Rethinking Informed Consent (Review)

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Slides from a presentation given to the Medical Sociology discussion group at the University of Leicester, reviewing Neil Manson and Onora O'Neill's 2007 book "rethinking informed consent in bioethics"
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Rethinking Informed Consent (Review)

  1. 1. Dr Chris Willmott Dept of Biochemistry, University of Leicester [email_address] Book Review : Rethinking Informed Consent In Bioethics Neil Manson and Onora O’Neill Social Science Group University of Leicester
  2. 2. About the authors Baroness Onora O’Neill Chair of Nuffield Foundation Professor of Philosophy, Cambridge Kantian framework Trust and Autonomy Neil Manson Senior Lecturer, Dept of Philosophy University of Lancaster Ethics of communication Virtues of not knowing
  3. 3. Necessity of Informed Consent Consent = Safeguard against paternalism Protecting individuals from harm Respecting individual autonomy
  4. 4. Necessity of Informed Consent “ Appeals to informed consent and its role on justifying clinical and research practice are now so well entrenched that their presence, indeed their necessity, and their justification are rarely questioned… ” (p2)
  5. 5. BUT: “… the quest for wider scope, for higher standards, for better justifications and for regulatory reinforcement, which aimed to make consent the lynchpin of biomedical ethics, has created intractable problems .” (p2) Necessity of Informed Consent?
  6. 6. Informed Consent: Problems? <ul><li>Is consent really necessary ? </li></ul><ul><li>Many procedures are conducted without genuine informed consent: - too young - dementia / severe mental illness - unconscious - otherwise incapacitated “Solution” = consent given by someone else? </li></ul><ul><li>Even when patient has capacity did they really understand? “Solution” = simplify or clarify information? </li></ul>
  7. 7. Informed Consent: Problems? <ul><li>Increasing emphasis post Declaration of Helsinki (1964 onwards) on consent being: - explicit (rather than implicit) - specific (rather than generic) </li></ul><ul><li>Rules out secondary uses of existing data/samples without renewed consenting </li></ul><ul><li>Inherent tension between making information more exhaustive and at same time simpler for patient </li></ul>
  8. 8. Informed Consent: Problems? <ul><li>Reality of much clinical practice undermines claims explicit consent is essential </li></ul><ul><ul><ul><li>Don’t seek specific (written) consent for routine procedures such as taking blood or temperature </li></ul></ul></ul><ul><ul><ul><li>Rely on implicit consent (e.g. rolling up sleeve) otherwise system would grind to halt </li></ul></ul></ul><ul><ul><ul><li>Impossible to describe all possible outcomes of a procedure (e.g. needle-stick injury  HIV test?) </li></ul></ul></ul><ul><ul><ul><li>Words and phrases , e.g. “tissue” @ Alder Hey </li></ul></ul></ul>
  9. 9. Informed Consent: Problems? <ul><li>“ Neither full explicitness nor complete specificity is possible… For human agents, with varying beliefs, varying inferential commitments and varying vocabularies, the best we can hope for is a mutually agreed level of specificity in the disclosure for a particular transaction” (p15-16) </li></ul>
  10. 10. What exactly IS Autonomy? <ul><li>At least three different conceptions of autonomy: </li></ul><ul><li>Principled autonomy – often attributed to Kant, but his notion of autonomy held it as serving everyone, not as a characteristic of individual </li></ul><ul><li>Individual autonomy – most popular notion, but not as far-reaching as painted, e.g. Public health measures v individual choice Standardised protocols v individual choice </li></ul>
  11. 11. What exactly IS Autonomy? <ul><li>“ If we think of autonomy as a matter of mere choice, arguments will be needed to show why all choices (however irrational, however poorly informed) should be protected… If, on the other hand we think of autonomy as a matter of reasoned or reflective choice , further arguments will be needed to show why only these choices should be protected .” (p20) </li></ul>
  12. 12. What exactly IS Autonomy? <ul><li>Rational autonomy – “ more cognitively demanding than a minimal conception of individual autonomy as mere, sheer choice ” (p21) </li></ul><ul><li>but... </li></ul><ul><ul><ul><li>Treatment on non-competent patients? </li></ul></ul></ul><ul><ul><ul><li>Treatment of competent but overwhelmed patients? </li></ul></ul></ul><ul><ul><ul><li>Purpose of informed consent often to legitimise choices that are not rational </li></ul></ul></ul>
  13. 13. How to deal with the problems <ul><li>Three ways: </li></ul><ul><li>Hypocritically pursue the status quo : pretend problems are not severe and consent a mirage </li></ul><ul><li>Live up to the standards demanded by legislation : clinical treatment and research would grind to a halt </li></ul><ul><li>Rethink informed consent : can we identify an alternative approach that is feasible & justifiable? </li></ul>
  14. 14. The importance of metaphor <ul><li>Discussion about informed consent generally dominated by a “ container/conduit ” metaphor </li></ul><ul><li>Terminology associated with transport, postal services, transmission and/or broadcast </li></ul><ul><li>Subconsciously pictures information as discrete units, pre-existing and context-independent, to be passed from one person to another </li></ul><ul><li>“ Our main reason for being cautious about the conduit/container model is not that it is wholly inaccurate but that it hides too much ” (p65) </li></ul>
  15. 15. Aspects obscured by this metaphor <ul><li>Information is context-dependent : meaning of statements frequently rest on shared knowledge </li></ul><ul><li>Information is norm-dependent : relies on accepted epistemic and ethical protocols </li></ul><ul><li>Information is propositional : not simply ‘content’, an invitation to action </li></ul><ul><li>Informing is a type of rational action : most communication is intentional, done for a reason </li></ul>
  16. 16. Aspects obscured by this metaphor <ul><li>Informing is rationally evaluable : we can legitimately be asked to explain why a statement we made is true </li></ul><ul><li>Informing is referentially opaque : full meaning may depend on prior knowledge and worldview (difference from 1?) </li></ul><ul><li>Informing is inferentially fertile : a simple statement may convey more than the words </li></ul><ul><li>Informing must be audience sensitive : merely making information available (e.g. on a website) is not communication </li></ul>
  17. 17. An alternative model: Agency <ul><li>Communication is a process of “constructing”, “negotiating” or “generating” with the action itself producing something at the time </li></ul><ul><li>Indispensible role played by inference </li></ul><ul><li>“ we realise how important these daily inferences are when (to our surprise) somebody fails to infer something that we take to be obvious ” (p54) </li></ul>
  18. 18. An alternative model: Agency <ul><li>“ Once we accept that all communication is context- based, and dependent upon a rich implicit knowledge of the shared interests, competences and commitments of participants, we have reason to be suspicious of any claim that, say, informed consent procedures require a ‘full’ or ‘fully explicit’ statement about proposed actions .” (p66-67) </li></ul>
  19. 19. Informed Consent as a ‘Waiver’ <ul><li>Agency model emphasises communicative transactions and informed consent to waive important ethical, legal and/or other requirements in limited ways and in particular contexts </li></ul><ul><li>Justifying actions that would otherwise violate important norms, standards or expectations </li></ul><ul><li>“ Informed consent requirements provide effective ways of waiving requirements and expectations in limited and defined ways in some cases, while insisting that these requirements and expectations nevertheless be respected whenever they are not specifically waived ” (p75) </li></ul>
  20. 20. Informed Consent as a ‘Waiver’ <ul><li>Where no ethically or legally important norm need be waived, action will not require consent unless legitimate expectations will be breached </li></ul><ul><li>“ The scope of informed consent requirements is set not by demands of autonomy (however conceived) but by a wide range of ethical and legal norms which must be waived or set aside if invasive medical or research interventions are to be acceptable .” (p79) </li></ul><ul><li>Informed consent can never provide complete justification for any medical treatment or research since it presupposes other standards, norms & rules </li></ul>
  21. 21. Successful Consent transactions <ul><li>Successful communication (including successful informed consent transactions) must be: </li></ul><ul><ul><li>Intelligible – in a language that the audience can understand </li></ul></ul><ul><ul><li>Relevant – stripped of irrelevant or distracting factors </li></ul></ul><ul><ul><li>Adequately accurate – contextualised, showing some grasp of audience’s background knowledge </li></ul></ul><ul><ul><li>True and truthful – mindful of epistemic norms </li></ul></ul>
  22. 22. Successful Consent transactions <ul><li>Conduit/container model combined with autonomy- based justification of informed consent promotes false view that one party discloses and the other decides </li></ul><ul><li>“ If we think of consent transactions as based on disclosure of information (by professionals) followed by decisions (by patients and research subjects) we will gloss over many of the norms that must be met by successful consent transactions ” (p87) </li></ul>
  23. 23. Communicating for consent <ul><li>The speech acts by which consent (or refusal) are given have three functions: </li></ul><ul><ul><ul><li>They communicate patient/research subject’s grasp of what was proposed </li></ul></ul></ul><ul><ul><ul><li>They make (or refuse to make) a conditional commitment </li></ul></ul></ul><ul><ul><ul><li>They communicate that commitment (or lack of commitment) </li></ul></ul></ul>
  24. 24. Informational privacy <ul><li>Have considered Informed Consent in relation to invasive actions (i.e. those that violate bodily integrity, liberty or property) </li></ul><ul><li>Move on to consider intrusive actions (i.e. those that violate privacy rights, however formulated) </li></ul><ul><li>Conceptions of information shape conceptions of informational privacy </li></ul>
  25. 25. Informational privacy Four distinctions: Agency v Conduit/container Transaction v Content Confidentiality v Data protection Communication ≠ Acquisition/possession
  26. 26. Focus on content... <ul><li>Downplays importance of intention : we can find things out inadvertently therefore there cannot philosophically be right against knowing something, only what they subsequently do with that knowledge (i.e. an action) </li></ul><ul><li>Hides importance of inferential fertility : people can sometimes make valid assumptions based on publically available information </li></ul>
  27. 27. Focus on content... <ul><li>Encourages misleading analogies between information and physical objects : can throw away object we no longer want, not necessarily with information, may be very hard to “unknow” (Example: e-mail exchange summer 2009) </li></ul>
  28. 28. Strictly between you and me, X is really struggling to cope at the moment Hard to ‘unknow’ something The programme for the autumn series of seminars is available I notice that X is no longer listed to speak, is this a mistake? By the way, do you realise the message you just sent went to the whole list Earlier today an e-mail was inadvertently sent to this discussion list. Please delete this message immediately
  29. 29. Focus on content... <ul><li>Encourages misleading analogies between information and physical objects : can throw away object we no longer want, not necessarily with information, may be very hard to “unknow” (Example: e-mail exchange summer 2009) May be impossible if information ‘relevant’ (see 5) Concern about ‘possession’ of information can give false impression that information itself has intrinsic ethical significance </li></ul>
  30. 30. Focus on content... <ul><li>Obscures fact ‘personal’ information may be used for impersonal ends : vast amount of research (medical and other) seeks to use ‘personal’ data for entirely impersonal reasons </li></ul><ul><li>Hides importance of audience’s knowledge and interests : something that seems trivial or inconsequential to us, may mean much more to someone else Example: Keith Vaz’s election brochure </li></ul><ul><li>Supports distorted view of informational obligations : implies we can identify certain info that intrinsically requires special handling </li></ul>
  31. 31. Agency model <ul><li>More realistic </li></ul><ul><li>“ Rather than starting by trying to establish a putative ‘right to informational privacy’ over certain sorts of content, this approach provides an appropriate framework for picking out specific ways of using information that would be wrong ” (p110) </li></ul>
  32. 32. Second-order Info Obligations <ul><li>i.e. obligations to observe, report on and enforce first-order aspects of informational privacy </li></ul><ul><li>UK Data Protection Act 1998 (DPA) = Highly influential, and highly flawed, example </li></ul><ul><li>DPA focuses on “ decontextualised informational content, rather than informational actions and transactions ” (p114) </li></ul><ul><li>As drawn up, all uses of ‘personal’ information are covered, regardless of purpose </li></ul><ul><li>Legal Guidance: “ it is difficult to envisage any action involving data which does not amount to processing within this definition ” (p114) </li></ul>
  33. 33. Data Protection Act <ul><li>Response to genuine concerns that new technology makes data acquisition, possession and transfer fast and cheap </li></ul><ul><li>UK outworking of EU Directive 95/46/EC </li></ul><ul><li>Latter asserts but does not justify informational privacy rights </li></ul><ul><li>Directive makes invalid appeal to Article 8 of ECHR (right to private and family life) </li></ul><ul><li>Both Directive and DPA based on container/conduit model </li></ul>
  34. 34. Consent, DPA & Medical Research <ul><li>DPA considered excessive re invasive research, let alone intrusive (non-invasive) research </li></ul><ul><li>DPA requires specific consent from research subject for each use of their data and/or tissue </li></ul><ul><li>DPA seems to demand complete (i.e. irreversible) anonymisation of data and tissue samples </li></ul><ul><li>Total anonymisation makes it impossible to seek consent for additional research using same material </li></ul>
  35. 35. Consent, DPA & Medical Research <ul><li>Even where possible to seek permission of data subject or tissue source, this may be impractical due to cost, death of subject, loss of capacity, or potential psychological harm revisiting issue </li></ul><ul><li>Rules out valuable projects that offer theoretical, but miniscule, risk to privacy of subject </li></ul><ul><li>May be feasible to work from pseudonymised data back to identification of individual but minute risk – researchers don’t have time or interest in so doing </li></ul>
  36. 36. Consent, DPA & Medical Research <ul><li>“ What, we may reasonably ask, justifies requiring further, more specific consent for non-invasive retrospective research that uses reversibly anonymised information or reversibly anonymised tissues that have been lawfully obtained and retained ?” (p157) </li></ul>
  37. 37. Recap <ul><li>Informed consent cannot serve as ethical panacea in biomedicine: </li></ul><ul><ul><li>Inapplicable where public rather than individual good is necessitated </li></ul></ul><ul><ul><li>Fails where individual’s capacity to consent not adequate to grasp relevant information </li></ul></ul><ul><ul><li>Fails where consent transactions are defective </li></ul></ul><ul><li>Attempts to set higher standards of ‘explicit’ and ‘specific’ consent exacerbate failings </li></ul><ul><li>Cannot be remedied by invoking implausible conceptions of individual autonomy </li></ul>
  38. 38. Data protection? <ul><li>“ Informed consent matters in biomedicine because patients and research subjects can use it to waive others’ obligations (and their own rights), if and when they have reason to do so. In particular, they can waive others’ obligations not to violate their bodily integrity, not to infringe other liberty rights, and not to intrude into private affairs .” (p130) </li></ul><ul><li>Informational privacy might be better served by rethinking and extending conceptions of confidentiality than by current approaches to data protection </li></ul>
  39. 39. Confidentiality: a better model? <ul><li>Obligations of confidentiality typically hold where there is a well-defined, but not necessarily legally- binding, relationship between two parties (friends, family, business associates, doctor and patient, etc) </li></ul><ul><li>“ In a confidential relation, the confider discloses, or permits the confidant to act in such a way that she acquires or may acquire, certain kinds of knowledge that may not be a matter of public knowledge. In return the confidant assumes obligations not to use that knowledge to harm the confider, and not to communicate that knowledge to third parties without the consent of the confider .” (p124) </li></ul>
  40. 40. Confidentiality: a better model? <ul><li>Obligations of confidence can make clear demands even where there is no explicit professional or contractual relationship, simply a reasonable presumption that certain information is not for wider consumption </li></ul><ul><li>“ confidentiality differs from data protection in that it seeks to regulate types of action – specifically, types of speech act – rather than the ‘processing’ of types of information.” (p126) </li></ul>
  41. 41. Confidentiality: a better model? <ul><li>“ The privacy of information disclosed on a confidential basis does not and cannot amount to a general form of ‘informational privacy’ over ‘personal’ data such as data protection approaches aspire to provide.” (p127) </li></ul><ul><li>At the same time, “ confidentiality provides a general way of protecting aspects of privacy, without any need to specify in general terms which types of information do and do not count as private or personal. ” (p127) </li></ul>
  42. 42. Confidentiality: a better model? <ul><li>“ By focusing on communicative action and transactions, on speech acts rather than detached speech content, we [can] draw on a robust framework for thinking about epistemic and ethical norms... Action in accordance with such norms can protect the privacy interests that Data Protection legislation is meant to protect without invoking the flawed assumption that some types of information have intrinsic ethical significance while other do not.” (p129) </li></ul>
  43. 43. Genetic information <ul><li>Authors question validity of Genetic Exceptionalism , the notion that genetic information is particularly and especially problematic and thus worthy of special protection </li></ul><ul><li>“ Some acts of acquiring, using and communicating genetic information will be wrong because they are invasive, intrusive, harmful, unjust, coercive, breach confidentiality, and so on. But what makes these actions wrong is that they breach a range of important obligations that are generally accepted and have a wide range of applications that have nothing to do with protecting putative rights of ‘genetic privacy’,” (p152-153) </li></ul>
  44. 44. Consent and Trust <ul><li>There are legitimate reasons for questioning the current dogma re Informed Consent </li></ul><ul><li>“ Where consent transactions fail, any ostensible consent will be bogus; and bogus consent can offer only bogus justification ” (p154) </li></ul><ul><li>Raises issues about distinction between trust and trustworthiness , the role of accountability and the enduring significance of paternalism </li></ul>
  45. 45. Trust and Trustworthiness <ul><li>“ A suspicion of trust is central to contemporary autonomy-based bioethics, and typically reflects fears that trust can be misplaced, and that cost of trusting the untrustworthy can be high ” (p158) </li></ul><ul><li>Accountability seen as successor to trust </li></ul><ul><li>However, authors suggest “ trust is not dispensable... It cannot be replaced by systems of accountability that support trustworthiness without requiring any form of trust.” (p158) </li></ul><ul><li>“ [Trust] need not be deferential, can be intelligently placed (or refused), and can be epistemically and ethically justified.” (p158) </li></ul>
  46. 46. Trust and Trustworthiness <ul><li>Trust is an inevitable component of human life; we always depend to some extent on the knowledge, expertise and goodwill of others </li></ul><ul><li>Most of us are trusted in many ways, by many people (family, friends, confidants) </li></ul><ul><li>Being treated by others as though we are untrustworthy can be psychologically and socially devastating </li></ul><ul><li>Societies manifesting little trust likely to manifest fear and divisiveness </li></ul>
  47. 47. Trust and Accountability <ul><li>“ Where we have full evidence or proof, or complete control and guarantees, trust is redundant ” (p162) </li></ul><ul><li>“ Given that trust is placed and refused on the basis of incomplete guarantees, it can be misplaced ” (p162) </li></ul><ul><li>Stronger and stricter models of accountability cannot eliminate the need for trust – in fact they merely shift trust from primary agent to those who operate second-order system </li></ul><ul><li>“ Pushing trust one stage, or several stages, back does not eliminate the need to place or refuse trust, and to do so intelligently ” (p163) </li></ul>
  48. 48. Trust and Accountability <ul><li>Accountability is always second-order obligation, cannot be determined until primary obligations are specified </li></ul><ul><li>Good systems of accountability can and do improve trustworthiness and provide useful evidence for placing trust intelligently </li></ul><ul><li>A lot of accountability systems do not </li></ul><ul><li>“ If accountability supports rather than replaces trustworthiness and trust, we might expect [mushrooming of accountability schemes] to have increased levels of trustworthiness, of trust or both. But this has not happened ” (p169) </li></ul>
  49. 49. Managerial v Professional <ul><li>Traditionally models of professional accountability have been shunned for fear of paternalism and incestuous relationships </li></ul><ul><li>Professional accountability = informed but not independent </li></ul><ul><li>‘ Audit society ’ – accountability to range of external and non-expert bodies </li></ul><ul><li>Managerial approaches thought to prevent insiders judging colleagues in undemanding ways </li></ul><ul><li>Managerial accountability = independent but not informed </li></ul>
  50. 50. Management ≠ Accountability <ul><li>Fundamental difficulty </li></ul><ul><li>Management generally downwards and prospective </li></ul><ul><li>Accountability is upwards and retrospective </li></ul><ul><li>Professional tasks do not always have simple and easily measurable outcomes </li></ul><ul><li>Targets emerging from “managerial accountability” skew professional performance - Waiting times at A&E - Focus on C:D borderline at GCSE </li></ul>
  51. 51. Rethinking  Change? <ul><li>Authors don’t underestimate difficulty introducing wholesale shift in paradigm re Informed Consent </li></ul><ul><li>Suggest following changes could be made: </li></ul><ul><ul><li>NHS (and equivalent) could stop trying to implement ever more rigorous and numerous consent requirements </li></ul></ul><ul><ul><li>NHS could remove requirement that are dysfunctional or unjustifiable </li></ul></ul><ul><ul><li>Research Councils (and other funders) could stop funding work on ‘improving’ consent procedures to fit unachievable purposes </li></ul></ul>
  52. 52. Rethinking  Change? <ul><ul><li>Research Councils could stop demanding the use of such consent procedures where they cannot or need not be used </li></ul></ul><ul><ul><li>Manuals for RECs could be rewritten that the purposes and limits of informed consent are clear and to deter inflationary elaborations of these requirements </li></ul></ul><ul><ul><li>Regulators could insist that effective communication not adherence to disclosure and dissemination protocols matters most, and judge performance on this basis </li></ul></ul>
  53. 53. Rethinking  Change? <ul><ul><li>Medical and Scientific Institutions could actively petition Information Commissioner to secure agreement on sensible and realistic application of the DPA regarding biomedical practice </li></ul></ul><ul><ul><li>Patient Support Groups could challenge dysfunctional models of accountability in favour of forms that support intelligent placing of trust </li></ul></ul><ul><ul><li>Everyone could do more to support any government moves towards ‘lighter touch’ regulation </li></ul></ul>
  54. 54. Final take-home message “ We hope that the juggernaut of informed consent requirements that has been constructed across the last fifty years will be reformed and reduced within a far shorter period” (p200)

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