Welcome to the Nexus of Ethics, Psychology, Morality, Philosophy and Health Care

Welcome to the nexus of ethics, psychology, morality, technology, health care, and philosophy
Showing posts with label Informed Consent. Show all posts
Showing posts with label Informed Consent. Show all posts

Monday, October 15, 2018

ICP Ethics Code

Institute of Contemporary Psychoanalysis

Psychoanalysts strive to reduce suffering and promote self-understanding, while respecting human dignity. Above all, we take care to do no harm. Working in the uncertain realm of unconscious emotions and feelings, our exclusive focus must be on safeguarding and benefitting our patients as we try to help them understand their unconscious mental life. Our mandate requires us to err on the side of ethical caution. As clinicians who help people understand the meaning of their dreams and unconscious longings, we are aware of our power and sway. We acknowledge a special obligation to protect people from unintended harm resulting from our own human foibles.

In recognition of our professional mandate and our authority—and the private, subjective and influential nature of our work—we commit to upholding the highest ethical standards. These standards take the guesswork out of how best to create a safe container for psychoanalysis. These ethical principles inspire tolerant and respectful behaviors, which in turn facilitate the health and safety of our candidates, members and, most especially, our patients. Ultimately, ethical behavior protects us from ourselves, while preserving the integrity of our institute and profession.

Professional misconduct is not permitted, including, but not limited to dishonesty, discrimination and boundary violations. Members are asked to keep firmly in mind our core values of personal integrity, tolerance and respect for others. These values are critical to fulfilling our mission as practitioners and educators of psychoanalytic therapy. Prejudice is never tolerated whether on the basis of age, disability, ethnicity, gender, gender identity, race, religion, sexual orientation or social class. Institute decisions (candidate advancement, professional opportunities, etc.) are to be made exclusively on the basis of merit or seniority. Boundary violations, including, but not limited to sexual misconduct, undue influence, exploitation, harassment and the illegal breaking of confidentiality, are not permitted. Members are encouraged to seek consultation readily when grappling with any ethical or clinical concerns. Participatory democracy is a primary value of ICP. All members and candidates have the responsibility for knowing these guidelines, adhering to them and helping other members comply with them.

The ethics code is here.

Saturday, September 15, 2018

Social Science One And How Top Journals View The Ethics Of Facebook Data Research

Kalev Leetaru
Forbes.com
Originally posted on August 13, 2018

Here is an excerpt:

At the same time, Social Science One’s decision to leave all ethical questions TBD and to eliminate the right to informed consent or the ability to opt out of research fundamentally redefines what it means to conduct research in the digital era, normalizing the removal of these once sacred ethical tenets. Given the refusal of one of its committee members to provide replication data for his own study and the statement by another committee member that “I have articulated the argument that ToS are not, and should not be considered, ironclad rules binding the activities of academic researchers. … I don't think researchers should reasonably be expected to adhere to such conditions, especially at a time when officially sanctioned options for collecting social media data are disappearing left and right,” the result is an ethically murky landscape in which it is unclear just where Social Science One draws the line at what it will or will not permit.

Given Facebook’s new focus on “privacy first” I asked the company whether it would commit to offering its two billion users a new profile setting allowing them to opt out of having their data made available to academic researchers such as Social Science One. As it has repeatedly done in the past, the company declined to comment.

The info is here.

Wednesday, September 12, 2018

How Could Commercial Terms of Use and Privacy Policies Undermine Informed Consent in the Age of Mobile Health?

Cynthia E. Schairer, Caryn Kseniya Rubanovich, and Cinnamon S. Bloss
AMA J Ethics. 2018;20(9):E864-872.

Abstract

Granular personal data generated by mobile health (mHealth) technologies coupled with the complexity of mHealth systems creates risks to privacy that are difficult to foresee, understand, and communicate, especially for purposes of informed consent. Moreover, commercial terms of use, to which users are almost always required to agree, depart significantly from standards of informed consent. As data use scandals increasingly surface in the news, the field of mHealth must advocate for user-centered privacy and informed consent practices that motivate patients’ and research participants’ trust. We review the challenges and relevance of informed consent and discuss opportunities for creating new standards for user-centered informed consent processes in the age of mHealth.

The info is here.

Sunday, September 2, 2018

Negative effects in psychotherapy

Alexander Rozental, Louis Castonguay, Sona Dimidjian, and others
BJPsych Open (2018) 4, 307–312.

Background

Psychotherapy can alleviate mental distress and improve quality of life, but little is known about its potential negative effects and how to determine their frequency.

Aims

To present a commentary on the current understanding and future research directions of negative effects in psychotherapy.

Method

An anonymous survey was distributed to a select group of researchers, using an analytical framework known as strengths, weaknesses, opportunities and threats.

Results

The researchers perceive an increased awareness of negative effects in psychotherapy in recent years, but also discuss some of the unresolved issues in relation to their definition, assessment and reporting. Qualitative methods and naturalistic designs are regarded as important to pursue, although a number of obstacles to using such methods are identified.

Conclusion

Negative effects of psychotherapy are multifaceted, warranting careful considerations in order for them to be monitored and reported in research settings and routine care.

The info is here.

Friday, July 27, 2018

Informed Consent and the Role of the Treating Physician

Holly Fernandez Lynch, Steven Joffe, and Eric A. Feldman
Originally posted June 21, 2018
N Engl J Med 2018; 378:2433-2438
DOI: 10.1056/NEJMhle1800071

Here are a few excerpts:

In 2017, the Pennsylvania Supreme Court ruled that informed consent must be obtained directly by the treating physician. The authors discuss the potential implications of this ruling and argue that a team-based approach to consent is better for patients and physicians.

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Implications in Pennsylvania and Beyond

Shinal has already had a profound effect in Pennsylvania, where it represents a substantial departure from typical consent practice.  More than half the physicians who responded to a recent survey conducted by the Pennsylvania Medical Society (PAMED) reported a change in the informed-consent process in their work setting; of that group, the vast majority expressed discontent with the effect of the new approach on patient flow and the way patients are served.  Medical centers throughout the state have changed their consent policies, precluding nonphysicians from obtaining patient consent to the procedures specified in the MCARE Act and sometimes restricting the involvement of physician trainees.  Some Pennsylvania institutions have also applied the Shinal holding to research, in light of the reference in the MCARE Act to experimental products and uses, despite the clear policy of the Food and Drug Administration (FDA) allowing investigators to involve other staff in the consent process.

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Selected State Informed-Consent Laws.

Although the Shinal decision is not binding outside of Pennsylvania, cases bearing on critical ethical dimensions of consent have a history of influence beyond their own jurisdictions.

The information is here.

Wednesday, June 27, 2018

Experts outline ethics issues with use of genealogy DNA to solve crimes

Carolyn Crist
Business Insider
Originally published June 1, 2018

With recent revelations that U.S. law enforcement can - and already has - dipped into consumer genealogy DNA databases to help solve crimes, experts say more discussion of the ethical issues raised by this unintended use of personal information is needed.

It's unclear, for instance, whether online genealogy site users know their DNA is available to criminal investigators - and whether they'd object to it being used for that purpose, write the authors of an essay exploring the topic in the Annals of Internal Medicine.

"We're seeing a divide about this right now. On one hand, it's a powerful technology to solve cases, but it also raises questions for consumers," said lead author Benjamin Berkman, who heads the section on the ethics of genetics and new technologies at the National Institutes of Health's Department of Bioethics in Bethesda, Maryland.

"The idea that they upload their data for genealogy purposes and it's used in such a different way really surprises some people," he told Reuters Health in a telephone interview. "The terms of service agreements don't explain this clearly, and even if they did, people wouldn't read it or find it in the dense legalese."

The information is here.

Tuesday, May 8, 2018

Many People Taking Antidepressants Discover They Cannot Quit

Benedict Carey & Robert Gebeloff
The New York Times
Originally posted April 7, 2018

Here is an excerpt:

Dr. Peter Kramer, a psychiatrist and author of several books about antidepressants, said that while he generally works to wean patients with mild-to-moderate depression off medication, some report that they do better on it.

“There is a cultural question here, which is how much depression should people have to live with when we have these treatments that give so many a better quality of life,” Dr. Kramer said. “I don’t think that’s a question that should be decided in advance.”

Antidepressants are not harmless; they commonly cause emotional numbing, sexual problems like a lack of desire or erectile dysfunction and weight gain. Long-term users report in interviews a creeping unease that is hard to measure: Daily pill-popping leaves them doubting their own resilience, they say.

“We’ve come to a place, at least in the West, where it seems every other person is depressed and on medication,” said Edward Shorter, a historian of psychiatry at the University of Toronto. “You do have to wonder what that says about our culture.”

Patients who try to stop taking the drugs often say they cannot. In a recent survey of 250 long-term users of psychiatric drugs — most commonly antidepressants — about half who wound down their prescriptions rated the withdrawal as severe. Nearly half who tried to quit could not do so because of these symptoms.

In another study of 180 longtime antidepressant users, withdrawal symptoms were reported by more than 130. Almost half said they felt addicted to antidepressants.

The information is here.

Tuesday, May 1, 2018

'They stole my life away': women forcibly sterilised by Japan speak out

Daniel Hurst
The Guardian
Originally published April 3, 2018

Here is an excerpt:

Between 1948 and 1996, about 25,000 people were sterilised under the law, including 16,500 who did not consent to the procedure. The youngest known patients were just nine or 10 years old. About 70% of the cases involved women or girls.

Yasutaka Ichinokawa, a sociology professor at the University of Tokyo, says psychiatrists identified patients whom they thought needed sterilisation. Carers at nursing homes for people with intellectual disabilities also had sterilisation initiatives. Outside such institutions, the key people were local welfare officers known as Minsei-iin.

“All of them worked with goodwill, and they thought sterilisations were for the interests of the people for whom they cared, but today we must see this as a violation of the reproductive rights of people with disabilities,” Ichinokawa says.

After peaking at 1,362 cases in a single year in the mid-1950s, the figures began to decline in tandem with a shift in public attitudes.

In 1972, the government triggered protests by proposing an amendment to the Eugenic Protection Law to allow pregnant women with disabled foetuses to have induced abortions.

The information is here.

Tuesday, April 3, 2018

Cambridge Analytica: You Can Have My Money but Not My Vote

Emily Feng-Gu
Practical Ethics
Originally posted March 31, 2018

Here is an excerpt:

On one level, the Cambridge Analytica scandal concerns data protection, privacy, and informed consent. The data involved was not, as Facebook insisted, obtained via a ‘breach’ or a ‘leak’. User data was as safe as it had always been – which is to say, not very safe at all. At the time, the harvesting of data, including that of unconsenting Facebook friends, by third-party apps was routine policy for Facebook, provided it was used only for academic purposes. Cambridge researcher and creator of the third-party app in question, Aleksandr Kogan, violated the agreement only when the data was passed onto Cambridge Analytica. Facebook failed to protect its users’ data privacy, that much is clear.

But are risks like these transparent to users? There is a serious concern about informed consent in a digital age. Most people are unlikely to have the expertise necessary to fully understand what it means to use online and other digital services.  Consider Facebook: users sign up for an ostensibly free social media service. Facebook did not, however, accrue billions in revenue by offering a service for nothing in return; they profit from having access to large amounts of personal data. It is doubtful that the costs to personal and data privacy are made clear to users, some of which are children or adolescents. For most people, the concept of big data is likely to be nebulous at best. What does it matter if someone has access to which Pages we have Liked? What exactly does it mean for third-party apps to be given access to data? When signing up to Facebook, I hazard that few people imagined clicking ‘I agree’ could play a role in attempts to influence election outcomes. A jargon laden ‘terms and conditions’ segment is not enough to inform users regarding what precisely it is they are consenting to.

The blog post is here.

Thursday, February 1, 2018

Ethics for healthcare data is obsessed with risk – not public benefits

Tim Spector and Barbara Prainsack
The Conversation
Originally published January 5, 2018

Here is an excerpt:

Health researchers working with human participants – or their identifiable information – need to jump through lots of ethical and bureaucratic hoops. The underlying rationale is that health research poses particularly high risks to people, and that these risks need to be minimised. But does the same rationale apply to non-invasive research using digital health data? Setting aside physically invasive research, which absolutely should maintain the most stringent of safeguards, is data-based health research really riskier than other research that analyses people's information?

Many corporations can use data from their customers for a wide range of purposes without needing research ethics approval, because their users have already "agreed" to this (by ticking a box), or the activity itself isn't qualified as health research. But is the assumptions that it is less risky justified?

Facebook and Google hold voluminous and fine-grained datasets on people. They analyse pictures and text posted by users. But they also study behavioural information, such as whether or not users "like" something or support political causes. They do this to profile users and discern new patterns connecting previously unconnected traits and behaviours. These findings are used for marketing; but they also contribute to knowledge about human behaviour.

The information is here.

Friday, January 26, 2018

Should Potential Risk of Chronic Traumatic Encephalopathy Be Discussed with Young Athletes?

Kimberly Hornbeck, Kevin Walter, and Matthew Myrvik
AMA Journal of Ethics. July 2017, Volume 19, Number 7: 686-692.

Abstract

As participation in youth sports has risen over the past two decades, so has the incidence of youth sports injuries. A common topic of concern is concussion, or mild traumatic brain injury, in young athletes and whether concussions sustained at a young age could lead to lifelong impairment such as chronic traumatic encephalopathy (CTE). While the pathway from a concussed young athlete to an adult with CTE remains unknown, current research is attempting to provide more clarity. This article discusses how health care professionals can help foster an informed, balanced decision-making process regarding participation in contact sports that involves the parents as well as the children.

The information is here.

Monday, January 8, 2018

Nudging, informed consent and bullshit

William Simkulet
Journal of Medical Ethics Published Online 
First: 18 November 2017. doi: 10.1136/medethics-2017-104480

Abstract

Some philosophers have argued that during the process of obtaining informed consent, physicians should try to nudge their patients towards consenting to the option the physician believes best, where a nudge is any influence that is expected to predictably alter a person’s behaviour without (substantively) restricting her options. Some proponents of nudging even argue that it is a necessary and unavoidable part of securing informed consent. Here I argue that nudging is incompatible with obtaining informed consent. I assume informed consent requires that a physician tells her patient the truth about her options and argue that nudging is incompatible with truth-telling. Instead, nudging satisfies Harry Frankfurt’s account of bullshit.

The article is here.

Friday, January 5, 2018

Changing genetic privacy rules may adversely affect research participation

Hayley Peoples
Baylor College of Medicine Blogs
Originally posted May 26, 2017

Do you know your genetic information? Maybe you’ve taken a “23andMe” test because you were curious about your ancestry or health. Maybe it was part of a medical examination. Maybe, like me, you underwent testing and received results as part of a class in college.

Do you ever worry about what could happen if your information landed in the wrong hands?

If you do, you aren’t alone. We’ve previously written about legislation affecting genetic privacy and public resistance to global data sharing, and the dialog about growing genetic privacy concerns only continues.

Wired.com recently ran an interesting piece on the House Health Plan and its approach to pre-existing conditions. While much about how a final, Senate-approved Affordable Care Act repeal and replace plan will address pre-existing conditions is still speculation, it brings up an interesting question – with respect to genetic information, will changing rules about pre-existing conditions have a chilling effect on research participation?

The information is here.

Thursday, January 4, 2018

Non-disclosing preimplantation genetic diagnosis: Questions, challenges and needs for guidelines

Robert Klitzman
Fertility and Sterility
Originally published December 6, 2017

Consider This:

Non-disclosing Preimplantation Genetic Diagnosis (ND-PGD) is performed, but controversial, raising many questions.  It has been used when prospective parents at-risk for mutations highly associated with serious disease (especially Huntington’s disease [HD](1)), do not want to know their mutation-status, but wish to ensure that no mutation-containing embryos are transferred.  Physicians would then transfer only mutation-negative embryos, and not tell the patient whether any mutation-positive embryos were identified.  In 2002, Stern et al. described using ND-PGD successfully with 10 couples.1 

Pros and cons of non-disclosing PGD

Several advantages and disadvantages have been articulated.  Few individuals at-risk for HD want to learn their mutation-status.  Caused by an autosomal dominant mutation, the disease lacks treatment, and leads to debilitating neurological and psychiatric symptoms and death, generally in the 4th-5th decade of life.  Many at-risk individuals see a mutation-positive test result as a “death sentence,” and only 3%-21% of at-risk adults get tested (e.g. only 3-5% in Sweden).(2)

Though the patient may not be infertile, ND-PGD requires IVF, which has certain risks.  Yet many patients may see the procedure’s benefits as outweighing these dangers.  Misdiagnoses can also occur, but prenatal confirmatory tests can be performed.

The article is here.

Monday, December 25, 2017

First Baby Born To U.S. Uterus Transplant Patient Raises Ethics Questions

Greta Jochem
NPR.org
Originally published December 5, 2017

Here is an excerpt:

We mention that not everyone is celebrating this. It raises some ethical questions. Is it possible with a procedure that is so experimental, so risky, to get informed consent from women who desperately want to have a baby?

Dr. Testa: I doubt it is possible for lay people to have informed consent about anything we do in medicine, if you ask me. This is even more complicated because we are going into uncharted waters. ... I think that we go through years of studying to understand what we do, and to achieve mastering the things we do. And then we pretend that in ten minutes we can explain something to anybody. ... I don't think it's really possible.

... We try to use the simplest terms we can think about and then we leave it to the autonomy of the patients, in this case not even patients, these women, to make the decisions. I think we really refrain, and it was really important for us, from any pressure of any kind from our side but then of course, the inner pressure of this woman to have a child I think drove the entire process and their decision at the end.

The article is here.

Thursday, December 7, 2017

Attica: It’s Worse Than We Thought

Heather Ann Thompson
The New York Times
Originally posted November 19, 2017

Here is an excerpt:

As the fine print of that 1972 article read: “We are indebted to the inmates of the Attica Correctional Facility who participated in this study and to the warden and his administration for their help and cooperation.” This esteemed physician, a man working for two of New York’s most respected hospitals and receiving generous research funding from the N.I.H., was indeed conducting leprosy experiments at Attica.

But which of Attica’s nearly 2,400 prisoners, I wondered, was the subject of experiments relating to this crippling disease, without, as Dr. Brandriss admitted, adequate consent? Might it have been the 19-year-old who was at Attica because he had sliced the top of a neighbor’s convertible? Or a man imprisoned there for more serious offenses? Either way, no jury had sentenced them to being a guinea pig in any experiment relating to a disease as painful and disfiguring as leprosy.

And what about the hundreds of corrections officers and civilian employees working at Attica? Even if no one in this extremely crowded facility was actually exposed to this dreaded disease, one in which “prolonged close contact” with an infected patient is a most serious risk factor, were these state employees at all informed that medical experiments being conducted on the men in their charge?

This is not the first time prisons have allowed secret medical experiments on those locked inside. A 1998 book on Holmesburg Prison in Pennsylvania revealed that a doctor there, Albert Kligman, had been experimenting on prisoners for years. After the book appeared, nearly 300 former prisoners sued him, the University of Pennsylvania and the manufacturers of the substances to which they had been exposed, but none of the defendants was held accountable.

The article is here.

Wednesday, August 30, 2017

Vignette 36: The Cancellation Conundrum

Dr. Wendy Malik operates an independent practice in a suburban area.  She receives a referral from a physician, with whom she has a positive working relationship.  Dr. Malik contacts the patient, completes a phone screening, and sets up an appointment with Mr. Larry David.

As is her practice, Dr. Malik sends a confirmation email, attaching her version of informed consent.  She instructs Mr. David that he does not have to print it out, only review it and they would discuss any questions at the initial appointment.

Several days later, Dr. Malik checks her email.  In it, Mr. David sent her an email with an attachment.  Mr. David asks Dr. Malik to review his edits on the informed consent document.

While Dr. Malik notes some suggested corrections on the document, Mr. David modified the cancellation policy.  Dr. Malik’s form (and standard policy) is appointments cancelled with less than 24-hour notice will be charged to the patient.  Mr. David added a sentence that if Dr. Malik cancels an appointment with less than 24 hours, Mr. David expects Dr. Malik to pay him an amount equal to her hourly rate.

Flustered by this edit, Dr. Malik contacts you for a consultation.

What are the ethical issues involved in this case?

What are the pertinent clinical issues in this case?

How would you help Dr. Malik work through these issues?

Would you recommend Dr. Malik call to address the issue ahead of the appointment or wait for the initial session?

At this point, must Dr. Malik keep Mr. David as a patient?

If not, does Dr. Malik need to contact her referral source about the issue?

Tuesday, August 22, 2017

Informed-consent ruling may have “far-reaching, negative impact”

Andis Robeznieks
AMA Wire
Originally published August 8, 2017

Here are two excerpts:

A lawsuit alleging Dr. Toms had not obtained informed consent was initiated by Shinal and her husband on Dec. 17, 2009. The brief notes that Shinal “did not assert that the harm was the result of negligence” and that “there is no contention” that Dr. Toms’ staff provided inaccurate information during the informed consent process.

A jury found for Dr. Toms. Shinal appealed and the Pennsylvania Superior Court affirmed the decision. The case was heard before the Pennsylvania Supreme Court in November 2016. The case was decided June 20.

According to Wecht, a key issue is “whether the trial court misapplied the common law and the MCARE Act when it instructed the jury that it could consider information provided to Mrs. Shinal by Dr. Toms' ‘qualified staff’ in deciding whether Dr. Toms obtained Mrs. Shinal's informed consent to aggressive brain surgery.”

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PAMED General Counsel Angela Boateng also weighed in.

“It was not uncommon for other qualified staff to assist a physician in providing the requisite information or answering follow-up questions a patient may have had. The Medical Practice Act and other professional regulations permitted this level of assistance,” she commented. “The patient’s ability to follow up with the physician or his qualified staff was usually aimed at promoting a patient’s understanding of the treatment or procedure to be completed. The court’s decision, however, has put an end to this practice.”

The article is here.

Thursday, May 11, 2017

Is There a Duty to Use Moral Neurointerventions?

Michelle Ciurria
Topoi (2017).
doi:10.1007/s11245-017-9486-4

Abstract

Do we have a duty to use moral neurointerventions to correct deficits in our moral psychology? On their surface, these technologies appear to pose worrisome risks to valuable dimensions of the self, and these risks could conceivably weigh against any prima facie moral duty we have to use these technologies. Focquaert and Schermer (Neuroethics 8(2):139–151, 2015) argue that neurointerventions pose special risks to the self because they operate passively on the subject’s brain, without her active participation, unlike ‘active’ interventions. Some neurointerventions, however, appear to be relatively unproblematic, and some appear to preserve the agent’s sense of self precisely because they operate passively. In this paper, I propose three conditions that need to be met for a medical intervention to be considered low-risk, and I say that these conditions cut across the active/passive divide. A low-risk intervention must: (i) pass pre-clinical and clinical trials, (ii) fare well in post-clinical studies, and (iii) be subject to regulations protecting informed consent. If an intervention passes these tests, its risks do not provide strong countervailing reasons against our prima facie duty to undergo the intervention.

The article is here.

Thursday, April 13, 2017

Identity change and informed consent

Karsten Witt
Journal of Medical Ethics
Published Online First: 20 March 2017.
doi: 10.1136/medethics-2016-103684

Abstract

In this paper, I focus on a kind of medical intervention that is at the same time fascinating and disturbing: identity-changing interventions. My guiding question is how such interventions can be ethically justified within the bounds of contemporary bioethical mainstream that places great weight on the patient's informed consent. The answer that is standardly given today is that patients should be informed about the identity effects, thus suggesting that changes in identity can be treated like ‘normal’ side effects. In the paper, I argue that this approach is seriously lacking because it misses important complexities going along with decisions involving identity changes and consequently runs into mistakes. As a remedy I propose a new approach, the ‘perspective-sensitive account’, which avoids these mistakes and thus provides the conceptual resources to systematically reflect on and give a valid consent to identity-changing interventions.

The article is here.

Editor's note: While this article deals with medical interventions, such as Deep Brain Stimulation, the similar concerns might be generalized to psychotherapy and/or psychopharmacology.