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Innovation is derived from the Latin innovatus which means “to renew or change”. In the broadest sense of the term, it can be viewed as the stimulus that modifies existing processes. Further, innovation has been one of the driving forces in the evolution of society through various revolutionary periods. This concept incorporates connotations of invention and creativity as impulses in themselves, however has recently been applied to commercialised settings. Hence, despite scientific interests, civic duties and altruism providing motivation for innovation, the strongest motive in recent times seems to be with a view to increasing profit. From a bottom-up level, inexperienced and junior innovators with the former inclinations could be met with resistance from the complexity of deriving economic viability. Furthermore, a central component to successful innovation involves promoting a culture to challenge outdated norms and the status quo. Change cannot occur if it is believed that present methods are infallible, as this removes the impetus for a goal-driven action. Consequently, many ideas may not reach fruition. However, within the medical field, it is wise that innovation occurs with incremental and calculated adjustments by enlarge, rather than with abrupt renovations. Wherever innovation leads to novel technology, the ultimate outcome of such is unforeseeable. The collingridge dilemma highlights an important notion that in early stages a new technology is still open to soc...
Innovation is derived from the Latin innovatus which means “to renew or change”. In the broadest sense of the term, it can be viewed as the stimulus that modifies existing processes. Further, innovation has been one of the driving forces in the evolution of society through various revolutionary periods. This concept incorporates connotations of invention and creativity as impulses in themselves, however has recently been applied to commercialised settings. Hence, despite scientific interests, civic duties and altruism providing motivation for innovation, the strongest motive in recent times seems to be with a view to increasing profit. From a bottom-up level, inexperienced and junior innovators with the former inclinations could be met with resistance from the complexity of deriving economic viability. Furthermore, a central component to successful innovation involves promoting a culture to challenge outdated norms and the status quo. Change cannot occur if it is believed that present methods are infallible, as this removes the impetus for a goal-driven action. Consequently, many ideas may not reach fruition. However, within the medical field, it is wise that innovation occurs with incremental and calculated adjustments by enlarge, rather than with abrupt renovations. Wherever innovation leads to novel technology, the ultimate outcome of such is unforeseeable. The collingridge dilemma highlights an important notion that in early stages a new technology is still open to social manipulation and as this malleability is lessened over time the potential for change is reduced.
The NHS system delivers care based on bioethical principles with emphasis on justice- that is, healthcare is widely accessible and free to all members of society, without discrimination on the grounds of socio-economic status, age and ethnicity. An evidence-based approach to treatment was exemplified with the inception of NICE in 2005. The use of scientific, robust research undoubtedly aids in the service of healthcare and ensures harm is reduced to a minimum. NICE publish updates and review their recommendations to reach this end, and in this way it is a protagonist in medical innovation. However, as the subject of healthcare is the human body, the complexities of such make it difficult to be certain of therapeutic successes being attributed to medical care alone. Other factors such as spontaneous remission, placebo and fundamental attribution error may skew our judgements of efficacy. In this way it is pertinent that we challenge customary management protocols wherever treatment failure occurs. Medical innovation, then, is essential to improve patient care.
However, speculation that financial motivations appear to provide the incentive for developing new therapies has naturally arisen. Authors have suggested this may manifest as delaying research results while researchers ascertain patents; leading to a culture of data distortion and neglect of the primary bioethical principles [1]. As the financial market provides the driving force for medical innovation to reach a profit goal, it follows that limiting product development through sanctioning of financial resources necessarily can limit innovation potential. Is it not then possible to foresee how this can be detrimental to patient care? Provided that political and social commitments i.e. moral, may impact the significance of medical research and its goals, innovation is an ideal. The competitive stimulus to acquire financial gains may drive innovation in other settings as well as medicine. This provides enough force for most individuals irrespective of personal concern for duty.
For medical professionals including medical students, the aim is for the improvement and promotion of care. Beginning with fundamentals; the adage “Primum non nocere”, is known to most students from the onset of medical studies. Medical students devote considerable time to through studying the principles of medical science, that it is often easy to forget the reason and aim of their work. With respect to bioethical principles, medical students ought to be encouraged to further medical progress but with an awareness that their actions are primarily for the benefit of patients. To improve the status quo, it is necessary to promote and implement a change in attitudes predominating medical schools. Naturally, when one devotes time, resources and efforts to achieve an aim, one would like compensation for these efforts. Despite the instrumental improvements that financial incentives influence with positive change, it is necessary that one remains conscious of the holistic approach to the patient.
References:
[1] Blumenthal D, Causino N, Campbell E, Louis K. Relationships between Academic Institutions and Industry in the Life Sciences — An Industry Survey. New England Journal of Medicine. 1996;334(6):368-374.
Paul et al. (2018) “Implementing post-trial access plans for HIV prevention research” present a much-needed discussion on the implementation of post-trial access plans. Here, I just want to signal a mistake on the conceptual definition of access, to an otherwise flawless paper.
If I am correct, the mistake would be related to the formulation of the following question:
"it the responsibility of researchers and sponsors only to ensure that all participants have access to effective preventive therapies, or does that responsibility extend further, to ensuring that participants actually receive them?" (Paul et al 2018:4)
I believe that "to ensure that participants have access to an intervention" is logically equivalent to "ensuring that participants actually receive an intervention". The MRCT Center's framework on post-trial responsibility defines access as “[…] the ability, right or permission of an individual to use an object or asset, and implies the removal of barriers to allow such use” (MRCT Center 2017:76). If a person does not actually receive an effective preventive therapy, she does not have the ability to use it. Therefor she has no access. Hence, distinguishing between the above expressions is conceptual mistake.
Instead, what I believe that the authors wanted to discuss is how much sponsors and researchers need to do to ensure access to an investigational intervention. In fact, irrespective of the abo...
Paul et al. (2018) “Implementing post-trial access plans for HIV prevention research” present a much-needed discussion on the implementation of post-trial access plans. Here, I just want to signal a mistake on the conceptual definition of access, to an otherwise flawless paper.
If I am correct, the mistake would be related to the formulation of the following question:
"it the responsibility of researchers and sponsors only to ensure that all participants have access to effective preventive therapies, or does that responsibility extend further, to ensuring that participants actually receive them?" (Paul et al 2018:4)
I believe that "to ensure that participants have access to an intervention" is logically equivalent to "ensuring that participants actually receive an intervention". The MRCT Center's framework on post-trial responsibility defines access as “[…] the ability, right or permission of an individual to use an object or asset, and implies the removal of barriers to allow such use” (MRCT Center 2017:76). If a person does not actually receive an effective preventive therapy, she does not have the ability to use it. Therefor she has no access. Hence, distinguishing between the above expressions is conceptual mistake.
Instead, what I believe that the authors wanted to discuss is how much sponsors and researchers need to do to ensure access to an investigational intervention. In fact, irrespective of the above formulation of the question, the author’s discussion of this question is about whether "referring participants" to local healthcare is enough to fulfil sponsors and post-trial access obligations or not, especially when "referral alone" is shown not be sufficient in some circumstances described in the paper to guarantee responsible transition to appropriate healthcare. However, “referral alone” is not equivalent to access but just a “post-trial access mechanism” (MRCT Center 2017:78).
Hence, I believe that the authors should reformulate the above question that may induce some conceptual confusion. Inspired by a question at the end of the paper, I suggest the following reformulation:
Is referral [alone] sufficient to fulfil [sponsors and] researchers’ [part of post-trial access] obligations [in all cases], or ought they to go further [sometimes?] [...] (Paul et al 2018:5, edited by Mastroleo)
Finally, what I believe that can be of help clarifying this conceptual mistake is to clearly distinguish between different questions, that is, (1) what would be the obligations entailed by post-trial access responsibility in a particular trial, including post-trial access, if any (Cho et al 2018); (2) what is the appropriate distribution of that responsibility between different responsible agents in a particular situation, and finally (3) what are the appropriate post-trial mechanisms that each agent has to fulfil to comply collectively with their part of the responsibility to (referral alone, improved referral, etc.).
References
Cho, H. L., Danis, M., & Grady, C. (2018). Post-trial responsibilities beyond post-trial access. The Lancet, 391(10129), 1478-1479. https://doi.org/10.1016/S0140-6736(18)30761-X
Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center). (2017). MRCT Center Post-Trial Responsibilities Framework Continued Access to Investigational Medicines I. Guidance Document [Version 1.2, November 2017]. MRCT Center. Retrieved from http://mrctcenter.org/wp-content/uploads/2017/12/2017-12-07-Post-Trial-R...
Paul, A., Merritt, M. W., & Sugarman, J. (2018). Implementing post-trial access plans for HIV prevention research. Journal of Medical Ethics, medethics-2017-104637. https://doi.org/10.1136/medethics-2017-104637
On p.5 the authors comment on the use of mindfulness exercises as "a tool to relieve suffering
and increase functioning". They claim that "This goes against common epistemic values" where these epistemic values are described as "the sort of values that lead one to accept uncomfortable truths, and to be honest, even brutally honest, with oneself."
As far as I can see there is no argument given for that claim, and what is more, it seems to go precisely contrary to the purpose of mindfulness exercises in that these are intended to enable one to be honest with oneself and face uncomfortable truths (e.g.: "... we cultivate acceptance by taking each moment as it comes and being with it fully, as it is [...] receptive and open to whatever we are feeling, thinking, or seeing". [Kabat-Zinn, Full catastrophe living, p.28f: https://books.google.at/books?id=fIuNDtnb2ZkC]). Mindfulness is to a large extent a tool to enable one be "honest, even brutally honest, with oneself".
There is a number of other strange claims in this article, I will mention only one: "Suppose an atheist was having trouble coping emotionally with a natural disaster in which there were many casualties. They might object to imagining the people who died in the disaster frolicking in heaven, even if doing so would help them cope. They do not believe in heaven, thus the imaginati...
On p.5 the authors comment on the use of mindfulness exercises as "a tool to relieve suffering
and increase functioning". They claim that "This goes against common epistemic values" where these epistemic values are described as "the sort of values that lead one to accept uncomfortable truths, and to be honest, even brutally honest, with oneself."
As far as I can see there is no argument given for that claim, and what is more, it seems to go precisely contrary to the purpose of mindfulness exercises in that these are intended to enable one to be honest with oneself and face uncomfortable truths (e.g.: "... we cultivate acceptance by taking each moment as it comes and being with it fully, as it is [...] receptive and open to whatever we are feeling, thinking, or seeing". [Kabat-Zinn, Full catastrophe living, p.28f: https://books.google.at/books?id=fIuNDtnb2ZkC]). Mindfulness is to a large extent a tool to enable one be "honest, even brutally honest, with oneself".
There is a number of other strange claims in this article, I will mention only one: "Suppose an atheist was having trouble coping emotionally with a natural disaster in which there were many casualties. They might object to imagining the people who died in the disaster frolicking in heaven, even if doing so would help them cope. They do not believe in heaven, thus the imaginative exercise is in tension with their core beliefs. Mindfulness exercises involve a similar tension with the core beliefs." Well, I am an atheist, and I would have no qualms whatsoever about such an imaginative exercise - after all, it is just imagination (of course, I would find it a bit surreal, but so what if it helps).
Discussing the alleged "metaphysical loadedness" of mindfulness exercises would need more space and time than I have here, but that claim seems no more convincing to me than the ones above, despite the constant repetition of this claim in the article.
Authors Montero and Villarroel discuss problems that might arise from “conscientious objection” (CO) to the new law in Chile that legalized abortion in cases of life endangerment of the woman, fatal fetal abnormality, and rape. (“A critical review of conscientious objection and decriminalisation of abortion in Chile”, Jan 6). The law provides the “right” to exercise CO, with the only caveat that health institutions are required to immediately refer patients to non-objecting practitioners. We share the authors’ concerns that conscientious objection may prove be quite widespread in Chile with the new law. In fact, we argue it will create serious, widespread problems for access to safe and legal abortion, despite the referral requirement.
Of course, in a Catholic-dominated country like Chile with a total abortion ban, the new law represents a major advance, and it will undoubtedly help many women. We appreciate the challenges and hard work to get the law passed and acknowledge it may have been difficult to do so without CO as a political compromise. Unfortunately, last-minute lobbying by Catholic hospitals resulted in a court’s expansion of the CO clause in the law, giving the “right” of CO to not just doctors, but also support workers and even institutions (when only individuals can have a conscience). This law will be very difficult to reverse and women will suffer the consequences.[1]
The authors rightly recognize the difference between conscientious object...
Authors Montero and Villarroel discuss problems that might arise from “conscientious objection” (CO) to the new law in Chile that legalized abortion in cases of life endangerment of the woman, fatal fetal abnormality, and rape. (“A critical review of conscientious objection and decriminalisation of abortion in Chile”, Jan 6). The law provides the “right” to exercise CO, with the only caveat that health institutions are required to immediately refer patients to non-objecting practitioners. We share the authors’ concerns that conscientious objection may prove be quite widespread in Chile with the new law. In fact, we argue it will create serious, widespread problems for access to safe and legal abortion, despite the referral requirement.
Of course, in a Catholic-dominated country like Chile with a total abortion ban, the new law represents a major advance, and it will undoubtedly help many women. We appreciate the challenges and hard work to get the law passed and acknowledge it may have been difficult to do so without CO as a political compromise. Unfortunately, last-minute lobbying by Catholic hospitals resulted in a court’s expansion of the CO clause in the law, giving the “right” of CO to not just doctors, but also support workers and even institutions (when only individuals can have a conscience). This law will be very difficult to reverse and women will suffer the consequences.[1]
The authors rightly recognize the difference between conscientious objection in health care, and civil disobedience. Yes, Chilean health care professionals who object to abortion and the new abortion law have been using the conscientious objection debate as a political weapon to undermine and repeal the new democratically-decided law. They are being disobedient, not conscientious, because they are prioritizing their personal religious beliefs over women’s right to heath and life. CO is “dishonourable disobedience.”[2] In contrast, other doctors exercise a conscientious commitment to their patients’ well-being and safety by providing abortion when necessary, especially in a stigmatized or legally restricted environment such as Chile.
However, the authors assert without any justification that if CO involves acting according to conscience, then both CO and conscientious commitment “merit identical regard” and one does not prevail over the other. We strongly disagree. CO in reproductive health care is a misnomer because it is not “conscientious” – it is the unethical abuse and abandonment of medical ethics and the duty of care, while conscientious commitment fully respects medical ethics and patients’ right to health care. CO exploits an imbalance of power between doctor and patient, with doctors enjoying a chosen and privileged position of trust and a state monopoly over health care, while vulnerable patients bear the full burden of CO. This is the opposite of CO in the military, where ordinary citizens are drafted into service against their will and must accept punishment or alternate service if they object.
The authors assume that CO in health care is a right, albeit one that must be limited. However, evidence-based arguments indicate that CO in health care is inappropriate and should be prohibited, in the same way as for refusals based on discriminatory racist or sexist beliefs.[2] Currently, Sweden, Finland, and Iceland do not allow a refusal to treat in reproductive health care,[3] and all countries should follow their example if they take evidence-based medicine and women’s human rights seriously.
It may be difficult to overcome the entrenched tradition of accepting CO, especially in Catholic-dominated countries like Chile, but the answer is not to accommodate CO as a right and regulate it – instead, it should be denounced as a violation of patient rights, with steps taken to reduce it as far as possible until it can be effectively abolished.
Some writers distinguish between what might be called ‘genuine CO’ and ‘obstructionist CO’[4] – but this distinction is impossible to make in an objective way. In fact, the very nature of CO is to be obstructionist because most of those who invoke it want to stop women from having abortions. As we have concluded elsewhere:
“Personal conscientious objection to a treatment that a patient requests has no valid place in health care. Treatment decisions by HCPs [health care professionals] must be patient-directed, not self-directed, and must be based on evidence, medical ethics, and professional obligations. If the treatment is legal, within the HCP’s qualifications, requested by a mentally healthy patient, and primarily beneficial (which abortion is), there is simply no excuse to refuse.”
Montero and Villarroel recommend that the Chilean government regulate CO to prevent “misuse.” But they offer no recommendations for how to do this. As they acknowledge, a significant number of hospitals and doctors will never obey any law allowing abortion, so we can safely assume that these objectors will never obey any regulations on CO either. It is naïve to call for CO regulation when existing CO regulations around the world are widely ignored and enforcement is almost non-existent.[2] In particular, it is well known that many anti-abortion doctors will refuse to make referrals because they feel this makes them “complicit”.[5] They are rarely if ever held to account for such refusals.
If CO regulations sometimes appear to “work”, it is only in a handful of countries that impose strict limits on it, including Norway, England, and Portugal. But Norway and England both have very low levels of objectors anyway, plus England side-steps the CO problem by shifting most abortion care to private clinics.[6] As for Portugal, no rigorous data exist on the prevalence of objection, few objectors are aware of their legal reporting duties under the law, and it is unknown if hospitals and objectors are obeying the law or what actually happens to women.[7]
The authors point out that the Chilean health care system is beset by major shortcomings, with the public sector experiencing “runaway demand, inadequate outpatient services, and a shortage of facilities and hospital beds.” In such an environment, converting the 100,000 estimated illegal abortions a year into safe, legal procedures will undoubtedly strain resources and run up against significant abortion stigma and widespread denial of services.
Historical experience and evidence from other countries, especially Catholic countries like Italy,[8] shows that allowing CO will seriously undermine Chile’s new abortion law and prevent Chilean women from accessing the service. Because that is the political intent of CO. It is a religiously-motivated boycott of a democratically-decided law. It is a refusal to treat based on personal beliefs, something that should not be allowed in any area of medicine – the fundamental purpose of which is to provide care, not refuse it. Chile will not succeed in regulating CO for the simple reason that you cannot “regulate” the exercise of religious beliefs with rational arguments. Similarly, it is impossible to avoid the “misuse” of CO, as CO is a misuse in itself.
Instead, governments should implement strong educational, enforcement, and disciplinary measures against the exercise of CO. Otherwise, not much will change. If the regulation of CO is to work, it must have as its goal the eventual elimination of CO. Some examples of measures that would reduce and eliminate the exercise of CO include:
• Require all public hospitals to provide abortions (as in Portugal, Norway, and France).
• Inform medical students applying to the Obstetrics/Gynecology specialty that abortion is a mandatory part of the curriculum and an expected part of their practice.
• Provide compulsory training in medical schools in abortion techniques for all Ob/Gyn students, and in contraception provision for all family medicine students.
• Include the requirement to participate in abortion in job descriptions at the point of hiring.
• Require existing objectors to take continuing education courses or values clarification workshops on the need for reproductive health care services, why women request abortions, the negative effects of CO on patients, and their fiduciary duty to patients. Also, expose them to patients needing abortion.
• Assist remaining objectors to move to other disciplines or areas where their objection won’t be a problem.
• Impose disincentives against any remaining objectors, such as: require them to register and file reports for each refusal, monitor and discipline them, hold objectors financially liable for harms done to patients, prohibit existing objectors from working alone, allow employers to prioritize hiring of non-objecting physicians, and pay objecting physicians less.
The point is that CO regulations should be designed to actively discourage and eliminate CO, with the understanding that CO is unethical and inappropriate in health care. Any law or policy that implies or recognizes a right to CO, while assuming that objectors will follow any prescribed limits without oversight, is bound to fail and will hurt women. We hope that steps can be taken in Chile to minimize these inevitable harms to women’s health and violations of their rights – such as encouraging pro-choice doctors to make a conscientious commitment to provide life-saving abortion care to women.
[3] Fiala C, Gemzell Danielsson K, Heikinheimo O, Guðmundsson JA, and Arthur J. Yes We Can! Successful Examples of Disallowing ‘Conscientious Objection’ in Reproductive Healthcare. European Journal of Contraception and Reproductive Healthcare. 2016 pp 201-206. http://www.conscientious-objection.info/wp-content/uploads/2016/10/Yes-w...
[7] Chavkin W, Swerdlow L, Fifield J. Regulation of Conscientious Objection to Abortion: An International Comparative Multiple-Case Study. Health and Human Rights Journal. 2017 Jun;19(1):55-68. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5473038/
I was intrigued to read this article about US practice relating to consent and minors.
Intrigued; and very pleased that I practice in the UK, where this was agreed, very sensibly, years ago.
The UK law permits a minor to consent to treatment, as long as they are capable of understanding the issues involved. And for vaccination, the issues (when you leave out the non-science-based scary stuff) are usually straightforward.
This means that vaccinating adolescents against HPV is straightforward - a few simple questions to establish that they understand what the vaccines for, and have an acceptable understanding of the almost-negligible risks involved, and you can vaccinate them, without requiring parental consent and with the full support of healthcare systems and the courts.
The ludicrous situation in the USA where some parents can prevent their children from accessing vaccines at the right time (before sexual debut), when the children themselves have a clearer understanding of the issues than their parents and want to be vaccinated is now, thankfully, a largely historical issue here.
The article by Brennan [1], which has just been drawn to my attention, only exists in hypothetically perfect world in which medical evidence is always clear cut and bureaucracies beyond fallibility, bias, corruption or perhaps even scrutiny - it hinges like a lot of ethical investigations round the word "if". You could agree "y" if "x" (though I am not sure whether in this case it would be a libertarian argument as opposed to just an argument) but we do not have flawless bureaucracies making perfect decisions based on immutable scientific laws. Of course, a crucial argument relating to political liberty is just that bureaucracies are inevitably imperfect.
While we could explore and criticize the basis of many such decisions (and despite huge institutional pressures many criticisms of vaccine products lie within mainstream scientific debate, for instance issues regarding influenza vaccination, HPV, aluminum adjuvants, mercury preservatives etc.) we are simply not talking about a branch of science which admits of such certainties. Nor are we dealing with just a few products. The US mandated schedule has perhaps dozens of products already, with hundreds in the pipeline which depend for their commercial viability on being licensed and mandated in their turn. Brennan does not engage with the problem that is not about one or two instances (for instance MMR vaccine is often cited) but an indefinitely large number products which could become c...
The article by Brennan [1], which has just been drawn to my attention, only exists in hypothetically perfect world in which medical evidence is always clear cut and bureaucracies beyond fallibility, bias, corruption or perhaps even scrutiny - it hinges like a lot of ethical investigations round the word "if". You could agree "y" if "x" (though I am not sure whether in this case it would be a libertarian argument as opposed to just an argument) but we do not have flawless bureaucracies making perfect decisions based on immutable scientific laws. Of course, a crucial argument relating to political liberty is just that bureaucracies are inevitably imperfect.
While we could explore and criticize the basis of many such decisions (and despite huge institutional pressures many criticisms of vaccine products lie within mainstream scientific debate, for instance issues regarding influenza vaccination, HPV, aluminum adjuvants, mercury preservatives etc.) we are simply not talking about a branch of science which admits of such certainties. Nor are we dealing with just a few products. The US mandated schedule has perhaps dozens of products already, with hundreds in the pipeline which depend for their commercial viability on being licensed and mandated in their turn. Brennan does not engage with the problem that is not about one or two instances (for instance MMR vaccine is often cited) but an indefinitely large number products which could become compulsorily mandated for citizens by already existing bodies.
Brennan weights the case by proposing on the one hand that we have reliable science and on the other hand a lady who has appeared in Playboy centerfolds, i.e. Jenny McCarthy, but of course the arguments against the perfection and safety of the program has often been taken up by scientific and medical professionals, and often against their professional interest. It is not a happy example for yet another reason. If we were to have reliable information about vaccine products (as opposed to Papal style declarations of infallibilty) scientists and doctors would need to listen respectfully to citizens about their experiences whether or not they had appeared in Playboy. For this purpose celebrities are just prominent members of the public. In the case of Jenny McCarthy she and her employers have been subject to professional intimidation lying well beyond the realms of dispassionate science [2]. The issue of false-flag "grass-roots" vaccine organizations has also recently been highlighted by Doshi [3]. Bureaucracies can maintain their record by socially repressive means against the public and Jenny McCarthy would be an example: this is what might happen to you if you stand up.
It is not helpful - indeed highly misleading - to talk in abstract propositions: the truth here is messy and likely unpleasant.
Abstract
Jason Brennan presents a justification for mandatory vaccination policy from a libertarian perspective. I reevaluate Brennan’s argument, focusing on the applicability and potential limit of the clean hands principle he proposed. I argue that the clean hands principle cannot tell us how to weight the degrees of risk of different collectively harmful activities; therefore, we could not distinguish the relative significance of coercive interventions that aim at stopping different kinds of collectively harmful activities. Using secondhand smoke prevention as an analogous policy example, I illustrate that many behaviors that suffice the five conditions could be qualified as collectively harmful activities. These activities are hence subject to coercive policies that are justified by the clean hands principle, including those obviously infringe individual rights and civil liberties and contradict with libertarianism. For libertarians, this implication of the clean hands principle might not be too comfortable to accept.
Main Text
Using David Gauthier’s strategy, Jason Brennan demonstrates that even starting with a theory “with strongly individualist and antigovernment premises” such as libertarianism, mandatory vaccination is justifiable (p.37).1 Drawing on one of his own works, Brennan argues that the clean hands principle requires a person not to participate in collectively harmful activities, and that libertarians should accept governments’ coercive...
Abstract
Jason Brennan presents a justification for mandatory vaccination policy from a libertarian perspective. I reevaluate Brennan’s argument, focusing on the applicability and potential limit of the clean hands principle he proposed. I argue that the clean hands principle cannot tell us how to weight the degrees of risk of different collectively harmful activities; therefore, we could not distinguish the relative significance of coercive interventions that aim at stopping different kinds of collectively harmful activities. Using secondhand smoke prevention as an analogous policy example, I illustrate that many behaviors that suffice the five conditions could be qualified as collectively harmful activities. These activities are hence subject to coercive policies that are justified by the clean hands principle, including those obviously infringe individual rights and civil liberties and contradict with libertarianism. For libertarians, this implication of the clean hands principle might not be too comfortable to accept.
Main Text
Using David Gauthier’s strategy, Jason Brennan demonstrates that even starting with a theory “with strongly individualist and antigovernment premises” such as libertarianism, mandatory vaccination is justifiable (p.37).1 Drawing on one of his own works, Brennan argues that the clean hands principle requires a person not to participate in collectively harmful activities, and that libertarians should accept governments’ coercive interventions to enforce this requirement.2 Since the behavior of anti-vaxxers is a collective harmful activity, these anti-vaxxers “are imposing unacceptable and unjust risks on others.” Therefore, the governments could rightly coerce them to be vaccinated. Even libertarians should be comfortable with this policy recommendation. However, as I will show, there are several issues to be considered, especially for libertarians, if readers were to accept this conclusion.
For the purpose of discussion, let us first recall the five conditions that constitute a collectively harmful activity. When a group of individuals 1. actively expose “themselves to potentially dangerous diseases,” and 2. actively do “things that have a high likelihood of spreading these diseases to others,” and 3. actively choose “not to take steps to reduce the risks they are imposing,” and 4. “are not epistemically justified in 3” for “they lack grounds for refusing to take precautions,” and 5. impose on others the risk that “cannot be justified as part of an equitable social system of risk-taking as it provides no advantage to others,” then this group of individuals perform a collectively harmful activity (p.41).1 Brennan suggests that under the circumstances that these five conditions present, governments’ coercive intervention to forbid individuals from participating in such activity is justifiable.
The major issue is that the clean hands principle cannot tell us how to weight the degrees of risk of different collectively harmful activities; therefore, we could not distinguish the relative significance of coercive interventions that aim at stopping different collectively harmful activities. In the field of public health, many behaviors could be qualified as collectively harmful activities and hence be subject to the clean hands principle. In other words, many governments’ coercive interventions aim at these unhealthy behaviors could be easily justified even they might contradict with libertarianism.
Take a common intervention policy – secondhand smoke prevention – for example. Is emission of tobacco smoke in places that expose others to secondhand smoke a collectively harmful activity done by smokers? Are these smokers imposing unacceptable and unjust risks on others? These smokers indeed expose themselves to potentially dangerous diseases (suppose we recognize the scientific evidence that exposure to tobacco smoke causes),3 such as lung cancer. Although they cannot literally spread lung cancer, they indeed have a high likelihood to spread secondhand smoke that causes lung cancer to others. When they emit the smoke in places where others present, they indeed actively choose not to take steps to reduce the risks they are imposing. So far, the smokers’ behavior has sufficed conditions 1 to 3. As for condition 4, considering the dominant propaganda on the health risks of tobacco, we could reasonably presume that most smokers already known the knowledge and hence lack grounds for refusing to take precautions (such as step to another place that on one present there). Lastly, those exposed to secondhand smoke are certainly not a part of an equitable social system of risk-taking, because there’s obviously no advantage could be obtained from inhaling secondhand smoke. Consequently, we establish an argument that emission of tobacco smoke to others is a collectively harmful activity done by smokers.
Suppose the analogy is right, then we could confidently accept a policy proposal that governments should forbids every smoking behavior that might cause secondhand smoke. Actually, this is what people in public health have already done. In the 2003-adopted World Health Organization Framework Convention on Tobacco Control (FCTC), Article 8 “Protection from exposure to tobacco smoke” requires parties to protect people “from exposure to tobacco smoke in indoor workplaces, public transport, indoor public places and, as appropriate, other public places” through legislative efforts.4 In practice, many countries have implemented similar laws and regulations to forbid secondhand smoke in public places. Furthermore, in our inference of the five conditions above, they have nothing to do with whether the conditions present in a public or a private place. We could actually argue that secondhand smoke should be forbidden not only in public but also in private places. Therefore, we should accept a coercive intervention that regulate smoking behavior in even the most private and intimate places, even if we were libertarians. This conclusion obviously infringes many individual rights and civil liberties that libertarians believe should be protected against governments’ coercion.
Some might argue that smokers’ spreading secondhand smoke is different from anti-vaxxers’ spreading infectious microbes, because infectious microbes are much more dangerous and fatal than tobacco smoke. However, I maintain that it is not so much a disanalogy; rather, it is just a matter of different degrees of risk. Different microbes cause different diseases and health outcomes to individuals. Some have longer latent, some have higher transmission rate, some cause higher mortality, some cause irreversible disability, and some are fatal only if the patient is exposed twice. The risks each microbe could cause are different. Suppose we consider secondhand smoke as a kind of microbe that have a long latent and cause fatal (and often painful and suffering in terms of life quality and finance) outcome – lung cancer, then it is no different from the others. What really different here is the degree of risk, depending on the measurement. The point is that the clean hands principle does not take the degree of risk into consideration. As long as the harms are caused by a collectively harmful activity, it is subject to governments’ coercive interventions.
Note that the degree of risk I refer here is different from the assumption (C) of a valid intervention, which assumes that the target of a intervention will cause serious illnesses (therefore the intervention can protect against them) (p.37).1 This implies that as long as a collectively harmful activity would cause serious enough illnesses (let us tentatively neglect the definition of ‘enough’ and just suppose that lung cancer is a serious one), it could be the target of the intervention (secondhand smoke prevention policy), regardless of its degree of risk. Therefore, accompanied with the (A) effectiveness and (B) harmlessness assumptions, the intervention is valid and could be defended (p.37).1
I take secondhand smoke prevention policy as an example to illustrate the applicability of the clean hands principle. From those related to individual-level life style (unhealthy behaviors) to community-level social determinants of health,5 in the field of public health, many more analogous examples could be easily proposed, and many coercive intervention policies could be defended accordingly. On this ground, it seems that the most radical public health advocates could march together with libertarians. I do not suggest that I am one of the public health advocates, but I figure that they would gratefully appreciate this conclusion, and I suspect that libertarians would be comfortable with it. Therefore, out of friendly intentions, I urge my libertarian peers to reconsider Brennan’s proposal.
References
1. Brennan J. A libertarian case for mandatory vaccination. Journal of Medical Ethics 2018;44(1):37-43. doi: 10.1136/medethics-2016-103486
2. Brennan J. The ethics of voting. Princeton: Princeton University Press 2011.
3. Öberg M, Jaakkola MS, Woodward A, et al. Worldwide burden of disease from exposure to second-hand smoke: a retrospective analysis of data from 192 countries. The Lancet 2011;377(9760):139-46. doi: https://doi.org/10.1016/S0140-6736(10)61388-8
4. World Health Organization Framework Convention on Tobacco Control. Geneva: World Health Assembly, 2003.
5. Marmot M, Atkinson T, Bell J, et al. Fair Society Healthy Lives The Marmot Review Executive Summary. London: The Marmot Review, 2010.
Indeed FGA type 1 and 2 would not rob me and so many like me who want to follow our religious rights and adhere to harmless procedures as well which are surely less invasive than male circumcision. Its would not make me feel harrassed by western oppression of allowing the afflent consenting woman undertake the same procedure while condemning me of mine. Since FGA type 1 n 2 are harmless they are on the rise as cosmetic surgeries, so why should my choice of doing it for religious purpose become harmful to be banned. Yes severe forms shouldn't be allowed but surely type 1 or 2 as alternatives can reduce severe forms from happening. Medicalization and strict protocols can be framed to ensure safety from FGA type 1 n 2 procedures as well.
A non-vaccinator is not the culprit for the existence of immunosuppressed persons. Hence, we must use overall and not conditionals probabilities here and pass to the population level. Let’s assume that the prevalence of immunosuppressed persons is 4/10.000 and that measles attack rate is 2/10.000 for the population. Then the probability to observe an immunosuppressed person that gets infected by measles is very low, say 4/10.000 * 2/10.000 = 8 * 10^(-8). The probability to get an encephalitis from measles vaccine is 1 * 10^(-6) and hence more probable.
Risk vs Risk is always problematic and should be avoided.
Recently we conducted a study that identified an “ethics ecosystem” that, as a form of research governance, ensures that common ethical principles are operationalised by a number of actors within this ecosystem. This ethics ecosystem includes researchers, research ethics committee members, research institutions, publishing houses and Editors, and external Associations [1, 2].
In their paper ‘In defence of governance: ethics review and social research’, Sheehan et al [3] attempt to find a strong ethical answer for the need for such levels of ethical governance at the ethical review level for the social sciences. In doing this, the authors respond to a number of hypothetical claims against the need for such a review governance system. They then create their case that society has a stake in social research because of its link to enquiry, and in turn, human flourishing. They explain that because individual members of society will reasonably disagree about this ‘stake’, i.e., what specific research enquiry should proceed through ethical review to further human flourishing, this needs to be settled via a ‘fair process’ governance (i.e., a committee style) model.
While this paper is certainly a comprehensive and interesting analysis highlighting many of the discussions in this area, the authors fail to sufficiently link their final argument to ‘enquiry’.
We believe we can provide a better defense for an ethical review framework. This can be achieved by...
Recently we conducted a study that identified an “ethics ecosystem” that, as a form of research governance, ensures that common ethical principles are operationalised by a number of actors within this ecosystem. This ethics ecosystem includes researchers, research ethics committee members, research institutions, publishing houses and Editors, and external Associations [1, 2].
In their paper ‘In defence of governance: ethics review and social research’, Sheehan et al [3] attempt to find a strong ethical answer for the need for such levels of ethical governance at the ethical review level for the social sciences. In doing this, the authors respond to a number of hypothetical claims against the need for such a review governance system. They then create their case that society has a stake in social research because of its link to enquiry, and in turn, human flourishing. They explain that because individual members of society will reasonably disagree about this ‘stake’, i.e., what specific research enquiry should proceed through ethical review to further human flourishing, this needs to be settled via a ‘fair process’ governance (i.e., a committee style) model.
While this paper is certainly a comprehensive and interesting analysis highlighting many of the discussions in this area, the authors fail to sufficiently link their final argument to ‘enquiry’.
We believe we can provide a better defense for an ethical review framework. This can be achieved by asking first and foremost “How can we conduct ethical social science research?” rather than, as Sheehan et al ask, How can we defend ethics review? By re-framing this initial question, the justification for a level of research ethics governance becomes clearer.
At present, our “ethics ecosystem” ensures that conducting ethical research and behaving ethically is reinforced through a governance network of interconnected actors from the academic system. The Ethics Ecosystem comprises individuals (researchers), organisations (research institutions) and external bodies (publishing houses, funding bodies, professional associations) all working together and playing a role in the promotion, evaluation and enforcement of a shared understanding of ethically responsible research behavior [1]. This ensures that research is conducted responsibly in a way that is valued by the academy, minimises risk to participants, and guards against academic misconduct.
When working well, it is hard to see the importance that each actor and each level of the ecosystem has in the maintenance of shared understandings of ethical behaviour. Only when this ecosystem is compromised can we see the need for a higher form of research ethics governance.
Such is the case for social media research.
Social media sites are increasingly being seen as rich sources of health data for scholars- as avenues for research project recruitment; as intervention platforms for specific health conditions; to explore social support and health; and as a source of publicly available data. Data-mining techniques used to access public health data have, for example, been drawn upon to improve infectious disease surveillance; to understand disease patterns; and to explore health behaviours[4]. A number of ethical concerns have emerged in relation to the use of such data, and the ongoing and complex nature of social media research has been suggested to be potentially challenging for researchers and ethics committees. Concerns relate to whether to classify social media research as human subjects’ research or text-based analysis; what constitutes public and private spaces; and vulnerability, potential harm, intrusiveness, and confidentiality [5-12].
We explored how the ethics ecosystem was functioning with relation to this new mode of ethically complex research. We spoke to actors at many levels of the ecosystem including researchers, research ethics committee members, universities, publishing houses, and journal Editors. We identified a lack of community consistency, which fosters a culture in which decisions about the ethical use of SM data is primarily made by a reliance on individual researchers implementing a form of “personal ethics”; rather than by a shared norm around the use of SM data by actors within an overarching ethics ecosystem. Such a ‘personal ethics’ if left unchecked, can be dangerous in terms of unethical research falling between the cracks in terms of research governance.
At the researcher level of the ethics ecosystem, researchers placed emphasis on the subjective, individual nature of ethics when justifying their research practices:
Interviewer: Are there any guidelines in particular that you follow in your own research?
Researcher : It’s my guidelines. Everybody has their own definition of ethics….
They spoke about working around the non-obligatory ‘vague’ guidelines to justify their research;
They are [guidelines] slightly contradictory in places and you can argue around them...so there is some issues around integrity that don’t necessarily hold true and you can argue either way for some of the issues around that
With such a personal approach to ethics, researchers’ ability to justify their ethical choices to both other researchers, as well as, where necessary, to ethical review boards became a key priority;
There is a sense of you got to develop the sense of what's right here, be the expert in that and then put that across and you know, make your case
At the researcher ethics committee level of the ethics ecosystem, because little social media research was submitted for ethical review (researchers used ‘personal ethics’ to often justify this decision), committee members had little experience or shared understanding of how to review this research. Within this framework of ethical decision-making, focus was placed on researchers’ justifications of their research approach
sometimes make different decisions even for projects that look pretty similar. It’s how they build up their case doing that particular project
Similar ethical decision-making, focused on a researcher’s justification of their personal ethics, was also evident at the Editor level of the ecosystem.
This personal ethics is not necessarily problematic per se but if we remove the stability of shared understanding within the ethics ecosystem, researchers are left to justify which research is ethical or not by themselves and not within themselves. This leads to the disintegration of the multi-member ethics ecosystem, its governance role and ethic pluralism applied at all levels. The risk of this, we argue, provides a stronger justification for research ethics governance than the ones considered by Sheehan et al.
Ethics Approval: Ethics approval for this research was granted by Lancaster University
References
1. Samuel G, Derrick G. Social media research, ‘personal ethics’, and the Ethics Ecosystem. New Social Media, New Social Science Blog 2017.
2. Social media approaches to health research: an empirical analysis of decision-making within the UK ethical landscape. Social Media and Health: Meeting the Ethical Challenges; 2017 4th October; Wellcome Trust.
3. Sheehan M, Dunn M, Sahan K In defence of governance: ethics review and social research Journal of Medical Ethics Published Online First: 10 October 2017. doi: 10.1136/medethics-2017-104443
4. Vayena E, Mastroianni A, Kahn J. Ethical Issues in Health Research With Novel Online Sources. American Journal of Public Health 2012;102(12):2225-30.
5. McKee HA, Porter JE. The ethics of internet research: a rhetorical, case-based process. New York: Peter Lang Publishing, 2009.
6. Zimmer M. ‘‘But the data is already public’’: on the ethics of research in Facebook. Ethics Inf Technol 2010;12:313-25.
7. Snee H. Making Ethical Decisions in an Online context: Reflections on using blogs to explore narratives of experience. Methodological innovations online 2013;8(2):52-67.
8. Lomborg S. Personal internet archives and ethics. Research Ethics 2013;9(1):20-31.
9. Swirsky E, Hoop J, Labott S. Using Social Media in Research: New Ethics for a New
Meme? American Journal of Bioethics 2014;14(10):60-61.
10. Convery I, Cox D. A review of research ethics in internet-based research. Practitioner Research in Higher Education 2012;6(1):50-57.
11. Markham A, Buchanan E. Ethical Decision-Making and Internet Research: Recommendations from the AoIR Ethics Working Committee, 2012.
12. Henderson M, Johnson NF, Auld G. Silences of ethical practice: dilemmas for researchers using social media. Educational Research and Evaluation: An International Journal on Theory and Practice 2013;19(6):546-60.
Innovation is derived from the Latin innovatus which means “to renew or change”. In the broadest sense of the term, it can be viewed as the stimulus that modifies existing processes. Further, innovation has been one of the driving forces in the evolution of society through various revolutionary periods. This concept incorporates connotations of invention and creativity as impulses in themselves, however has recently been applied to commercialised settings. Hence, despite scientific interests, civic duties and altruism providing motivation for innovation, the strongest motive in recent times seems to be with a view to increasing profit. From a bottom-up level, inexperienced and junior innovators with the former inclinations could be met with resistance from the complexity of deriving economic viability. Furthermore, a central component to successful innovation involves promoting a culture to challenge outdated norms and the status quo. Change cannot occur if it is believed that present methods are infallible, as this removes the impetus for a goal-driven action. Consequently, many ideas may not reach fruition. However, within the medical field, it is wise that innovation occurs with incremental and calculated adjustments by enlarge, rather than with abrupt renovations. Wherever innovation leads to novel technology, the ultimate outcome of such is unforeseeable. The collingridge dilemma highlights an important notion that in early stages a new technology is still open to soc...
Show MorePaul et al. (2018) “Implementing post-trial access plans for HIV prevention research” present a much-needed discussion on the implementation of post-trial access plans. Here, I just want to signal a mistake on the conceptual definition of access, to an otherwise flawless paper.
If I am correct, the mistake would be related to the formulation of the following question:
"it the responsibility of researchers and sponsors only to ensure that all participants have access to effective preventive therapies, or does that responsibility extend further, to ensuring that participants actually receive them?" (Paul et al 2018:4)
I believe that "to ensure that participants have access to an intervention" is logically equivalent to "ensuring that participants actually receive an intervention". The MRCT Center's framework on post-trial responsibility defines access as “[…] the ability, right or permission of an individual to use an object or asset, and implies the removal of barriers to allow such use” (MRCT Center 2017:76). If a person does not actually receive an effective preventive therapy, she does not have the ability to use it. Therefor she has no access. Hence, distinguishing between the above expressions is conceptual mistake.
Instead, what I believe that the authors wanted to discuss is how much sponsors and researchers need to do to ensure access to an investigational intervention. In fact, irrespective of the abo...
Show MoreOn p.5 the authors comment on the use of mindfulness exercises as "a tool to relieve suffering
and increase functioning". They claim that "This goes against common epistemic values" where these epistemic values are described as "the sort of values that lead one to accept uncomfortable truths, and to be honest, even brutally honest, with oneself."
As far as I can see there is no argument given for that claim, and what is more, it seems to go precisely contrary to the purpose of mindfulness exercises in that these are intended to enable one to be honest with oneself and face uncomfortable truths (e.g.: "... we cultivate acceptance by taking each moment as it comes and being with it fully, as it is [...] receptive and open to whatever we are feeling, thinking, or seeing". [Kabat-Zinn, Full catastrophe living, p.28f: https://books.google.at/books?id=fIuNDtnb2ZkC]). Mindfulness is to a large extent a tool to enable one be "honest, even brutally honest, with oneself".
There is a number of other strange claims in this article, I will mention only one: "Suppose an atheist was having trouble coping emotionally with a natural disaster in which there were many casualties. They might object to imagining the people who died in the disaster frolicking in heaven, even if doing so would help them cope. They do not believe in heaven, thus the imaginati...
Show MoreAuthors Montero and Villarroel discuss problems that might arise from “conscientious objection” (CO) to the new law in Chile that legalized abortion in cases of life endangerment of the woman, fatal fetal abnormality, and rape. (“A critical review of conscientious objection and decriminalisation of abortion in Chile”, Jan 6). The law provides the “right” to exercise CO, with the only caveat that health institutions are required to immediately refer patients to non-objecting practitioners. We share the authors’ concerns that conscientious objection may prove be quite widespread in Chile with the new law. In fact, we argue it will create serious, widespread problems for access to safe and legal abortion, despite the referral requirement.
Of course, in a Catholic-dominated country like Chile with a total abortion ban, the new law represents a major advance, and it will undoubtedly help many women. We appreciate the challenges and hard work to get the law passed and acknowledge it may have been difficult to do so without CO as a political compromise. Unfortunately, last-minute lobbying by Catholic hospitals resulted in a court’s expansion of the CO clause in the law, giving the “right” of CO to not just doctors, but also support workers and even institutions (when only individuals can have a conscience). This law will be very difficult to reverse and women will suffer the consequences.[1]
The authors rightly recognize the difference between conscientious object...
Show MoreI was intrigued to read this article about US practice relating to consent and minors.
Intrigued; and very pleased that I practice in the UK, where this was agreed, very sensibly, years ago.
The UK law permits a minor to consent to treatment, as long as they are capable of understanding the issues involved. And for vaccination, the issues (when you leave out the non-science-based scary stuff) are usually straightforward.
This means that vaccinating adolescents against HPV is straightforward - a few simple questions to establish that they understand what the vaccines for, and have an acceptable understanding of the almost-negligible risks involved, and you can vaccinate them, without requiring parental consent and with the full support of healthcare systems and the courts.
The ludicrous situation in the USA where some parents can prevent their children from accessing vaccines at the right time (before sexual debut), when the children themselves have a clearer understanding of the issues than their parents and want to be vaccinated is now, thankfully, a largely historical issue here.
The article by Brennan [1], which has just been drawn to my attention, only exists in hypothetically perfect world in which medical evidence is always clear cut and bureaucracies beyond fallibility, bias, corruption or perhaps even scrutiny - it hinges like a lot of ethical investigations round the word "if". You could agree "y" if "x" (though I am not sure whether in this case it would be a libertarian argument as opposed to just an argument) but we do not have flawless bureaucracies making perfect decisions based on immutable scientific laws. Of course, a crucial argument relating to political liberty is just that bureaucracies are inevitably imperfect.
While we could explore and criticize the basis of many such decisions (and despite huge institutional pressures many criticisms of vaccine products lie within mainstream scientific debate, for instance issues regarding influenza vaccination, HPV, aluminum adjuvants, mercury preservatives etc.) we are simply not talking about a branch of science which admits of such certainties. Nor are we dealing with just a few products. The US mandated schedule has perhaps dozens of products already, with hundreds in the pipeline which depend for their commercial viability on being licensed and mandated in their turn. Brennan does not engage with the problem that is not about one or two instances (for instance MMR vaccine is often cited) but an indefinitely large number products which could become c...
Show MoreAbstract
Jason Brennan presents a justification for mandatory vaccination policy from a libertarian perspective. I reevaluate Brennan’s argument, focusing on the applicability and potential limit of the clean hands principle he proposed. I argue that the clean hands principle cannot tell us how to weight the degrees of risk of different collectively harmful activities; therefore, we could not distinguish the relative significance of coercive interventions that aim at stopping different kinds of collectively harmful activities. Using secondhand smoke prevention as an analogous policy example, I illustrate that many behaviors that suffice the five conditions could be qualified as collectively harmful activities. These activities are hence subject to coercive policies that are justified by the clean hands principle, including those obviously infringe individual rights and civil liberties and contradict with libertarianism. For libertarians, this implication of the clean hands principle might not be too comfortable to accept.
Main Text
Show MoreUsing David Gauthier’s strategy, Jason Brennan demonstrates that even starting with a theory “with strongly individualist and antigovernment premises” such as libertarianism, mandatory vaccination is justifiable (p.37).1 Drawing on one of his own works, Brennan argues that the clean hands principle requires a person not to participate in collectively harmful activities, and that libertarians should accept governments’ coercive...
Indeed FGA type 1 and 2 would not rob me and so many like me who want to follow our religious rights and adhere to harmless procedures as well which are surely less invasive than male circumcision. Its would not make me feel harrassed by western oppression of allowing the afflent consenting woman undertake the same procedure while condemning me of mine. Since FGA type 1 n 2 are harmless they are on the rise as cosmetic surgeries, so why should my choice of doing it for religious purpose become harmful to be banned. Yes severe forms shouldn't be allowed but surely type 1 or 2 as alternatives can reduce severe forms from happening. Medicalization and strict protocols can be framed to ensure safety from FGA type 1 n 2 procedures as well.
A non-vaccinator is not the culprit for the existence of immunosuppressed persons. Hence, we must use overall and not conditionals probabilities here and pass to the population level. Let’s assume that the prevalence of immunosuppressed persons is 4/10.000 and that measles attack rate is 2/10.000 for the population. Then the probability to observe an immunosuppressed person that gets infected by measles is very low, say 4/10.000 * 2/10.000 = 8 * 10^(-8). The probability to get an encephalitis from measles vaccine is 1 * 10^(-6) and hence more probable.
Risk vs Risk is always problematic and should be avoided.
Recently we conducted a study that identified an “ethics ecosystem” that, as a form of research governance, ensures that common ethical principles are operationalised by a number of actors within this ecosystem. This ethics ecosystem includes researchers, research ethics committee members, research institutions, publishing houses and Editors, and external Associations [1, 2].
In their paper ‘In defence of governance: ethics review and social research’, Sheehan et al [3] attempt to find a strong ethical answer for the need for such levels of ethical governance at the ethical review level for the social sciences. In doing this, the authors respond to a number of hypothetical claims against the need for such a review governance system. They then create their case that society has a stake in social research because of its link to enquiry, and in turn, human flourishing. They explain that because individual members of society will reasonably disagree about this ‘stake’, i.e., what specific research enquiry should proceed through ethical review to further human flourishing, this needs to be settled via a ‘fair process’ governance (i.e., a committee style) model.
While this paper is certainly a comprehensive and interesting analysis highlighting many of the discussions in this area, the authors fail to sufficiently link their final argument to ‘enquiry’.
We believe we can provide a better defense for an ethical review framework. This can be achieved by...
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