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Vol. LVIII, No. 7
April 7, 2006
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Law, Ethics Not the Same
Ethics Rounds Examines Confidentiality

On the front page...

Say you're a nurse or doctor at the Clinical Center. In the course of a research study, you discover a patient breaking the law. What do you do? If your decision seems simple, it's likely you're missing important ethical — not to mention, legal — considerations and consequences. An Ethics Grand Rounds discussion, "Research Subjects Engaged in Illegal Behavior: How Should Clinicians Respond?" tackled the topic on Feb. 1 in Lipsett Amphitheater.

If the notion of a patient involved in an illegal act in the hospital seems farfetched, consider this true story (to protect confidentiality, some facts have been changed): A 35-year-old woman volunteers to take part in an NIMH clinical trial. Sally has a 21-year history with a major mental illness. To be eligible for the study — an inpatient, phase-II drug trial — volunteers could not be active substance abusers. Potential participants who had a substance abuse history longer than 5 years were excluded from the study. A customary toxicology screening for illegal substances, done during admission, cleared Sally to take part.

Continued...

Six weeks after admission, however, during a weekly search (routine for adult inpatient mental health units), nurses find ash residue in Sally's room. Clinical staff have a talk with Sally. They remind her of study rules. "No illegal drug use allowed. Violators will be dropped from the program." Sally is agitated during the chat. Because of her history of self-harming behavior, she's placed on close observation. Another tox screen again finds Sally clean.

 
  Attorney Barbara Mishkin

A few days later, Sally completes the first part of the study. Routine lab tests find her liver enzymes elevated, so she is taken off the protocol but kept on the unit until the enzymes can return to normal. The next day, Sally tells a staff member that she's been smoking marijuana for the past 2 weeks. A urine tox screen confirms the drug use. A search of her room finds a marijuana cigarette.

"How should staffers respond to Sally's possession of an illegal substance, if her judgment is impaired by her mental illness?" asks Julie Kohn, a CC adult mental health clinical nurse specialist who presented Sally's story. "Do we remove Sally from NIH, and/or call the police? What should we do with the marijuana?"

In a case like Sally's, advises attorney Barbara Mishkin, "care and compassion" should be the first responses. "She may have been self-medicating with the drugs, as people in her condition often do before they get into adequate treatment settings. There may have been some disruption or interference with her [prescription] drugs and whatever the study drug was." Dispose of the drug from Sally's room, then get her referred for drug counseling and treatment, Mishkin said.

A former NIMH research psychologist who is now a partner with Hogan and Hartson law firm, Mishkin specializes in legal-ethical issues involving human subjects in medical research. She was invited by the CC department of clinical bioethics to help analyze and discuss various ways to view the topic.

"Law and ethics are not the same thing," she emphasized. "Sometimes the law will head you in one direction, while ethics will head you in another direction. In this particular instance, they really are compatible."

In general, Mishkin said, clinicians facing such a problem should consider five issues:

  • Protecting the participant and others from harm. "This case isn't one where you'd have to worry about the patient assaulting other patients, visitors or staff, but in some cases you may have to confront that kind of a problem," she said.

  • Protecting the integrity of the study. With-drawal of the participant from the study is almost always recommended, Mishkin said. Use of unauthorized substances — whether or not illicit — can skew the study results, interfere with the study drug or even cause harmful reactions in the participant. "This is a research institution," she stressed. "You spend a lot of money on your studies and you do want to protect them."

  • Protecting the confidentiality of the study participant. The Public Health Service Act protects the confidentiality of research subjects, she noted. In addition, other laws, such as the Mental Health Patient's Bill of Rights, restrict disclosure of the health records of mental health and drug abuse patients. "You'd have to be very careful if you want to disclose anything about a patient who is now using illicit drugs and has a history of having used illicit drugs," Mishkin pointed out. "You're probably not going to be able to disclose that except under very extraordinary circumstances."

  • Honoring promises made to the study participant. What did the consent form tell the participants about NIH policies on the campus or on the unit? Information about NIH policies and reminders-prominently posted signs and warnings, for example — are always a good idea, she suggested.

    "If the research staff have promised them confidentiality, then it would be a real break in trust to disclose anything about them to anyone outside without a real need to protect public health or individual people," Mishkin said. "Violation of trust with one participant will make trust with other participants somewhat shaky."

  • And finally, protecting what she termed the "fiduciary" relationship. "Although it's not [technically] a doctor/patient relationship," said Mishkin, "you're going to find that participants — no matter how much you tell them that you're not their treating physicians — are going to look at the staff as their protectors. For that reason, I think you have a fiduciary relationship, an element of trust established between you and your patients and you don't want to disrupt that."
 
Julie Kohn, CC adult mental health clinical nurse specialist, responds to questions with Dr. Josť A. Apud, medical director for the Schizophrenia Inpatient Research Program, NIMH Clinical Brain Disorders Branch.  

But what if Sally had been found using a stronger illicit drug like heroin or crack cocaine? asked an audience member. Or, what if she was sharing or even selling drugs to fellow patients? What if a study participant brings a gun into the hospital? How about you discover a patient doing something illegal but not otherwise harmful to himself or others, like cheating on his taxes? Would any of these circumstances change the way clinicians ought to handle things? At what point would you need to call in the police?

Rounds moderator Dr. Dave Wendler of the NIH Clinical Bioethics Consult Service had set the ground rules before the discussion began. "We're not here to dissect this particular case, how this case was or was not handled," he reminded. "Instead, we're using this as a jumping- off point to talk about the general ethical issues that get raised by these kinds of cases."

Skillfully — and with great humor — Mishkin addressed each query, not only offering potential legal perspectives of both lawyers and judges, but also providing opinions as someone comfortable with issues specific to the scientific research community. The first priority, she said, is always to make sure everyone on the unit is safe. Sally's health would be the paramount concern, if she were using a more dangerous substance. So getting the research participant the medical help she needs is critical, Mishkin pointed out. The possibility of distributing or selling poses a threat to the whole patient population, she said. That activity would have to be reported to authorities. Similarly, a gun on the unit is a hazard to everyone. Mishkin said she would immediately remove the gun from the person and secure it before letting hospital security handle the matter.

After ensuring the welfare of both study participants and the research itself, Mishkin said clinicians should review the consent forms and the handouts and other materials that are given to patients before they begin the protocol. In addition, hospital policies and procedures should be reread and aligned with both federal and PHS rules and regulations. Clear communication can prevent many problems, and can often determine appropriate responses by clinicians, she said.

As for the tax cheat, a smiling Mishkin concluded, "Physicians and clinicians have a lot of responsibility and power, but it doesn't empower them to be busybodies. So unless the criminal behavior poses a threat to the health and safety of others, then I'd let it go."

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