The Belmont Report, the Nurembug Code, and the Declaration of
Helsinki all discuss the need for informed, voluntary consent from
research subjects. Possible issues concerning the validity of informed
consent in borderline subjects center on the voluntariness of consent.
Most borderline patients, except if in a brief psychotic episode when
under severe stress, have normal cognitive function, and will be able
to comprehend and speak about the risks and benefits of a study.
However, long-term health benefits or more abstract service to
society may not be as important to them as their immediate
psychological needs. Such needs may include recapitulations of
childhood abuse. For example, they may involve a need to feel the study
doctor is hurting them or putting them in danger, and the subject may
consent to research in order to gain this position. BPD subjects may
have an immediate need to use the idealizing side of the splitting
defense; they may feel special because they were selected for the
study, and consent in order to have more contact with the idealized
doctor. Alternatively, a borderline subject's actions may be motivated
by the abrupt devaluing tendency seen in their interpersonal
relationships: they may refuse to consent to a study that could
significantly benefit them based on unwarranted anger toward the study
staff. Finally, a borderline patient may enter a study because she is
suicidal, and hopes he or she will die as part of the study.
Just as financial compensation may be in fact coercive to some
populations, these perceived benefits may in fact be considered
coercive for the borderline subject. The Freudian concept of psychic
determinism, which states that all decisions are predestined by the
interplay of intrapsychic forces and therefore always necessarily
subjective, might in the extreme lead us to conclude that no consent is
purely voluntary. However, the concern that decisions are not made
based on logical consideration but rather on psychological needs
applies especially to borderline subjects, for whom rational decision
making is a clear weakness.
Carl Elliott raised somewhat similar concerns regarding informed consent for research with the severely depressed [3].
Recognizing that in an extremely depressed state, a subject may
understand risks but not be concerned about them, Elliott called for an
appreciation of emotional and motivational factors in the informed
consent process. He argued that consent might not be considered valid
for a depressed subject because of state-dependent changes in
priorities which wouldn't coincide with the subject's "usual"
personality. This argument flounders when we consider the borderline
subject, whose most prominent personality trait is instability. Elliott
also contends that consent may be considered invalid if it is not
motivated in part by self-interest. This thesis applies better to BPD
subjects, who may enroll hoping to be harmed. It does not, however,
completely acknowledge that BPD patients have wants and needs that they
try to meet; these are just wants and needs that are strange to those
without BPD.
In light of these concerns, should borderlines be excluded from
research studies? Obviously not. First of all, this would not be
practically possible with current standards. There are many more
patients with BPD than those who have it documented in their medical
records. Even if a study involves formal psychiatric evaluation,
practitioners often mistake BPD for other conditions (for example,
chronic major depression or bipolar disorder) [6].
This may be due to lack of long-term knowledge of the subject and his
or her persistent coping mechanisms. Alternatively, practitioners
hesitate to assign a diagnosis that many consider pejorative and
untreatable.
Even if borderlines could be more reliably identified prior to
informed consent, they cannot be ethically excluded from research
because this condition desperately needs better treatments [4,5].
While there is some evidence of efficacy for antidepressants,
antipsychotics, Dialectical Behavior Therapy, and other
psychotherapies, recent systematic reviews on both psychopharmacology
and psychosocial interventions for BPD called for more research. What
specialized treatments there are, are not widely available, and many
borderlines are prescribed somewhat haphazard polypharmacy regimens
with little empiric basis.
If borderline subjects' chronic problems with transference,
splitting, impulsivity, paranoia, self-injury, and suicidality
complicate the informed consent process, but if this process is none
the less imperative, how are we to proceed? As very little research has
been done in this area, hard guidelines for informed consent are
premature. But future research should seek to address such questions
about informed consent. It may be that borderlines should undergo the
consent process with people who are used to working with this disorder.
This could include experienced mental health nursing staff, or, more
likely, someone with psychotherapy training. Experience and training in
psychotherapy enables one to monitor transference and
counter-transference throughout the encounter with the borderline
subject, lending insight into the subject's current motivational state
and helping keep her or his affect from spinning out of control. These
skills may also minimize unconscious acting out by the study team. For
example, someone inexperienced with borderlines may not recognize that
he or she is being idealized and may think "we really will be able to
do great things for this person; I must get her into the trial." Or an
inexperienced clinician may encounter a hostile subject and
unconsciously adjust entry criteria such that she does not qualify, or
over-emphasize risks in a way that leads her to decline enrollment.
Future studies should aim to determine whether psychotherapeutic
knowledge and experience affects the informed consent process with BPD
subjects. Experiments could potentially involve having researchers with
varying levels of psychotherapeutic experience consent the same
subjects for similar studies, comparing the resultant interpersonal
interactions.
Another relevant question is whether the person obtaining consent
can ethically be the subject's therapist or psychiatrist. One of the
criteria for the diagnosis of BPD is "frantic efforts to avoid real or
imagined abandonment." Whatever the consent form says about lack of
consent not affecting provision of medical care, borderlines live in a
world where desertion is always seconds away. Thus, they may be easily
coerced to participate based on the fear of loss of love; they also
might refuse a trial that could benefit them, in order to test the
loyalty of those seeking their participation. This question could be
tested by comparing a consent experience using a BPD's own therapist
with another using an unknown researcher.
In addition, given the chronic impulsivity BPD subjects display, it
may be that informed consent processes that take place over more than
one visit could increase the validity of the consent (as well as help
retention rates). Letting the subject consider the study away from the
interpersonal context of the clinic may help him to be more objective
about his desires and less interpersonally reactive. Multiple consents
could be fairly easily added to a research protocol with follow-up
subject satisfaction surveys and comparisons of retention rates.
Whether proxy decision-makers apply to this situation is another
question. Severely-ill borderlines may have court-appointed guardians
that will be enlisted in the consent process; however, in some cases in
which the patient is his or her own guardian but seems incapable of
making a rational decision, surrogate decision-makers could be
considered.
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