Informed-Consent Forms for HIV Research Too Long: Study

Randy Dotinga

Medicinenet.com

The informed-consent documents that study volunteers must sign before joining HIV/AIDSresearch trials in countries around the world -- including the United States -- are too long and complicated, researchers say.

The consent forms added up to more than 20 pages, according to an analysis of 124 such documents used in multinational research projects funded by the United States at home and abroad, the new study found.

"While we were familiar with many fairly long consent forms for several different types of studies, we were honestly surprised to see that the median length was 22 pages, and the median length for adult forms was a full 27 pages," study lead investigator Nancy Kass, deputy director for public health at the Johns Hopkins Berman Institute of Bioethics, said in a news release from Johns Hopkins Medicine.

The forms gave very little information on research methods, such as explaining concepts like randomization and placebos, which means that study participants may not understand that they might get a different medication than other participants or no medicine at all, Kass said.

The researchers also found that most of the forms weren't easy enough to understand and often required higher-level reading skills, with most written for at least a ninth-grade reading comprehension level.

About half of the U.S. population reads at or below an eighth-grade reading level, the authors pointed out in the report published in the August issue of the Journal of General Internal Medicine.

The problems may begin with forms provided by funders. "In this study, the forms that researchers were given by their funders as models -- what we call 'template' forms -- were themselves very, very long," Kass said.

"I imagine many researchers wish they could use methods that were not only shorter, but maybe that used strategies other than written communication altogether," particularly in light of the rise of research trials in countries like India and Bangladesh, where much of the population cannot read, she added.

Psychiatric Times Apologies to Readers for Data Breach

An Apology to our Readers

June 10, 2011

Psychiatric Times

Dear Readers,

Not long ago, we posted a survey on our website that included a series of questions about ethical dilemmas mental health professionals face in daily practice. Exactly 1400 of you responded to that survey. . . and more than half of the respondents were psychiatrists. The idea for the survey came from our editorial board member, Cynthia Geppert, MD, PhD, MPH, who subsequently wrote an overview of the survey results. Dr Geppert's commentary, which was based on a summary of the copious data derived from the survey, was published in the May issue of Psychiatric Times, and —- on June 7th—- it was posted to our website.

When the essay was posted, it contained a live link to the original ethics survey. Our intent in including that link was to give interested readers a chance to review the original survey questions and to click on the hundreds of detailed responses to those questions. The day after the essay was posted, it was brought to our attention by a reader that – with enough drilling down –  the names and email addresses of some of the respondents could be found. Dr Geppert was not aware of this, nor were we because we worked from the same data summary instead of the live survey. We immediately deleted the link and disabled the survey itself so that it would no longer be accessible to anyone. Still, the survey was live for about 16 hours.

The irony that this breach occurred in the context of one of the largest surveys ever on ethical issues facing psychiatrists – and in the middle of an essay about whether ethical dilemmas have changed in recent years and how prepared we are to manage changing dilemmas –- is not lost on us.

We know full well how much you value your privacy and we sincerely apologize to our survey respondents. We’ve taken steps to ensure that this won’t happen again.

We and Dr Geppert plan another ethics survey next year. We hope you’ll join in.

Please let us hear from you? Slings? Arrows? We’d welcome your thoughts and comments.

--Susan Kweskin
Group Editorial Director

Amicus Curiae Brief on Forced Medication of Loughner

ARLINGTON, Va. (Aug 4, 2011) - The American Psychiatric Association (APA) and the American Academy of Psychiatry and the Law (AAPL) have submitted an amicus curiae brief on the issue of forcibly administering antipsychotic medication in the case of the United States v. Jared Lee Loughner.

The brief was submitted August 3 to the U.S. Court of Appeals for the Ninth Circuit.

Loughner has pleaded not guilty in the Tucson, Arizona shootings that killed 6 people and injured 13 others, including Rep. Gabrielle Giffords.

He has been diagnosed with schizophrenia, was found incompetent to stand trial and is being held in a federal prison hospital in Springfield, Mo.

The APA/AAPL brief argues that under existing standards the government may administer involuntary medication to a pre-trial detainee who is a danger to himself or others if appropriate administrative procedures are followed.

It was also argued that such decisions should be made by those having custody of the defendant and should not require a judicial hearing.

"We have two interests in this case," said Paul S. Appelbaum, M.D., chair of APA's Committee on Judicial Action.

"When the courts address issues concerning psychiatric disorders, we want them to have accurate data on the nature and consequences of those illnesses and on appropriate treatments.

In addition, we believe psychiatrists working in correctional facilities need the flexibility to deal with dangerous persons without the delay involved in lengthy court proceedings. Those are the issues that we focus on in the brief."

The defense in the Tucson shootings case has opposed the defendant's being treated with antipsychotic medication, and the 9 th Circuit Court of Appeals halted further treatment with antipsychotics until a hearing before that court at the end of August.

Since then, the psychiatrists treating Loughner concluded he was rapidly deteriorating and represented a danger to himself, and antipsychotic medication was restarted on an emergency basis.

The brief submitted by APA and AAPL did not side with either party, but seeks to clarify issues regarding managing violent, including self-injurious, inmates and about the use of antipsychotic medications.

The brief addresses the scientific evidence of the benefits and risks associated with antipsychotic medications, likely side effects, the medical reasons for involuntary administration in certain circumstances, and the inappropriateness of using other medications (i.e., sedatives) in the place of antipsychotics.

In Loughner's appeal the court will address whether, in a case involving a pre-trial detainee, the Washington v. Harper standard may be applied in a prison administrative process or whether the greater protection of a judicial proceeding is required.

Washington v. Harper holds that the government may treat a prison inmate who has a serious mental illness with antipsychotic drugs against his will if he is dangerous to himself or others and if the treatment is in his medical interest.

In that case - which involved a convicted prisoner - the court also held that an administrative hearing was adequate to satisfy procedural due process.

Loughner's lawyers have raised additional substantive and procedural arguments.

The APA's position in the brief, approved by the APA Board of Trustees, is consistent with the organization's ongoing support of adequate mental health care for individuals in the criminal justice system.

Please see our prior blog post that details a history of this case.

Thanks to Ken Pope for this information.

Loughner's Exams Will Not Be Recorded

(Courthouse News Service) - The government does not have to videotape medical evaluations of the suspected Tucson shooter, a federal judge ruled Thursday, finding that it would be distracting to the suspect, Jared Lee Loughner, and a burden to doctors.

"The defendant's original competency examination was videotaped, and this was apparently very distracting to the defendant and a hindrance to the FMC staff conducting the examination," U.S. District Judge Larry Burns wrote, referring to the Medical Center for Federal Prisons in Springfield, Mo., where Loughner is undergoing treatment for schizophrenia after a federal judge declared him incompetent to stand trial.

Loughner is charged with carrying out a shooting rampage on Jan. 8 that killed six people and injured 13, including Congresswoman Gabrielle Giffords.

During the competency exampination, Loughner "more than once ... questioned the need for the camera while the staff was interacting with him, and on one occasion in particular he reacted violently to it," Burns added.

Loughner's attorney Judy Clarke had asked for an order to videotape future sessions Loughner has since the suspect is expected to remain at the facility indefinitely while doctors assess his competence.

Burns said Clarke's notion of what constitutes a clinical assessment is too broad and would place an undue burden on examiners.

"The uncertain duration of the defendant's present commitment to FMC, coupled with the extensive attention and care he is now receiving because of his mental condition, would make videotaping all clinical assessments a substantial imposition on the work of the FMC staff," the three-page decision states. "This difficulty is partially illustrated by the defendant's conception of a 'clinical assessment,' which defense counsel define as 'interactions by clinical staff at Springfield with Mr. Loughner that relate to discussions of medication, competence, restoration, clinical symptoms, and current functioning.' Such a broad, catch-all definition will invariably invite an interaction-by-interaction analysis as to whether videotaping is necessary, and it is not fair to burden the FMC staff with that analysis." 

Prescription pain medication addiction prevalent among chronic pain patients

News Release

A new study by Geisinger Health System researchers finds a high prevalence of prescription pain medication addiction among chronic pain patients. In addition, researchers found that the American Psychiatric Association’s (APA) new definition of addiction, which was expected to reduce the number of people considered addicts who take these medicines, actually resulted in the same percentage of people meeting the criteria of addiction.

Published in the Journal of Addictive Diseases, the study found that 35 percent of patients undergoing long-term pain therapy with opioids like morphine, OxyContin, Percocet and Vicodin, meet the criteria for addiction.

“Most patients will not know if they carry the genetic risk factors for addiction,” said study lead Joseph Boscarino, senior investigator II, Geisinger Health System. “Improper or illegal use of prescription pain medication can become a lifelong problem with serious repercussions for users and their families.”
Boscarino added that “genetic predisposition to addiction further exacerbates the risks associated with misuse of prescription pain medication.”

Using electronic health records, a random sample of outpatients undergoing long-term opioid therapy for non-cancer pain was identified and 705 participants completed telephone interviews from August 2007 through November 2008.

When comparing the APA’s newly revised criteria for addiction with the old criteria, researchers were surprised to find the prevalence of and risk factors for addiction to be virtually the same. It was determined that different symptoms now qualify the same patients for inclusion who would have been excluded under the previous classification system.

The study states that pain medication addiction often happens in people under 65, with a history of opioid abuse, withdrawal symptoms and substance abuse treatment. Risk factors for severe pain medication addiction also include a history of anti-social personality disorder.

“Ultimately, we hope our research will aid the development of newer classes of medications that don’t negatively impact the brain and therefore avoid addiction entirely,” Boscarino said.

Researchers from New York University also contributed to the study.

Vignette 4: A Psychologist in Turmoil

You have been treating a fellow licensed psychologist for several months. He presents himself as having a dissociative identity disorder. Although his condition has been deteriorating he continues to maintain a private practice and one of his egos reports that he has been flirting with several of his female patients.

What are possible emotional reactions would you have in this situation?

What would be your best options for this scenario?

To add some additional detail, you live in Pennsylvania where the reporting requirement for impaired professionals does not apply to patients you see in treatment. Therefore, you, the treating psychologist, are not required to report your patient to the licensing board.

Reviewing Autonomy

Implications of the Neurosciences and the Free Will Debate for the Principle of Respect for the Patient's Autonomy

Sabine Muller & Henrik Walter. Cambridge Quarterly of Healthcare Ethics. New York: Apr 2010. Vol. 19, Iss. 2; pg. 205, 13 pgs

Introduction

Beauchamp and Childress have performed a great service by strengthening the principle of respect for the patient's autonomy against the paternalism that dominated medicine until at least the 1970s. Nevertheless, we think that the concept of autonomy should be elaborated further. We suggest such an elaboration built on recent developments within the neurosciences and the free will debate. The reason for this suggestion is at least twofold: First, Beauchamp and Childress neglect some important elements of autonomy. Second, neuroscience itself needs a conceptual apparatus to deal with the neural basis of autonomy for diagnostic purposes. This desideratum is actually increasing because modern therapy options can considerably influence the neural basis of autonomy itself.

Beauchamp and Childress analyze autonomous actions in terms of normal choosers who act (1) intentionally, (2) with understanding, and (3) without controlling influences (coercion, persuasion, and manipulation) that determine their actions. ¹ In terms of the free will debate, the absence of external controlling influences, their third criterion, corresponds to the freedom of action: to do what one wants to do without being hindered to do so. Criteria one and two are related to volition: that a choice is intentional, that is, that it has a certain goal that is properly understood by the person choosing.

According to Beauchamp and Childress, the principle of autonomy implies that patients have the right to choose between different medical therapy options taking into account risks and benefits as well as their personal situation and individual values. To enable an autonomous decision the procedure of informed consent ² has been developed. This procedure has become the gold standard in almost every part of medicine. Importantly, Beauchamp and Childress demand respect for a patient's autonomy under the premise that the patient is able to act in a sufficiently autonomous manner. ³ The crucial question in a special situation is whether this is the case.

Let us consider the example of the recent controversial discussion of Body Integrity Identity disorder: ⁴ If a patient asks a physician to amputate one of his legs although it neither hurts nor is deformed, paralyzed, or ugly (in the patient's view), and if the patient understands the consequences of the amputation and is not controlled by external influences, then one could deduce from the principle of respect for the patient's autonomy that the physician should amputate the leg. Although some commentators regard this as self-evident, we think that the case is not yet made, as it is important which internal processes have led to the wish of the patient.

We propose to add a fourth criterion for autonomous actions, namely, freedom of internal coercive influences. In the case of the patient who desires an amputation, it would have to be investigated whether his decision is based on internal coercion. Clear examples for that would be an acute episode of schizophrenia or a brain tumor. More controversial are neurotic beliefs, obsession and compulsion, severe personality disorders, or neurological dysfunctions not accessible with conventional diagnostic tools.

Although Beauchamp and Childress have not elaborated the principle of autonomy with regard to internal coercions, they clearly argue that the obligations to respect autonomy do not apply to persons who show a substantial lack of autonomy because they are immature, incapacitated, ignorant, coerced, or exploited, for example, infants, irrationally suicidal individuals, severely demented subjects, or drug-dependent patients. ⁵ But these kinds of patients are treated in medical ethics as exceptions and therefore as marginal cases. They are not considered to be important for the formulation of the principles.

The rest of the article can be found here.  Without access to PubMed.gov, it is not available for free.  A university library may also be helpful in reading the entire article.

Parental Military Deployment Has Detrimental Affect On Adolescent Boys

Mary Guiden
University of Washington

Medical News Today

In 2007, nearly two million children in the United States had at least one parent serving in the military. Military families and children, in particular, suffer from mental health problems related to long deployments. 

A new study from researchers at the University of Washington (UW) concludes that parental military deployment is associated with impaired well-being among adolescents, especially adolescent boys. The study, "Adolescent well-being in Washington state military families," was published online in the American Journal of Public Health.

Lead author Sarah C. Reed, who has a master's degree from the UW School of Public Health, said the findings show that it is time to focus more on the children that are left behind in times of war. "There is a lot of research about veterans and active-duty soldiers, and how they cope or struggle when they return from a deployment," said Reed. "Those studies hit the tip of the iceberg of how families are coping and how their children are doing."

Adolescents are uniquely vulnerable to adverse health effects from parental military deployment. Healthy development, including identifying a sense of self and separation from family, can be interrupted during parents' active military service.

Media exposure and the developmental ability to understand the consequences of war may further disrupt adolescents' adjustment and coping. Teens may also have additional responsibilities at home after a parent's deployment, researchers said.

UW researchers used data from the Washington state 2008 Healthy Youth Survey, administered to more than 10,000 adolescents in 8th, 10th- and 12th grade classrooms. Female 8th graders with parents deployed to combat appear to be at risk of depression and thoughts of suicide, while male counterparts in all grades are at increased risk of impaired well-being in all of the areas examined (low quality of life, binge drinking, drug use and low academic achievement). 

Read the entire story here.

Harvard Researchers Accused of Breaching Students' Privacy

Social-network project shows promise and peril of doing social science online

By Marc Parry
Chronicle of Higher Education

In 2006, Harvard sociologists struck a mother lode of social-science data, offering a new way to answer big questions about how race and cultural tastes affect relationships.

The source: some 1,700 Facebook profiles, downloaded from an entire class of students at an "anonymous" university, that could reveal how friendships and interests evolve over time.

It was the kind of collection that hundreds of scholars would find interesting. And in 2008, the Harvard team began to realize that potential by publicly releasing part of its archive.

But today the data-sharing venture has collapsed. The Facebook archive is more like plutonium than gold—its contents yanked offline, its future release uncertain, its creators scolded by some scholars for downloading the profiles without students' knowledge and for failing to protect their privacy. Those students have been identified as Harvard College's Class of 2009.

The story of that collapse shines a light on emerging ethical challenges faced by scholars researching social networks and other online environments.

The Harvard sociologists argue that the data pulled from students' Facebook profiles could lead to great scientific benefits, and that substantial efforts have been made to protect the students. Jason Kaufman, the project's principal investigator and a research fellow at Harvard's Berkman Center for Internet & Society, points out that data were redacted to minimize the risk of identification. No student seems to have suffered any harm. Mr. Kaufman accuses his critics of acting like "academic paparazzi."

Adding to the complications, researchers like Mr. Kaufman are being asked to safeguard privacy in an era when grant-making agencies increasingly request that data be shared—as the National Science Foundation did as a condition for backing Harvard's Facebook study.

The Facebook project began to unravel in 2008, when a privacy scholar at the University of Wisconsin at Milwaukee, Michael Zimmer, showed that the "anonymous" data of Mr. Kaufman and his colleagues could be cracked to identify the source as Harvard undergraduates.

The entire story can be read here.