This paper aims to show that the ethical justifications and the processes for requiring consent for interventional research or treatment are different to requiring consent for the disclosure of patient or subject information. I will argue that these process and theoretical differences are sufficient to view “consent” in the two situations as different concepts and suggest that the phrase “permission to disclose” would be more appropriate in the information disclosure situations.
OtlowskiMFA. Tackling legal challenges posed by population biobanks: reconceptualising consent requirements. Med Law Rev2012; 20: 191–226.
2.
Otlowski (2012): 204.
3.
Independent Review Group on retention of organs at Post-Mortem, Report on Phase 3, Appendix 2 Draft Standards for the Management of Post-Mortem Examinations instructed by the Procurator Fiscal, p.13 accessed at http://www.sehd.scot.nhs.uk/publications/romp3/romp3-07.htm. Their context was the permission to use organs and tissues at postmortem. The move away from the term “consent” in that situation helps to illustrate the fact that the use of this term carries with it the expectations of a process that is not always applicable. This paper will argue that there are other contexts and situations where it would be better to use a different term and process.
4.
O’BrienJChantlerC. Confidentiality and the duties of care. J Med Ethics2003; 29: 36–40.
5.
Beauchamp TL. Autonomy and consent. In: Miller FG and Wertheimer A (eds) The Ethics of Consent. New York: Oxford University Press, 2010, pp.55–78.
6.
For a comprehensive analysis of the difficulties with consent in research, see Foster C. The Ethics of Medical Research on Humans. Cambridge: Cambridge University Press, 2001, pp.113–129. She lists for example the evidence that subjects often misinterpret the information they are given, such as a lack of understanding of randomized case–control designs. The critical difference between consent for treatment and research is that in the therapeutic setting, the patient believes that the doctor knows what is best for her, whereas in research, the patient/subject does not. Also, clearly in nontherapeutic research, the benefit is for others rather than the subject. However, these differences do not affect the way “informed consent” is being used for this paper, especially as the requirements and the processes followed are the same.
7.
This is to be distinguished from disclosure of information to patients in order to obtain their informed consent. See for example Beauchamp TL. Informed consent: its history, meaning and present challenges. Cambr Quart Healthcare Ethics 2011; 20: 515–523: “in the United States … informed consent has often been treated as synonymous with this legal doctrine, which is centered almost entirely on disclosure and on liability for injury”(emphasis added). However, it is not claimed that PTD is necessarily the best term, but it distinguishes consent for disclosure from “informed consent” for the purposes of this paper. For example, “permission to disclose” is more applicable when used in the context of a report, as opposed to research based on data, as the permission may not always be for disclosure of data, but may also be for further uses of that data (p.518).
8.
Faden RR and Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford University Press, 1986, p.274.
9.
Manson NC and O'Neill O. Rethinking Informed Consent in Bioethics. Cambridge: Cambridge University Press, 2007, p.2. See also Faden RR and Beauchamp TL. A history and theory of informed consent. New York: Oxford University Press, 1986, pp.153–156.
10.
BeauchampTLChildressJF. Principles of Biomedical Ethics2001,5th ed. New York: Oxford University Press, pp. 77–77.
11.
Beauchamp TL and Childress JF (2001): 70.
12.
Beauchamp TL and Childress JF (2001): 70–71.
13.
See for example Dworkin G. The Theory and Practice of Autonomy. Cambridge University Press, 1988, pp.12–20.
14.
Manson NC and O’Neill (2007): 70.
15.
See for example Downie RS and Calman KC. Healthy Respect, Ethics in Health Care. 2nd ed. Oxford: Oxford University Press, 1994, p.63, where they view respect for the autonomous individual as being the underlying moral principle from which other moral principles derive their authority.
16.
At Ref. 1, p.200.
17.
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, DHEW Publication No. (OS) 78-0012. Washington, DC: U.S. Government Printing Office, 1978, p.4.
18.
HarrisJ. Consent and end of life decisions. J Med Ethics2003; 29: 10–15.
19.
Beauchamp TL. Informed consent: its history, meaning and present challenges. Cambr Quart Healthcare Ethics 2011, 20, 515–523.
20.
BrazierM. Patient autonomy and consent to treatment: the role of the law?. Legal Stud1987; 7: 169–193.
21.
Chester v Afshar [2004] UKHL 41.
22.
At 18.
23.
BrazierMCaveE. Medicine, Patients and the Law2011,5th ed. London: Penguin Books, pp. 116–116.
24.
Sidaway v. Governors of the Bethlem Royal Hospital and Maudsley Hospital [1985] UKHL 1, p.659.
25.
MiolaJ. On the materiality of risk: paper tigers and panaceas. Med Law Rev2009; 17: 76–108.
26.
CoggonJ. Varied and principled understandings of autonomy in English law: justifiable inconsistency or blinkered moralism?. Health Care Anal2007; 5: 235–255.
27.
McLean SAM. Autonomy, Consent and the Law. Abingdon: Routledge, 2010, p.87 She argues for example that for policy reasons, the patient’s individual choice makes way to an “objective” or “reasonable patient” test.
28.
MacLeanA. From sidaway to Pearce and beyond: is the legal regulation of consent any better following a quarter of century of judicial scrutiny?. Med Law Rev2012; 20: 108–129.
29.
MacLean, 2012: 121. He appears to use “self-determination” as a concept similar to Dworkin’s (1988) “second order” autonomy, where those who exercise this “define their nature, give meaning and coherence to their lives, and take responsibility for the kind of person they are” (at 20).
30.
DevaneyS. Autonomy rules ok. Med Law Rev2005; 13: 102–107.
31.
Eyal N. Informed consent. In: Zalta EN (ed) The Stanford Encyclopaedia of Philosophy (Fall 2011 Edition), URL = http://plato.stanford.edu/archives/fall2012/entries/informed-consent/, 2.4. The other reasons listed are: protection, autonomy, preventing abusive conduct, self-ownership, non-domination and personal integrity (forthcoming).
32.
Eyal (2011): 2.4.
33.
Eyal (2011): 2.4.
34.
Autonomy and Trust in Bioethics, the Gifford Lectures 2001. Cambridge: Cambridge University Press, 2002, p.151.
35.
See Dworkin G (1988): 12–20.
36.
Tauber AI. Patient Autonomy and the Ethics of Responsibility. Massachusetts: MIT Press, 2005, p.120.
37.
At 121.
38.
O’Neill (2002): 18.
39.
At 19.
40.
See for example Dyer AR and Bloch S. Informed consent and the psychiatric patient. J Med Ethics 1987; 13: 12–16, at 15; Brazier M and Lobjoit M. Fiduciary relationship: an ethical approach and a legal concept? In: Bennett R and Erin CA (eds) HIV and AIDS Testing: Screening and Confidentiality. Oxford: Oxford University Press, 1999, pp.179–199, at 187. It also requires a power imbalance between the parties, which is said to be present: Kennedy I. The fiduciary relationship and its application to doctors and patients. In: Birks P (ed) Wrongs and remedies in the twenty-first century. Oxford: Oxford University Press, 1996, pp.111–140.
41.
Tamin J. “Models of occupational medicine practice: an approach to understanding moral conflict in ‘dual obligation’ doctors,” published online first in Medicine, Healthcare and Philosophy, Digital Object Identifier (DOI) 10.1007/s11019-012-9426-4.
42.
Joffe S and Truog RD. Consent to medical care: the importance of fiduciary context. In: Miller FG and Wertheimer A (eds) The Ethics of Consent. New York: Oxford University Press, 2010, pp.347–373.
43.
At 353.
44.
At 354.
45.
Manson and O’Neill (2007); p.158.
46.
General Medical Council. Consent: Patients and Doctors Making Decisions Together. London, 2008; listed under “The duties of a doctor registered with the General Medical Council”: “Patients must be able to trust doctors with their lives and health.”.
47.
For example, Rogers WA and Braunack-Mayer AJ. Practical Ethics for General Practice. 2nd ed. Oxford: Oxford University Press, 2009, p.115: “the principle of respect for patient autonomy has become one of the central planks of contemporary medical ethics, with the practice of informed consent serving as a legal reminder of its importance.”.
48.
For a fuller description, see Baier A. Moral Prejudices: Essays on Ethics. Massachusetts: Harvard University Press, 1994, pp.20–23, where she contrasts “personal autonomy and independence” with “the more satisfactory interdependence.”.
49.
For example, Tauber (2005): 120.
50.
For example, O’Neill O. A question of trust, The BBC Reith Lectures 2002. Cambridge: Cambridge University Press, 2002 suggested that she “might trust (her) GP to diagnose and prescribe for a sore throat, but not for a heart attack.”.
51.
See for example Otlowski (2012): 192–193.
52.
For example, in England and Wales, the patient has up to 21 days to view the report before it is sent under the Access to Medical Reports Act 1988, chapter 28, HMSO at 4(2)(b).
53.
Dworkin (1988): 104.
54.
Manson and O’Neill (2007): 22.
55.
For example, Laurie G. Genetic Privacy: A Challenge to Medico-Legal Norms. Cambridge: Cambridge University Press, 2002; p.213: “discrimination and stigmatisation can result from disclosure of sensitive personal information.”.
56.
At p.99.
57.
At pp.100–101.
58.
GillonR. Philosophical Medical Ethics, Chichester: John Wiley & sons, 1985, pp. 106–106.
59.
They claim that doctors owe an obligation of fidelity to patients and assert that “the physician’s obligation to live up to the patient’s reasonable expectations of privacy and confidentiality is one way to specify the general obligation of fidelity.”.
60.
Beauchamp TL and Childress JF (2001): 306–308.
61.
General Medical Council (GMC). Confidentiality, London, 2009.
62.
W v Egdell [1990] 1 All ER 835; Campbell v MGN [2004] UKHL 22.
63.
GMC (2009) para 8; W v Egdell [1990] per Lord Bingham at 848. However, “public interest” is different to “what the public may find interesting”: see Lion Laboratories Ltd v Evans [1984] 2 All ER 417 at 422–423.
64.
Laurie (2002): 211–212. However, in addition to the doctor–patient relationship, the nature of the information itself (such as health information) is important in determining whether information is private and confidential: Campbell v MGN [2004] UKHL 22 per Baroness Hale at 145: “It has always been accepted that information about a person's health and treatment for ill-health is both private and confidential. This stems not only from the confidentiality of the doctor-patient relationship but from the nature of the information itself.”.
65.
Ash v McKennitt [2006] EWCA Civ 1714, per Buxton LJ at 23: “A person’s health is in any event a private matter, as the Campbell case demonstrated. It is doubly private when information about it is imparted in the context of a relationship of confidence.”.
66.
Laurie G. Genetic Privacy: A Challenge to Medico-Legal Norms. Cambridge: Cambridge University Press, 2002; 250. In addition, if one is in control of one’s information, the House of Lords has maintained that one can impose a duty of confidence (Douglas v Hello [2007] UKHL 21, at 118).
67.
Health information is classed as “sensitive personal data” (s 2), which requires explicit consent for processing, save for exemptions listed in Schedule 3.
68.
Laurie (2002): 253.
69.
Article 8 of the European Convention on Human Rights (ECHR), in HRA Schedule 1: “Everyone has the right to respect for his private and family life …”.
70.
Ash v McKennitt [2006] EWCA Civ 1714, per Buxton LJ at 8(ii).
71.
See Wainwright v Home Office [2003] UKHL 53 per Lord Hoffman at 14–35; and Campbell v MGN [2004] UKHL 22 per Baroness Hale at 133: “our law cannot, even if it wanted to, develop a general tort of invasion of privacy.” This contrasts with the earlier case of Douglas v Hello! [2001] QB 967 which suggested that English law would recognise and protect a right of privacy, a position not endorsed by subsequent cases, such as Wainwright. Whether in fact there ought to be a discrete privacy tort rather than “shoehorning” article 8 into the tort of breach of confidence is beyond the scope of this article.
72.
see Ref. 58.
73.
Douglas v Hello! [2001] QB 967 at 126. However, as mentioned above, subsequent judgments have not supported a freestanding “right to privacy” in English common law.
74.
Campbell v MGN [2004] UKHL 22 at 50.
75.
Dworkin (1988): 104. He gives the following examples to support this view: “One way of interfering with your autonomy is to deceive you. This kind of interference with information is, however, just the opposite kind from that involved in interference with privacy. What is controlled is the information coming to you, not the information coming from you. I do not know something about you that you might wish to conceal. I conceal something from you that you might wish to know. Thus, autonomy but not privacy is diminished. Similarly, privacy may be interfered with but not autonomy. If someone taps your phone conversations without your knowledge he interferes with your privacy. But your decisions, your actions, your values, are in no way changed or altered from what they might be otherwise. You are as self-determining as ever.” He also cites the Supreme Court decision in Griswold v Connecticut 381 US 479 (1965) when it ruled “that prohibition of the use of contraceptives was a violation of the constitutional right of privacy” as an example of “the intellectual disorder from confusing these two notions.”.
76.
Laurie (2002): 83.
77.
Feldman D. Privacy as a civil liberty. In: Freeman MDA (ed) Current Legal Problems. London: University College 1994; 47: 41–51.
78.
Per Lord Hoffman in Campbell, at 46.
79.
Lord Hoffman in Campbell, at 53: “the extent to which information about one's state of health, including drug dependency, should be communicated to other people was plainly something which an individual was entitled to decide for herself.”.
80.
For example, “informational autonomy” is described in Case P. Confidence matters: the rise and fall of informational autonomy in medical law. Med Law Rev2003; 11: 208–236.
81.
Sidaway v. Governors of the Bethlem Royal Hospital and Maudsley Hospital [1985] UKHL 1, Chester v Afshar [2004] UKHL 41, and see discussions in Fovargue S and Miola J, How much information is ‘enough’? Clin Ethics 2010; 5: 13–15, and MacLean A.. From Sidaway to Pearce and beyond: is the legal regulation of consent any better following a quarter of century of judicial scrutiny?. Med Law Rev2012; 20: 108–129.
82.
See for example Devaney S. Autonomy rules ok. Med Law Rev2005; 13: 102–107.
83.
OtlowskiMFA. Tackling legal challenges posed by population biobanks: reconceptualising consent requirements. Med Law Rev2012; 20: 191–226, at 203–208.
84.
Australian Government, National Statement on Ethical Conduct in Human Research, 2007, accessed at http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e72.pdf on 19 February 2013, at p21: “‘unspecified’: given for the use of data or tissue in any future research. The necessarily limited information and understanding about research for which extended or unspecified consent is given can still be sufficient and adequate for the purpose of consent.”.
85.
Otlowski (2012): 203. This is her preferred approach, and she defines hybrid consent as “specific consent for collection and storage together with broad consent for future unspecified use.”.
86.
However, it is still possible for the patient or subject to claim post-event that information given prior to the event was not sufficient for valid informed consent, as was argued in Chester.
