer Patient - a Lonely Cry in the Wilderness.” European Journal of Cancer 33 (6): 825-828.

Tobias, J. & Souhami, S. (1993). “Fully informed consent can be needlessly cruel.” British Medical Journal 307: 1199-1201.

Wilson, K. & Rose, K. (1998). “Patient recruitment and retention strategies in randomised controlled trials.” Nurse Researcher 6(1): 35-46.

Fawcett, J. & Downs, F. S. (1992) The Relationship of Theory and Research, 2nd edition, F. A. Davis Company, Philadelphia.

Pearsell, J. (ed.) (1999) The Concise Oxford Dictionary 10th Edition, Oxford,. Oxford University Press.

Preece, R. (1994) Starting Research, London, Cassell.

Allan, K. (2001) Drawing out views on services: ways of getting started. Journal of Dementia Care 8(7) 23-25

Bro Taf Local Research Ethics Committee. Research on patients unable to give informed consent. Bulletin of Medical Ethics 1999, No 150: 6-7.

Dewing, J. (2001 work in progress). No more missing persons. International Journal of Dementia Research

Dresser, R. (1994) Missing persons:legal perceptions of incompetent patients. Rutgers Law Review 46 92) 609-719

Medical Research Council (1991) The Ethical Conduct of Research on the Mentally Incapacitated. London. Medical Research Council.

Post , S. G. (1995a) Alzheimer’s disease and the “then” self. Kennedy Institute of Ethics Journal. 5 (4) 307-321

Post, S.G. (1995b) The Moral Challenge of Alzheimer’s disease. Baltimore . John Hopkins University.

Zuckerman c (1994) Ethics in Clinical Practice pp90-99. Boston MA Little, Brown and Co.

Tait, T & Higginson, J (2000) ‘Partnerships and Power in Care’, in Bishop, V and Scott, I. (eds) Challenges in Clinical Practice, Palgrave, London.

References Rumbold, G (1996) Ethics in Nursing Practice 2nd Edition. Balliere Tindall. London

Tait, T & Higginson, J (2000) Partnerships and Power in Care IN Challenges in Clinical Practice Bishop, V and Scott, I EDS. Palgrave. London.

British Medical Association. Consent tool kit: Children and young people. London: British Medical Association, March, 2001.

Cuttini M. Proxy informed consent in pediatric research: A review. Early Human Development 2000;60:89-100.

Dalla-Vorgia P. Mason S, Megone C et al. Overview of European legislation on informed consent for neonatal research. Archives of Disease in Childhood Fetal Neonatal Edition 2001;84:F70-F73.

Giddings SS, Camp D, Flanagan MH et al. A policy regarding research in healthy children. Journal of Pediatrics 1993;123:852-855.

Koren G. Textbook of ethics in pediatric research. Malabar, FL:Krieger Pub. Co, 1993.

Medical Research Council, UK. MRC ethics series: The ethics of conduct of research on children. www.mrc.ac.uk/ethics_b.html.

Alt-White AC, Obtaining “informed” consent from the elderly. Western Journal of Nursing Research (1995) Dec; 17 (6): 700-705.

Bayer A, Tadd W, Unjustified exclusion of elderly people from studies submitted to research ethics committees for approval: descriptive study, 2000 BMJ Oct 21; 321 (7267): 992-3.

Bujega G, Kumar A, Bannerjee AK, Exclusion of elderly people from clinical research: a descriptive study of published reports. British medical Journal (1997) Oct 25; 315 (7115) 1059.

Collopy BJ, Autonomy in long term care: some crucial distinctions. Gerontologist. (1988) Jun; 28(3, Suppl.): 10-17.

Edwards S, (1997) Nursing Ethics: A principled approach. Macmillan: Houndsmills, Basingstoke.

Hutchins LF, Unger JM, Crowley JJ, Coltman CA, Albain KS, Uner-representation of patients 65 years of age or older in cancer-treatment trials. New England Journal of medicine (1999) Feb; 25 (1): 31-36.

Pullman D, The ethics of autonomy and dignity in long term care. Canadian Journal on Aging. (1999) Spring; 18 (1) 26-46.

Tadd W, Bayer A, Commentary: medical decision making based on chronological age – cause for concern. J Clin Ethics 2000 Winter; 11 (4): 328-33.

Tadd W The Helsinki Declaration: why all the fuss? Nursing Ethics 2000 Sep; 7 (5): 439-50.

Wager E, Tooley PJH, Emanuel MB, Wood SF, Get patients’ consent to enter clinical trials. British medical Journal. (1995) Sep 16; 311 (7007) 734-37.

World Medical Association (WMA) Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Adopted by the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000

Calman, K. & Hine, D. (1995) A Policy Framework for Commissioning Cancer Services. Department of Health.

Purandare, L. (1997) Attitudes to cancer may create a barrier to communication between patient and caregiver. European Journal

The Human Tissues Act 1961.

King EM-FO, Smith A, Jobst KA. Autopsy: consent, completion and communication in Alzheimer’s disease research. Age and Ageing 1993; 22: 209-214

Department of Health Guidelines to Local Research Ethics Committees (DOH 1991)

Royal College of Physicians, Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects, 3rd ed, London, 1996.

Royal College of Physicians, Guidelines on Research with Healthy Volunteers, London, 1986.

The British Paediatric Association, Guidelines for the Ethical Conduct of Research Involving Children, 1992.

R. Nicholson, “The Ethics of Research with Children” in M. Brazier and M. Lobjoit (eds.) Protecting the Vulnerable, London: Routledge, 1991.

Royal College of Psychiatrists, ‘Guidelines for Psychiatric Research Involving Human Subjects’ Psychiatric Bulletin 1990, 14, 48.

K. Fulford and K. Howse, “Ethics of research with psychiatric patients: principles, problems and the primary responsibilities of researchers” Journal of Medical Ethics 1993, 19, 85.