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Caution should be exercised in obtaining informed consent for research from subjects …

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- Informed consent for research in Borderline Personality Disorder

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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