Manipulation of information in medical research: Can it be morally justified?

Research Ethics8(1) 9–23

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Manipulation of information in medical research: Can it be morally justified?

Sapfo Lignou PhD student, University College London, UK

Sarah JL EdwardsUniversity College London, UK

AbstractThe aim of this article is to examine whether informational manipulation, used intentionally by the researcher to increase recruitment in the research study, can be morally acceptable. We argue that this question is better answered by following a non-normative account, according to which the ethical justifiability of informational manipulation should not be relevant to its definition. The most appropriate criterion by which informational manipulation should be considered as morally acceptable or not is the researcher’s special moral duties towards their subjects. We also propose that a broader definition of manipulation of information should be adopted (than that already existing in the literature) since informational manipulation can affect not only a person’s beliefs but also their desires in decision-making. We conclude that manipulation of information can either be used to protect the potential subject and facilitate the informed consent process or be used to exploit and merely use a person for scientific goals.

Keywordsmanipulation of information, framing effects, desires, beliefs, researcher’s moral duties

1. IntroductionMedical research is essential for medical progress and thus for the social benefit. However, a main reason that this process is constrained is due to low recruitment

Corresponding author:Sapfo Lignou, PhD student, Division of Medicine, The Rayne Institute, 5 University Street, University College London, London WC1E 6JF, UK. Email: [email protected]

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10 Research Ethics 8(1)

rates. One of the ways by which researchers have aimed to change this situation is by manipulating information to influence potential subjects’ decision to participate. This practice has, however, generally being considered morally unacceptable. In particular, it is argued that manipulated information violates the most fundamental principle regarding the ethics of research on human subjects; the requirement for voluntary participation based on subject’s consent after being adequately informed about the research proposal (this does not apply to special cases such as those involving mentally non-competent subjects). Thus, according to this view, when a researcher uses informational manipulation to increase recruitment rates, they actu-ally use the potential subject as a means only and not as an end in itself.

The aim of this article is to argue that this view is not necessarily true and that there are cases where manipulation of information can be compatible with the requirement of informed consent. We argue that in certain cases a researcher by intentionally manipulating information can protect and secure a subject’s rights and at the same time benefit society. Moreover, we claim that manipulation of information may also affect a person’s desires to take part in a research without modifying or altering their beliefs and thus that a definition of manipulation of information broader than that found in the literature should be adopted. However, in that case, as we will see, infor-mational manipulation may also be morally problematic, although informed consent is not compromised. We conclude that a non-normative account of manipulation of information is preferable, where moral justification is not relevant to the fact that manipulation has been used, but will depend on the context of the trial and the research-er’s motives (i.e. how the researcher intends to affect the subject’s decision to partici-pate in the trial). Our thesis then is that to judge whether manipulation of information should be accepted, we should consider whether the researcher’s intentions are com-patible with their special moral duties as a researcher towards their subjects.

In the following sections we see how the researcher can intentionally use some of weaknesses that lay people face in understanding medical/research information and in making decisions on their care to influence their decision to participate in a trial. Moreover, we present some of the main features of informational manipulation and try to explore which of them should be relevant to its moral evaluation. Finally, we briefly refer to the special duties of the medical investigator and argue that they should be the moral base on which the researcher’s intentions and acts should be assessed as acceptable or not in a research setting.

2. Definition and methods

2.1. DefinitionEvidence has shown that the manner by which information is provided can affect people’s understanding of that information or modify their desire to accept or deny



Lignou and Edwards 11

a treatment recommendation or a research proposal (Flory et al., 2008; Lloyd, 2001: i14; Read et al., 2009; Ubel, 2002: 41). Moreover, subjective factors can affect a person’s ability to understand and appreciate the information provided (heuristics, therapeutic misconception, social prejudges; Edwards et al., 2002: 828; Lloyd, 2001: i14; Schwartz, 1999: 127; Slovic et al., 1986). In this article, we consider the cases where the researcher intentionally exploits these facts to provide information in a manner that may positively affect potential subjects’ decision to participate. These are the cases, we argue, where manipulation of information takes place. Manipulation of information in medical research could be (preliminarily) defined as the intentional attempt of the medical investigator to influence a potential subject’s decision to participate in a research, by presenting the related information in a manner that may modify or alter the potential subject’s understanding or appreciation of the situation or merely their desire to take part.

It is often argued that informational manipulation affects what a person believes and thus that there is an intimate connection between informational manipulation and the condition of understanding (Faden and Beauchamp, 1986: 362). However, since people make decisions arising not only from their beliefs but also their desires (Davidson, 2001), we argue that manipulation may also occur by modifying or altering a person’s desires without affecting their beliefs at all. In the following paragraphs we consider some of those cases.

Manipulation of information as an influence should be distinguished from manipu-lation of options. Manipulation of information does not change the person’s actual options (Faden and Beauchamp, 1986), but the understanding or desire in them is modified as a result of the manipulation. This is the reason why in our discussion we do not refer to financial inducements or other similar methods of manipulation.

2.2. Methods of manipulationWe now refer to some of the most popular methods by which informational manipu-lation occurs. In all these cases, we can see that the attempt of the researcher is not straightforward but implicit, in contrast with other types of influence used by the researcher, such as persuasion, where the researcher uses reasonable arguments to persuade the potential subject to participate. However, the fact that this influence is implicit does not constitute a reason to argue that manipulation is morally prob-lematic, as we will later see.

One of the most commonly used methods of informational manipulation is fram-ing effects (Edwards et al., 2002: 828). Evidence has shown that the way the risk information is presented or framed can predictably influence people’s choices between risky alternatives. Thus, ‘whether the proverbial glass is described as half empty or half full establishes a frame of reference against which risky outcomes and contin-gencies are viewed as either losses or gains’ (Faden and Beauchamp, 1986: 319).




Clinical investigators, aware of this situation, often intentionally use framing effects to present research information in a way that leads the potential participant to draw certain predictable inferences.

Since positive framing is more effective than negative framing in persuading people to take risky options such as treatments, researchers often prefer to use survival instead of mortality data when presenting research information (Edwards et al., 2002: 828). They also often present ‘loss’ framing (i.e. the potential losses from not participating in a particular research) rather than ‘gain’ framing (i.e. what the subject will gain if they participate in a particular research), since that framing will make participation more likely (Edwards et al., 2002: 828).

Another ‘efficient’ way by which researchers aim to affect the way by which risk information is interpreted is by presenting only information about the relative risk in isolation without reference to base rates (Edwards et al., 2002: 828). This technique is also widely used by pharmaceutical companies when they present the effects of their drugs to professionals. Skolbekken, for instance, has noticed how pharmaceu-ticals manipulate risk information by using relative risk reduction to enhance the apparent effectiveness of cholesterol-lowering drugs (Lloyd, 2001: i16).

The use of this method has also being noticed in a recent Breast Cancer Prevention Trial where the asymmetric framing intended to emphasize the benefit of tamoxifen and minimize the harm. In particular, the benefit of tamoxifen, was only presented as a relative risk reduction: ‘Women [taking tamoxifen] had about 49% fewer diagnoses of invasive breast cancer’, while an explicit statement about baseline risk was not mentioned. The baseline risk (i.e. the chance per year of developing invasive breast cancer for women in the placebo arm) was 68 cases per 10,000 women per year, while the 49% relative risk reduction yielded a risk of 34 cases per 10,000 women per year in the tamoxifen arm. If the increased uterine cancer was expressed using the relative risk format with the base rates, the statement would read ‘… 275% more uterine cancer’, which would probably elicit a very different response (Schwartz, 1999: 129).

Studies have shown that much information that is more understandable to the patient/subject is associated with a greater wariness to take treatments or tests (Edwards et al., 2002: 828). Researchers aiming to avoid wariness prefer to withhold certain kinds of information, so that the proposal to take part seems more attractive. In certain cases bits of information are intentionally missing, for instance how long the procedure will last or how many times it may be repeated, to avoid initial incon-venience. In others, information is intentionally withheld to secure the scientific validity of the study. For instance, in certain trials potential subjects are informed that they cannot be told the treatment they are to receive. In behavioural and social science research, there are similar examples of blinded randomizations to experi-mental treatments where subjects are sometimes informed that the purpose or the specific topic of the research cannot be revealed (Athanassoulis and Wilson, 2009).




Another method of informational manipulation is the intentional provision of research information by provoking or taking advantage of negative affective or cognitive states such as fear, anxiety, pain, which reduce understanding. Those are often cases where the researcher tries to influence a patient’s decision to take part in a research, while they are in a vulnerable or compromise state. In those cases, it is more likely that the potential participant will not try to adequately understand or evaluate the content of the information provided before accepting the researcher’s proposal (Faden and Beauchamp, 1986: 365).

Potential subjects’ willingness to participate in a research study may also be influenced by the physician’s communication style. Studies demonstrate that researchers verbally presenting consent form information in using a formal disclo-sure interview create a sense of being more involved in decision-making among potential participants, as well as a sense of greater obligation to sign the consent form (Nelson and Merz, 2002). Moreover, it is argued that the researcher who behaves in a ‘reflective, patient-centred, supportive, and responsive manner’ when providing information about benefits and risks of the trial, and expressly addresses patient concerns, is more successful in recruiting study subjects (Nelson and Merz, 2002). This type of manipulation clearly affects a person’s desires related to the information provided, while not necessarily affecting their beliefs. A person may have exactly the same beliefs about the presented research throughout the process (e.g. that the potential benefit is not high enough), but after discussion with the researcher the desire to participate may have been totally altered.

Finally, manipulation of information can also occur with other methods, such as lying, or intentional overloading a potential participant with an excessive amount of information in order to cause confusion.

3. Towards a non-normative accountManipulation of information is often presented as an immoral practice, which forces a person to do what they do not wish to do. It is argued then that when manipulation occurs, another person is used to the manipulator’s own ends, violating in that way Kant’s fundamental moral maxim against exploitation (which is a categorical impera-tive). (Faden and Beauchamp, 1986: 354) In contrast to this thesis, our aim in this article is to argue that ethical justifiability should not be relevant to the definition of informational manipulation; therefore, the fact that a researcher has manipulated a potential subject’s decision does not in and of itself make it morally problematic. What should be of moral concern, as we will see, is what the researcher intends to achieve by using this practice. We try to defend this view by using three examples. In each of them a different method of informational manipulation is used. Each example has two cases, one of them being morally acceptable and the other morally problematic; in the following we explain why.




Example 1: The researcher attempts to increase recruitment by withholding informationCase A: The researcher is aware that the provision of too much information may cause confusion to the potential participants. Because of that, they decide not to provide all possible descriptions of the procedures that will be followed in a research study, so as not to scare the subjects away from participation. However, all the rel-evant information that is material to the subject’s evaluation and all-important descrip-tions about the treatment tested are provided (potential risks, painful procedures, potential benefits and so on).

Case B: The researcher is aware that an important reason for people to participate in a research study is the prospect of being cured or receiving treatment for their condition. In order to make potential subjects’ participation more likely, they decide to provide information about all the procedures that will be followed in a non-therapeutic clinical trial without mentioning, though, that the study is not designed to offer any medical benefit.

Example 2: The researcher attempts to increase recruitment by using positive framingCase A: Evidence shows that people living in very stressed conditions because of their disease often introduce inferential errors and disproportionate exaggera-tion of risks when they have to make decisions about their treatment. A researcher, who is also the potential subject’s personal physician, knows that this is true about their patient, who is seriously ill from a non-life-threatening disease; this patient is very pessimistic and disproportionately exaggerates considering probabilities of negative outcomes when having to decide about their treatment. Because of this fact, the researcher/personal doctor decides to present the probability of a positive outcome of the tested therapy (which is fairly high) rather than the prob-ability of a negative outcome (i.e. to inform them that there is a 97% probability of success rather than a 3% probability of failure if they decide to take part in the study) in order to influence their decision to participate. Moreover, the risk of harm that this study imposes is low.

Case B: The researcher is aware that positive framing is more effective than nega-tive framing in persuading people to take risky options such as treatments. Because of that, they decide to present the chance of survival (97%) instead of the chances of death (3%) when they provide the information on the potential subject. However, though the survival frame makes the participation very likely, it prevents a potential subject from understanding that there will be a risk of death on the trial.




In both examples, the researcher intentionally attempted to affect the subject’s understanding on the information provided by withholding information or by using framing effects. However, despite the fact that in both examples the same method of manipulation is used for Cases A and B, Case A seems morally acceptable, while Case B is morally problematic. In the following we try to explain why.

In Example 1, the importance of the information withheld was not the same in both cases. In Case A, the researcher decided to omit some non-important (for the participant) technical details about the procedures, which if provided, could prob-ably lead to misunderstandings and confusion. Moreover, as evidence has shown, when people have difficulties in comprehending and interpreting the information with which they are provided, they absorb little information that they quickly forget and fail to fit this information into their own experience (Lloyd, 2001: i16). Therefore in Case A the researcher, by manipulating the information, actually facilitated informed consent, since better understanding of the situation was achieved. In contrast, in Case B the researcher decided to withhold information – the aim of the research – which was essential for the decision-making. In this case, we argue, informed consent was invalid and the subjects were deceived, since they were uninformed about what the researcher actually proposed. Therefore, the fact that the subjects appear to fully agree to the researcher’s proposals does not actually license the researcher to act as they proposed (O’Neill, 2007).

In Example 2, the researcher used positive framing in order to encourage a potential subject’s decision to participate. In Case A, framing effects were used to emphasize the probability of success of the tested intervention, which was very high (97%). The researcher’s attempt was to help the patient/subject not to rely on their decisions on cognitive errors (bias) and to help the patient to better understand that their condi-tion could be cured. By presenting positive instead of negative effects the researcher tried to exclude negative feelings and exaggerations that would prohibit the correct interpretation and evaluation of the information described. (The fact that the patient of this case is very pessimistic about their condition also means that they do not hold a false belief that there is no chance of failure in the proposed treatment.) Thus, the researcher’s attempts in Case A could not violate informed consent.

In Case B, positive framing was also used but for the provision of even more crucial information than that of Case A: to emphasize the chances of survival instead of the chances of death. Moreover, framing effects in this case had a blinding impact; the way the information was provided led to false beliefs, although it was not decep-tive (as in Example 1, Case B). However, when framing may keep the person from simultaneously being able to ‘see’ or understand generally material descriptions of the proposed research (as in this case that there will be a risk of death), then the potential subject’s choice to consent would be based on less than substantial under-standing and cannot but qualify as an informed decision. Therefore, in Case B, there




was no adequate understanding of the proposal, since truth-claims were not under-stood by the subject as being material and true. A consent based on these facts is clearly defective and fails to legitimate the proposed intervention (O’Neill, 2007). The attempt of a researcher to encourage participation by letting the potential subject hold a false belief, material to their decision, cannot be justified.

Therefore, the main difference between the two cases is that in Case A the research-er’s intentions were to address false beliefs and to help the subject decide without compromising their understanding of the situation, while in Case B the researcher attempted to influence the subjects’ decision by the falsity of their belief.

Before we proceed to our next example, where we explore the case where manipu-lation of information is used to influence a person’s desires, we will briefly refer to some important issues concerning withholding of information. We now refer to the cases where information is withheld in order to secure the scientific validity of a study. In those cases, potential subjects are informed that they will be kept partially ignorant about a particular intervention or a research project. The main difficulty with these cases is to decide whether the potential subjects can nonetheless give informed consent, since they cannot have access to all relevant information about the research proposed. We argue that this should depend on the potential subject’s ability to judge the materiality of the withheld information.

In certain cases, it is not difficult to assess whether unknown information is likely to be less important or trivial. These are the cases where the potential subjects can have adequate understanding of the information that is withheld and are in a position to judge for themselves how material the withheld information is for them to decide whether or not to participate (Faden and Beauchamp, 1986: 312). Moreover, in such cases, if the potential subjects believe that missing information is material for them to decide (for some personal reasons), then they are able to refuse research participa-tion if they wish (Faden and Beauchamp, 1986: 312).

However, subjects are not always in a good position to evaluate whether the withheld information is material for their decision or not. It can be argued that potential subjects having gaps in their understanding cannot confidently evaluate the materiality of withheld information and, thus, are not able to consent. However, it is important that, even in these last cases, the potential participants are still able to decide whether they wish or not to participate, given that they do not have all the material information to judge whether that would be in their best interests or not. In Case B of Example 1, the problem was that the subject was not aware that material information was missing.

Therefore, although understanding is a precondition for valid informed consent, apprehension of all the relevant and possible descriptions is not essential. However, what the potential subject should apprehend and understand is the information material to the subject’s evaluation to consent (Faden and Beauchamp, 1986: 302).




Thus, a person could be wholly ignorant of relatively unimportant but nevertheless relevant propositions about a research and still be able give informed consent. In addition, it should be argued that informed consent could also be valid in the case where the subject is aware that they cannot be informed about the research question. Even in that case, a potential participant could autonomously authorise specific research based on terms that guarantee that what is material to their decision is understood despite ignorance about specific research details (Faden and Beauchamp, 1986: 313).

Consequently, research involving openly withheld information, when informa-tional manipulation does not preclude substantial understanding condition, can be compatible with informed consent. We believe the same is true in the cases where participants are asked to consent to studies after being informed that the research procedures will be intentionally deceptive, as in the case of a research containing placebo therapy.

Example 3: The researcher tries to increase recruitment by using a formal disclosure interview, after the potential participant has read the information in the consent form. By using their excellent communication skills they now attempt to create a sense of greater obligation to the potential subject to sign the consent form without altering the informational substanceIn Case A, the potential subject is a healthy volunteer and is called to participate in a very important trial which imposes only minimal risk. The potential subject gen-erally believes that contributing to social benefit is very important.

In Case B, the potential subject is a critically ill patient and is called to participate in a very important research, which imposes high risk while it is not designed to provide any therapeutic benefit. The potential subject also believes that contributing to social benefit is very important.

In this last example the researcher does not attempt to influence the potential subject’s understanding, since the content of the information is identical to that in the consent form. The researcher knows that the person to whom the message is directed has adequately understood the information provided and so does not attempt to confuse or distort their beliefs. However, by providing exactly the same informa-tion in a more persuasive way (without altering its informational substance), they now try to affect the subject’s desires to positively respond to the proposal.

We should note that there is nothing inherently contrary to reason about the research-er’s attempt to influence in that way; informed consent is not compromised when the agent can consciously decide to adopt what the influence agent is advocating for their




own reasons (e.g. wanting to please the researcher, finding the researcher attractive). However, it still seems that Case B is morally problematic. The reason for this will be identified in the following paragraphs.

The research in both Cases A and B is not designed to medically benefit the potential participant. Moreover, in both cases the candidate participant believes that it is important to contribute to social benefit, and thus possible participation would be consistent with their values. Finally, in both cases, although the subject has adequately understood the information, in both written and oral forms, they are not yet convinced whether they should participate.

Two main differences are obvious between the two cases. First of all, in Case B, the risk is very high and obviously against the subject’s best interests, while in Case A the risk is minimal (and thus not against their best interests). Moreover, in Case B the potential participant can be considered as vulnerable because of their condition.

It is obvious, then, that the reason why Case B seems morally problematic, even though the same method with Case A has been used, is due to the nature of the research (the fact that it contains high risk). Is the researcher morally justified when trying to influence a potential subject’s (let’s assume a person in a vulnerable posi-tion) decision to participate in a risky trial for the social benefit? We argue that, although the researcher does not violate the subject’s right to make an autonomous decision, thus not compromising informed consent, the act is still morally problem-atic, because they actually fail to protect their subject from undue harm. (Whether the person’s decision to participate or not is a reasonable choice is another matter.)

Although manipulation of information is an implicit kind of influence and often precludes the manipulatee from consciously resisting, in contrast to other forms of manipulation (for instance, financial inducements), it is not true that all informa-tional manipulations require by their very nature that the manipulatee be kept in partial ignorance or unaware that he or she is in any respect the subject of an influ-ence attempt. For instance, in our last example the potential subject could be aware that the researcher wanted to influence their decision and still desired to participate (thus their desires are still modified). But even in that case the researcher is still morally accountable since they are aware that the research is against the subject’s best interests. (Here we do not argue that a research imposing serious risks while at the same time being very important should be prohibited; our argument is that the researcher should not try to influence a person’s decision in that direction when the research is against the subject’s interests. Moreover, our scope in this article is not to explore what constitutes a reasonable choice for a person and thus whether a decision to participate can rely on reasons that are not relevant to the aim of the research, for instance to please the researcher.)

In all the above examples we saw that the same method can be used either to correct false beliefs or to lead to false beliefs. Also by using the same method, the researcher may deceive potential subjects or facilitate them to make valid informed




decisions. Finally, manipulation can be used to encourage a subject to act according to their values while protecting them or while imposing undue harm.

4. Which features of informational manipulation are morally relevant?In case B of each of the aforementioned examples, the researcher failed to act mor-ally by compromising informed consent and precluding autonomous action or by failing to protect the potential subject from undue harm. This begs the question of similarities in all these cases; what do they all have in common? In every case B, the researcher obviously attempted to increase recruitment in their studies by using the potential subject merely as a means, thus exploiting their subject.

Certain methods of informational manipulation, such as lying or intentionally taking advantage of negative affective or cognitive states to provide information are more difficult to be justified, since they are often used to compromise under-standing and thus exploit the potential subject. However, as we have already stated, the reason these methods lead to morally unacceptable actions is not due to their nature but due to the researcher’s immoral intentions. As we noted previously, even deception (that is often used to compromise understanding and violate autonomous action) can be acceptable in certain cases.

Moreover, some methods are more likely to be successful than others. People do not have the same beliefs, values and needs. They also come from different socio-economic backgrounds and some are more vulnerable than others. Therefore, dif-ferent people would find the same attempt to influence easier or harder to resist. For instance, the researcher’s communication skills will not impress all potential subjects, and certainly not all of them will feel a strong obligation to consent. Whether the researcher’s attempt to control the potential subject’s behaviour will succeed will depend heavily on their subjective response to that attempt.

According to evidence, factors related to status and power may have variable impact on the consent discussion. For example, educational background and financial status have been found to significantly affect the patient’s experience of social power in biomedical settings with rigid research protocols. Studies have shown that individuals with greater financial resources and those with more advanced education are likely to have a less passive role and to be more comfortable discussing the goals and procedures involved in a research project with medical professionals than those from lower finan-cial or educational backgrounds (Kuczewski and Marshall, 2002: 50).

Moreover, even gender differences may impact the power dynamics in consent discussions. In certain cases, obtaining voluntary consent from a woman could be compromised if she comes from a cultural environment where she is expected to act subordinately in relation to figures of authority, e.g. male heads of household,




including husbands or fathers. Under these conditions, if a woman believes she must comply with the authority of the health care investigator, she would probably not try to resist to this kind of influence (Kuczewski and Marshall, 2002: 50).

Generally, weak and vulnerable persons – people living in constrained conditions – are considered more susceptible to be engaged in manipulating practices. In clini-cal contexts, for instance, the populations of patients that are significantly vulnerable include seriously ill patients, the elderly, poorly educated and hospitalized. Moreover, in non-clinical populations, institutionalized persons, such as prisoners, are gener-ally considered vulnerable to manipulations of all sorts, because of their endemic role and the constrained set of options under their situation (Appelbaum et al., 2009). Evidence has shown that vulnerable people often adjust to their constraining roles and learn to be generally passive. Therefore, while people living in such con-ditions can yet make voluntary choices, they are particularly susceptible to acts of manipulation (Appelbaum et al., 2009).

It seems thus reasonable to argue that whether the attempt to manipulate will be successful or not will significantly depend on the personal characteristics of the potential subject. What seems to be more important in a moral sense is to judge whether the researcher acted in a moral way. Rather than focusing on whether the manipulation was successful, attention should be paid to whether the researcher’s intentions to act in that way can be morally justified. Therefore, when a researcher uses informational manipulation intending to compromise a vulnerable person’s understanding (taking advantage of the fact that this person is more likely to hold false beliefs about the consequences of refusing to comply with the requests or is more prone to please the researcher), then they have actually behaved in an immoral way, regardless of whether or not they finally achieved their goal.

Another factor, which, we argue, is not relevant to the moral justification of informational manipulation, is the degree of influence this may exercise on a person. Faden and Beauchamp have argued that the influences that are compatible with autonomy (and thus morally acceptable) are so as a matter of degree. Therefore, according to this view, to judge whether a particular influence is morally acceptable or not, we should understand its place on the continuum. An influence can lie along a continuum from self-controlled to other-controlled, reflecting an increasing prob-ability that any given researcher behaviour will in fact control a potential subject’s choice to participate (Faden and Beauchamp, 1986: 354).

Thus for Faden and Beauchamp the manipulations that are morally acceptable are those that either limit autonomy in inconsequential ways or do not limit autonomy at all. These are called minor manipulations and are compatible with informed consent (Faden and Beauchamp, 1986: 354). They also argue that these are closer to one end of the continuum – influences that do not limit autonomy, such as persuasion – while at the other end are influences that the person finds irresistible, such as coercion.




Moreover, according to their thesis, when the researcher tries to influence a person’s decision to take part in research by using persuasion (at one end of the continuum), they do not control the person’s behaviour, only presenting a motive or reason for action. A reliance on ‘reasons’ in the persuasive appeal suggests that ‘an autonomous act of acceptance is caused, by pointing out to the person a motive or reason for acceptance’ (Faden and Beauchamp, 1986: 348). In this case, the potential subject can resist the influence imposed by the researcher and thus autonomy is not restricted.

In contrast, when coercion takes place (the influence at the other end of the continuum), the will of the researcher dominates, so that the potential subject’s ‘choice’ is not their own but effectively that of the researcher. Coercion controls a person’s decision to the degree that deprives the person of autonomous choice (the person cannot act to avoid this influence), and thus is incompatible with informed consent (Faden and Beauchamp, 1986: 339)

In Faden and Beauchamp’s account of persuasion (the morally acceptable influ-ence) the persuader is not required to believe that the reasons offered for consideration are good reasons. What is important in persuasion, they argue, is that the persuader believes that the reasons advanced are true or at least warranted by the evidence. Persuasion thus cannot involve appeal to false, invalid reasons or arguments even if the target of appeal believes them to be justified (Faden and Beauchamp, 1986: 350).

They use the following example:

A physician may believe it is a bad reason for a heart patient to consent to drug therapy, while eliminating cardiac surgery, if the patient’s reason is that drugs do not leave a scar. (Faden and Beauchamp, 1986: 350)

They go on to argue that the physician’s influence on their patient to choose drug therapy over heart surgery should be considered persuasive, and thus morally accept-able, ‘so long as the physician believes the determinative reason—the absence of a scar—to be true, though unwise, and treated it accordingly in their communication’ (Faden and Beauchamp, 1986: 350).

We argue that this account is problematic, especially when applied in a research setting, where the potential of risk is always present. For example, a researcher would not be morally justified if they tried to influence the subject’s decision by providing true information but not good reasons for a very risky trial. In other words, we argue that a researcher’s attempt to persuade a potential subject to participate in a trial by arguing that they will not be left with any scars after the tested treat-ment (true reasons) cannot be justified in case such participation would be against the subject’s best interests (unwise reasons).

Therefore, we believe not only that researchers’ reasons should be true and valid, but that there should also be good reasons for the potential subject to follow their proposal. Consequently, the mere fact that persuasion does not constitute an irresist-ible influence does not make the influence morally acceptable.




5. The moral duties of the clinical investigatorBased on the discussion in the previous sections, we argue that neither the method of informational manipulation used, nor the degree of the influence nor whether it is successful or not may be valid criteria when a decision on whether the researcher acted in a moral way is made. The cases that we judged as morally problematic in the examples (cases B) were cases in which the researcher actually treated the potential subject merely as a means to achieve their ends. This leads us to argue that the moral criterion by which we should judge whether informational manipu-lation is morally acceptable or not is the researcher’s moral duties towards their subjects. Therefore, we should consider what these duties are and whether the researcher’s intentions could be compatible with them when manipulation of information takes place.

Despite the disagreement concerning some of the duties of the clinical investiga-tor, such as the extent to which they are obliged to provide clinical care to the patient/subject, it is widely accepted that in all trials the clinical investigator has certain moral obligations that should always be respected. In particular, in the aftermath of the ethical abuses in research with human subjects in the past, such as the infamous Tuskegee Syphilis Study, the protection of human research subjects is held as an uncompromisable precondition for the ethical conduct of medical research on humans, as stated in the Declaration of Helsinki (WMA, 1975). Clinical researchers have moral duties that also apply to clinical practice, such as protecting patients/subjects from harm, maintaining confidentiality, and in certain cases ben-efiting the subjects (Miller and Weijer, 2007).

Investigators are not only morally required to provide to potential subjects the information they need to make a decision, but they must also make sure that the subjects (or their representatives) have substantial understanding of the informa-tion, and are not facing any restricting conditions that could compromise their ability to act autonomously (Levine, 1988). Since the information about the pro-posed research participation is complicated and often not within the experience of the prospective subject in advance, the researcher should assess the understand-ing of the potential subjects continually and provide additional information as required to correct misperceptions or misunderstandings that may occur (manipu-lation of information, as we saw, in certain cases could be justified in order to achieve that).

Informational manipulation should only be used by the researcher when their moral duties towards their subjects are respected and their relationship is not under-mined for the sake of scientific knowledge. When manipulation occurs along these ethical lines, not only is trust established in the investigator–subject relationship, but this also generates a positive impact on peoples’ decision in favour of participa-tion in clinical trials, thus helping to improve health outcomes.




6. ConclusionThe aim of this article was to explore whether manipulation of information used to increase research recruitment can be morally acceptable. We have concluded that when this practice is compatible with the researcher’s special duties towards their subjects, manipulation of information could both protect and respect the rights of the potential subject and also contribute to social benefit.

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Manipulation of information in medical research: Can it be morally justified?

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