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 Disclosure. Show all posts
Showing posts with label Disclosure. Show all posts

Tuesday, April 26, 2022

Ethical considerations for psychotherapists participating in Alcoholics Anonymous

Kohen, Casey B.,Conlin, William E.
Practice Innovations, Vol 7(1), Mar 2022, 40-52.

Abstract

Because the demands of professional psychology can be taxing, psychotherapists are not immune to the development of mental health and substance use disorders. One estimate indicates that roughly 30% to 40% of psychologists know of a colleague with a current substance abuse problem (Good et al., 1995). Twelve-step mutual self-help groups, particularly Alcoholics Anonymous (AA), are the most widely used form of treatment for addiction in the United States. AA has empirically demonstrated effectiveness at fostering long-term treatment success and is widely accessible throughout the world. However, psychotherapist participation in AA raises a number of ethical concerns, particularly regarding the potential for extratherapy contact with clients and the development of multiple relationships. This article attempts to review the precarious ethical and practical situations that psychotherapists, either in long-term recovery or newly sober, may find themselves in during AA involvement. Moreover, this article provides suggestions for psychotherapists in AA regarding how to best adhere to both the principles of AA (i.e., the 12 steps and 12 traditions) and the American Psychological Association’s Ethical Principles of Psychologists and Code of Conduct

Here is an excerpt:

Recent literature regarding the use of AA or other mutual self-help groups by psychotherapists is scant, but earlier studies suggest its effectiveness. A 1986 survey of 108 members of Psychologists Helping Psychologists (a seemingly defunct support group exclusively for substance dependent doctoral-level psychologists and students) shows that of the 94% of respondents maintaining abstinence, 86% attended AA (Thoreson et al., 1986). A separate study of 70 psychologists in recovery who were members of AA revealed the majority attained sobriety outside of formal treatment or intervention programs (Skorina et al., 1990). 

Because AA appears to be a vital resource for psychotherapists struggling with substance misuse, it is important to consider how to address ethical dilemmas that one might encounter while participating in AA.

Conclusion

Psychotherapists participating in AA may, at times, find that their professional responsibility of adhering to the APA Code of Ethics hinders some aspects of their categorical involvement in AA as defined by AA’s 12 steps and 12 traditions. The psychotherapist in AA may need to adjust their personal AA “program” in comparison with the typical AA member in a manner that attempts to meet the requirements of the profession yet still provides them with enough support to maintain their professional competence. This article discusses reasonable compromises, specifically tailored to the length of the psychotherapist’s sobriety, that minimize the potential for client harm. Ultimately, if the psychotherapist is unable to find an appropriate middle-ground, where the personal needs of recovery can be met without damaging client welfare and respecting the client’s rights, the psychotherapist should refer the client elsewhere. With these recommendations, psychotherapists should feel more comfortable participating in AA (or other mutual self-help groups) while also adhering to the ethical principles of our profession.

Saturday, April 16, 2022

Morality, punishment, and revealing other people’s secrets.

Salerno, J. M., & Slepian, M. L. (2022).
Journal of Personality & Social Psychology, 
122(4), 606–633. 
https://doi.org/10.1037/pspa0000284

Abstract

Nine studies represent the first investigation into when and why people reveal other people’s secrets. Although people keep their own immoral secrets to avoid being punished, we propose that people will be motivated to reveal others’ secrets to punish them for immoral acts. Experimental and correlational methods converge on the finding that people are more likely to reveal secrets that violate their own moral values. Participants were more willing to reveal immoral secrets as a form of punishment, and this was explained by feelings of moral outrage. Using hypothetical scenarios (Studies 1, 3–6), two controversial events in the news (hackers leaking citizens’ private information; Study 2a–2b), and participants’ behavioral choices to keep or reveal thousands of diverse secrets that they learned in their everyday lives (Studies 7–8), we present the first glimpse into when, how often, and one explanation for why people reveal others’ secrets. We found that theories of self-disclosure do not generalize to others’ secrets: Across diverse methodologies, including real decisions to reveal others’ secrets in everyday life, people reveal others’ secrets as punishment in response to moral outrage elicited from others’ secrets.

From the Discussion

Our data serve as a warning flag: one should be aware of a potential confidant’s views with regard to the morality of the behavior. Across 14 studies (Studies 1–8; Supplemental Studies S1–S5), we found that people are more likely to reveal other people’s secrets to the degree that they, personally, view the secret act as immoral. Emotional reactions to the immoral secrets explained this effect, such as moral outrage as well as anger and disgust, which were associated correlationally and experimentally with revealing the secret as a form of punishment. People were significantly more likely to reveal the same secret if the behavior was done intentionally (vs. unintentionally), if it had gone unpunished (vs. already punished by someone else), and in the context of a moral framing (vs. no moral framing). These experiments suggest a causal role for both the degree to which the secret behavior is immoral and the participants’ desire to see the behavior punished.  Additionally, we found that this psychological process did not generalize to non-secret information. Although people were more likely to reveal both secret and non-secret information when they perceived it to be more immoral, they did so for different reasons: as an appropriate punishment for the immoral secrets, and as interesting fodder for gossip for the immoral non-secrets.

Monday, October 25, 2021

Federal Reserve tightens ethics rules to ban active trading by senior officials

Brian Cheung
Yahoo Business News
Originally posted 21 OCT 21

The Federal Reserve on Thursday said it will tighten its ethics rules concerning personal finances among its most senior officials, the latest development in a trading scandal that has led to the resignation of two policymakers.

The central bank said it has introduced a “broad set of new rules” that restricts any active trading and prohibits the purchase of any individual securities (i.e. stocks, bonds, or derivatives). The new restrictions effectively only allow purchases of diversified investment vehicles like mutual funds.

If policymakers want to make any purchases or sales, they will be required to provide 45 days of advance notice and obtain prior approval for any purchases and sales. Those officials will also be required to hold onto those investments for at least one year, with no purchases or sales allowed during periods of “heightened financial market stress.”

Fed officials are still working on the details of what would define that level of stress, but said the market conditions of spring 2020 would have qualified.

The new rules will also increase the frequency of public disclosures from the reserve bank presidents, requiring monthly filings instead of the status quo of annual filings. Those at the Federal Reserve Board in Washington already were required to make monthly disclosures.

The restrictions apply to policymakers and senior staff at the Fed’s headquarters in Washington, as well as its 12 Federal Reserve Bank regional outposts. The new rules will be implemented “over the coming months.”

Fed officials said changes will likely require divestments from any existing holdings that do not meet the updated standards.

Saturday, September 12, 2020

Psychotherapy, placebos, and informed consent

Leder G
Journal of Medical Ethics 
Published Online First: 20 August 2020.
doi: 10.1136/medethics-2020-106453

Abstract

Several authors have recently argued that psychotherapy, as it is commonly practiced, is deceptive and undermines patients’ ability to give informed consent to treatment. This ‘deception’ claim is based on the findings that some, and possibly most, of the ameliorative effects in psychotherapeutic interventions are mediated by therapeutic common factors shared by successful treatments (eg, expectancy effects and therapist effects), rather than because of theory-specific techniques. These findings have led to claims that psychotherapy is, at least partly, likely a placebo, and that practitioners of psychotherapy have a duty to ‘go open’ to patients about the role of common factors in therapy (even if this risks negatively affecting the efficacy of treatment); to not ‘go open’ is supposed to unjustly restrict patients’ autonomy. This paper makes two related arguments against the ‘go open’ claim. (1) While therapies ought to provide patients with sufficient information to make informed treatment decisions, informed consent does not require that practitioners ‘go open’ about therapeutic common factors in psychotherapy, and (2) clarity about the mechanisms of change in psychotherapy shows us that the common-factors findings are consistent with, rather than undermining of, the truth of many theory-specific forms of psychotherapy; psychotherapy, as it is commonly practiced, is not deceptive and is not a placebo. The call to ‘go open’ should be resisted and may have serious detrimental effects on patients via the dissemination of a false view about how therapy works.

Conclusion

The ‘go open’ argument is based on a mistaken view about the mechanisms of change in psychotherapy and threatens to harm patients by undermining their ability to make informed treatment decisions. This paper has argued that the prima facie ethical problem raised by the ‘go open’ argument is diffused if we clear up a conceptual confusion about what, exactly, we should be
going open about. Therapists should be open with patients about the differing theories of the mechanisms of change in psychotherapy; this can, but need not involve discussing information
about the therapeutic common factors.

The article is here.

Note from Dr. Gavazzi: Using "deception" is the wrong frame for this issue.  How complete is your informed consent?  Can we ever give "perfect" informed consent?  The answer is likely no.

Wednesday, September 11, 2019

Assessment of Patient Nondisclosures to Clinicians of Experiencing Imminent Threats

Levy AG, Scherer AM, Zikmund-Fisher BJ, Larkin K, Barnes GD, Fagerlin A.
JAMA Netw Open. Published online August 14, 20192(8):e199277.
doi:10.1001/jamanetworkopen.2019.9277

Question 

How common is it for patients to withhold information from clinicians about imminent threats that they face (depression, suicidality, abuse, or sexual assault), and what are common reasons for nondisclosure?

Findings 

This survey study, incorporating 2 national, nonprobability, online surveys of a total of 4,510 US adults, found that at least one-quarter of participants who experienced each imminent threat reported withholding this information from their clinician. The most commonly endorsed reasons for nondisclosure included potential embarrassment, being judged, or difficult follow-up behavior.

Meaning

These findings suggest that concerns about potential negative repercussions may lead many patients who experience imminent threats to avoid disclosing this information to their clinician.

Conclusion

This study reveals an important concern about clinician-patient communication: if patients commonly withhold information from clinicians about significant threats that they face, then clinicians are unable to identify and attempt to mitigate these threats. Thus, these results highlight the continued need to develop effective interventions that improve the trust and communication between patients and their clinicians, particularly for sensitive, potentially life-threatening topics.

Friday, August 16, 2019

Federal Watchdog Reports EPA Ignored Ethics Rules

Alyssa Danigelis
www.environmentalleader.com
Originally published July 17, 2019

The Environmental Protection Agency failed to comply with federal ethics rules for appointing advisory committee members, the General Accounting Office concluded this week. President Trump’s EPA skipped disclosure requirements for new committee members last year, according to the federal watchdog.

Led by Andrew Wheeler, the EPA currently manages 22 committees that advise the agency on a wide range of issues, including developing regulations and managing research programs.

However, in fiscal year 2018, the agency didn’t follow a key step in its process for appointing 20 committee members to the Science Advisory Board (SAB) and Clean Air Scientific Advisory Committee (CASAC), the report says.

“SAB is the agency’s largest committee and CASAC is responsible for, among other things, reviewing national ambient air-quality standards,” the report noted. “In addition, when reviewing the step in EPA’s appointment process related specifically to financial disclosure reporting, we found that EPA did not consistently ensure that [special government employees] appointed to advisory committees met federal financial disclosure requirements.”

The GAO also pointed out that the number of committee members affiliated with academic institutions shrank.

The info is here.

Monday, March 11, 2019

Steven Mnuchin’s financial disclosures haven’t earned ethics officials’ blessing. What’s the hold-up?

Carrie Levine
The Center for Public Integrity
Originally published March 8, 2019

The executive branch’s chief ethics watchdogs have yet to certify Treasury Secretary Steven Mnuchin’s annual financial disclosure — an unusually lengthy delay in finalizing a document they’ve had for more than eight months.

While the Office of Government Ethics won’t publicly explain the holdup, an analysis of Mnuchin’s disclosure, which was obtained by the Center for Public Integrity, identified entries that outside ethics experts say could be the hitch.

The disclosure statement covers Mnuchin’s 2017 personal finances, and Treasury’s own ethics officials certified it after finding no conflicts of interest.

Some entries on Mnuchin’s 53-page form involve Stormchaser Partners LLC, a film production company owned by Mnuchin’s wife, Louise Linton.

Mnuchin’s ethics agreement, negotiated when he joined the government, required him to step down from the chairmanship of Stormchaser Partners and divest his own ownership interest in it within 90 days of his confirmation in February 2017. (Mnuchin also agreed to divest dozens of other assets that ethics officials said potentially presented conflicts of interest or the appearance of one.)

The info is here. 

Sunday, December 16, 2018

Institutional Conflicts of Interest and Public Trust

Francisco G. Cigarroa, Bettie Sue Masters, Dan Sharphorn
JAMA. Published online November 14, 2018.
doi:10.1001/jama.2018.18482

Here is an excerpt:

It is no longer enough for institutions conducting research to only have conflict of interest policies for individual researchers, they also must directly address the growing concern about institutional conflicts of interest. Every research institution and university deserving of the public’s trust needs to have well-defined institutional conflict of interest policies. A process must be established that will ensure research is untainted by any personal financial interests of the researcher, and that no financial interests exist for the institution or the institution’s key decision makers that could cloud otherwise open and honest decisions regarding the institution’s research mission.

Education and culture are fundamental to the successful implementation of any policy. It is incumbent upon institutional decision makers and all employees involved in research to be knowledgeable about individual and institutional conflict of interest policies. It may not always be obvious to researchers that they have a perceived or real conflict of interest or bias. Therefore, it is important to establish a culture of transparency and disclosure of any outside interests that could potentially influence research and include individuals at the highest level of the institution. Policies should be clear and easy to implement and permit pathways to provide disclosure with adequate explanation, as well as information regarding how potential or real conflicts of interest are managed or eliminated. This will require the establishment of interactive databases aimed at mitigating, to the extent possible, both individual and institutional conflicts of interest.

Policies alone are not sufficient to protect an institution from conflicts of interest. Institutional compliance toward these policies and dedication toward establishing processes by which to identify, resolve, or eliminate institutional conflicts of interest are necessary. Institutions and their respective boards of trustees should be prepared to address sensitive situations when a supervisor, executive leader, or trustee is identified as contributing to an institutional conflict of interest and be prepared to direct specific actions to resolve such conflict. In this regard, it would be prudent for governance to establish an institutional conflicts of interest committee with sufficient authority to manage or eliminate perceived or real conflicts of interest affecting the institution.

Thursday, October 18, 2018

Medicine’s Financial Contamination

Editorial Board
The New York Times
Originally posted September 14, 2018

Here is an excerpt:

Sloan Kettering’s other leaders were well aware of these relationships. The hospital has said that it takes pains to wall off any employee involved with a given outside company from the hospital’s dealings with that company. But it’s difficult to believe that conflicts of this magnitude could have truly been worked around, given how many of them there were, and how high up on the organizational chart Dr. Baselga sat. It also strains credulity to suggest that he was the hospital’s only leader with such conflicts or with such apparent difficulty disclosing them. After the initial report, but before Dr. Baselga’s resignation, the hospital sent a letter to its entire 17,000-person staff acknowledging that the institution as a whole needed to do better. It remains to be seen what additional actions will be taken — and by whom — to repair the situation.

Financial conflicts are hardly confined to Sloan Kettering. A 2015 study in The BMJ found that a “substantial number” of academic leaders hold directorships that pay as much as or more than their clinical salaries. According to other surveys, nearly 70 percent of oncologists who speak at national meetings, nearly 70 percent of psychiatrists on the task force that ultimately decides what treatments should be recommended for what mental illnesses, and a significant number of doctors on Food and Drug Administration advisory committees have financial ties to the drug and medical device industries. As bioethicists have warned and as journal publishers have long acknowledged, not all of them report those ties when and where they are supposed to.

The info is here.

Thursday, March 29, 2018

Authors of premier medical textbook didn’t disclose $11 million in industry payments

Adam Marcus and Ivan Oransky
www.statnews.com
Originally published March 6, 2018

Here is an excerpt:

“These findings indicate that full transparency of [author conflicts] should become a standard practice among the authors of biomedical educational materials,” according to the authors, whose study appears in the journal AJOB Empirical Bioethics.

McGraw-Hill, which publishes Harrison’s, did not respond to STAT’s requests for comment.

Financial disclosures have become de rigueur in scientific journals, where many of Harrison’s authors also publish and are subject to guidelines for such disclosures. Textbooks, however, have typically not required disclosures — and that means they’ve fallen even more behind standard practices.

The researchers, led by Brian Piper, a neuroscientist at the Geisinger Commonwealth School of Medicine in Scranton, Pa., acknowledge that simply looking at patent awards and fees from biomedical companies doesn’t prove the existence of biased work. But they note that medical textbooks are enormously influential due to their perceived authority and the wide readership they receive.

The article 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.

Wednesday, May 24, 2017

Ethics office rejects White House attempt to halt inquiry into lobbyists

Associated Press
Originally posted May 23, 2017

Donald Trump’s administration says the government ethics office lacks the authority to force the president to reveal how many waivers he’s granted to ex-lobbyists in his new administration.

Trump’s budget director, Mick Mulvaney, is asking that the office of government ethics (OGE) director, Walter Shaub, halt his inquiry into lobbyists-turned-Trump administration employees. Mulvaney wrote in a letter last week to Shaub: “This data call appears to raise legal questions regarding the scope of OGE’s authorities.”

Shaub fired back Monday that OGE’s request was well within bounds. The ethics director says he expects to see the waiver information within 10 days.

The article is here.

Wednesday, April 19, 2017

Should healthcare professionals breach confidentiality when a patient is unfit to drive?

Daniel Sokol
The British Medical Journal
2017;356:j1505

Here are two excerpts:

The General Medical Council (GMC) has guidance on reporting concerns to the Driver and Vehicle Licensing Agency (DVLA). Doctors should explain to patients deemed unfit to drive that their condition may affect their ability to drive and that they—the patients—have a legal obligation to inform the DVLA about their condition.

(cut)

The trouble with this approach is that it relies on patients’ honesty. As far back as Hippocratic times, doctors were instructed to look out for the lies of patients. Two and a half thousand years later the advice still holds true. In a 1994 study on 754 adult patients, Burgoon and colleagues found that 85% admitted to concealing information from their doctors, and over a third said that they had lied outright. Many patients will lie to avoid the loss of their driving licence. They will falsely promise to inform the DVLA and to stop driving. And the chances of the doctor discovering that the patient is continuing to drive are slim.

The article is here.

Tuesday, February 14, 2017

Medical errors: Disclosure styles, interpersonal forgiveness, and outcomes

Hannawa, A. F., Shigemoto, Y., & Little, T. (2016).
Social Science & Medicine, 156, 29-38.

Abstract

Rationale

This study investigates the intrapersonal and interpersonal factors and processes that are associated with patient forgiveness of a provider in the aftermath of a harmful medical error.

Objective

This study aims to examine what antecedents are most predictive of patient forgiveness and non-forgiveness, and the extent to which social-cognitive factors (i.e., fault attributions, empathy, rumination) influence the forgiveness process. Furthermore, the study evaluates the role of different disclosure styles in two different forgiveness models, and measures their respective causal outcomes.

Methods

In January 2011, 318 outpatients at Wake Forest Baptist Medical Center in the United States were randomly assigned to three hypothetical error disclosure vignettes that operationalized verbally effective disclosures with different nonverbal disclosure styles (i.e., high nonverbal involvement, low nonverbal involvement, written disclosure vignette without nonverbal information). All patients responded to the same forgiveness-related self-report measures after having been exposed to one of the vignettes.

Results

The results favored the proximity model of interpersonal forgiveness, which implies that factors more proximal in time to the act of forgiving (i.e., patient rumination and empathy for the offender) are more predictive of forgiveness and non-forgiveness than less proximal factors (e.g., relationship variables and offense-related factors such as the presence or absence of an apology). Patients' fault attributions had no effect on their forgiveness across conditions. The results evidenced sizeable effects of physician nonverbal involvement-patients in the low nonverbal involvement condition perceived the error as more severe, experienced the physician's apology as less sincere, were more likely to blame the physician, felt less empathy, ruminated more about the error, were less likely to forgive and more likely to avoid the physician, reported less closeness, trust, and satisfaction but higher distress, were more likely to change doctors, less compliant, and more likely to seek legal advice.

Conclusion

The findings of this study imply that physician nonverbal involvement during error disclosures stimulates a healing mechanism for patients and the physician-patient relationship. Physicians who disclose a medical error in a nonverbally uninvolved way, on the other hand, carry a higher malpractice risk and are less likely to promote healthy, reconciliatory outcomes.

The article is here.

Friday, February 3, 2017

Beyond Conflicts of Interest: Disclosing Medical Biases

David M. Shaw
JAMA. 2014;312(7):697-698.
doi:10.1001/jama.2014.8035

The editors of medical and scientific journals always ask authors of papers to declare any financial conflicts of interest (COIs) related to their research. There has recently been a shift away from allowing authors to decide what constitutes a financial COI toward asking them to disclose any potential perceived COI; some journal editors even ask authors to disclose any and all financial interests that they have. But there has also been a shift away from this focus on financial COIs toward a wider conception of COI that includes other types of bias. Since 2010, all journals associated with the International Committee of Medical Journal Editors (ICMJE) have asked authors to complete a unified COI form that requires disclosure of the following:

1. Associations with commercial entities that provided support for the work reported in the submitted
manuscript (the timeframe for disclosure in this section of the form is the life span of the work being reported).

2. Associations with commercial entities that could be viewed as having an interest in the general area of the submitted manuscript (in the three years before submission of the manuscript).

3. Non-financial associations that may be relevant or seen as relevant to the submitted manuscript.

The article is here.

Friday, July 29, 2016

When Doctors Have Conflicts of Interest

By Mikkael A. Sekeres
The New York Times - Well Blog
Originally posted June 29, 2016

Here is an excerpt:

What if, instead, the drug for which she provided advice is already commercially available. How much is her likelihood of prescribing this medication – what we call a conflict of commitment – influenced by her having been given an honorarium by the manufacturer for her advice about this or another drug made by the same company?

We know already that doctors are influenced in their prescribing patterns even by tchotchkes like pens or free lunches. One recent study of almost 280,000 physicians who received over 63,000 payments, most of which were in the form of free meals worth under $20, showed that these doctors were more likely to prescribe the blood pressure, cholesterol or antidepressant medication promoted as part of that meal than other medications in the same class of drugs. Are these incentives really enough to encroach on our sworn obligation to do what’s best for our patients, irrespective of outside influences? Perhaps, and that’s the reason many hospitals ban them.

In both scenarios the doctor should, at the very least, have to disclose the conflict to patients, either on a website, where patients could easily view it, or by informing them directly, as my mother-in-law’s doctor did to her.

The article is here.

Tuesday, July 26, 2016

The Paradox of Disclosure

By Sunita Sah
The New York Times
Originally published July 8, 2016

Here is an excerpt:

To some extent, they do work. Disclosing a conflict of interest — for example, a financial adviser’s commission or a physician’s referral fee for enrolling patients into clinical trials — often reduces trust in the advice.

But my research has found that people are still more likely to follow this advice because the disclosure creates increased pressure to follow the adviser’s recommendation. It turns out that people don’t want to signal distrust to their adviser or insinuate that the adviser is biased, and they also feel pressure to help satisfy their adviser’s self-interest. Instead of functioning as a warning, disclosure can become a burden on advisees, increasing pressure to take advice they now trust less.

The article is here.


Friday, September 26, 2014

Females ignored in basic medical research

By Erin White
Science Daily
Published August 28, 2014

A new study from Northwestern Medicine® has found that surgical researchers rarely use female animals or female cells in their published studies -- despite a huge body of evidence showing that sex differences can play a crucial role in medical research.

Editors of the five major surgical journals reviewed in this study have responded to this finding and will now require authors to state the sex of animals and cells used in their studies. If they use only one sex in their studies, they will be asked to justify why.

The entire article is here.

Wednesday, May 29, 2013

The SUPPORT Study and the Standard of Care Read

By Lois Shepherd
The Hastings Center Bioethics Forum
Originally posted May 17, 2013

The clinical research community and a number of prominent bioethicists have swiftly come to the defense of investigators conducting the SUPPORT study, in which approximately 1,300 premature infants were randomly assigned to be maintained at higher or lower levels of oxygen saturation. The study took place between 2005 and 2009, involved 22 sites and was reviewed by at least as many institutional review boards. In March, the Office of Human Research Protection (OHRP) concluded that investigators had violated the informed consent provisions of the federal regulations governing research by failing to inform parents of infants enrolled in the study about risks of retinopathy, neurological injury, and death. Results from the study revealed that infants assigned to receive the lower range of oxygen suffered higher rates of death than infants assigned to the upper range, while the latter suffered higher rates of retinopathy than the former.  Defenders accuse OHRP of faulting the investigators for failing to inform parents of risks they learned about only through the study.

The central point of disagreement between defenders and critics of the study appears to be whether participants in the study were receiving medical care that was different from the care they would have received outside the study and whether participation in research therefore carried any medical risks that required risk/benefit scrutiny by IRBs or disclosure to parents of the infants enrolled.  This would appear to be a factual matter about which one could obtain some clarity, but discussions of this issue have been somewhat opaque.

Part of the reason for this may be different, but unacknowledged, understandings of the concept of “standard of care,” a term used – both in the informed consent forms and the commentary about them – but rarely defined in this debate.

The entire article is here.

Saturday, December 22, 2012

Conflict of Interest: Disclosure to Whom? And How?


By Jane Robbins
Inside Higher Ed - Sounding Board
December 11, 2012

Conflict of interest in academic science is a controversial, but most of all a highly emotional, issue in the academy. Scientists and administrators disagree vehemently about whether it is a good or bad thing, and many aver that it has no impact on research—or that it is no one’s business. The thing is that the term conflict of interest is descriptive of a state, not a quality, and its effects or impacts can only be known, sometimes tragically and always far beyond the individual involved, after-the-fact. This is why disclosure is generally considered to be a poor means of avoiding bias or harm—it is too little, too late, and we are left with not knowing who or what to trust, and may need to run around retracting articles, shutting down trials, imposing sanctions, firing people, or engaging in yet another political effort to rein in a growing ill. Physician, heal thyself: an ounce of prevention is worth a pound of cure.

At the moment, though, disclosure is the modus operandi. Even that took decades to put in place, and efforts to make disclosure, let alone enforcement, more robust have been disappointing exercises in which the whole point—the integrity of science and scientific institutions—bows to external pressure and resistance. One of the many disappointments in the recent (2009-2011), largely failed effort to strengthen conflict of interest rules and enforcement was the rejection of additional reporting to the federal government. In making my public comments at the time, I for one had called for reporting of all disclosures, patent/royalty data, equity values, contract terms, management plans, and other conflict-specific data to a central website created and maintained by the Public Health Service (HHS/PHS), the funding agent soliciting comments on proposed new rules. Some others made similar recommendations, as discussed below. In a rationalized interpretation of lessening the administrative and financial burden to institutions, the final rules instead called for each institution to create its own site and/or respond to requests for information on a case-by-case basis.  Appeasement often yields the irrational.

The entire story is here.