Code of Ethics Can Guide Responsible Data Use

Katherine Noyes
The Wall Street Journal
Originally posted September 26, 2019

Here is an excerpt:

Associated with these exploding data volumes are plenty of practical challenges to overcome—storage, networking, and security, to name just a few—but far less straightforward are the serious ethical concerns. Data may promise untold opportunity to solve some of the largest problems facing humanity today, but it also has the potential to cause great harm due to human negligence, naivety, and deliberate malfeasance, Patil pointed out. From data breaches to accidents caused by self-driving vehicles to algorithms that incorporate racial biases, “we must expect to see the harm from data increase.”

Health care data may be particularly fraught with challenges. “MRIs and countless other data elements are all digitized, and that data is fragmented across thousands of databases with no easy way to bring it together,” Patil said. “That prevents patients’ access to data and research.” Meanwhile, even as clinical trials and numerous other sources continually supplement data volumes, women and minorities remain chronically underrepresented in many such studies. “We have to reboot and rebuild this whole system,” Patil said.

What the world of technology and data science needs is a code of ethics—a set of principles, akin to the Hippocratic Oath, that guides practitioners’ uses of data going forward, Patil suggested. “Data is a force multiplier that offers tremendous opportunity for change and transformation,” he explained, “but if we don’t do it right, the implications will be far worse than we can appreciate, in all sorts of ways.”

The info is here.

When Patients Request Unproven Treatments

Casey Humbyrd and Matthew Wynia
medscape.com
Originally posted March 25, 2019

Here is an excerpt:

Ethicists have made a variety of arguments about these injections. The primary arguments against them have focused on the perils of physicians becoming sellers of "snake oil," promising outlandish benefits and charging huge sums for treatments that might not work. The conflict of interest inherent in making money by providing an unproven therapy is a legitimate ethical concern. These treatments are very expensive and, as they are unproven, are rarely covered by insurance. As a result, some patients have turned to crowdfunding sites to pay for these questionable treatments.

But the profit motive may not be the most important ethical issue at stake. If it were removed, hypothetically, and physicians provided the injections at cost, would that make this practice more acceptable?

No. We believe that physicians who offer these injections are skipping the most important step in the ethical adoption of any new treatment modality: research that clarifies the benefits and risks. The costs of omitting that important step are much more than just monetary.

For the sake of argument, let's assume that stem cells are tremendously successful and that they heal arthritic joints, making them as good as new. By selling these injections to those who can pay before the treatment is backed by research, physicians are ensuring unavailability to patients who can't pay, because insurance won't cover unproven treatments.

The info is here.

It’s Our ‘Moral Responsibility’ to Give The FBI Access to Your DNA

Jennings Brown
www.gizmodo.com
Originally published April 3, 2019

A popular DNA-testing company seems to be targeting true crime fans with a new pitch to let them share their genetic information with law enforcement so cops can catch violent criminals.

Two months ago, FamilyTreeDNA raised privacy concerns after BuzzFeed revealed the company had partnered with the FBI and given the agency access to the genealogy database. Law enforcement’s use of DNA databases has been widely known since last April when California officials revealed genealogy website information was instrumental in determining the identity of the Golden State Killer. But in that case, detectives used publicly shared raw genetic data on GEDmatch. The recent news about FamilyTreeDNA marked the first known time a home DNA test company had willingly shared private genetic information with law enforcement.

Several weeks later, FamilyTreeDNA changed their rules to allow customers to block the FBI from accessing their information. “Users now have the ability to opt out of matching with DNA relatives whose accounts are flagged as being created to identify the remains of a deceased individual or a perpetrator of a homicide or sexual assault,” the company said in a statement at the time.

But now the company seems to be embracing this partnership with law enforcement with their new campaign called, “Families Want Answers.”

The info is here.

Ethical Considerations Regarding Internet Searches for Patient Information.

Charles C. Dike, Philip Candilis, Barbara Kocsis  and others
Psychiatric Services
Published Online:17 Jan 2019

Abstract

In 2010, the American Medical Association developed policies regarding professionalism in the use of social media, but it did not present specific ethical guidelines on targeted Internet searches for information about a patient or the patient’s family members. The American Psychiatric Association (APA) provided some guidance in 2016 through the Opinions of the Ethics Committee, but published opinions are limited. On behalf of the APA Ethics Committee, the authors developed a resource document describing ethical considerations regarding Internet and social media searches for patient information, from which this article has been adapted. Recommendations include the following. Except in emergencies, it is advisable to obtain a patient’s informed consent before performing such a search. The psychiatrist should be aware of his or her motivations for performing a search and should avoid doing so unless it serves the patient’s best interests. Information obtained through such searches should be handled with sensitivity regarding the patient’s privacy. The psychiatrist should consider how the search might influence the clinician-patient relationship. When interpreted with caution, Internet- and social media–based information may be appropriate to consider in forensic evaluations.

The info is here.

Nova Scotia to become 1st in North America with presumed consent for organ donation

Michael Gorman
www.cbc.com
Originally posted April 2, 2019

Here is an excerpt:

Premier Stephen McNeil said the bill fills a need within the province, noting Nova Scotia has some of the highest per capita rates of willing donors in the country.

"That doesn't always translate into the actual act of giving," he said.

"We know that there are many ways that we can continue to improve the system that we have."

McNeil pledged to put the necessary services in place to allow the province's donor program to live up to the promise of the legislation.

"We know that in many parts of our province — including the one I live in, which is a rural part of Nova Scotia — we have work to do," he said.

"I will make sure that the work that is required to build the system and supports around this will happen."

The bill will not be proclaimed right away.

Health Minister Randy Delorey said government officials would spend 12-18 months educating the public about the change and working on getting health-care workers the support they need to enhance the program.

Even with the change, Delorey said, people should continue making their wishes known to loved ones, so there can be no question about intentions.

The info is here.

Call for retraction of 400 scientific papers amid fears organs came from Chinese prisoners

Melissa Davey
The Guardian
Originally published February 5, 2019

A world-first study has called for the mass retraction of more than 400 scientific papers on organ transplantation, amid fears the organs were obtained unethically from Chinese prisoners.

The Australian-led study exposes a mass failure of English language medical journals to comply with international ethical standards in place to ensure organ donors provide consent for transplantation.

The study was published on Wednesday in the medical journal BMJ Open. Its author, the professor of clinical ethics Wendy Rogers, said journals, researchers and clinicians who used the research were complicit in “barbaric” methods of organ procurement.

“There’s no real pressure from research leaders on China to be more transparent,” Rogers, from Macquarie University in Sydney, said. “Everyone seems to say, ‘It’s not our job’. The world’s silence on this barbaric issue must stop.”

A report published in 2016 found a large discrepancy between official transplant figures from the Chinese government and the number of transplants reported by hospitals. While the government says 10,000 transplants occur each year, hospital data shows between 60,000 to 100,000 organs are transplanted each year. The report provides evidence that this gap is being made up by executed prisoners of conscience.

The info is here.

‘Three Identical Strangers’: The high cost of experimentation without ethics

Barron H. Lerner
The Washington Post
Originally published January 27, 2019

Here is an excerpt:

Injunctions against unethical research go back at least to the mid-19th century, when the French scientist Claude Bernard admonished his fellow investigators never to do an experiment that might harm a single person, even if the result would be highly advantageous to science and the health of others. Yet despite Bernard’s admonition, the next century was replete with experiments that put orphans, prisoners, minorities and other vulnerable populations at risk for the sake of scientific discovery. Medical progress often came at too high a human cost, something the CNN documentary exposes.

Human experimentation surged during World War II as American scientists raced to find treatments for diseases encountered on the battlefield. This experimental enthusiasm continued into the Cold War years, as the United States competed with the Soviet Union for scientific knowledge. In both eras, a utilitarian mind-set trumped concerns about research subjects.

That the experiments continued after the war was especially ironic given the response to the atrocities committed by Nazi physicians in concentration camps. There, doctors performed horrific experiments designed to help German soldiers who faced extreme conditions on the battlefield. This research included deliberately freezing inmates, forcing them to ingest only seawater and amputating their limbs.

The info is here.

Choices

Christy Shake
Calvin's Story Blog
Originally published February 13, 2019

Here is an excerpt:

If Michael and I had known early on of Calvin's malformed brain, and had we known the dreadful extent to which it might impact his well-being and quality of life, his development, cognition, coordination, communication, vision, ability to move about and function independently, and his increased odds of having unstoppable seizures, or of being abused by caregivers, would we have chosen to terminate my pregnancy? I really can't say. But one thing I do know with certainty: it is torturous to see Calvin suffer on a daily basis, to see him seize repeatedly, sometimes for several consecutive days, bite his cheek so bad it bleeds, see terror in his eyes and malaise on his face, be a veritable guinea pig for neurologists and me, endure the miseries of antiepileptic drugs and their heinous side effects, to see him hurt so needlessly.

Especially during rough stints, it's hard not to imagine how life might have been—perhaps easier, calmer, happier, less restricted, less anxious, less heartbreaking—if Calvin had never come into this world. One moment I lament his existence and the next I wonder what I would do without him. And though Calvin brings me immense joy at times, and though he is as precious to me as any mother's child could be, our lives have been profoundly strained by his existence. All three of us suffer, but none more than our sweet Calvin. Life with him, worrying about and watching him endure his maladies—despite, or perhaps owing to, the fact I love him immeasurably—is such a painful and burdensome endeavor that at times I regret ever deciding to have a child.

The blog post is here.

Even psychological placebos have an effect

University of Basel Press Release
Published February 5, 2019

Psychotherapy and placebos are both psychological interventions that not only have comparable effects, but that are also based on very similar mechanisms. Both forms of treatment are heavily influenced by the relationship between patients and those treating them, as well as by the expectations of recovery. Whereas placebo research mostly focuses on a biomedical model – an inert pill is provided with a medical rationale, which produces a corresponding effect – little is known about the effect of placebos provided with a psychological rationale.

“Green is calming”

Placebos can also have effects when specific psychological effects are attributed to them. This is the conclusion that researchers from the Division of Clinical Psychology and Psychotherapy at the University of Basel reached in three independent experiments with 421 healthy participants. The accompanying explanation – the narrative – played a key role when dispensing the placebos, as did the relationship between the researchers and the participants.

The researchers used the color green as the placebo in the video experiments, examining it both with and without a psychological narrative (“green is calming because it activates early conditioned emotional schemata”), as well as in the context of a neutral or a friendly relationship.

After viewing the videos, the participants assessed their subjective condition with questionnaires over several days. The results showed that the placebo had a positive effect on the participants’ well-being when it was prescribed together with a psychological narrative and in the context of a friendly relationship. The observed effect was strongest after administering the placebo but remained evident for up to one week.

Ethical implications

“The observed effects were comparable with those of psychotherapeutic interventions in the same populations,” says principal investigator Professor Jens Gaab. The fact that psychological placebos can have significant effects is not only important for understanding psychological interventions: “It challenges both research and clinical practice to address these mechanisms and effects, as well as their ethical implications.”

The pressor is here

What “informed consent” really means

Stacy Weiner
www.aamcnews.org
Originally published January 19, 2019

Here is an excerpt:

Conflicts around consent

The informed consent process is not without its thornier aspects. At times, malpractice suits shift the landscape. For example, in a 2017 Pennsylvania case with possible implications in other states, the court ruled that the physician performing a procedure — not a delegate — must personally ensure that the patient understands the risks involved.

And sometimes, informed consent grabs headlines, as happened recently with allegations that medical students are performing pelvic exams on anesthetized women without consent.

That claim, Orlowski notes, relied on studies from more than 10 years ago, before such changes as more detailed consent forms. Typically, she says, students practice pelvic exams with special mannequins and standardized patients who are specifically trained for this purpose. When students and residents do perform pelvic exams on surgical patients, Orlowski adds, specific consent must be obtained first. “Performing pelvic examinations under anesthesia without patients’ consent is unethical and unacceptable,” she says.

In fact, the American College of Obstetricians and Gynecologists states that “pelvic examinations on an anesthetized woman … performed solely for teaching purposes should be performed only with her specific informed consent obtained before her surgery.”

Marie Walters, a student at Wright State University Boonshoft School of Medicine, says she was perplexed by the allegations, so she checked with fellow students at her school and elsewhere. Her explanation: medical students may not know that patients agreed to such exams. “Although students witness some consent processes, we’re likely not around when patients give consent for the surgeries we observe,” says Walters, who is a member of the AAMC Board of Directors. "We may be there just for the day of the surgery,” she notes.

The info is here.

CRISPR in China: Why Did the Parents Give Consent?

Dena Davis
The Hastings Center
Originally posted December 7, 2018

The global scientific community has been unanimous in condemning Chinese scientist He Jiankui, who announced last week that he used the gene-editing technology called CRISPR to make permanent, heritable changes to the genes of two baby girls who were born this month in China. Criticism has focused on Dr. He’s violation of worldwide acknowledgement that CRISPR has not been proven to be safe and ready to use in humans. Because CRISPR edits the actual germline, there are safety implications not only for these two girls, but for their progeny. There is also fear, expressed by the American Society for Reproductive Medicine, that this one renegade scientist could spark a backlash that would result in overly restrictive regulation.

Largely missing from the discussion is whether the twins’ parents understood what was happening and the unproven nature of the technology.  Was the informed consent process adequate, and if so, why on earth would they have given their consent?

The info is here.

Is It Ethical to Use Prognostic Estimates from Machine Learning to Treat Psychosis?

Nicole Martinez-Martin, Laura B. Dunn, and Laura Weiss Roberts
AMA J Ethics. 2018;20(9):E804-811.
doi: 10.1001/amajethics.2018.804.

Abstract

Machine learning is a method for predicting clinically relevant variables, such as opportunities for early intervention, potential treatment response, prognosis, and health outcomes. This commentary examines the following ethical questions about machine learning in a case of a patient with new onset psychosis: (1) When is clinical innovation ethically acceptable? (2) How should clinicians communicate with patients about the ethical issues raised by a machine learning predictive model?

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Conclusion

In order to implement the predictive tool in an ethical manner, Dr K will need to carefully consider how to give appropriate information—in an understandable manner—to patients and families regarding use of the predictive model. In order to maximize benefits from the predictive model and minimize risks, Dr K and the institution as a whole will need to formulate ethically appropriate procedures and protocols surrounding the instrument. For example, implementation of the predictive tool should consider the ability of a physician to override the predictive model in support of ethically or clinically important variables or values, such as beneficence. Such measures could help realize the clinical application potential of machine learning tools, such as this psychosis prediction model, to improve the lives of patients.

Document ‘informed refusal’ just as you would informed consent

James Scibilia
AAP News
Originally posted October 20, 2018

Here is an excerpt:

The requirements of informed refusal are the same as informed consent. Providers must explain:

• the proposed treatment or testing;
• the risks and benefits of refusal;
• anticipated outcome with and without treatment; and
• alternative therapies, if available.

Documentation of this discussion, including all four components, in the medical record is critical to mounting a successful defense from a claim that you failed to warn about the consequences of refusing care.

Since state laws vary, it is good practice to check with your malpractice carrier about preferred risk management documentation. Generally, the facts of these discussions should be included and signed by the caretaker. This conversation and documentation should not be delegated to other members of the health care team. At least one state has affirmed through a Supreme Court decision that informed consent must be obtained by the provider performing the procedure and not another team member; it is likely the concept of informed refusal would bear the same requirements.

The info is here.

Re-thinking Data Protection Law in the Age of Big Data and AI

Sandra Wachter and Brent Mittelstadt
Oxford Internet Institute
Originally posted October 11,2 018

Numerous applications of ‘Big Data analytics’ drawing potentially troubling inferences about individuals and groups have emerged in recent years.  Major internet platforms are behind many of the highest profile examples: Facebook may be able to infer protected attributes such as sexual orientation, race, as well as political opinions and imminent suicide attempts, while third parties have used Facebook data to decide on the eligibility for loans and infer political stances on abortion. Susceptibility to depression can similarly be inferred via usage data from Facebook and Twitter. Google has attempted to predict flu outbreaks as well as other diseases and their outcomes. Microsoft can likewise predict Parkinson’s disease and Alzheimer’s disease from search engine interactions. Other recent invasive applications include prediction of pregnancy by Target, assessment of users’ satisfaction based on mouse tracking, and China’s far reaching Social Credit Scoring system.

Inferences in the form of assumptions or predictions about future behaviour are often privacy-invasive, sometimes counterintuitive and, in any case, cannot be verified at the time of decision-making. While we are often unable to predict, understand or refute these inferences, they nonetheless impact on our private lives, identity, reputation, and self-determination.

These facts suggest that the greatest risks of Big Data analytics do not stem solely from how input data (name, age, email address) is used. Rather, it is the inferences that are drawn about us from the collected data, which determine how we, as data subjects, are being viewed and evaluated by third parties, that pose the greatest risk. It follows that protections designed to provide oversight and control over how data is collected and processed are not enough; rather, individuals require meaningful protection against not only the inputs, but the outputs of data processing.

Unfortunately, European data protection law and jurisprudence currently fails in this regard.

The info is here.

Even The Data Ethics Initiatives Don't Want To Talk About Data Ethics

Kalev Leetaru
Forbes.com
Originally posted October 23, 2018

Two weeks ago, a new data ethics initiative, the Responsible Computer Science Challenge, caught my eye. Funded by the Omidyar Network, Mozilla, Schmidt Futures and Craig Newmark Philanthropies, the initiative will award up to $3.5M to “promising approaches to embedding ethics into undergraduate computer science education, empowering graduating engineers to drive a culture shift in the tech industry and build a healthier internet.” I was immediately excited about a well-funded initiative focused on seeding data ethics into computer science curricula, getting students talking about ethics from the earliest stages of their careers. At the same time, I was concerned about whether even such a high-profile effort could possibly reverse the tide of anti-data-ethics that has taken root in academia and what impact it could realistically have in a world in which universities, publishers, funding agencies and employers have largely distanced themselves from once-sacrosanct data ethics principles like informed consent and the right to opt out. Surprisingly, for an initiative focused on evangelizing ethics, the Challenge declined to answer any of the questions I posed it regarding how it saw its efforts as changing this. Is there any hope left for data ethics when the very initiatives designed to help teach ethics don’t want to talk about ethics?

On its surface, the Responsible Computer Science Challenge seems a tailor-built response to a public rapidly awakening to the incredible damage unaccountable platforms have wreaked upon society. The Challenge describes its focus as “supporting the conceptualization, development, and piloting of curricula that integrate ethics with undergraduate computer science training, educating a new wave of engineers who bring holistic thinking to the design of technology products.”

The info is here.

Nine risk management lessons for practitioners.

Taube, Daniel O.,Scroppo, Joe,Zelechoski, Amanda D.
Practice Innovations, Oct 04 , 2018

Abstract

Risk management is an essential skill for professionals and is important throughout the course of their careers. Effective risk management blends a utilitarian focus on the potential costs and benefits of particular courses of action, with a solid foundation in ethical principles. Awareness of particularly risk-laden circumstances and practical strategies can promote safer and more effective practice. This article reviews nine situations and their associated lessons, illustrated by case examples. These situations emerged from our experience as risk management consultants who have listened to and assisted many practitioners in addressing the challenges they face on a day-to-day basis. The lessons include a focus on obtaining consent, setting boundaries, flexibility, attention to clinician affect, differentiating the clinician’s own values and needs from those of the client, awareness of the limits of competence, maintaining adequate legal knowledge, keeping good records, and routine consultation. We highlight issues and approaches to consider in these types of cases that minimize risks of adverse outcomes and enhance good practice.

The info is here.

Here is a portion of the article:

Being aware of basic legal parameters can help clinicians to avoid making errors in this complex arena. Yet clinicians are not usually lawyers and tend to have only limited legal knowledge. This gives rise to a risk of assuming more mastery than one may have.

Indeed, research suggests that a range of professionals, including psychotherapists, overestimate their capabilities and competencies, even in areas in which they have received substantial training (Creed, Wolk, Feinberg, Evans, & Beck, 2016; Lipsett, Harris, & Downing, 2011; Mathieson, Barnfield, & Beaumont, 2009; Walfish, McAlister, O’Donnell, & Lambert, 2012).

Do We Need To Teach Ethics And Empathy To Data Scientists?

Kalev Leetaru

Forbes.com

Originally posted October 8, 2018

Here is an excerpt:

One of the most frightening aspects of the modern web is the speed at which it has struck down decades of legislation and professional norms regarding personal privacy and the ethics of turning ordinary citizens into laboratory rats to be experimented on against their wills. In the space of just two decades the online world has weaponized personalization and data brokering, stripped away the last vestiges of privacy, centralized control over the world’s information and communications channels, changed the public’s understanding of the right over their digital selves and profoundly reshaped how the scholarly world views research ethics, informed consent and the right to opt out of being turned into a digital guinea pig.

It is the latter which in many ways has driven each of the former changes. Academia’s changing views towards IRB and ethical review has produced a new generation of programmers and data scientists who view research ethics as merely an outdated obsolete historical relic that was an obnoxious barrier preventing them from doing as they pleased to an unsuspecting public.

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Ironically, however, when asked whether she would consent to someone mass harvesting all of her own personal information from all of the sites she has willingly signed up for over the years, the answer was a resounding no. When asked how she reconciled the difference between her view that users of platforms willingly relinquish their right to privacy, while her own data should be strictly protected, she was unable to articulate a reason other than that those who create and study the platforms are members of the “societal elite” who must be granted an absolute right to privacy, while “ordinary” people can be mined and manipulated at will. Such an empathy gap is common in the technical world, in which people’s lives are dehumanized into spreadsheets of numbers that remove any trace of connection or empathy.

The info is here.

Japan Set to Allow Gene Editing in Human Embryos

David Cyranoski
Scientific American
Originally posted on October 3, 2018

Japan has issued draft guidelines that allow the use of gene-editing tools in human embryos. The proposal was released by an expert panel representing the country’s health and science ministries on 28 September.

Although the country regulates the use of human embryos for research, there have been no specific guidelines on using tools such as CRISPR–Cas9 to make precise modifications in their DNA until now.

Tetsuya Ishii, a bioethicist at Hokkaido University in Sapporo, says that before the draft guidelines were issued, Japan’s position on gene editing in human embryos was neutral. The proposal now encourages this kind of research, he says.

But if adopted, the guidelines would restrict the manipulation of human embryos for reproduction, although this would not be legally binding.

Manipulating DNA in embryos could reveal insights into early human development. Researchers also hope that in the long term, these tools could be used to fix genetic mutations that cause diseases, before they are passed on.

The info is here.

Bolton says 'excessive' ethics checks discourage outsiders from joining government

Nicole Gaouette
CNN.com
Originally posted October 31, 2018

A day after CNN reported that the Justice Department is investigating whether Interior Secretary Ryan Zinke has broken the law by using his office to personally enrich himself, national security adviser John Bolton told the Hamilton Society in Washington that ethics rules make it hard for people outside of the government to serve.

Bolton said "things have gotten more bureaucratic, harder to get things done" since he served under President George H.W. Bush in the 1990s and blamed the difficulty, in part, on the "excessive nature of the so-called ethics checks."

"If you were designing a system to discourage people from coming into government, you would do it this way," Bolton said.

"That risks building up a priestly class" of government employees, he added.

"It's really depressing to see," Bolton said of the bureaucratic red tape.

The info is here.

My take: Mr. Bolton is wrong.  We need rigorous ethical guidelines, transparency, enforceability, and thorough background checks.  Otherwise, the swamp will grow much greater than it already is.

The dismantling of informed consent is a disaster

David Penner
KevinMD.com
Originally posted September 26, 2018

Informed consent is the cornerstone of medical ethics. And every physician must defend this sacred principle from every form of evil that would seek to dismantle, degrade and debase it. If informed consent is the sun, then privacy, confidentiality, dignity, and trust are planets that go around it. For without informed consent, the descent of health care into amorality is inevitable, and the doctor-patient relationship is doomed to ruination, oblivion, and despair. It is also important to acknowledge the fact that a lack of informed consent has become endemic to our health care system.

This betrayal of patient trust is inextricably linked to three violations: a rape of the body, a rape of the mind and a rape of the soul. The rape of the mind is anchored in a willful nondisclosure of common long-term side effects associated with powerful drugs, such as opioids and certain types of chemotherapy. When a patient starts a chemotherapy regimen, they are typically briefed by a nurse, who proceeds to educate them regarding common short-term side effects such as mouth sores, constipation, and nausea, while failing to mention any of the typical long-term side effects, such as cognitive difficulties and early menopause. It is the long-term side effects that underscore the tragedy of having to resort to chemotherapy, as they can have a devastating impact on a patient’s quality of life, even long after remission has been attained.

The info is here.