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Disclosure and Consent to Medical Research Participation
Abstract
Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it.
... Such a communicative strategy does not change the actual options available to the consent-giver, but it is likely to have an impact on how they reason about their options, making them more inclined to choose one option over another. (Bromwich and Millum 2015;Faden & Beauchamp 1986, pp. 362-365). ...
... However, as Bromwich and Millum (2015) note, misrepresenting or withholding information from consent-givers is morally problematic only when the information is relevant to the decision being made. Following Feinberg (1984), Bromwich and Millum (2015) call this set of information "inducement set", which is the set of those propositions that would dispose consent-givers one way or another with respect to the proposed action. ...
... However, as Bromwich and Millum (2015) note, misrepresenting or withholding information from consent-givers is morally problematic only when the information is relevant to the decision being made. Following Feinberg (1984), Bromwich and Millum (2015) call this set of information "inducement set", which is the set of those propositions that would dispose consent-givers one way or another with respect to the proposed action. However, since consentreceivers are not in the position to know which propositions exactly belong to a consent-giver's inducement set, they should disclose information that is likely to be relevant for consent-givers' decision. ...
This paper analyses the information disclosures in two biobank consent documents used by biobanks operating under the General Data Protection Regulation (GDPR). The aim of the analysis is to investigate how these documents inform potential sample donors about possible future uses of biobank data. The findings suggest that the consent documents provide potentially misleading information regarding the range of possible future uses of biobank data. Based on these information disclosures, potential sample donors may reasonably believe that the data can only be used for a narrowly defined range of research purposes. However, the range of lawful uses of the data is much broader and less clearly defined. Consent provided based on misleading information is not morally transformative, even if it were legally valid. To facilitate morally transformative biobank consent, this paper provides two recommendations for information disclosure to potential sample donors regarding future uses of biobank data: first, potential sample donors should be informed about the legal scope of consent; and second, they should be informed about the full range of lawful uses of biobank data.
... Research ethics, an essential branch of bioethics, has its foundations in a history marked by instances of abuse and exploitation (Dhai, 2017). As a result, research ethics places a strong emphasis on preventing exploitation, encompassing the protection of study participants from exploitation and the safeguarding of the communities involved in supporting the research (Gbadegesin and Wendler, 2006;Bromwich and Millum, 2015). ...
This paper explores the intricate dynamics of trust, power, and vulnerability in the relationship between researchers and study participants/communities in the field of bioethics. The power and knowledge imbalances between researchers and participants create a structural vulnerability for the latter. While trust-building is important between researchers and study participants/communities, the consenting process can be challenging, often burdening participants with power abrogation. Trust can be breached. The paper highlights the contractual nature of the research relationship and argues that trust alone cannot prevent exploitation as power imbalances and vulnerabilities persist. To protect participants, bioethics guidance documents promote accountability and ethical compliance. These documents uphold fairness in the researcher-participant relationship and safeguard the interests of socially vulnerable participants. The paper also highlights the role of shared decision-making and inclusive deliberation with diverse stakeholders and recommends that efforts should be made by researchers to clarify roles and responsibilities, while research regulatory agents should transform the research-participant relationship into a legal-based contract governed by accountability principles. While trust remains important, alternative mechanisms may be needed to ensure ethical research practices and protect the interests of participants and communities. Striking a balance between trust and accountability is crucial in this regard.
... Finally, explanatory opacity refers to the inability to explain why the input data are causally connected to the prediction-a problem of particular importance in machine learning, which relies on identifying statistical regularities that may not have well-characterized causal explanations. It is unclear, however, whether principles of informed consent require clinicians to explain to patients the precise causal pathway between diseases and diagnostic tests (32,33). Moreover, a detailed explanation of the causal mechanisms underlying imaging results and disease diagnosis would require a greater understanding of statistics and nuclear medicine than most patients possess. ...
The deployment of artificial intelligence (AI) has the potential to make nuclear medicine and medical imaging faster, cheaper, and both more effective and more accessible. This is possible, however, only if clinicians and patients feel that these AI medical devices (AIMDs) are trustworthy. Highlighting the need to ensure health justice by fairly distributing benefits and burdens while respecting individual patients' rights, the AI Task Force of the Society of Nuclear Medicine and Molecular Imaging has identified 4 major ethical risks that arise during the deployment of AIMD: autonomy of patients and clinicians, transparency of clinical performance and limitations, fairness toward marginalized populations, and accountability of physicians and developers. We provide preliminary recommendations for governing these ethical risks to realize the promise of AIMD for patients and populations.
... 72-77], and Joseph Millum and Danielle Bromwich argue that consent governs the way normative boundaries between patient and medical practitioner may be drawn [2]. Other justifications for the practice of requiring informed patient consent include preventing bodily trespass and promoting self-ownership [37], preventing abusive conduct [38], and building trust in the medical profession [1, ch. 7]. 5 All the various justifications for moral and legal informed consent requirements also support informing patients about the probabilities of the risks they face. ...
In this paper, we illustrate some serious difficulties involved in conveying information about uncertain risks and securing informed consent for risky interventions in a clinical setting. We argue that in order to secure informed consent for a medical intervention, physicians often need to do more than report a bare, numerical probability value. When probabilities are given, securing informed consent generally requires communicating how probability expressions are to be interpreted and communicating something about the quality and quantity of the evidence for the probabilities reported. Patients may also require guidance on how probability claims may or may not be relevant to their decisions, and physicians should be ready to help patients understand these issues.
... A more minimal view of the understanding requirement separates what must be disclosed from what must be understood. 22 On our version of this view, the primary function of dis closure is not to achieve understanding but to avoid a form of illegitimate control (Bromwich and Millum 2015;Millum and Bromwich 2018). Omitting to disclose a major or common risk would constitute such control because it would be likely to mislead the par ticipant about how dangerous the study is and so potentially affect their consent decision. ...
This handbook is currently in development, with individual articles publishing online in advance of print publication. At this time, we cannot add information about unpublished articles in this handbook, however the table of contents will continue to grow as additional articles pass through the review process and are added to the site. Please note that the online publication date for this handbook is the date that the first article in the title was published online. For more information, please read the site FAQs.
... Consent is informed if the individual knows the relevant facts about the medical procedure. The quantity and nature of these facts has been the focus of a large and still rapidly growing debate 4 A Novel Account of Voluntary Consent 4 Bromwich & Millum, 2015;Dougherty, 2020;Manson & O'Neill, 2007). Voluntariness, on the other hand, requires that a person be able to give her consent freely and not be subject to constraints that impair her self-determination. ...
... A more minimal view of the understanding requirement separates what must be disclosed from what must be understood. 22 On our version of this view, the primary function of dis closure is not to achieve understanding but to avoid a form of illegitimate control (Bromwich and Millum 2015;Millum and Bromwich 2018). Omitting to disclose a major or common risk would constitute such control because it would be likely to mislead the par ticipant about how dangerous the study is and so potentially affect their consent decision. ...
This handbook is currently in development, with individual articles publishing online in advance of print publication. At this time, we cannot add information about unpublished articles in this handbook, however the table of contents will continue to grow as additional articles pass through the review process and are added to the site. Please note that the online publication date for this handbook is the date that the first article in the title was published online. For more information, please read the site FAQs.
It is standardly accepted that medical interventions can be permissibly administered to a patient who has decision-making capacity only when she has given her valid consent to the intervention. However, this requirement for valid medical consent is much less frequently discussed in relation to psychological interventions (‘PIs’) than it is in relation to bodily interventions (‘BIs’). Moreover, legal and professional consent requirements in respect of PIs are laxer than the analogous requirements in respect of BIs. One possible justification for these differences appeals to the Differential Importance View—the view that it is presumptively morally less important to obtain explicitly given valid consent for PIs than for BIs. In this article, we argue against the Differential Importance View by considering and rejecting three possible justifications for it. These invoke differences between PIs and BIs with respect to implicit consent, risk, and wrongfulness.
Importance
There is unprecedented clinician, industry, and patient interest in the therapeutic development of psychedelic drugs. This is due to a combination of promising clinical trial results, positive media coverage, and the lack of novel pharmacologic treatments for psychiatric disorders in recent decades. However, the field faces a key methodological challenge: masking participants to treatment conditions in psychedelic clinical trials has been largely unsuccessful.
Objective
When participants can tell whether they received active drug or placebo, their responses to clinical assessments, questionnaires, and even their functional imaging and biological data can be influenced by preconceptions about treatment effects. Positive patient expectancies combined with ineffective masking may skew outcomes and inflate effect sizes. This complicates efforts to determine the safety and efficacy of psychedelic drugs. Here, we explore a method to help address this problem: modifying informed consent to obscure information about the study design.
Evidence Review
We reviewed all contemporary (2000-2024) clinical trials of psychedelic or methylenedioxymethamphetamine (MDMA) therapy and corresponded with the investigators to compile information on the use of modifications to informed consent in these studies.
Findings
Modifying informed consent to obscure details of the study design has been implemented in several psychedelic clinical trials and may offer a way to strengthen masking. However, this approach poses significant ethical risks. We examine examples of modifications used in the psychedelic literature, discuss the current regulatory landscape, and suggest strategies to mitigate risks associated with modified informed consent.
Conclusions and Relevance
Incorporating modified informed consent in future psychedelic clinical trials may improve interpretability and impact, but this has not been explicitly tested. Modifications to informed consent may not be appropriate in all cases, and risks to participants should be minimized by implementing appropriate guardrails.
During the COVID-19 pandemic, there were many vaccine trials which had significant purposes which participants needed to understand to validly consent. For example, participants needed to understand that the purpose of dose-escalation vaccine trials was to give incremental doses of a vaccine until participants became ill. Likewise, participants needed to understand that even if they received placebos, they could not take a genuine vaccine to preserve the integrity of the trials. Yet, these intuitive judgements about what participants need to understand to validly consent are rejected by recent accounts of consent. According to these accounts, as long as participants were given a good opportunity to learn these purposes, they do not need to actually understand them to consent. In this paper, I reject this consensus, and I argue that participants who failed to understand these aims associated with vaccine trials failed to provide legitimate consent. I defend this claim by developing and defending a new understanding condition for valid consent. According to this understanding condition, a participant must understand when a consent transaction has features which violate the norms which govern the medical practice with which they are acquainted. I argue that this condition is independently plausible and best explains why participants needed to understand these aims associated with vaccine trials to validly consent.
Using examples from psychiatric research, the authors explore the ethical dilemma of the "therapeutic misconception," where, despite explanation, patient-subjects believe that research protocols are designed to benefit them directly rather than to test or compare treatment methods. Even potential subjects who demonstrate an understanding of randomization, double-blinded studies, and the use of placebos frequently persist in a belief that they purposely will receive the treatment most likely to benefit them. They expect the standards of personal care that characterize the therapeutic relationship to carry over to the clinical trial, failing to understand that the need for valid research results makes this impossible. Appelbaum et al. suggest ways in which patients can be made to understand the differences between treatment and research, and the disadvantages and advantages of participation in the latter.
In standard medical care, physicians select treatments for patients based on clinical judgment, considering which treatment is best for the individual patient, given the patient's history and circumstances. In contrast, investigators conducting randomized clinical trials select treatments for participants based on a random selection process. Because this process represents a significant departure from the norms of standard medical care, it is widely assumed that potential research participants must understand randomization to give valid informed consent. This assumption, together with data that many research participants do not understand randomization, implies that randomized clinical trials often fail to obtain adequately informed consent. Before accepting this conclusion, and before initiating extensive efforts to improve research participants' understanding of randomization, we should assess the plausible, but rarely analyzed assumption that participants need to understand randomization to give valid informed consent for randomized clinical trials.
According to this paper, respect for informed consent implies that subjects should often be told a good deal more than ethical guidelines explicitly or implicitly require. Unless subjects are informed of the researchers’ personal characteristics, views, and sponsors whenever they would be likely to consider them significant, their autonomy is being overridden. However, overriding subjects’ autonomy is sometimes required by the interests of researchers in not being discriminated against or suffering intrusions into their privacy. This paper resolves the conflict between informed consent and the interests of researchers by recommending that (i) subjects generally should be told of the personal characteristics of researchers when relevant as part of the researchers’ job and (ii) that subjects should be told of researchers’ views when conceptually connected to the research and (iii) that subjects should almost always be told about sponsorship. While the paper explicitly limits the role of informed consent, these recommendations go significantly beyond most guidelines in their requirements about what information should be disclosed.
In this article, I propose and defend a new analysis of claim-rights. My proposal is a hybrid of the two best known analyses, the Will theory and the Interest theory. For good reason, the debate between these theories is often regarded as a stand-off. That is because the Will theory has had no satisfactory answer to the Interest theory’s best objections (inalienable rights and incompetent right-holders), while the Interest theory has likewise had no satisfactory answer to the Will theory’s best objection (third party beneficiaries). After reviewing these various objections and criticizing some recent attempts to meet them, I introduce my hybrid alternative and explain how it provides a satisfactory solution to all of these objections.
A sliding-scale model for assessing patient competency to consent to medical treatments is proposed. The least stringent standard, to be applied in the case of safe and effective treatments, assumes a valid consent if the patient is aware of what is happening and assents to the rational expectations of the physician. The second standard, applicable in the case of less certain treatments, requires that the patient understand the treatment options and have the capacity to choose or reject a treatment based on a weighing of risks and benefits. The third and most stringent standard, reserved for very dangerous treatments, bases competence to consent on an appreciation of the implications of the medical information for the patient's life and on an ability to state the reasons for the decision in terms of the medical issues and the patient's personal values.
The trouble with informed consent is that it is not educated consent. Let us assume that the experimental subject, whether a patient, a volunteer, or otherwise enlisted, is exposed to a completely honest array of factual detail. He is told of the medical uncertainty that exists and that must be resolved by research endeavors, of the time and discomfort involved, and of the tiny percentage risk of some serious consequences of the test procedure. He is also reassured of his rights and given a formal, quasilegal statement to read. No exculpatory language is used. With his written signature, the subject then caps the transaction, and whether he sees himself as a heroic martyr for the sake of mankind, or as a reluctant guinea pig dragooned for the benefit of science, or whether, perhaps, he is merely bewildered, he obviously has given his “informed consent.” Because established routines have been scrupulously observed, the doctor, the lawyer, and the ethicist are content.
The psychological principles that govern the perception of decision problems and the evaluation of probabilities and outcomes
produce predictable shifts of preference when the same problem is framed in different ways. Reversals of preference are demonstrated
in choices regarding monetary outcomes, both hypothetical and real, and in questions pertaining to the loss of human lives.
The effects of frames on preferences are compared to the effects of perspectives on perceptual appearance. The dependence
of preferences on the formulation of decision problems is a significant concern for the theory of rational choice.
To describe ways in which intuitive thought processes and feelings may lead patients to make suboptimal medical decisions.
Review of past studies from the psychology literature.
Intuitive decision making is often appropriate and results in reasonable choices; in some situations, however, intuitions lead patients to make choices that are not in their best interests. People sometimes treat safety and danger categorically, undervalue the importance of a partial risk reduction, are influenced by the way in which a problem is framed, and inappropriately evaluate an action by its subsequent outcome. These strategies help explain examples where risk perceptions conflict with standard scientific analyses. In the domain of emotions, people tend to consider losses as more significant than the corresponding gains, are imperfect at predicting future preferences, distort their memories of past personal experiences, have difficulty resolving inconsistencies between emotions and rationality, and worry with an intensity disproportionate to the actual danger. In general, such intangible aspects of clinical care have received little attention in the medical literature.
We suggest that an awareness of how people reason is an important clinical skill that can be promoted by knowledge of selected past studies in psychology.
Decision making for incompetent elderly people is an increasingly serious issue for American society. The decision-making processes we choose will reflect choices among a number of ethical principles--those specifying the purpose of substituted judgment, those guiding the surrogate decision maker, and those used in choosing the surrogate--and depends as well on the way we construe the concept of decision-making competence.
According to this paper, respect for informed consent implies that subjects should often be told a good deal more than ethical guidelines explicitly or implicitly require. Unless subjects are informed of the researchers' personal characteristics, views, and sponsors whenever they would be likely to consider them significant, their autonomy is being overridden. However, overriding subjects' autonomy is sometimes required by the interests of researchers in not being discriminated against or suffering intrusions into their privacy. This paper resolves the conflict between informed consent and the interests of researchers by recommending that (i) subjects generally should be told of the personal characteristics of researchers when relevant as part of the researchers' job and (ii) that subjects should be told of researchers' views when conceptually connected to the research and (iii) that subjects should almost always be told about sponsorship. While the paper explicitly limits the role of informed consent, these recommendations go significantly beyond most guidelines in their requirements about what information should be disclosed.