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Modern Bioethics Frameworks Flip Book

Welcome to Modern Bioethics. I have pulled together articles and books covering broad topics to demonstrate the methods and frameworks in place for analyzing traditional and new issues in bioethics. I also highlight the shortfalls of some known frameworks and offer inclusive frameworks or necessary add-ons in some cases. By curating a collection that includes authors who analyze fact patterns using different approaches, I aim to promote forward thinking approaches to complex scientific and medical ethical dilemmas. For example, some issues are best resolved by using a broad syndemics framework, e.g., in analyzing the effects of policies on the harms caused by the pandemic. Other issues may require expanding on the four principles — looking more deeply into how beneficence is interpreted with an eye to underlying philosophy or creating multiple justice frameworks.

What to Make of Beneficence

Beneficence, for example, is doing good, which differs from being good, something that might be better addressed with virtue ethics. Beneficence cannot operate without limitation or autonomy would be sacrificed.

Can Expansive Frameworks Help Broaden Thinking?

This website focuses on how these expansive frameworks apply and which frameworks are most helpful in addressing which issues. This project is an effort to contextualize bioethical dilemmas, to expand the thought process to include more considerations, and to explore  the stakeholders and the ethical differences in their stake. Critical thinking and logic will help you see the breadth of the issues, contextualize them, delineate the role of public policy or even global cooperation from the role of corporate, hospital, or even individual behaviors. There are a lot of stakeholders in bioethics, sometimes the arena is global and individuals everywhere will be impacted by a scientific discovery. Some people are more able to speak for themselves or hold more power in the conversation. In some countries corporations or the government drown out other voices.

The Goal is Thinking and Reasoning

I do not focus on the conclusions as much as on how to reach well-reasoned valid conclusions. This program expands the bioethics arena beyond principlism and expands the depth of analysis when principlism is applied. Rather than leading to checklists, something I do find valuable in preventing ethics breaches or problems in clinical settings, this mini-course’s goal is to promote thinking about bioethics using multiple frameworks to define issues and problem-solving techniques. The best solutions involve compromise if not consensus, although as you will analyze the role of stakeholders, some solutions concern individual rights or autonomy. In those cases, sometimes the best solution might reflect negative rights, sometimes called natural rights, and the compromise or consensus is that individuals decide for themselves.

The frameworks inform analysis of person-centered care, justice issues, disasters and pandemics, big data, genetic enhancement, and conflicts of interest.

We Cannot Always Agree to Disagree

This website is not meant to promote a viewpoint. It is meant to promote thinking and to encourage depth of discussion with an eye to consensus or compromise. Rather than agreeing to disagree, something that allows people to walk away righteous and even angry, those evaluating bioethical dilemmas should think through both positions and aim to understand the other stakeholders’ reasoning. Reasoning and deliberation can lead to mutual understanding, allowing people to appreciate other viewpoints, and ensuring that the most well-reasoned, all-things-considered approach will be contemplated and poised for success, or at least for respect. By propelling views supported by reasoning, data, and ethics, inclusive ethical frameworks can move bioethics to forward-thinking field that values multiple stakeholders and brings parties together.

If accessing the lessons here, please note that the post about each topic describes the issues and problems, sometimes in depth. The recommended reading (found below the text) demonstrates varying viewpoints. I continue to add articles (mostly available in the public domain). (Links will be improved.) The slides and videos provided tend to be lighter overviews and do give some background. Each lesson’s slides end with the framework slide also found on this post’s slides. THIS ENTIRE PROJECT IS A WORK IN PROGRESS. It will likely remain free and accessible. Any views are my own.

TO VIEW THE MATERIALS, CLICK CURRICULUM. THERE IS NO CHARGE FOR “COURSE”.

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Slides for Introduction to Modern Bioethics Frameworks — Each Framework is Outlined Here

Copy of Welcome Page

Modern Bioethics Frameworks Flip Book

Welcome to Modern Bioethics. I have pulled together articles and books covering broad topics to demonstrate the methods and frameworks in place for analyzing traditional and new issues in bioethics. I also highlight the shortfalls of some known frameworks and offer inclusive frameworks or necessary add-ons in some cases. By curating a collection that includes authors who analyze fact patterns using different approaches, I aim to promote forward thinking approaches to complex scientific and medical ethical dilemmas. For example, some issues are best resolved by using a broad syndemics framework, e.g., in analyzing the effects of policies on the harms caused by the pandemic. Other issues may require expanding on the four principles — looking more deeply into how beneficence is interpreted with an eye to underlying philosophy or creating multiple justice frameworks.

Beneficence, for example, is doing good, which differs from being good, something that might be better addressed with virtue ethics. Beneficence cannot operate without limitation or autonomy would be sacrificed.

This website focuses on how these expansive frameworks apply and which frameworks are most helpful in addressing which issues. This project is an effort to contextualize bioethical dilemmas, to expand the thought process to include more considerations, and to explore  the stakeholders and the ethical differences in their stake. Critical thinking and logic will help you see the breadth of the issues, contextualize them, delineate the role of public policy or even global cooperation from the role of corporate, hospital, or even individual behaviors. There are a lot of stakeholders in bioethics, sometimes the arena is global and individuals everywhere will be impacted by a scientific discovery. Some people are more able to speak for themselves or hold more power in the conversation. In some countries corporations or the government drown out other voices.

I do not focus on the conclusions as much as on how to reach well-reasoned valid conclusions. This program expands the bioethics arena beyond principlism and expands the depth of analysis when principlism is applied. Rather than leading to checklists, something I do find valuable in preventing ethics breaches or problems in clinical settings, this mini-course’s goal is to promote thinking about bioethics using multiple frameworks to define issues and problem-solving techniques. The best solutions involve compromise if not consensus, although as you will analyze the role of stakeholders, some solutions concern individual rights or autonomy. In those cases, sometimes the best solution might reflect negative rights, sometimes called natural rights, and the compromise or consensus is that individuals decide for themselves.

The frameworks inform analysis of person-centered care, justice issues, disasters and pandemics, big data, genetic enhancement, and conflicts of interest.

This website is not meant to promote a viewpoint. It is meant to promote thinking and to encourage depth of discussion with an eye to consensus or compromise. Rather than agreeing to disagree, something that allows people to walk away righteous and even angry, those evaluating bioethical dilemmas should think through both positions and aim to understand the other stakeholders’ reasoning. Reasoning and deliberation can lead to mutual understanding, allowing people to appreciate other viewpoints, and ensuring that the most well-reasoned, all-things-considered approach will be contemplated and posed for success, or at least for respect. By propelling views supported by reasoning, data, and ethics, inclusive ethical frameworks can move bioethics to forward-thinking field that values multiple stakeholders and brings parties together.

If accessing the lessons here, please note that the post about each topic describes the issues and problems, sometimes in depth. The recommended reading (found below the text) demonstrates varying viewpoints. I continue to add articles (mostly available in the public domain). (Links will be improved.) The slides and videos provided tend to be lighter overviews and do give some background. Each lesson’s slides end with the framework slide also found on this post’s slides. THIS ENTIRE PROJECT IS A WORK IN PROGRESS. It will likely remain free and accessible. Any views are my own.

Copyright CC-BY-NC

Slides for Introduction to Modern Bioethics Frameworks — Each Framework is Outlined Here

A Framework of Empowerment: Conflicts of Interest

Flip Book best viewed in full screen:

Oversight and Empowerment Framework for Conflicts of Interest

In a framework designed to highlight bias, conflicts of interest, and promote transparency around the reflexivity inherent in some research, some conflicts of interest can be managed while others should be avoided. The fundamental issues and analysis surround who holds power and how the consumer of health-related goods and services can empower themselves and harness the tools of deliberative democracy and courts to level the playing field by highlighting and resolving conflicts. Recognizing the people whose health, well-being, or rights are affected or could be affected by the conflict are the stakeholders whose stake is generally bodily or personal, and secondarily financial. The stake of the corporation or government varies, is not bodily, and is usually foremost financial, making ethical claims arguably weaker. Both the degree and the type of stake matter.

Research and Clinical Care Financial Conflicts of Interest

Shutting down every financial relationship for the inherent conflict could have ancillary problematic results. Some research would not be performed if not for the collaboration between clinicians, researchers, and pharmaceutical companies. Sometimes disclosure could be enough. In other circumstances, disclosing a large profit motive only serves to highlight the conflict.

The research itself and the sanctity of the data is always going to be challenged or disputed when a financial interest exists. Independent research would be the best solution but in the research landscape, partnerships are becoming more prevalent. Disclosure is not always enough and is unlikely to foster additional public trust. Examples of fraud or cover-ups like Vioxx or Purdue Pharma’s opioid research are heavily publicized yet most pharmaceutical research is valid. It becomes difficult to argue for disentanglement if innovation were stifled. Measuring public distrust of pharmaceutical research is also difficult with so many consumers of pharmaceuticals who maintain their trust and need medications. Those lacking trust in the data are generally welcome to avoid pharmaceutical products with exceptions like vaccination requirements. Building public trust would help so that public health authorities interact with more respect and integrity in their advocating or requiring vaccination.

Conflicts of interest at the doctor-patient level that spring from relationships to pharmaceutical companies can be approached many ways. The upstream considerations include the role of large academic medical centers. I am not convinced that having doctors do both research and clinical care is beneficial to the person seeking care. Yet the systems grew and there is now a prevailing pattern of doctors who have a lab as well. As researchers, they collaborate directly with pharmaceutical companies or medical device manufacturers. (The ACA promoted transparency by reporting requirements when accepting anything ($10 or more) from manufacturers of most drugs, biological agents, medical devices, or supplies.)

Financial conflicts of interest when a clinician recommends a pharmaceutical brand or product is an ongoing concern, especially because disclosure of the relationship is the general requirement but might not be enough. Ways to assess financial interests and how the investment might grow help evaluate the enormity of the conflict. (A little stock in a company or payment for a speaking engagement is different from a lot of stock in a company whose drug sales are likely to take off.)

Hospitals as a Business; Fee for Service Physicians

Within the care structure, conflicts of interest can arise at many levels. The hospital inherently has a conflict due to its desire to provide care and operate as a business. Should they discharge a person if the same bed is needed for a more expensive person? These conflicts seem like distant hypotheticals in the current ethics landscape, and are an on-the-ground concern that must be handled personally (physician’s moral code), locally, and rigorously.

Hospital Ethics Committees and Mediators

Conflicts of interest are inherent in ethics committee and patient representatives. There are not policies requiring ethics boards to be comprised of only non-employees or to be majority non-scientists. All people have a stake in ethics regardless of education, background, or specific degrees. Overvaluing the stature of doctors, the dual degree in public health, or an MD with an MS in bioethics can undermine the value of simply the voice of the patient, the parent, the surrogate, the social workers, and lawyers who also sit on ethics committees. A medicalized viewpoint can be prevalent. Ethics serves as a check on the power of some professionals. The asymmetry in medical knowledge should not drown out other valuable opinions.

Inhouse mediators are avoidable and should be managed by a model that prohibits the conflict of interest. Outside independent mediators may be helpful as long as mediation is entered freely by both parties.

Fear of Liability

The role that protection from potential liability plays in person-centered care and autonomy creates an inherent conflict sometimes, especially when the person disagrees with a doctor about the choice of care. If the lingering issue of whether the doctor will be held responsible for not giving the treatment that was refused, the doctor’s interest in protection from liability can obscure clinical judgment.

Government Conflicts

In some areas, it would be easy to eliminate conflicts, for example, by not allowing those who work for universities that profit from medical research to sit on the Presidential Commission or other seemingly unbiased organizations meant to promote ethics. There are conflicts at every level of government. In the United States, many elected representatives hold pharmaceutical and medical device stock. The revolving door between industry and government causes constant conflict, especially when the government agency has a role in industry oversight. A prohibition on government or upstream conflicts would be easily achieved with the political will to do so.

There are policies that were intended to create a check on pharmaceutical industry projects seeded by NIH funding.  The safety nets like march-in rights (that would take away the patent holder’s exclusivity) and other fair price initiatives have not really been used. (See Zimmerman, below). The pure financial incentives of pharmaceutical corporations conflicts with the government role in incentivizing affordable solutions. The financial interests align if enough people in Congress own stock, and that leads to the more serious conflict of interest: in neoliberal society, government could be more aligned with corporate interests than with individuals’ interests when the two conflict. 

Other Applications

The framework of empowerment to address conflict of interest applies to corporate behaviors that affect health. For example, nutrition research is often financed by food manufacturers or sellers and the policies surrounding food are influenced by lobbyists. Corporate free speech allows advertising of pharmaceuticals, giving power to corporations that refutes consumer empowerment.

Non-Financial Conflicts of Interest

A doctor’s personal ambitions (like wanting to become famous for a novel approach or having a medical risk reward threshold that differs from the standard) or religious beliefs may compete with what is best for the person receiving care. Subtle biases may also stem from receiving gifts even when a physicians sees themselves as unswayable and the gift is not of much value.

The Framework

A person-, consumer-, or population-centered empowerment approach to conflicts of interest covers broad considerations. First, the ethically required and best practice should put the person receiving care first and act in that person’s interest. The responsibility stems from old oaths, philosophical notions of doing the right thing for someone in need, altruism, and that the moral goods associated with medical care run to the patient. The landscape has changed with increasing financial complexity and an open door to relationships with pharma, etc. Legal changes encouraged relationships that drive innovation, but come with the risk of abuse of position or power. Doing the right thing has become increasingly challenging because now it is a weighing process where generating data by encouraging use of a drug can be a public good, arguably (to some) justifying some financial gain for the physician, researchers, and company. Second, trust and integrity run from the patient to the doctor, clinicians, and the system. There is a give and take where the system of big medicine must be trustworthy.

Anne Zimmerman, “Who really funds early pharmaceutical research? Taxpayers, and they deserve fairness in both pricing and policy,” Zimmerman, A., Unpublished Report, 2019. WhoReallyFundsPharma

Patient Outcomes Research Teams (PORTS): Managing Conflict of Interest (1991) Chapter: 5 Managing Conflicts of Interest: General Models and Approaches, page 61. Managing Conflicts of Interest Article

Matt Lamkin, “Conflicts of Interest at the President’s Bioethics Commission,”
December 20, 2011, Law and Biosciences Blog, Stanford Law School Lamkin Article (concerns who was on the commission and their conflicts in objectively contributing to the commission’s report on research subjects)

Josephine Johnston, “Conflict of Interest in Biomedical Research,” Bioethics Briefings, The Hastings Center, September 21,  2015 Johnston Article (Overview of conflicts of interest)

Christopher Mayes, Ian Kerridge, Roojin Habibi & Wendy Lipworth (2016) Conflicts of interest in neoliberal times: perspectives of Australian medical students, Health Sociology Review, 25:3, 256-271, DOI: Conflicts of Interest in Neoliberal Times

DuBois JM, Kraus EM, Mikulec AA, Cruz-Flores S, Bakanas E. A humble task: restoring virtue in an age of conflicted interests. Acad Med. 2013 Jul;88(7):924-8. A Humble Task

Brody H. Professional medical organizations and commercial conflicts of interest: ethical issues. Ann Fam Med. 2010 Jul-Aug;8(4):354-8.  Brody Article  (Coca-Cola corporate donation to fund obesity research and other commercial conflicts.)

Greenberg RD. Conflicts of Interest: can a physician serve two masters? Clin Dermatol. 2012 Mar-Apr;30(2):160-73. PMID: 22330659.  Greenberg Article (regulation vs improved physician ethics)

Schofferman J. The medical-industrial complex, professional medical associations, and continuing medical education. Pain Med. 2011 Dec;12(12):1713-9. doi: 10.1111/j.1526-4637.2011.01282.x. Epub 2011 Dec 6. PMID: 22145759.The Medical Industrial Complex

ConflictsofInterestSlides

Big Data: A Modern Privacy Framework

Big Data PowerPoint

A modern privacy and big data framework must address the use of both health-related data as well as seemingly innocuous data on behaviors, consumer preferences, voting, employment history, credit rating, and social media use. Biometrics, health records, new technologies like facial recognition bring new ethical issues that require expanded frameworks. Privacy is vulnerable due to the newness of certain technologies, which are not yet addressed by laws and best practices, and the hackability in the cybersecurity arena.

Risks of Abuse of the Data: Marketing and Discrimination

In the marketing arena, corporate free speech propelled the commercial value of deidentified information including physician prescribing practices, data sets correlating disease predictors with heretofore seemingly unrelated things (like what television station a person watches or where they shop), and genetic, physical, psychological health records. If a data set indicates a person listens to NPR, watches MSNBC, shops at Whole Foods, we can guess they voted for Joe Biden. What is unexpected is that big data also is being used to predict their pharmaceutical needs. The risk of reidentification, inappropriate gathering of data, or abuse (disease creep or upselling) could be weighed against the benefits. For much of the use, the benefit runs to pharmaceutical sales and marketing departments, not to the people whose data was collected. For large health data sets, the benefit runs both to public health initiatives and individual care. The issue of which uses of the data are ethical, whether the data should be available for all uses, and whether the people whose data it is should have any say in the matter (by creating the regulations or opting to keep their data from being collected) are the backbone of the framework.

Large data sets are used for predictions of the future health of people with certain characteristics. Large data sets prejudice employers and lenders against groups of people with certain traits, who engage in certain behaviors, or simply by their habits and preferences. For example, data correlates both bike shop customers and people who vote in midterm elections with good health. (Zarsky) While that seems interesting from a public health perspective, in the hands of an employer, lender, or someone marketing products to the unhealthy, the data can be used unethically. The likelihood that people and groups face discrimination already based on big data, some of which seemingly has nothing to do with actual health records, is concerning.

Large searchable databases open the possibility of reidentification (identifying a person with the deidentified health data) leading to possible discriminatory treatment based on genetics or medical history. The ADA does not address the use of predictive data.

In facial recognition, special issues include whether the patient knows and understands how an image can be used to identify genetic disorders, whether the algorithms are accurate and what human error can impact the use of images, and whether facial images and templates can be deidentified. The Genetic Nondiscrimination Act (GINA) does not cover facial recognition as it is not categorized as a specifically genetic test. (see Martinez-Martin.)

Black-box Medicine and Data in Clinical Care

The lack of certainty surrounding whether a causal relationship exists when large data sets provide information can create ethical dilemmas. Black-box medicine pulls together huge datasets to predict what medicines might work, primarily based on patterns rather than an understanding of disease mechanisms. (Price) The patterns can be based on genetic and biological data, can be beneficial to health, and can lead a hypothesis later tested. That is, research eventually may answer the why and confirm causality. There are vast benefits to black-box medicine but it is unclear how to evaluate the duty of the doctor to a patient for whom the recommendation fails or what to do when the recommendation the algorithm produces violates the known standard of care. Does black-box data equate to the best medical judgment of the doctor or replace it? The algorithm choice does not corroborate a care choice (it does not supplement expertise), it supplants expertise. The level of risk (the side effect profile and risk of foregoing the standard of care based on the condition) is an important consideration. Risk 1: Following the computer-generated advice. Risk 2: Forgoing the standard treatment. Risk 3: Who is responsible if it turns out bad (negligence, malpractice, no consequences)? Risk 4: Can the developers be held responsible? Risk 5: The regulations do not keep up with the technology.

Data-Generating Patents

Data generating patents require a new ethical approach as well. Intellectual property rights are expanding. Data-generating patents can preclude other ways of obtaining, collecting, or generating the same type of data. The data generated is protected as a trade secret. The patents provide a windfall of market share in the data market which is not the market of the technology or biomedical device patented. (e.g., if a patented search engine of social media outlet collects data from millions of people, trade secret law protects the actual data; when a way of testing for BRCa is patented this way, the company has access to all of the data of those tested.) In Association for Molecular Pathology v. Myriad Genetics, Inc. Myriad’s patents were mostly upheld (the Court distinguished natural sequences of DNA (gDNA) (unpatentable) from cDNA that is synthetic and therefore patentable). 569 US 576 (2013). Myriad continues to use trade secret law to protect the database of patient information. (Simon and Sichelman) Trade secret law does not have an end date so the ability to create a monopoly, barrier of entry to competing businesses, or to use big data as an advantage in marketing and producing other products is great. The market control can inhibit innovation and access to data for the public good or public health, hurting consumers and the public.

What Does Privacy Mean?

Does modern privacy mean nothing is actually private yet many things remain protected from government interference. There may be a paradigm shift in privacy law. While many regulations speak to cybersecurity, hacking is increasingly sophisticated. While slander and libel cover things that are not true, the argument that something is private may face limitations. It is not unusual for private information to be leaked, stolen, held for ransom, and made public. 

FBI follows data wrongdoers, recognizing that hacking a health database can lead to extortion and can influence politics and careers.

Big Picture

The framework requires considerations: weighing the value of privacy, possibility of data-based “precision” medicine, and the benefits of data-based public health approaches against the risk of de-identification (violation of privacy, individual discrimination by employers, insurers, and lenders, public embarrassment, extortion, or other crimes against individuals), discrimination against groups based on correlations, a system of passed blame rather than malpractice claims, and limits to innovation based on patents and data-generating patents, and hacking (access to large data storage, financial risks, large data sets used by bad actors, national security).

Some systems could help: Blockchain transparency (with less ability to identify individuals), edge computing (keeps data closer to home compared to cloud), and the ever-increasing cybersecurity software upgrades. Keeping ahead of hackers is always going to be difficult making all data collection risky. The framework has to weigh the option of not collecting or storing the data at all, sacrificing the benefits of pooled data. Regulating cybersecurity, data storage, searchable public or private large datasets, the companies creating black-box data algorithms, hospital and doctor use of data not proven to evidence causal relationships, while a large job, is the necessary ethical response to the fast-moving new discoveries changing the delivery of care and the storage of data. Moving beyond the four principles allows bioethicists to harness the sophisticated language of big data, view the broad discriminatory and criminal potential without the constraints of “justice”, and avoid phrases more conducive to the doctor patient relationship.

J. Zhang, B. Chen, Y. Zhao, X. Cheng and F. Hu, “Data Security and Privacy-Preserving in Edge Computing Paradigm: Survey and Open Issues,” in IEEE Access, vol. 6, pp. 18209-18237, 2018, doi: 10.1109/ACCESS.2018.2820162 (Privacy is outsourced opening vulnerability to security breaches; the four layer architecture can present data security and privacy challenges.)

Emily Mullin, “Bad Actors Getting Your Health Data Is the FBI’s Latest Worry,” leapsmag, February 25, 2019. Mullin Article

Martinez-Martin N. What Are Important Ethical Implications of Using Facial Recognition Technology in Health Care? AMA J Ethics. 2019 Feb 1;21(2):E180-187. Martinez-Martin Article

Mulligan, J., Esq, & VonderHaar, M., Esq. (2016). Health Hackers: Questioning the Sufficiency of Remedies When Medical Information is Compromised. The Health Lawyer, 29(1), 29-37.  PDF: Mulligan PDF

Loi, M., Christen, M., Kleine, N., & Weber, K. (2019). Cybersecurity in health – disentangling value tensions. Journal of Information, Communication & Ethics in Society, 17(2), 229-245.  Cybersecurity in Health Article “5.4 Prioritizing non-maleficence and (privacy-related) autonomy at the expense of beneficence and autonomy Consider a system of medical health records optimized to promote privacy and safety. The most extreme form of this would be a system minimizing data collection, data sharing, communication and networking. Such a system may be able to avoid privacy breaches and impersonation and denial of service attacks, thus avoiding device malfunctions. It would be responsive to the principle of non-maleficence and also of autonomy, i.e. it protects privacy, which is crucial for autonomy.

Such a design, however, could not be used for providing data intensive services, which may involve a sacrifice in quality and/or cost-effectiveness. This is contrary to the principle of beneficence. In the context of implantable medical devices, maximizing privacy and safety leads to sacrificing certain aspects of usability (e.g. no wireless monitoring) with implications on autonomy.” (Article applies four principles; stretching autonomy to be the principle relevant to privacy. Autonomy as self-direction and even liberty does not, to me, perfectly grasp the gravity or the type of control over data that one wants, nor does it way the benefits of added choice of care or possible autonomy-like benefits from improved information.)

Perakslis, E. D. (2014). Cybersecurity in health care. The New England Journal of Medicine, 371(5), 395-397. Perakslis Article

Zimmerman, A. (2020). Marketing madness: The disingenuous use of free speech by big data and big pharma to the detriment of medical data privacy. Voices in Bioethics6Zimmerman, Marketing Madness

Brenda M. Simon, Ted Sichelman, “Data-Generating Patents,” Northwestern University Law Review, Vol 111, Issue 2 (2017) Data-Generating Patents

Kathleen Charlebois, Nicole Palmour, Bartha Maria Knoppers “The Adoption of Cloud Computing in the Field of Genomics Research: The Influence of Ethical and Legal Issues,” October 18, 2016 . PLoS ONE 11(10):
e0164347. The Adoption of Cloud Computing  (Empirical research identifying ethical issues and finding a balance between data sharing and privacy.)

Sharona Hoffman, “Big Data’s New Discrimination Threats,” Big Data, Health Law, and Bioethics, Chapter 6, edited by I. Glenn Cohen, Holly Fernandez Lynch, Effy Vayena, Urs Gasser, Cambridge University Press, 2018.

W. Nicholson Price, III, “Medical Malpractice and Black-Box Medicine,” Big Data, Health Law, and Bioethics, Chapter 20.

Tal Zarsky, “Correlation versus Causation in Health-Related Big Data Analysis” Big Data, Health Law, and Bioethics, Chapter 3.

Ashish M. Bakshi, Gene patents at the Supreme Court: Association for Molecular Pathology v. Myriad Genetics, Journal of Law and the Biosciences, Volume 1, Issue 2, June 2014, Pages 183–89, Bakshi Article

Singer, Natasha, “The government protects our food and our cars. Why not our data?” New York Times, Nov. 2, 2019. Beckerman, Michael, “Americans will pay a price for state privacy laws,” New York Times, Oct. 14, 2019. Singer Article

Whitney, Jake, “Big (Brother) Pharma,” New Republic, August 29, 2006. Whitney Article

Kaplan, Bonnie, “Selling Health Data: De-identification, Privacy, and Speech,” ISPS Bioethics Working Paper, Yale Interdisciplinary Center for Bioethics, Oct. 7, 2014. Kaplan Paper  (notes the Court’s failure to evaluate Sorrell as a constitutional privacy case.  Kaplan says that “the State deciding which speech is permitted and which data users are favored over others is detrimental to both personal freedom and the marketplace of ideas.”

Rothstein, Mark A. “Is deidentification sufficient to protect health privacy in research?.” American Journal of Bioethics, Vol. 10,9 (2010): 3-11. doi:10.1080/15265161.2010.494215 Rothstein Article

Booth, Katie, “The all-or-nothing approach to data privacy: Sorrell v. IMS Health, Citizens United, and the future of online data privacy legislation,” JOLT Digest Harvard Law School, Aug. 7 2011.  Booth Article (Arguing there is a role for corporate responsibility.)

BigDataPowerpoint

Dignity: A Framework for Ensuring Person-Centered Care

Please start with this linked flipbook best viewed in full screen:

Dignity-Based Framework for Person-Centered Care

Person-Centered Care

Person-centered care places people in charge of their medical decisions as well as their long-term healthcare plans. Person-centered care should reflect people’s healthcare priorities and values. Centering healthcare around people receiving care rather than projecting only the goals of the practitioners calls for a framework beyond principlism. A dignity-based framework adds ethical heft to principles in the realm of clinical care. Drawing on interpretive sociology, a framework should include the meaning people attach to their world, whether that meaning comes from social or cultural phenomena or personal priorities. Then, critical theories can inform public and hospital policy deficiencies.

Autonomy, described as self-direction, remains the crux of person-centered care. Self-direction in medical care is generally legally protected and falls within recognized rights. However, physician or hospital duress and court-compelled care provide challenges to self-direction. The use of capacity assessments also plays a role in limiting a person’s ability to direct their own care. Informed consent and informed refusal are precursors to autonomous decision making in health care. Yet the cloaked language surrounding autonomy or beneficence can imply that a doctor or clinician is giving a person “permission” or “allowing them” to be the decision maker. Really, there is an established presumption that people decide for themselves, which should be respected by doctors.

Person-Centered Beneficence

Attention to defining beneficence more broadly calls for a new term, person-centered beneficence. Person-centered beneficence (a term I made up) could help guide a dignity-based analysis and avoid paternalism cloaked as beneficence. Person-centered beneficence addresses who defines a good outcome (success) and who decides what to tolerate on the road to potential success. Under the dignity-based framework, doctors should look to maintaining the patient’s sense of self, respecting their privacy, listening to their concerns, and understanding their healthcare values. Evaluating considerations as beneficent recognizes the good in each of those four propositions. That alleviates autonomy from its large role of acting as a counterweight to paternalistic beneficence. Folding in decision making as a moral good, recognizing its moral value allows doctors (and even courts) to see that beneficence may be at the discretion of the autonomous decision maker, even subjective and not always only something objective. Beneficence cannot allow forcing the treatment the doctor finds medically best. Beneficence as an ethical term has to do with moral goodness. We ask good for whom? Good in what way? And good among what other competing goods (better for whom, better in what way)? In person-centered care, if an older adult refuses intrusive care, a dignity-based framework with person-centered beneficence would consider the stakeholders and weigh the importance of their concerns (the patient would bear the intrusion and live with the side effects; the doctor feels the treatment is worthwhile and would lead to the best medical outcome). The person’s viewpoint on quality of life and on medicalization would be prominent. Dignity includes many facets and informs a framework which considers the big picture issues of how we as a society should recognize an underlying tendency to push life at all costs — that societal tendency should be separated from individual refusals. While sometimes a state interest in continued life is relevant (as decided by a court), usually adults can direct their own care based on their personal views.

Dignity

Dignity might also rightly limit the social work role in evaluating why people refuse care. For example, many people think refusing care due to cost is wrong. Yet for a family trying to save to send children to college, an adult refusing care that would cost them both in lost earnings and their savings is reasonable. The problem would be better addressed legislatively than clinically. The right to refuse even for the wrong reasons is essentially protected by law. The ability to access care when you are socioeconomically disadvantaged is a justice issue incorporated into a dignity framework (an inability to access care is an indignity). A dignity-based framework has room to consider the public policies surrounding how care is accessed so that the financially disadvantaged are not forced to refuse care or to accept a charitable donation or create a go-fund-me page.

The stakeholder that matters most is the person whose care is in question. A doctor’s stake and the state’s stake must be kept in perspective and evaluated in the context of the burden of potential outcomes.

Note: In refusals, sometimes legal issues govern. Considerations include applicable statutes limiting the right to refuse (e.g. Baby Doe laws), whether the statute is constitutional, and who decides (ethics committees cannot trump courts; mediation is a possibility and mediators must be impartial.)

Jacobson, Nora. “Dignity Violation in Health Care.” Qualitative Health Research, vol. 19, no. 11, Nov. 2009, pp. 1536–1547.  https://pubmed.ncbi.nlm.nih.gov/19797155/

Barclay L, “Dignitarian medical ethics,” Journal of Medical Ethics 2018;44:62-67. https://pubmed.ncbi.nlm.nih.gov/29030395/

Liu, P. “Dignity and equality in healthcare,” Journal of Medical Ethics 2018;44:651- 52. ttp://dx.doi.org/10.1136/medethics-2017-104665

(Criticism of Linda Barclay’s Dignitarian Medical Ethics. “First, it is not obvious that failing to treat someone as a social equal is incompatible with respecting her dignity. Second, it is not always clear what treating someone as a social equal amounts to in practice.”)

William Selde, Know When and How Your Patient Can Legally Refuse Care 3.25.2015 Journal of Emergency Medical Services https://www.jems.com/administration-and-leadership/know-when-and-how-your-patient-can-legal/

Carrese JA. Refusal of Care: Patients’ Well-being and Physicians’ Ethical Obligations: “But Doctor, I Want to Go Home”. JAMA. 2006;296(6):691–695. doi:10.1001/jama.296.6.691; Leo R. J. (1999). Competency and the Capacity to Make Treatment Decisions: A Primer for Primary Care Physicians. Primary care companion to the Journal of clinical psychiatry1(5), 131–141. https://sites.duke.edu/geriatrics/files/2015/04/02A-article-refusal-of-care.pdf

Lothian, K., & Philp, I. (2001). Care Of Older People: Maintaining The Dignity And Autonomy Of Older People In The Healthcare Setting. BMJ: British Medical Journal, 322(7287), 668-670, p. 669. Retrieved May 3, 2021, from http://www.jstor.org/stable/25466477

Bynum, J. P., Barre, L., Reed, C., & Passow, H. (2014). Participation of very old adults in health care decisions. Medical decision making : an international journal of the Society for Medical Decision Making34(2), 216–230. https://doi.org/10.1177/0272989X13508008

Birrell, J., Thomas, D., & Jones, C. A. (2006). Promoting privacy and dignity for older patients in hospital. Nursing Standard20(18), 41+.(Table 1, p. 42.) https://pubmed.ncbi.nlm.nih.gov/16425598/

Bozinovski, S. D. (1995). Self-neglect among the elderly: Maintaining continuity of self (Order No. 9543993). Available from ProQuest Dissertations & Theses Global. (304191320), University of Denver, 1995. https://www.proquest.com/openview/aff0fef6c5c4d0a826a15f97ec88dc95/1?pq-origsite=gscholar&cbl=18750&diss=y

Annas, G., & Glantz, L. (1986). The Right of Elderly Patients to Refuse Life-Sustaining Treatment. The Milbank Quarterly, 64, 95-162, at 116. doi:10.2307/3349961 https://www.jstor.org/stable/3349961?seq=1

Leo R. J. (1999). Competency and the Capacity to Make Treatment Decisions: A Primer for Primary Care Physicians. Primary care companion to the Journal of clinical psychiatry1(5), 131–141. https://doi.org/10.4088/pcc.v01n0501  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC181079/

King G, Farmer J. What older people want: evidence from a study of remote Scottish communities. Rural Remote Health. 2009 Apr-Jun;9(2):1166. Epub 2009 Jun 24. PMID: 19594291. http://citeseerx.ist.psu.edu/viewdoc/download;jsessionid=477FB9233B5C2AE8A31DB999C02E75AF?doi=10.1.1.505.8150&rep=rep1&type=pdf

Nilsen, A. (2021). Independence and relationality in notions of adulthood across generations, gender and social class. The Sociological Review, 69(1), 123–138.  (“independence… has the moral high ground over dependence.”)https://doi.org/10.1177/0038026120931425

For your convenience, see slides as PDF: Dignity Framework & Patient-Centered Care

Four Principles, their value, and why we need to move beyond them

Four Principles Flip Book (Best viewed in full screen):

Four Principles: Their Value and Why We Need to Move Beyond Them

The four principles defined by Beauchamp and Childress were published in their 1979 book, Principles of Biomedical Ethics.

The Principles

Autonomy: self-direction

Beneficence: doing good (to whom, at what cost, how to define what is good, comparing and weighing competing goods)

Nonmaleficence: doing no harm (context of physician, Big Pharma, policymaker, public policy wrongdoing)

Justice: providing opportunity (many contexts and calls for more frameworks)

Usefulness

The four principles of bioethics provide a method for evaluating ethical dilemmas of all sorts. Ethics committees sometimes rely on them. Their value is that they allow those practitioners who are trained in delivery of care to quickly assess ethical dilemmas. Sometimes, there is not time for philosophy — ethics is moral philosophy — and a quick discussion or ethics committee meeting uses the principles to make a decision. In the academic literature, many authors, some philosophers and bioethicists, fully investigate the application of a principle and address a largescale problem. I observe that many of those doing so use the principles effectively by placing them in a framework that reflects critical thinking rather than pulling them out of their roots and using them to simplify complex problems with many diverse stakeholders.

Limitations

While the principles influenced bioethics greatly, they also have limitations. They can contribute to a box-checking, narrow approach seen in hospital ethics committees. That is, they save some people the heavy lifting of applying philosophy or broad approaches to complex scientific dilemmas. Each principle can be applied many ways and subjective and objective interpretations muddy the waters. Principles can cut out other worthy frameworks, limit or expand the number of stakeholders, or lead to a false equivalency when analyzing competing priorities. Principles also, to some degree, let bioethics committees off the hook. By describing one option as beneficent, they further paternalism, especially when they devalue autonomy despite its legal protections or fail to recognize the beneficent choices of those outside of science and medicine. Justice needs more description leading to the effort here to create different justice frameworks.

Stalemate

The four principles can lead to stalemate. In ethics, we cannot always agree to disagree. If there is not consensus, a move to compromise is better. The consensus or the compromise may be that the issue is best left to individuals. In bioethics, a majority viewpoint does not always quiet the minority viewpoint.

As bioethics became more all-encompassing, limitations of the application of the core principles grew. For example, the four principles may not be the best tool for climate change, artificial intelligence, cybersecurity, new technologies and computer science, or cloning, much of which were speculative when the principles were articulated but now are operational and present possibilities of actions that can harm or benefit humanity. The complexity of recent scientific innovation should not be limited by the four principle as rhetorical devices and calls for incorporating other ethical imperatives into the discourse. The most important role of bioethics is to operate as a check on the power held by Big Pharma, Big Tech, and Big Medicine. The balancing set forth by the principles does not always go far enough or deep enough to analyze the power structure.

Beauchamp T, Childress J. Principles of biomedical ethics [4th ed]. New York, Oxford: Oxford University Press, 1994. (See also Beauchamp, Tom L, and James F. Childress. Principles of Biomedical Ethics. New York: Oxford University Press, 2009.) Original publication, 1979.

Macklin, R. “Applying the Four Principles.” Journal of Medical Ethics, vol. 29, no. 5, 2003, pp. 275–280. JSTORhttp://www.jstor.org/stable/27719100. Accessed 8 May 2021.

Beauchamp TL. Methods and principles in biomedical ethics. J Med Ethics. 2003 Oct;29(5):269-74. doi: 10.1136/jme.29.5.269. PMID: 14519835; PMCID: PMC1733784. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1733784/pdf/v029p00269.pdf

Callahan D. Principlism and communitarianism. J Med Ethics. 2003 Oct;29(5):287-91. doi: 10.1136/jme.29.5.287. PMID: 14519838; PMCID: PMC1733787. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1733787/pdf/v029p00287.pdf  (Author dislikes the individualist bias in principlism (a contention with which I disagree) and also criticizes its blocking substantive ethical inquiry (something I find to be its primary problem.)

Gillon R. Defending the four principles approach as a good basis for good medical practice and therefore for good medical ethics. J Med Ethics. 2015 Jan;41(1):111-6. doi: 10.1136/medethics-2014-102282. Erratum in: J Med Ethics. 2015 Jun;41(6):446. Erratum in: J Med Ethics. 2015 Oct;41(10):829. PMID: 25516950.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1376826/pdf/jmedeth00299-0005.pdf

Danner Clouser, Ph.D., Bernard Gert, Ph.D., A Critique of Principlism, The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine, Volume 15, Issue 2, April 1990, Pages 219–236, https://doi.org/10.1093/jmp/15.2.219 https://academic.oup.com/jmp/article-abstract/15/2/219/903616?redirectedFrom=fulltext

Clouser, K. Danner. “Common Morality as an Alternative to Principlism.” Kennedy Institute of Ethics Journal, vol. 5 no. 3, 1995, p. 219-236. Project MUSE,  doi:10.1353/ken.0.0166.

Matthew Shea, Forty Years of the Four Principles: Enduring Themes from Beauchamp and Childress, The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine, Volume 45, Issue 4-5, August 2020, Pages 387–395, https://doi.org/10.1093/jmp/jhaa020

Griffin Trotter, The Authority of the Common Morality, The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine, Volume 45, Issue 4-5, August 2020, Pages 427–440, https://doi.org/10.1093/jmp/jhaa015 (Abstract: “Beauchamp and Childress seem to hold that (1) the norms they articulate in Principles of Biomedical Ethics are derived in an objective way from the common morality, and also that by virtue of being so derived (2) they carry a moral authority that objectively exceeds the authority of norms constituting particular moralities. My thesis in this essay is that both of these claims are false.”)

Matthew Shea, Principlism’s Balancing Act: Why the Principles of Biomedical Ethics Need a Theory of the Good, The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine, Volume 45, Issue 4-5, August 2020, Pages 441–470, https://doi.org/10.1093/jmp/jhaa014 (One of the many problems I see with beneficence is the inability to agree on what is good. Beneficence implies a universal good. This article highlights the lapse.)

Page, K. The four principles: Can they be measured and do they predict ethical decision making?. BMC Med Ethics 13, 10 (2012). https://doi.org/10.1186/1472-6939-13-10 https://bmcmedethics.biomedcentral.com/articles/10.1186/1472-6939-13-10 (empirical research questioning the practical use of the four principles.)

Campbell AV. The virtues (and vices) of the four principles. J Med Ethics. 2003 Oct;29(5):292-6. doi: 10.1136/jme.29.5.292. PMID: 14519839; PMCID: PMC1733783.  https://jme.bmj.com/content/29/5/292 (Criticizes principlism for its “neglect of emotional and personal factors, oversimplification of the issues, and excessive claims to universality. Virtue ethics offers a complementary approach, providing insights into moral character, offering a blend of reason and emotion, and paying attention to the context of decisions.”)

Cummins PJ, Nicoli F. Justice and Respect for Autonomy: Jehovah’s Witnesses and Kidney Transplant. J Clin Ethics. 2018 Winter; 29(4):305-312. PMID: 30605440. https://pubmed.ncbi.nlm.nih.gov/30605440/ (Applies the principle of justice concluding it is unethical to refuse to include people who are Jehovah’s Witnesses in need of a transplant on the waiting list even if they require bloodless organ transplant.)

Johan Christiaan Bester (2020) Beneficence, Interests, and Wellbeing in Medicine: What It Means to Provide Benefit to Patients, The American Journal of Bioethics, 20:3, 53-62, DOI: 10.1080/15265161.2020.1714793 (Aims to define two aspects of beneficence one of which incorporates the patient’s  view.)

Frameworks of Justice

Flip book best viewed in full screen.

Justice Flip Book

In bioethics, justice has many dimensions, interpretations, and applications. The best frameworks for thinking about justice need to recognize its breadth and its many meanings. The doctor patient relationship as well as macro public policy lead to injustices that need to be addressed. Categorizing the type of justice at stake shapes the framing of the issues.

Justice of Opportunity

Justice as a level playing field or fair opportunity, referred to here as “justice of opportunity” is best applied to bioethical dilemmas in the realm of access to those social goods known to determine health, like education and fair wages. In such situations justice of opportunity should include making some people whole, accounting for past injustices, and leveling the playing field.

Justice of Equal Access

“Justice of equal access” can apply to situations where the goal is to end discrimination, especially if the discrimination prevented a group or individual from accessing the same amount of the same resource. For example, justice of equal access is a good framework to ensure every school child has internet access, but justice of opportunity is a framework to ensure every child in need of educational support like tutoring has it. One has been blocked out of the status quo, denied equal access; the other needs something extra to ensure opportunity.

In the clinical setting, justice of equal access can help sort out allocation of scarce resources, like ventilators in the pandemic. The framework must account for fairness when equal access is not achievable. A fair waiting list can meet the standards, while one that is not thoughtful or bars a marginalized group might not.

Public Goods

Justice of access can apply to “public goods.” Some economists view public goods as having a weak link between the payor and the receiver or user of the good. For example, taxpayers finance many things they do not use like national parks they do not visit or public schools they do use to educate their children. They also pay for intangible public goods like national security and the military, the appreciation of which varies significantly among taxpayers.

It has been difficult to ascertain the degree to which health care is a private good. Insurance is clearly a private good. Medicaid is also arguably a public good and has a tangible personal value to some (although not to the payers), and Medicare, is essentially purchased. Even the Affordable care Act is a move toward making health care more of a public good. But for now, health care is a private good. It falls in between the fact pattern for justice of opportunity and justice of access. The most ethical position, to me, is universal access with taxpayers covering people through Medicaid who cannot afford care. To some, nothing less than a single payer plan is ethical. To others, that is seen as an unfairness, and contrary to innovation or free choice. To those who think of healthcare as “extra”, the justice of opportunity framework also calls for providing care, even if it is seen as additional.

Apply Justice of Opportunity

To apply justice of opportunity, the fact pattern should show that those with access to certain social goods (but not others) are not reaching the goals that their peers are. Whether categorized by race, ethnicity, physical or neurological differences, the group (or the individual) needs something extra (a product or service) to reach success. The framework starts with critical analysis of what would help, not of what works for the others. A justice of opportunity process requires creativity and operates in a public, non-profit, and private sphere. After school tutoring or access to a part time job for a high school student to earn money could create opportunity. Justice of opportunity is significantly more tailored to groups and individuals.

Apply Justice of Access

To apply justice of equal access, the information collected must show a deprivation. Then, the framework is a process for remedying the deprivation through public policy. For example, if one cohort of public school students has internet access and a laptop and the interconnectedness, research opportunities, and college acceptances or ability to attain jobs with good wages is better, then under an analysis of justice of equal access, the critical analysis does not focus on what would help, but on how to get it. Rather than a simple call for computers, the ethical impetus to solve the practical problem should shape public policy, and possibly include charitable donations.

Both frameworks of justice apply to global health and well-being.

Recognizing limitations makes bioethics a realistic source of public policy input. To many people, justice and fairness are defined by getting one’s share, paying in equally (doing one’s fair share, whether through taxes or through becoming vaccinated), or getting out in proportion to what one paid in. Those issues are fundamental to both justice of opportunity and justice of equal access. There will be weighing processes that inform reasonable goals and best solutions. 

Competing Views of Fairness

It is important to define the way fairness is discussed. Whether it is fair that some people pay more in and get less out of a system (for example health insurance) depends on the framework and analysis. Societal goals and priorities can be legislated and sometimes a personal vote is the most involvement a person has. In policies that affect health and have the goal of elevating the worst off by providing health opportunity, justice frameworks shape the inevitable weighing process that values some public goods over others.

Justice in the Legal and Criminal Law Sphere

“Legal justice” effects bioethics as well. In the legal arena, to many people, justice can mean punishing for a past action. In bioethics, that type of justice may be relevant to a wrongdoer who fudged research to get FDA approval for an unsafe drug. It also can apply in the arena of medical neglect where justice could ensure that all people (often parents) are subject to investigation based on like behaviors. For example if a Black mother and a White mother each refuse the same treatment for their child with the same condition, they should face equal treatment whether that is respect for the refusal or a motion to compel care.

Discerning which framework applies will help those in bioethics apply justice in a more goal-oriented way.

Benjamin R. Informed Refusal: Toward a Justice-based Bioethics. Science, Technology, & Human Values. 2016;41(6):967-990. doi:10.1177/0162243916656059 Ruha Benjamin Article

Jonathan Haidt, (2012). The righteous mind: Why good people are divided by politics and religion. Pantheon/Random House.

HÄYRY, M. (2019). Justice and the possibility of good moralism in bioethics: CQ. Cambridge Quarterly of Healthcare Ethics, 28(2), 236-263.  Hayry Justice and the Possibility of Good Moralism (Explores six different interpretations of justice and discusses morality versus moralism. Contrasts bioethical approaches in the American and European domain, addresses polarized political constructs and their relevance to bioethics. Explores libertarianism, communitarian, socialist, utilitarian, capability, and identity and recognition. The different realms cover some space where views on justice do not overlap or necessarily address the same concerns.)

Ubaka Ogbogu Lorian Hardcastle, “Bioethics and practical justice in the post‐COVID‐19 era,” Developing World Bioethics, July 2020. Volume 21, Issue 1 (March 2021) First published: 30 July 2020  Hardcastle Article

Gabriela Arguedas‐Ramírez, “Bioethics in the Times of Contagious Populism,” Developing World Bioethics, March 3, 2021 Bioethics in Contagious Populism

Zimmerman, Anne, “Reframing the healthcare debate: targeted problems and solutions,” Master’s Thesis, Columbia University, 2020. Reframing the Healthcare Debate

Malte Luebker, “Income Inequality, Redistribution, and Poverty: Contrasting Rational Choice and Behavioral Perspectives,” The Review of Income and Wealth, February4, 2014 Leubker Article

(Income inequality and whether it results in greater redistribution. “The findings challenge the narrow concept of human motivation that underpins rational choice, and point to the importance of fairness orientations that have been emphasized in behavioral economics.”)(Relevant to justice of opportunity as arguably some opportunities should be created with public taxpayer dollars.)

Bradley, David, et al. “Distribution and Redistribution in Postindustrial Democracies.” World Politics, vol. 55, no. 2, 2003, pp. 193–228. JSTORhttp://www.jstor.org/stable/25054218. Distribution and Redistribution in Postindustrial Democracies  (Covers the role of many theories in the support of distribution of resources; vindicates power resources theory, that working class power leads to the most redistributive policies, using data to demonstrate the strong relationship to redistribution.)(Applying this article to the US — implies that issues of who holds political power, or whose vote is drowned out either by structures (electoral college or senate representation that is geographic rather than population-based), voter disenfranchisement or suppression, or waning unions affects outcomes for those hurt by income inequality.)

Global justice and bioethics / edited by Joseph Millum and Ezekiel J. Emanuel.

New York : Oxford University Press, c2012. includes:

Global bioethics and political theory / Joseph Millum

Is there a human right to essential pharmaceuticals? : the global common, the intellectual common, and the possibility of private intellectual property / Mathias Risse

Global justice and health : the basis of the global health duty / Jonathan Wolff

Justice in the diffusion of innovation / Allen Buchanan & Robert O. Keohane

What is non-ideal theory? / Gopal Sreenivasan

Global justice and the “standard of care” debates / Ezekiel J. Emanuel

The bioethics of second-best / Robert E. Goodin

INGO health programs in a non-ideal world : imperialism, respect, and procedural justice / Lisa Fuller

Promoting global health through accreditation : the case of medical tourism / Nir Eyal

The obligations of researchers amidst injustice or deprivation / Alan Wertheimer.

Justice Slides

Future of Humankind: Enhancement, Genetics, and Cloning

Please begin with flipbook. Full screen recommended:

Future of Humankind Flip Book

Enhancement should be contextualized to include the collective impact of existing and potential enhancements. A macro, upstream policy or organization to consider the impact in context is important. Various administrations have had special councils (Presidential Commission and the older Presidential Council on Bioethics) considered cloning, stem cell research, and some enhancements. Special commissions in the executive branch may not have the wherewithal to handle incremental changes, considering each new technology and its impact. The FDA, as the ground level approval body, is not specifically tasked with contextualizing and considering the implications beyond safety and efficacy. Because there is not a clear line on what falls within enhancement and many technologies or medicines can be used to treat or to enhance, the Commissions can lead to sweeping acceptance or rejection (or occasionally compromise) and the FDA could approve something safe and effective without enough context.

Enhancement

This is not a simple debate between “transhumanists” and bio-conservatives. Enhancement calls for critical analysis of the reasoning of both sides. In the middle ground, more ethical issues abound and the ability to achieve the desired effect is greater. A framework to navigate enhancements must begin by distinguishing treatment of a medical condition from enhancement. The nature of the controversy arose because medicine and science somewhat encroached naturally on bodily manipulations beyond the curative or therapeutic. Enhancements give an advantage and to many seem outside the ethos of medicine. “Enhancement, here defined as choosing the physical (but not explicitly medical) traits like height, strength, intellect, memory, or talent, touches on the essence of what societal values should be protected and who should be part of the decisions to allow or prohibit enhancements.” (Zimmerman, Opting Out, publication pending) Enhancement tends to include augmentation that moves someone from the normal range to beyond normal for humans. There are many enhancements currently in use. Some have enhancement as the innovative goal, like Botox for cosmetics and steroids for athletic improvement. Other innovations have an enhancing side effect. (I love the metal plate and screws in my wrist which is probably stronger than my other wrist and possibly above the status quo for my age if compared to natural bone strength, but I got the treatment which happened to enhance after breaking a bunch of bones.) Medicine is not always able to target or define “normal’, something that is normative itself.

What is the ethical difference between new technologies inside the body versus those outside the body? What if an Apple watch measuring our steps were implanted under the skin? The ability to Google something could replace broader memorization skills without touching the human body. The enhanced ability to look up something forgotten when it is an outside-the-body tool is well accepted. Vagus nerve stimulators (an epilepsy implant) and pacemakers are both designed to bring people to a normal status quo. Their capabilities if used differently or at older ages would push beyond the human status quo. If contact lenses were improved to provide super distance vision and acted like multi-focal existing lenses as well, would that be ethically different from a new twist on Lasik that accomplishes a super distance vision (I mean well beyond 20-20)?

Genetics

CRISPR made gene editing affordable and faster. Medicines also can target genes, activating and deactivating them, blocking receptors, and changing their expression. There is opposition to embryonic changes that would be hereditary. Some of those changes, if targeting those with known genetic diseases, would have a result similar to a preimplantation genetic diagnosis. By manipulating the gene line in embryos, diseases could be eliminated if the use were universal, something unlikely. The Chinese experiment to produce HIV resistant embryos was met with dismay, but HIV medications are heralded as welcome scientific feats. There would be an ethical difference in targeting those with an illness (propelling the risks of the gene editing onto at-risk embryos versus an embryo without elevated risk). In the He Jiankui controversy, where allegedly two births with an edited CCR5 gene occurred, the alleged gene editing also could have had ancillary implications related to intelligence. The original Chinese HIV embryonic experiments did not really work (four out of 263 embryos were changed). I find the issue of informed consent (the bar for consent to research that is not therapeutic is higher and this was not therapeutic as the genetic material did not have HIV) and the issue of justice beside the point. Discussions about the sanctity of the human genome fail as drugs and other alterations or choices (like in PGD) are so well-accepted. Even nutrition can change the expression of genes. Moving forward, separating the issues of humanness, diversity, and fragility from “sanctity” is helpful as it reflects the many ways genes and genetic expression already are manipulated.

Whether disease resistance should fall within enhancement should depend on the normal human status quo. If fragility were a special circumstance, below the status quo, the change would not be seen as enhancement. I assert that this type of disease-proofing is not ethical both because it poses unknown risks (presumably science will improve), because it fails to target a specifically at-risk population (too broad if used at the societal level), targeted versions may become feasible (for now, when genes are identified that make people have a special susceptibility, then PGD already avoids the embryos with a genetic mutation), and the public should have a voice in the role of human fragility in defining humanness. The safety and efficacy issues will likely be resolved making the issues surrounding quality of life, what makes life special, and incorporation of diverse views the big picture ethical issues. Rather than using embryonic germline enhancement, discarding embryos with a mutation and implanting those without is a solution many choose.

A focus on the use of CRISPR in ways that effect gene expression but are not inheritable is more realistic for now. Many interventions are likely not inherently unethical or ethical. The increasing therapeutic use currently in play  concerns reprogramming somatic cells to fight disease, not enhancement. 

Germline changes and cloning should be evaluated under a framework that considers the future of humanity. Instead of stretching the word justice and applying the typical autonomy arguments, when technology affects future generations as well as those pursuing the technology to make a genetic enhancement (even a nonhereditary one), an inclusive analysis is needed.

Use-Based Regulations: Is the enhancement “radical”

The focus should be on the use of the intervention rather than the intervention itself. (That it changes a gene is understood but who would use it for what purpose should drive the analysis and the regulatory approval structure.) The  broader implications of the intervention (what it could mean for society) must consider the implications for the enhanced and those unenhanced. Societal enhancement happens slowly through each small invention. A regulatory framework that approves of certain medications for certain uses is in place but is not the right body to expand to some new developments. In medications, we see off-label use is predominant and often beneficial. Each use of a procedure that could potentially enhance should be contextualized. Adderall and Ritalin differ in depth and scope from neurosurgery or gene editing, yet used inappropriately may cause personal and societal problems as well. The societal acceptance (and legal prescribing) of them despite the downsides of their use are not enough to justify societal acceptance of other (including germline) enhancements.

Justice is Not the Crux of the Issue

There are many causes of the development of social classes and there is an apparent lack of political will to decrease socioeconomic inequality. To me, germline editing certainly could exacerbate injustices but, much more importantly, it can change humanity as we know it. Relying on justice alone would open the floodgates if the enhancement became cheap and accessible to everyone. There would be no further ethical safety net. There is a big picture concern, yet justice (as seen in principlism) seems to limit constructive approaches.

A justice framework can result in a failure to define what we collectively value about humanness. (An analogous line of reasoning is in the Hayry article: arguments against incest that are based solely on potential genetic abnormalities miss the ethical point.) Justice as a vocabulary word does not do enough for what could go wrong. That is, if the sea change to humanity were done in a just way (whether everyone had equal opportunity, or the entire population was enhanced in the same way to the same degree), bioethical frameworks still must require more reasoning to support it. Certainly, the view that full-on population enhancement is likely a bad outcome goes well beyond justice. 

Other Considerations

Enhancement poses risks to compassion (if everyone could choose to enhance, there may be less compassion for those who do not or are comparatively less-abled) and risk to competition or appreciation of a talent or intellect (if you can buy the enhancement, it would not speak to practice or effort although arguably being born with a special trait is not a reflection of dedication either). Those considerations speak to humanity and why people value diversity of health, intellect, talent, and strength in deeper ways than reflected in the literature.

Efforts to “disease-proof” by diet and lifestyle have known effects on outcome. The role of science in quick fixes could foster less responsibility in self-care. The comparison of ways to achieve outcomes should include healthy diet and lifestyle, and the use of and improved access to known treatments. Scientists compete for the same research money, something reflecting political will and budgets. Resources directed to food and lifestyle could have reduced the COVID-19 death toll based on data about comorbidities. Would research to design babies to be resistant to all coronaviruses be better or worse? Should science get more total research dollars and explore both?

When a germline is not involved, autonomy interests and rights could support access to enhancement. Constitutionally guaranteed liberty interests are unclear in the arena of enhancement, where new state interests could develop.

The stakeholders with a say in defining what makes humanity special should be broad. Regulating germline enhancements in deliberative democracy requires participation of voters. Traditions, religious beliefs, and cultural views that celebrate regular people could be marginalized by an enhanced population, even if the enhancement reflects justice. Furthermore, the distribution of work would become fraught with problems if enhancement elevated everyone intellectually or with physical strength. In enhancement, not everyone has an equal stake. To assign some people to represent future society (maybe philosophers and sociologists) is difficult. In the scientific arena, often the scientists are self-policing and the reasoning is already relegated to one side of the equation. The philosophers and sociologists could be alarmist as seen in the paper below by members of the Presidential Commission.

Hypothetically, what if there were an infertility pandemic and enhancement becomes part of the solution to infertility problems, i.e., if a stronger zygote (or blastocyst) were the only way to create babies at all, and the alteration had an ancillary effect of a computer-like brain or excessive height?

In the diminishment arena, the question of improving life by taking away or limiting a capacity also impacts the theoretical issue of how to define enhancement. If ignorance is bliss, then diminished intellect becomes an enhancement. See Earp and Savulescu below.

RESOURCES

David Masci, “Human Enhancement: The Scientific and Ethical Dimensions of Striving for Perfection,” Pew Research Center, Science and Society, July 26, 2016  https://www.pewresearch.org/science/2016/07/26/human-enhancement-the-scientific-and-ethical-dimensions-of-striving-for-perfection/

Twine, R., “Constructing Critical Bioethics by Deconstructing Culture/nature Dualism.” Med Health Care Philos 8, 285–295 (2005). https://pubmed.ncbi.nlm.nih.gov/16283491/

Huxley, J. “Transhumanism”. Ethics in Progress, Vol. 6, no. 1, Feb. 2015, pp. 12-16. https://pressto.amu.edu.pl/index.php/eip/article/view/9303(Basic article pro transhumanism; seems to favor radical …)

Anita L. Allen,  Nicolle K. Strand, “Cognitive Enhancement and Beyond: Recommendations from the Bioethics Commission,” Trends in Cognitive Science, Volume 19, Issue 10, October 2015, Pages 549-551 https://doi.org/10.1016/j.tics.2015.08.001 (paper comments that media hype creates concerns and provides the Commission’s recommendations focused more on prioritizing therapeutic innovation and use. The author’s concern for justice in the realm of “safe and beneficial” enhancements drowns out some of the other concerns, especially surrounding how to define beneficial. For example, a use of CRISPR to cure Alzheimer’s is medical and, to me, not enhancement, yet some could argue the status quo in certain age group includes weak memory. The author’s also mix medical treatment with enhancement making an unclear distinction.)

HÄYRY, M. (2019). Justice and the possibility of good moralism in bioethics: CQ. Cambridge Quarterly of Healthcare Ethics, 28(2), 236-263. (Awaiting permissions)  https://pubmed.ncbi.nlm.nih.gov/31113512/

Earp Brian, Sandberg Anders, Kahane Guy, Savulescu Julian, “When is diminishment a form of enhancement? Rethinking the enhancement debate in biomedical ethics,” Frontiers in Systems Neuroscience, Vol. 8 2014 https://www.frontiersin.org/articles/10.3389/fnsys.2014.00012/full (Article explores potential values of diminishment–making a trait worse, e.g. worsening memory or concentration, or capacity to love, Argues that while diminishment seems wrong under a functional-augmentation framework, under a goal-oriented reasoning, the authors assert the overarching goal, generally a better life, is the relevant framework. In that analysis, they broaden the definition of neuroenhancement beyond enhancing specific capacity to enhancing life.) (To me, an argument that a vasectomy is enhancement falls within their logic and represents a fact pattern that already operates under their assumptions.)

Reynolds, Joel Michael, “Health for Whom? Bioethics and the Challenge of Justice for Genomic Medicine,” Hastings Center Report, June 29, 2020. https://onlinelibrary.wiley.com/doi/full/10.1002/hast.1149(Views justice as “lifeblood” of medicine. This Hastings Center Special Report has 5 essays.)

Colin Koopman, “Coding the Self: The Infopolitics and Biopolitics of Genetic Sciences,” Hastings Center Report, June 29, 2020. https://onlinelibrary.wiley.com/doi/full/10.1002/hast.1150 (Abstract:
“The three analytical approaches are referred to as the
 state‐politics model, the biopolitical model, and the infopolitical model. Each of these models is valuable for different purposes. In terms of their influence in contemporary discussions, the first is by far the dominant approach, the second is gaining in importance, and the third is almost entirely neglected.” The article challenges assumptions in conceptual frameworks and highlights broader methods of analyzing bioethical issues.)

Nam, Jeesoo, “Biomedical Enhancements as Justice,” Bioethics, September 30, 2013 https://doi.org/10.1111/bioe.12061 (article uses social justice to justify a moral obligation to enhance. I find this pushes justice too far and exemplifies some limits of justice and the four principles approach.)

Older Cloning Articles:

Talbot, Margaret. The Cloning Mission; a Desire to Duplicate. New York Times. Feb. 4, 2001 https://www.nytimes.com/2001/02/04/magazine/the-cloning-mission-a-desire-to-duplicate.html

The Ethics of Cloning-to-Produce-Children. President’s Council on Bioethics. 2002. https://bioethicsarchive.georgetown.edu/pcbe/reports/cloningreport/children.html

Steinbock, Bonnie. Reproductive Cloning: Another Look (2006) University of Chicago Legal Forum: Vol. 2006, Art. 4. 111. https://chicagounbound.uchicago.edu/cgi/viewcontent.cgi?article=1388&context=uclf

Brock, Dan W. Cloning Human Beings: An assessment of the ethical issues, pros and con. Report and Recommendations of the National Bioethics Advisory Commission. (1997). https://govinfo.library.unt.edu/nbac/pubs/cloning2/cc5.pdf

Robertson, John A. Children of Choice: Freedom and the new reproductive technologies. (1996) Princeton University Press. Procreative Liberty. Chapter 2. https://journals.sagepub.com/doi/abs/10.1177/027046769501500127

Robertson, John A., Two Models of Human Cloning. 27 Hofstra L Rev 618 (1999). https://scholarlycommons.law.hofstra.edu/hlr/vol27/iss3/10/

The Witherspoon Council on Ethics and the Integrity of Science. The Threat of Human Cloning: Ethics, Recent Developments and the Case for Action. New Atlantis. Summer, 2015. https://www.thenewatlantis.com/publications/the-threat-of-human-cloning

Future of Humankind Slides

Pandemics and “Natural Disasters”

EditPandemics and “Natural Disasters”

No Natural Disasters Concept

New theoretical frameworks challenge the categorizing of natural events “natural disasters”. See this link for information about the #nonaturaldisasters movement, which is a campaign “to change the terminology to show that whilst some hazards are natural and unavoidable, the resulting disasters almost always have been made by human actions and decisions.” Without agreeing that policy can prevent every vulnerability, I argue the terminology change highlights the role of policy in preventing harm. Addressing the particular vulnerabilities that many people constantly experience would reduce the ability of an event (weather or pandemic) to cause widespread harm. The no natural disasters concept can be the basis for a syndemic framework to analyze COVID-19, weather events, climate change, and can be stretched to inform inner city crime and gun violence in the US. Social, environmental, economic, and political conditions influence outcomes. Under such an approach, the issues could include what legal or policy structures were in place that allowed people (and animals and the environment) to be harmed. Then movement in two analytical directions could ensue. First, was there an issue of political will that influenced vulnerability to contracting COVID-19 (or increased exposure to it)? Second, what ground level protections would help eliminate vulnerability?

Global Poverty

For example, one issue worthy of investigation is global poverty. Are there ways in which wealthier countries take advantage of low wage workers that contribute to poverty and made them more vulnerable, less able to afford PPE, or more susceptible to difficult cases of COVID-19 due to pre-existing conditions? Are there political structures within countries with lower average and median wealth per capita that increased vulnerability? Is a global approach or a national approach helpful? Looking at the harms of COVID-19 through the lens of poverty provides important context.

Another issue is poverty in the United States, a wealthy country. In California, workers in these jobs had the highest number of COVID-19 cases: Food and agriculture, transportation or logistics, facilities, and manufacturing. Was there added vulnerability due to a systemic injustice, the absence of protections that people in other jobs enjoy, the inability to stay home, a lack of precautions?

Upstream and Downstream Actions

A broader approach could lead to a solution that involves a broad policy change, even something like an international treaty, accord, or convention that could decrease the pressure on downstream solutions like more PPE or a quick way to make ventilators. Some of the manufacturing and distribution during the COVID-19 pandemic presented or solved ethical problems of scarce resources. Reorganizing on a national and international level could decrease personal vulnerability. Can both approaches be reconciled? A broad framework would best solve both the macro and the downstream issues.

A Healthy Population

Another issue during COVID-19 was preexisting health conditions. In bioethics, the social determinants of health take scientific data (proof that certain things that seem not to be medical or biological influence health significantly) and create a structure to analyze why a person or group is disproportionately harmed by sickness. The social determinants of health reflect research on justice and they reflect actions that at the societal and the workplace level could be beneficent. Moral philosophy underpinning the social determinants stems from early philosophers looking to define the role of government, some trying to expand it and others pushing back to ensure individual liberties. In COVID-19, at various levels (global, federal, state, local), government could have done more, but at what cost? Corporations have a role in ending the pandemic. But, there can be downsides. How should we approach the bioethical issues of the role of patents in vaccination? What is the moral value in maintaining  incentive to innovate? Does that moral value compare to an opportunity to have more countries manufacture vaccines, something that arguably arrangement among corporations achieves anyway.

Syndemics & Justice

A syndemics framework addresses those issues by beginning with a macro framework and working toward the policies at state and local levels that may govern individual behaviors. “A syndemics framework examines the health consequences of identifiable disease interactions and the social, environmental, or economic factors that promote such interaction and worsen disease.” https://www.thelancet.com/series/syndemics

To learn from COVID-19, many bioethical and philosophical frameworks can inform the disparate effects of the virus. The justice of equal access framework contributes to a syndemic approach. In the United States, vulnerability mirrored demographics like race, ethnicity, and income. Humanism and sociology frameworks like integrative theory melding micro and macro objective and subjective considerations add to a broad approach as well.

A syndemic framework with the no natural disasters movement in mind would inform evaluation of the pandemic as well as preparation for future events including storms, volcanos, pandemics, epidemics, and environmental disasters.

Resources

Bruce Jennings, The COVIDs of Our Climate, Minding Nature: Spring 2021, Volume 14, Number 1   (Points out similarities in COVID-19 and climate change as public commons, arguing the relationship between humanity and the natural world is broken. Optimistic that social goods are politically within reach. Argues for climate change adaptation and support for public health, reducing impact, and protecting vulnerable.)

Srajana Kaikini, The Necessity of Understanding Disasters in the Language of Suffering | Voices in Bioethics (columbia.edu)

Inês Fronteira, Mohsin Sidat, João Paulo Magalhães, et al., “The SARS-CoV-2 pandemic: A syndemic perspective,” One Health, Volume 12, June 2021, 100228 https://doi.org/10.1016/j.onehlt.2021.100228 (The failure to recognize that COVID-19 is syndemic in nature negatively affected public policy and public health.)

Merrill Singer, Nicola Bulled, Bayla Ostrach, Emily Mendenhall, Syndemics and the biosocial conception of health The Lancet, Volume 389, Issue 10072, 4–10 March 2017, Pages 941-950.

Emily Mendenhall, Brandon A Kohrt, Shane A Norris, David Ndetei, Dorairaj Prabhakaran, “Non-communicable disease syndemics: poverty, depression, and diabetes among low-income populations,” The Lancet, Volume 389, Issue 10072, 2017, Pages 951-963, https://doi.org/10.1016/S0140-6736(17)30402-6

Sarah S Willen, Michael Knipper, César E Abadía-Barrero, Nadav Davidovitch,
Syndemic vulnerability and the right to health, The Lancet, Volume 389, Issue 10072, 2017, Pages 964-977 https://doi.org/10.1016/S0140-6736(17)30261-1

https://www.nonaturaldisasters.com/useful-information provides further reading.

NoNaturalDisastersSlides

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