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.
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,
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
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
- 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,
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