Manson and O'Neill present the idea of informed consent as waiver as an approach for informed consent that fulfils the requirements of being both feasible and justifiable. They wish to put forward the idea of informed consent as a ``distinctive type of communicative transaction'', emphasising the circumstances that require consent over the idealistic principles behind it. They correctly identify that consent is really just another layer on top of an already complex set of legal, conventional social, or other requirements. Consent standards need to assess the situational requirements against the norms of the legitimate expectations, identify where they may violate these expectations, and then take appropriate action to acquire consent for the waiving of the expectations. For example, consider the legitimate expectation presented earlier, that one would not be able to go up to someone and cut them open with a knife. Here, consent is required before a surgeon may operate on a patient, and there is a set of requirements for consent that is quite specific in a situation where a person requires surgery. They acknowledge that assessment of which norms are important is largely situational, however they defend their claim to a set of normative expectations by stating that there are certain norms that are ``very widely accepted'' even among diverse cultural, social, and ethical thinking, and suggesting that ``certain types of action will be prohibited in most jurisdictions'', such as bodily injury to another person, for example.
The style of waiver Manson and O'Neill suggest is particularly suited to biomedical applications, such as medical intervention or research, where the usual ethical, legal, and societal norms are commonly waived in order for a better outcome. Informed consent procedures can permit certain waivers of these norms in limited and defined ways and in this way work to highlight the importance of respecting them whenever they are not waived specifically. They acknowledge that for some cases consent may not be enough but emphasise that consent ``functions reliably as an everyday way of permitting action that would otherwise violate important norms and standards'', thus relying on consent as a permission mechanism rather than as the standard required itself. The scope, accordingly, would not be set by ``demands of autonomy (however conceived)'' but by the range of the norms that need to be waived. It is, they suggest, and I agree, extremely difficult to standardise a general set of informed consent rules, although it may be useful to standardise particular repeated consent situations, such as consent forms for a particular purpose. This is understandable in an information technology context, because there are many different areas where informed consent is or should be sought, each with its own complex sets of norms that would need to be waived under Manson and O'Neill's theory. A more detailed discussion of this will be entered into in Chapter 3.
Even though Manson and O'Neill claim that general standards for informed consent procedures cannot be realised, they go to some effort to describe some standards which can be realised within most informed consent frameworks, and suggest that these considerations play a large part in any informed consent policy formation. They claim that communication is fundamental to good informed consent policy, since informed consent procedures are an act of communication in the first place, and lay down some suggestions for a successful communications framework. Communication, they say, must ``use a language that its audience can follow'', and must ``be relevant to its audiences''. This requires knowledge of background on both sides, so that the consent-requester will communicate effectively with the consenter through understanding where gaps in common knowledge occur. The consent-requester, for example, must know what sorts of information affects the consenter, or which the consenter would be most interested in, the sorts of normative expectations a consenter might have, and the sorts of context in which the consenter is making the consent decision. The consenter, on the other hand, needs to know about the context in which they are being asked to consent, who is asking for the consent, and why the consenter is being asked for consent (for example; these requirements in an IT context are elaborated on in Chapter 3). The language used needs to be simple and easily understandable, to make it easy for the consenter to come to an understanding about the nature of the consent request. It is also important for the information to be relevant, and not crowd out the important information with irrelevant or distracting information, which shows that it is particularly important for the consent-requester to have a background understanding about the consenter. Other requirements for successful communication in informed consent procedures are the need for respect for ``specific epistemic norms'', in particular that ``what is said is true, and what is done in saying it is truthful''. Manson and O'Neill accept that there are many difficulties in assessing truth-claims in this situation, but that for informed consent communications to be successful the truth-claims provided need to be ``at least adequately accurate for the purpose at hand and not dishonest'' (p. 87). Disclosure is necessary but not sufficient for informed consent, they state, although they do not explain why. I would suggest that the reason disclosure is necessary but fails sufficiency tests is because there needs to be some sort of recognition of acceptance and understanding of the disclosed information on the behalf of the consenter in order to then make an informed response to the consent request. For example, a surgeon simply telling a patient that they are going to cut into them with a knife would not qualify as informed consent. The patient would at least need to agree before the word ``consent'' could be used in this situation. This is particularly important in an information technology setting, as will be discussed in later chapters. Manson and O'Neill make the important point that mere disclosure can often be seen by consent-requesters to be sufficient for informed consent, but it often sidelines or ignores the requirements for intelligible information, relevance, and adequate accuracy. This is quite a common occurrence in the information technology field, and so it is important to remember that a transaction is being enacted, not just a one-sided provision of information on behalf of the consent-requester, and that in order for this transaction to be successful both parties need to communicate effectively with each other so that an understanding about the nature of the consent decision is reached.
Informed consent as a waiver of normative expectations is a reasonable approach that does not suffer from the same problems as the Faden and Beauchamp or Appelbaum theories, that led Brownsword to condemn them as creating a ``cult of consent'', by placing informed consent on a pedestal, worthy of being an independent value [Brownsword, 2004]. Focussing on consent in this way is problematic because of the resulting tendency for the interest in informed consent to end with the consent decision, rather than dealing with the actual issues and values that need protecting. Manson and O'Neill's model, instead, integrates informed consent into a theory that establishes it as a useful way of allowing specific epistemic and behavioural norms to be waived, given specific circumstances, and makes it a part of the already established legal, ethical, and social standards, and as an enhancement to those, rather than as a norm itself. However, it is not without its critics: James M. DuBois identifies two areas that are not addressed adequately by this theory, since they have little to do with waiving norms. He argues that it does not take into consideration the fact that patients are given choices about treatments they can receive, rather than being simply told what is going to happen and making a decision whether to waive their rights or not. DuBois, therefore, denies that ``consent will always be irrelevant where no important norms would be breached'' [Manson & O'Neill, 2007] (p. 83), by stating that consent may be used as a ``guide'' to decision making [DuBois, 2007]. He also argues that the theory does not capture the idea that patients are in the best position to determine what is best for them, since informed consent is ``closely related to beneficence or the promotion of patient well-being'', and that this theory does not address any practicalities of shifting the responsibility of the required communication framework onto the physician.
These concerns are valid, but do not undermine the theory entirely: it could be reasonable to incorporate a guideline for dealing with patient choice and the theory already takes into account personal expectations, so patient well-being and personal choice could be more firmly established in the theory. As it stands, though, these criticisms are less of an issue for information technology, since the choice is made by users to enter into the situation where consent is required in the first place (for the most part), by choosing the software or hardware to install or Websites they view. Where a doctor may reassure a patient by explaining all the other relevant treatments or giving more information than is necessary, this is not necessary in a computing context, because it does not make sense for software, for example, to present alternatives to itself. Software installation is thus equivalent in some ways to voluntary surgery, in that the computer user is seeking to complete a particular procedure (that is, the installation and subsequent use of the software). Computer users are generally actively pursuing the task that they wish to accomplish, so not only is reassurance not needed, but the more appropriate the information given, the less information overload on the user, and the better the consent decision.
Merle Spriggs (2007) also presents some criticisms to this theory of informed consent, stating that O'Neill (in another paper, separate from the book with Manson) exaggerates the claims that there is great difficulty with understanding. O'Neill's claims are that understanding in current informed consent practice is hugely problematic, and that informed consent has become so much of a ritual that in order to get explicit and specific consent to avoid litigation patients are overwhelmed with information and end up ``ticking boxes''. Spriggs says that reforming views on consent based on this problem (which are limited to individual issues and not symptomatic of problems with the theory on the whole) is not worthwhile because effective communication is compatible with the current theory (and some people and/or institutions are just bad at it). However, she agrees with O'Neill:
Informed consent procedures are important but when the idea of informed consent is reduced to a procedure or `ritual' it can make consent meaningless. When satisfying the procedure and getting a signature on the consent form become the focus, this can displace concern about the quality of deliberation or the quality of understanding required to give informed consent. [...] The guiding value may be fear of legal liability and the interests of institutions, and be altogether unrelated to the patient and to medical considerations. (Spriggs, 2007, p. 7)
This accurately describes the current status of informed consent in information technology situations, and reinforces the problems that Brownsword brings to light about the issues with the ``cult'' of consent.
Another concern Spriggs has with O'Neill's theory is that the latter ``complains that informed consent procedures protect choices that are not worthy of being protected'' (Spriggs, 2007, p. 8). Spriggs suggests that this complaint is generally invalid due to a flawed view of informed consent and autonomy, because people can autonomously ``make tragic choices''. She argues that there is still value in tragic choices because the person is still choosing according to their preferences, and still requires information for the consent process. I do not believe that Spriggs' argument is valid, because the case of ``tragic choices'' only covers one particular situation (and type of choice), and there is no explicit statement by O'Neill that tragic choices are considered unworthy. Spriggs hints at this in saying that cases where protecting unworthy choices may be a problem are when ``the emphasis is on procedures [...where...] the patient's best interests are not the primary concern and informed consent does not rule out the possibility of exploitation'' (Spriggs, 2007, p. 9). I think this is exactly the sort of problem O'Neill is trying to avoid, but Spriggs makes a good point that some exploitation can still be consistent with freedom of choice: a mutually consensual decision for one party to be exploited could be conceived here1.17. Spriggs ultimately claims that ``contrary to O'Neill, the ethical importance of informed consent is that it secures some form of individual autonomy - and the account of autonomy we rely on is important'' (Spriggs, 2007, p. 14) (I assume here that she is not concerned particularly with which account is used, but is simply arguing against dismissing autonomy as a justificatory basis). This is well and good in a medical setting, where the interactions between patients and doctors have a greater level of face-to-face communication and thus have more of an opportunity to give feedback and negotiate. However, it does not apply well to information technology settings, where there is little interaction between the vendor and the user, and where the account of what constitutes an autonomous action is created by the vendors, almost solely based on litigious concerns and highly biased against the user. This setting is unlikely to change, since the user will always be relatively1.18 anonymous and distanced from the vendor, so Spriggs' issue here does not take away from the application of Manson and O'Neill's theory to information technology settings.