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  • 1
    Mykhalovskiy E , Weir L . The problem of evidence-based medicine: directions for social science . Social Science & Medicine , 2004 ; 59 : 10591069 .
  • 2
    Taylor KM , Margolese RG , Soskolne CL . Physicians’ reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer . New England Journal of Medicine , 1984 ; 310 : 13631367 .
  • 3
    Ross S , Grant A , Counsell C , Gillespie W , Russell I , Prescott R . Barriers to participation in randomised controlled trials: a systematic review . Journal of Clinical Epidemiology , 1999 ; 52 : 11431156 .
  • 4
    Nield-Anderson L , Dixon JK , Lee K . Issues in clinical nursing research: random assignment and patient choice in a study of alternative pain relief for sickle cell disease . Western Journal of Nursing Research , 1999 ; 21 : 266274 .
  • 5
    Morris AD , Zaritsky AL , LeFever G . Evaluation of ethical conflicts associated with randomized controlled trials in critically ill children . Critical Care Medicine , 2000 ; 28 : 11521156 .
  • 6
    Hales G , Beveridge A , Smith D . The conflicting roles of clinicians versus investigators in HIV randomised clinical trials . Culture, Health & Sexuality , 2001 ; 3 : 6779 .
  • 7
    McCleary L . Equipoise in clinical nursing research . Canadian Journal of Nursing Research , 2002 ; 34 : 4960 .
  • 8
    Howard L , deSalis I , Tomlin Z , Thornicroft G , Donovan J . Why is recruitment to trials difficult? An investigation into recruitment difficulties in an RCT of supported employment in patients with severe mental illness Contemporary Clinical Trials , 2008 ; 30 : 4046 .
  • 9
    Schroen AT , Petroni GR , Wang H et al. Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials . Clinical Trials , 2010 ; 7 : 312321 .
  • 10
    Abraham NS , Young JM , Solomon MJ . A systematic review of reasons for nonentry of eligible patients into surgical randomized controlled trials . Surgery , 2006 ; 139 : 469483 .
  • 11
    Fayter D , McDaid C , Ritchie G , Stirk L , Eastwood A . Systematic Review of Barriers, Modifiers and Benefits Involved in Participation in Cancer Clinical Trials . York : Centre for Reviews and Dissemination, University of York , 2006 .
  • 12
    Treweek S , Pitkethly M , Cook J et al. Strategies to improve recruitment to randomised controlled trials (Review) . Cochrane database of systematic reviews , 2010 ; 4 .
  • 13
    Hill AB . Medical ethics and controlled trials (Marc Daniels lecture) . British Medical Journal , 1963 ; 1 : 10431049 .
  • 14
    Fried C . Medical Experimentation: Personal Integrity and Social Policy . Amsterdam : North-Holland Publishing , 1974
  • 15
    Freedman B . Equipoise and the ethics of clinical research . New England Journal of Medicine , 1987 ; 312 : 141145 .
  • 16
    Ashcroft R . Equipoise, knowledge and ethics in clinical research and practice . Bioethics , 1999 ; 13 : 315326 .
  • 17
    Hippocratic Oath : Text, Translation, and Interpretation, by Ludwig Edelstein . Baltimore : Johns Hopkins Press , 1943 : Accessed at http://guides.library.jhu.edu/content.php?pid=23699&sid=190555 on 1/08/2011 .
  • 18
    Donovan J , Mills N , Smith M et al. Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study . British Medical Journal , 2002 ; 325 : 766770 .
  • 19
    Bower P , King M , Nazareth I , Lampe F , Sibbaldd B . Patient preferences in randomised controlled trials: conceptual framework and implications for research . Social Science & Medicine , 2005 ; 61 : 685695 .
  • 20
    PCRG (Preference Collaborative Review Group) . Patients’ preferences within randomised trials: systematic review and patient level meta-analysis . British Medical Journal , 2008 ; 337 : a1864 .
  • 21
    Lilford RJ , Jackson J . Equipoise and the ethics of randomization . Journal of the Royal Society of Medicine , 1995 ; 88 : 552559 .
  • 22
    Wade J , Donovan JL , Lane JA , Neal DE , Hamdy FC . It’s not just what you say, it’s also how you say it: opening the ‘black box’ of informed consent appointments in randomised controlled trials . Social Science & Medicine , 2009 ; 68 : 20182028 .
  • 23
    Faden RR , Beauchamp TL . A History and Theory of Informed Consent . Oxford : Oxford University Press , 1986 .
  • 24
    Alderson P . Informed consent: ideal or reality? Journal of Health Services Research & Policy , 1998 ; 3 : 124126 .
  • 25
    Jenkins VA , Fallowfield LJ , Souhami A , Sawtell M . How do doctors explain randomised clinical trials to their patients? European Journal of Cancer , 1999 ; 35 : 11871193 .
  • 26
    Fallowfield L , Jenkins V , Farewell V , Saul J , Duffy A , Eves R . Efficacy of a Cancer Research UK communication skills training model for oncologists: a randomised controlled trial . Lancet , 2002 ; 359 : 650656 .
  • 27
    Mills N , Donovan JL , Wade J , Hamdy FC , Neal DE , Lane JA . Exploring treatment preferences facilitated recruitment to randomised controlled trials . Journal of Clinical Epidemiology , 2011 ; 64 : 11271136 .
  • 28
    Brown RF , Butow PN , Butt DG , Moore AR , Tattersall MHN . Developing ethical strategies to assist oncologists in seeking informed consent to cancer clinical trials . Social Science & Medicine , 2004 ; 58 : 379390 .
  • 29
    Brown RF , Butow PN , Ellis P , Boyle F , Tattersall MHN . Seeking informed consent to cancer clinical trials: describing current practice . Social Science & Medicine , 2004 ; 58 : 24452457 .
  • 30
    Featherstone K , Donovan J . Random allocation or allocation at random? Patients’ perspectives of participation in a randomised controlled trial British Medical Journal , 1998 ; 317 : 11771180 .
  • 31
    Hietanen B , Aro AR , Holli K , Absetz P . Information and communication in the context of a clinical trial . European Journal of Cancer , 2000 ; 36 : 20962104 .
  • 32
    Robinson EJ , Kerr J , Stevens A , Lilford R , Braunholtz D , Edwards S . Lay conceptions of the ethical and scientific justifications for random allocation in clinical trials . Social Science & Medicine , 2004 ; 58 : 811824 .
  • 33
    Applebaum PS , Roth LH , Lidz CW , Benson P , Winslade W . False hopes and best data: consent to research and the therapeutic misconception . Hastings Center Report , 1987 ; 17 : 2024 .
  • 34
    Applebaum PS , Lidz CW , Grisso T . Therapeutic misconception in clinical research: frequency and risk factors . IRB Ethics and Human Research , 2004 ; 26 : 18 .
  • 35
    McCann SK , Campbell MK , Entwistle VA . Reasons for participating in randomised controlled trials: conditional altruism and considerations for self . Trials , 2010 ; 11 : 31 .
  • 36
    Donovan JL , Hamdy F , Neal D et al. Prostate Testing for Cancer and Treatment (ProtecT) feasibility study . Health Technology Assessment , 2003 ; 7 : 142 .
  • 37
    Britten N . Qualitative research: qualitative interviews in medical research . British Medical Journal , 1995 ; 311 : 251253 .
  • 38
    Murphy E , Dingwall R . Qualitative Methods in Health Policy Research . New York : Aldine de Gruyter , 2003 .
  • 39
    Charmaz K . Shifting the grounds: constructivist grounded theory methods . In : Morse JM , Stern PN , Corbin J , Bowers B , Charmaz K , Clarke AE ( eds ) Developing Grounded Theory: The Second Generation . Walnut Creek California : Left Coast Press , 2009 : 27154 .
  • 40
    Roberts C , Sarangi S . Theme-oriented discourse analysis of medical appointments . Medical Education , 2005 ; 39 : 632640 .
  • 41
    Donovan JL , Athene JL , Peters TJ et al. Development of a complex intervention improved randomization and informed consent in a randomized controlled trial . Journal of Clinical Epidemiology , 2009 ; 62 : 2936 .
  • 42
    Ness DE , Kiesling SF , Lidz CW . Why does informed consent fail? A discourse analytic approach Journal of the American Academy of Psychiatry and the Law , 2009 ; 37 : 349362 .
  • 43
    Miller FG , Brody H . The clinician-investigator: unavoidable but manageable tension . Kennedy Institute of Ethic Journal , 2003 ; 13 : 329346 .
  • 44
    Morreim EH . The clinical investigator as fiduciary: discarding a misguided idea . Journal of Law Medicine & Ethics , 2005 ; 33 : 586598 .
  • 45
    Theodosius C . Recovering emotion from emotion management . Sociology , 2006 ; 40 : 893910 .
  • 46
    ICH . Harmonised Tripartite Guideline for good clinical practice Topic E 6 (R1) . 1996 .
  • 47
    Fallowfield L , Saul J , Gilligan B . Teaching senior nurses how to teach communication skills in oncology . Cancer Nursing , 2001 ; 24 : 185191 .
  • 48
    Hewitt J . A critical review of the arguments debating the role of the nurse advocate . Journal of Advanced Nursing , 2002 ; 37 : 439445 .
  • 49
    Allen D . What do you do at work? Profession building and doing nursing International Nursing Review , 2007 ; 54 : 4148 .
  • 50
    Armstrong D . The fabrication of nurse-patient relationships . Social Science & Medicine , 1983 ; 17 : 457460 .
  • 51
    Porter S . The patient and power: sociological perspectives on the consequences of holistic care . Health & Social Care in the Community , 1997 ; 5 : 1720 .
  • 52
    Wilson-Barnett J . The nurse-patient relationship . In : Gillon R . ( ed .) Principles of Healthcare Ethics . Chichester : John Wiley & Sons , 1994 : 367377 .
  • 53
    Woodrow P . Nurse advocacy: is it in the patient’s best interest? British Journal of Nursing , 1997 ; 6 : 225229 .
  • 54
    WMA (World Medical Association) . Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects 2008 . Seoul : 59th WMA General Assembly. Available at: http://www.wma.net/en/30publications/10policies/b3/index.html, accessed 1 August 2011 .
  • 55
    Charles C , Gafni A , Whelan T . Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango) Social science & Medicine , 1997 ; 44 : 681692 .
  • 56
    Makoul G , Clayman ML . An integrative model of shared decision making by healthcare professionals . Patient Education & Counseling , 2006 ; 3 : 301312 .
  • 57
    Sackett DL , Rosenbergm WMC , Gray JAM , Haynes RB , Richardson WS . Evidence based medicine: what it is and what it isn’t . British Medical Journal , 1996 ; 312 : 7172 .
  • 58
    Edwards A , Elwyn G . Shared Decision-Making in Health Care: Achieving Evidence-Based Patient Choice , 2nd edn . Oxford : Oxford University Press , 2009 .
  • 59
    Cribb A , Entwistle VA . Shared decision making: trade-offs between narrower and broader conceptions . Health Expectations , 2011 ; 14 : 210219 .
  • 60
    Bergum V . Relational ethics, what is it? In Touch 1 1998. At: Provincial Health Ethics Network. http://www.phen.ab.ca/materials/intouch/vol1/intouch1-02.html, accessed 2 March 2011 .
  • 61
    Sherwin S , Winsby M . A relational perspective on autonomy for older adults residing in nursing homes . Health Expectations , 2010 ; 14 : 182190 .
  • 62
    MacDonald H . Relational ethics and advocacy in nursing: literature review . Journal of Advanced Nursing , 2007 ; 57 : 119126 .
  • 63
    Borry P , Schotsmans P , Dierickx K . The birth of the empirical turn in bioethics . Bioethics , 2005 ; 19 : 4971 .
  • 64
    Oberle K , Allen M . Ethical considerations for nurses in clinical trials . Nursing Ethics , 2006 ; 13 : 180186 .
  • 65
    Campbell MK , Snowdon C , Francis D et al. Recruitment to randomised trials: strategies for trial enrolment and participation study. The STEPS study . Health Technology Assessment , 2007 ; 11 : 3942 .
  • 66
    Instone SL , Mueller MR , Gilbert TL . Therapeutic discourse among nurses and physicians in controlled clinical trials . Nursing Ethics , 2008 ; 15 : 803812 .
  • 67
    Spilsbury K , Petherick E , Cullum N , Nelson A , Nixon J , Mason S . The role and potential contribution of clinical research nurses to clinical trials . Journal of Clinical Nursing , 2008 ; 17 : 549557 .