I. Abstract 

Since the beginning of biomedical research on human subjects, the notion of consent has been widely debated and highly contentious. With philosophers and bioethicists focusing on the issue of what constitutes truly informed consent and the proper ethical guidelines for retrieving it, the existing notion of consent in biomedical research fails to fully consider the potentially coercive forces on participants. Consent has also been an issue of import amongst philosophers of sex and feminist scholars. Rallying behind the contemporary idea of a robust version of consent—one that fully encompasses the ways in which agents may be coerced into consenting to a sexual act—these philosophers have argued that societal norms, external pressures, and the nature of consent itself often render consent insufficient to guarantee the moral permissibility of sex. I will argue that these two seemingly distinct concepts of consent in sexual and biomedical spheres face many of the same ethical issues. Borrowing from recent discussions around coercive factors influencing consent in sexual interactions and my own experiences in biomedical research settings, I will draw parallels between these two notions of consent in order to illuminate a more accurate and robust philosophical framework for setting ethical guidelines around obtaining consent in biomedical research settings. 

II. Introduction 

As biomedical research has increased exponentially with regard to both enhanced funding for the practice of human-subject experimentation and new research methodologies for promising medical interventions, there is an urgent need for robust ethical guidelines around utilizing human subjects in biomedical research contexts. This paper will focus on the use of human subjects in average biomedical research experiments, which typically recruit and pay individuals to undergo a certain medical procedure, take a specific drug, etc. before approval of the medical intervention for the general population. Across all of the varying perspectives regarding how to best recruit, treat, and compensate human subjects, consent has remained an absolute standard and necessity for conducting ethical biomedical research. While philosophers and bioethicists have contentiously debated over the necessary conditions for obtaining consent, most have widely (if not completely) neglected factors that may wrongfully induce human subjects to consent to biomedical research. 

Consent has also been a central topic of importance within the philosophy of sex and feminist philosophy, yet its development has remained quite distinct from the understanding of consent in the field of biomedical research and subject recruitment. Philosopher and bioethicist Alan Wertheimer has made a connection between the notion of consent in sexual interactions and biomedical research, but my parallels and conclusions will clearly be distinct from his and will primarily focus on developing thoughts inspired by the initial connection made by Quill Kukla in “A Nonideal Theory of Sexual Consent.” In sexual interactions, most philosophers agree that consent is a necessary, but insufficient, element for ensuring the permissibility of sex between partners. Consent is something to be given freely, and many forces may serve to coerce or influence an individual into granting their consent, thus potentially curtailing the normative goal of “ideal” consent. Traditional discussions of consent are structured around fulfilling the normative goal of obtaining consent that is free from undue influence on one’s agency, autonomy, ability to make rational decisions, etc. Consent, under this view, is either valid or not—anything constraining an agent’s ability to consent automatically invalidates its moral force. 

Quill Kukla has introduced a “nonideal theory of sexual consent,” which classifies consent as degreed and emphasizes that genuine consent can still be achieved in the presence of potentially coercive factors. Under this conception, agency and autonomy are present in lesser and greater degrees within different sexual interactions, and agents are continually pressured by coercive forces. Thus, consent is not valid or invalid; instead, genuine consent (or robust consent as I will often refer to it) is built when coercive factors are controlled to such a degree that all sexual partners possess sufficient agency to make a fully rational decision to consent. This does not deny our ability to determine whether a sexual act is morally permissible and establish a standard for morally permissible ways to obtain consent. Rather, it allows us to adopt a nuanced view of consent as a nonideal concept, wherein agents can consent under our oft-constrained and coerced statuses. Philosophical inquiries into coercive factors impacting one’s ability to obtain genuine, robust consent in sexual interactions have focused on external pressures, societal norms, and the implications of consent as the dominant framework itself. Yet, bioethicists have neglected this crucial area in their understanding of consent.

Much can be gained for our existing notion of consent in biomedical research settings by embracing the approach taken by philosophers of sex. Consent operates in many different facets of life—agreeing to consent forms, consenting to a sexual interaction, consenting to someone entering your home, and many other forms of implicit and explicit acts of consent. However, the nature of consent within sexual interactions and biomedical research settings is distinct from other forms, making them especially morally-laden. Given violations of these kinds of consent are particularly harmful to one’s bodily autonomy, sexual interactions and biomedical research settings are especially deserving of rigid consent guidelines. The genuine robustness of these two forms of consent is also dependent upon the satisfaction of external conditions not always under the control of the agent granting consent (ex. a non-coercive partner in sexual interactions or a biomedical institutional review board that grants approval for a biomedical experiment), opening up the potential for coercive factors to render a certain act morally impermissible. These two distinct forms of consent face many of the same ethical issues and should be engaged in a conversation with one another—a conversation that has been neglected thus far. I hope to build a more accurate, encompassing framework in the biomedical sphere by which we can set ethical guidelines for engaging human research subjects in a truly consensual manner based on the progress made by philosophers of sex, like Kukla and others.

To conduct this comparative analysis, I will begin by discussing the existing notion of consent within the biomedical research field and detailing the major issues of importance currently debated. I will then proceed to review the ways in which many philosophers of sex have taken a broader approach to defining consent—one that takes into account the coercive factors that may inhibit an agent’s ability to grant consent with full autonomy and agency. I will then draw comparisons between these two distinct notions of consent to reveal several coercive factors in biomedical research settings that may render “informed” consent coerced. Finally, I will suggest how we may build a broader philosophical framework to scaffold the agency of human subjects when consenting to potentially dangerous biomedical research experiments.

III. The Existing Notion of Consent in Biomedical Research 

After many instances of harmful treatments being given to vulnerable, often marginalized populations, such as the Tuskegee Syphilis study, bioethicists began to question what truly constitutes informed consent in biomedical research settings. This question has included exploration into both the best ways to obtain consent, as well as the proper way to interpret the term, “informed.” The predominant conclusion on how to best define informed consent has overwhelmingly neglected consideration of coercive factors that impact the ability for human subjects to rationally consent to biomedical trials. As will become clear, there are an abundance of underexplored factors that may constrain one’s ability to rationally consent to participate in a biomedical research trial. This paper aims to fill this lacuna in the current understanding of biomedical research consent.

There are many interesting debates around the understanding of biomedical consent that will become relevant to my argument later, the first being the therapeutic misconception. This phenomenon occurs quite often in biomedical research settings, where human subjects possess the incorrect belief that they are receiving life-changing or potentially beneficial treatments, despite being told about the potential of receiving a placebo treatment, or the chance that the experimental drug may be ineffective. The implications of the therapeutic misconception for ensuring the genuine nature of a human subject’s consent are vast. Consent hinges upon an agent’s uncoerced ability to make an informed decision, and philosophers of biology have rightfully debated what constitutes truly meeting the informed standard of consent. Can one really be said to have full decision-making agency and possess the needed information to genuinely consent if they wrongly believe, as subjects with the therapeutic misconception do, that they are guaranteed life-saving treatment? This is not to say that consent is in some way unobtainable in biomedical research settings; however, we ought to properly understand the implications of the therapeutic misconception on a subject’s ability to grant their consent in a knowing, informed fashion.

In addition to the therapeutic misconception, there is another important debate around whether informed consent requires comprehension in any way. Some argue that full comprehension of what the study entails is the only way to ensure the participant is aware of all of the risks and does not possess the therapeutic misconception. Participants have also been shown to severely misunderstand the actual procedures, treatments, etc. they are consenting to, whether that be due to not reading the consent form or not fully understanding the researcher’s explanation of what will occur during the study. By not comprehending both the purpose of the study and the exact particulars involved in it, research subjects may fail to meet the “informed” requirement of informed consent.

Regardless of the exact answers to these concerns, it is clear that the current discourse surrounding biomedical consent has yet to satisfactorily explore the intricacies of the coercive factors impacting consent in medical experiments. Participants may be hindered in their ability to grant genuine, uncoerced consent when, as research shows is often the case, they do not understand the purpose or specifics of the research study to which they are consenting. In a way, participants in many biomedical studies consent to a version of the study that does not carry the significant risks of harm they take on when consenting—is this morally permissible? How can we ensure coercive factors, like the therapeutic misconception, do not wrongly influence a human subject to consent to a potentially dangerous experiment? These ethical issues debated within the philosophy of biology can be better answered with a revised, robust version of consent—one which thoroughly examines and addresses the coercive factors that unduly encourage someone to grant consent without being truly informed and open to participating. 

IV. Moving Beyond Mere Consent: Philosophy of Sex 

While consent works to preserve the agency of a sexual partner, the vast majority of philosophers agree that consent is necessary for sex to be morally permissible, not sufficient. When consenting to a sexual act, a person is utilizing their agency and autonomy—their capacity to make free and independent decisions to meet their own ends—to make a rational choice, so consent both contributes to and draws from one’s agency. We now recognize the ability of rational agents to utilize their agency to consent to sexual acts that may still be morally problematic, whether that consists of morally dubious sexual actions or acts obtained with a coerced notion of consent. Given the importance of sexual consent, we need an understanding of it that can account for any and all factors that may coerce a sexual partner into granting consent when they otherwise would not have.

Philosophers have addressed the issue of consensual sex that may be coerced in a variety of fashions. Some feminist scholars, like Catharine MacKinnon, have taken a radical approach, claiming that no consent is truly valid under heteronormative structures. Their understandings of consent highlight the ways in which external societal conditions may render consent insufficient if they constrain one’s options to the point where consent becomes obligatory, rather than freely given. Nicola Gavey provides a compelling account of how heteronormative, oppressive structures may render one’s consent involuntary or obligatory in sexual situations because of societal conditions pressuring women. Women sometimes feel obligated to consent to unwanted sexual advances because of the heteronormative forces that pressure them to enter a subservient, diminutive role within sexual interactions.

Other philosophers take a different approach to consent by illuminating varying ways in which traditional consent is not sufficient to guarantee a good moral standard for sex. Power dynamics, a misunderstanding of what will actually take place during sex, the offer of money, socialized behaviors, and societal pressures are all examples of coercive factors that may encourage one to say yes, even when one did not originally intend to. A person may not be able to fully, rationally consent to a sexual act if pressured by these sorts of coercive factors. Philosophers operating with this lens focus less on making a valid versus invalid distinction of consent and instead emphasize the way consent can be constrained or limited by oppressive structures and other coercive forces. The moral permissibility of a sexual act depends on the agency and autonomy possessed by all of the sexual partners consenting, which may be constrained by coercive factors. By emphasizing the coercive factors outside of direct threats from a partner that may constrain one’s genuine consent, feminist philosophers have been able to build a more robust understanding of consent—one that accounts for the coercive factors that may wrongfully influence one to consent to a sexual act.

To summarize all of this into a more digestible framework, I find Quill Kukla’s non-ideal theory of consent to be particularly illuminating. Essentially, under Kukla’s perspective, consent is a “nonideal concept,” where virtually no sex will turn out to be consensual if consent requires the full autonomy of its participants. Their framework allows for the permissibility of sex and obtaining consent even when coercive forces are present; all agents are constrained in different ways, by different power relations, as a result of different identities, and that does not fully invalidate our ability to consent. Instead, to ensure one’s consent is genuine in the presence of common coercive factors, Kukla argues we must “scaffold” consent by “[being] sensitive to the limits of and possibilities for agency and consent in a given context and [adjusting] accordingly,” to ensure a partner possesses agency and autonomy. Scaffolding can be accomplished socially or interpersonally, where practices, environments, and relationships can help to enable a sexual partner’s agency. Kukla uses the example of a retirement facility embracing guidelines, policies, and management that allow its patients to have sex in such a way that does not threaten their ability to participate safely or diminish their own agency in pursuing sexual relationships. On the interpersonal level, agents can also aid in scaffolding their sexual partner’s (or partners’) agency and autonomy by ensuring their partner feels the, “ability to exit a situation, trust, [and] safety,” among other crucial practices that build and protect one’s ability to genuinely consent. Policies here scaffold consent by examining potential coercive factors and building social practices which are inclusive and protective of sexual agency.

Again, philosophers of sex, like Kukla, have explicated external factors, such as power dynamics, money, the traditional, overriding depiction of a woman “giving” consent to a man’s request, and heteronormative structures, that may coerce someone to consent to a sexual act. In identifying these, philosophers can strategically recommend scaffolding structures to ensure the moral permissibility of sexual interactions and to enhance the agency and autonomy of sexual partners. I argue that the bioethicist ought to take on a similar project of identifying coercive factors and scaffolding their designs to preserve agency, autonomy, and genuine consent in biomedical research experiments. This challenge has been neglected thus far, and the current understanding of informed consent fails to fully account for coercive factors; thus, the biomedical research community is in need of a scaffolding strategy to preserve genuine, robust consent. The following section attempts to embrace the approach taken by Kukla and others in developing a more robust theory of consent within biomedical research settings.

V. Can Biomedical Research Achieve Genuine, Robust Consent? 

To curb coercive factors from playing a role in one’s decision to have sex, Kukla proposes a more robust, nonideal theory of consent, which works to scaffold protections for an individual’s autonomy in the process of granting consent. Kukla’s framework understands that agents are constantly influenced by external, coercive factors. I argue that we should embrace this approach in the biomedical research field, which requires a thorough understanding of the implicit and explicit factors that encourage participants to grant consent to medical experiments and treatments. I will now begin to detail four primary coercive factors that have been underexplored by philosophers of biology, highlighting the direct parallels that can be found with the coercive factors that impact sexual consent. In drawing these parallels and embracing a more robust understanding of consent, this paper will aim to demonstrate the need for greater encompassing ethical guidelines around biomedical research experiments.

A. Compensation: Fair or Coercive? 

The standard practice for most biomedical research trials is to compensate their human subjects for their participation and time spent completing the study (and any additional costs incurred, medical expenses, inter alia). To recruit enough human subjects for a statistically valid biomedical study, researchers must offer compensation as an inducement to participate. Many ethical questions have been explored by philosophers and bioethicists, including how much to pay human subjects, whether payment for certain kinds of research is morally acceptable, and if payment can truly compensate for the serious risks involved in participating in experimental research. However, most have neglected to explore the role money plays as a coercive factor to participate in potentially dangerous research and its impact from a scaffolding perspective.

Participating in biomedical research can be a valuable way to earn both active and passive income, yet money is known to influence the rational decision-making of moral agents. Might someone “consent” to engaging in a biomedical research study that crosses their ethical and/or physical level of comfort in desperation for money? Philosophers of sex have rightly acknowledged that money can serve as an influential and potentially coercive force for consenting to certain actions because an agent may, in an attempt to earn crucial income for themselves, consent to sex in which they would not normally be comfortable engaging. 

A very similar ethical dilemma arises in the case of biomedical research. Consider this fictional example: an extremely poor woman who struggles to pay for her basic necessities agrees to take a highly experimental drug that could have damaging, long-term side effects. She would not normally endanger her own health in this way, but she is so desperate for passive income that this compensation is too important to pass up. Under the existing notion of informed consent in biomedical research, this kind of participation would still be considered fully consensual when, clearly, money played a coercive role in her decision. This is not to say that all sexual interactions and all biomedical research settings involving the exchange of cash are coercive (e.g. sex work depends on the presence of money, but is not necessarily coerced), but we ought to pay crucial attention to these areas because of the morally problematic force money can have on obtaining consent. Money has the potential of encouraging and even forcing one into doing things they would not normally be comfortable with, so compensation is especially deserving of ethical guidelines. See Largent, et. al. for a further discussion of the concerns here.

Imagine a case where someone decides to consent to a risky biomedical research trial with full comprehension of the risks and particulars involved with the medical study. They choose to accept all of the accompanying risks with participation because the potential compensation is worth their involvement according to a rational assessment by the agent in question. I concede here that this person may not be making a coerced decision to consent—this person, depending on the background circumstances and personal costs, may be choosing to utilize their agency to make a rational decision to pursue compensation. But, it is equally important for research designers to ask, ‘If this subject were in a greater position of agency and authority, would they still be comfortable with making the same decision?’ This question concerning the potential for coercive influence is neglected and unaddressed in the vast majority of biomedical research settings. Not all cases will reveal coercive factors influencing a subject’s decision, but bioethicists have neglected to fully accept the incredibly powerful and sometimes coercive influence compensation can have on a person’s ability to rationally consent.

Furthermore, many research studies design their compensation schedule in a way to coerce participants into completing the entirety of a biomedical experiment by offering a significant “bonus” at the end of the study. Given that consent hinges on the ability for an agent to say “no” at any time to any part of an experiment, compensation can wrongfully be utilized as a tool of coercion, in that a research subject may feel unduly compelled to complete a study in hopes of receiving the bulk of their compensation at the end of the research. Compensation, in this role, can coerce consent and thus render the consent given as less robust, less agential, and likely to be less morally permissible than a more scaffolded version of biomedical consent.

B. Underexplored Power Dynamics 

Furthermore, there exist underexplored power dynamics that may induce individuals to consent to biomedical research that they might not otherwise. It is not uncommon for physicians to offer (or even suggest) participating in an experimental research trial to their ailing patients. The physician here possesses a status of authority and level of power that may wrongfully induce their patient to agree to participate, despite the overwhelming risks, in benefits to their own research or that of their colleagues. This is not to say that all actions by a doctor wrongfully operate on a power dynamic, but recommending someone to consent to a trial with clear and substantial potential for harm rightfully deserves a more critical lens for moral judgments. Another example worth noting is when professors recruit their students to participate in their own biomedical research. Might a student consent to participate merely because their professor, who is in a position of power, asked them to do so? 

I argue that both of these cases illuminate a power dynamic that may render the given consent here as below the standard for moral permissibility and fully robust consent. Just as a boss requesting to have sex with their employee possesses an imbalanced power dynamic, so do certain recommendations of research studies by people of authority. By understanding the coercive influence of underexplored power dynamics in biomedical research recruitment, we can begin to build a more robust theory of consent that accounts for this coercive factor. 

C. The Misunderstanding of Particulars By Research Participants 

As previously discussed, it has been well documented that human subjects often misunderstand the particular actions and risks involved with their participation in biomedical research trials. While comprehension is difficult to fully impart on human subjects, might some of these knowledge gaps wrongfully encourage one to consent to a research study? As mentioned earlier, if one is under the guise of the therapeutic misconception, they may be more willing to consent to potentially dangerous research in the hope of receiving free treatment; however, there is no guarantee they will receive any sort of efficacious medical intervention. Research participants are also often unaware of the particular procedures, treatments, etc. they will have to undergo, meaning they cannot grant fully informed consent to them. A similar ethical dilemma arises in the case of sexual consent: one may consent to a sexual interaction without knowing the full breadth of what will occur. Biomedical researchers ought to work (or alternatively, “scaffold”) toward ensuring their research participants have full knowledge and comprehension of any factor of the research that might change their decision to consent. Only a more robust consent framework within biomedical research settings can properly protect the autonomy of human subjects to provide truly informed consent. 

D. Lack of Knowledge Regarding Research Intentions

The final factor that I argue merits greater consideration in our ethical guidelines around biomedical consent concerns the ability of the patient to understand the intentions of the research. Due to the nature of biomedical research, human subjects are often not informed of every detail of the study in order to maintain scientific objectivity and integrity. So, a human subject may be told what the study consists of, while not fully understanding the intentions of the research. What if a human subject consents to participating in a Phase I biomedical trial without knowing that the intention of the research is to produce a drug that only the extremely wealthy will be able to afford (an unfortunately common occurrence in the US)? Or, what if the aim of the research is to reach a conclusion that goes against one’s own morals, like that racial differences are essential rather than constructed? Just as one possesses a right to know the intentions behind their partner asking for consent to have sex, human subjects have a right here as well because the information presented may actively encourage one to not offer consent in the first place.

Our existing definition of consent for human subjects in biomedical research experiments does not properly account for preserving, or scaffolding, the full rational decision-making of human subjects. While understanding the need for a certain level of confidentiality, the intentions behind the research itself may serve as a deterrent for someone to grant consent. So, in order to have genuine, robust consent, we must be able to set ethical guidelines that actively inform the participant of any detail that may render their consent below the bar for moral permissibility if unknown.

VI. An Argument for a More Robust Consent in Biomedical Experiments

I present these four coercive factors not in an attempt to develop a fully-fledged account of proper consent in biomedical research, but rather to demonstrate that our existing notion does not go far enough to protect the autonomy of human subjects. All four of these concerns do not apply equally in every context, but they do merit a greater, more nuanced understanding of consent and how to ethically scaffold against coercive factors. Philosophers of sex, like Kukla, have begun to popularize the idea of a robust, nonideal theory of consent as a way to scaffold ethical precautions to engaging in sexual acts with a partner. The field of biomedical research ought to embrace a similar strategy and approach, and these four factors can begin to identify the key elements influencing the autonomy and agency of sexual partners. 

To scaffold a human subject’s ability to grant their uncoerced consent, we need to maximize their knowledge of anything essential to their rational decision-making. This would involve instituting clear and expansive policies to combat the therapeutic misconception and ensure participants understand the potential harms they may undergo. Researchers should also develop pay schedules and formats that work to ensure that the benefit incurred from compensation does not wrongly coerce one into participating or lacking the ability to revoke their participation at any time. Crucially, though, we ought to concurrently reform the issues of capitalism and systemic wealth inequality that force many people in the US to sell their own bodies for lifesaving income. Finally, we should adopt stricter guidelines for participating in biomedical research experiments to both restrict coercive power dynamics and pursue further scaffolding of subjects’ agency and autonomy. It is important to note, though, that this paper is primarily concerned with the philosophical issues that might constrain one’s genuine consent, and I invite bioethicists to create a more concrete and thorough list of ethical guidelines to scaffold agency in experiments.

By conducting a rigorous philosophical analysis of coercive factors that influence human subjects, philosophers of biology will be better equipped to develop their own version of robust consent that can account for coercive factors. This new, reinspired lens from a philosopher of sex into scaffolding consent should help to control the damaging effects of coercive factors and grant the human subject greater autonomy in making rational decisions regarding whether and when to participate in biomedical research. Research study designers can utilize the recognition of these coercive forces, scaffold ethical practices to combat their influence on diminishing an agent’s authority and embrace a more robust understanding of consent in biomedical research experiments.

VII. Conclusion 

My aim in this paper has been to draw parallels between the currently distinct notions of consent within sexual interactions and biomedical research to illuminate the similar ethical issues facing both. Many feminist scholars and philosophers of sex have taken an approach of examining the societal conditions, other external pressures, and nature of consent itself to illuminate the ways consent may be unduly coerced in rational agents. In doing so, they have been able to develop a more robust framework around a nonideal theory of consent that socially and interpersonally scaffolds (but not completely) a person’s agency in order to minimize coercive factors in one’s decision to consent to sex. By detailing parallel coercive factors present in the biomedical research field, I hope further philosophical inquiries will be able to develop a similar robust consent framework for biomedical research involving human subjects.

On a more practically conclusive note, biomedical research experiments are luring; research designers purposefully advertise their studies to sound like easy, safe ways to make money, despite their risks. As shown by decades of research studies with devastating effects on communities of color, biomedical research experiments target specific populations…populations that are often BIPOC, low-income, young, and most vulnerable to being coerced into consenting in a biomedical research setting (see NIH for more on the crucially important element of structural medical racism). I’ve seen firsthand the consequences of a biomedical research industry that has consistently used advertising to tempt many young people, like myself, to participate in potentially harmful studies—experiments where we may not be in a fully agential capacity due to coercive factors. Money, power relations, a lack of understanding regarding the experiment, and other coercive factors constantly influence the ability for people, especially those of marginalized or fiscally disadvantaged backgrounds, to make a fully rational choice in consenting to biomedical research. This should not detract from the important results found in biomedical research and the necessity for it; instead, I am hoping to emphasize the stakes of and potential harms from coerced consent. We need to scaffold the ability for everyone of every identity to make a fully rational, uncoerced decision on whether and when to consent to a biomedical research experiment. 

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