BIOETHICS - Spring 1999

Exam Grading Notes

Part I

1.a. Threshold questions: Is this research and do federal regs apply? Yes and yes, on these facts: it's a drug study, so FDA approval is presumably the object, and FDA requires compliance with regs re: protection of human subjects. No real question, either, about "research," since generalizable knowledge (in the form of a statistically valid study to establish the superiority of one drug or the other) is the goal of a drug study. Enrollment in an RCT without informed consent in the emergency room is alright under limited circumstances. IRB approval "yesterday" may have followed or preceded notice to the community of the existence of the study, risks and benefits; discussion with representatives of the communities from which subjects will be drawn; and establishment of an independent data and safety monitoring board. Lloyd has a life-threatening condition and research isn't practicable without the waiver. Does he satisfy 50.24(a)(1) ("available treatments are unproven or unsatisfactory")? Maybe, if "unsatisfactory" means there may be a better drug out there, or (less helpfully) if it means that the approved drug doesn't produce sufficiently good outcomes in a sufficiently large percentage of cases to be "satisfactory". If it doesn't mean one of those two things, it may not mean much at all, and the reg should be read to give meaning to all of its parts and all of its terms. Important: Lurleen needs to be told of Lloyd's inclusion in the study immediately and given the chance to withhold consent to his continued participation.

b. Randomization to a placebo is clearly not ethical when there is an approved therapy that represents the standard of care (i.e. is known to be beneficial). Keeping the patient/subject from a treatment known to provide a benefit is what Tuskegee was all about. Randomization to an experimental drug, on the other hand, should be okay as long as researchers really are uncertain which drug is superior (i.e., they are in equipoise); superiority is something that can only be determined by a study such as this one. Question also raises problem of the duties of a hospital attorney when the IRB appears to have approved a research protocol that the attorney believes violates federal standards for human research. Should the attorney flatly forbid the doctor from randomizing Lloyd to the placebo, when that has (erroneously) been okayed by the IRB?

2. c. This question simply requires a recitation of the final rule. The Medicare condition of participation imposes several requirements a hospital must meet that are designed to increase organ donation. One of these requirements is that a hospital must have an agreement with the Organ Procurement Organization (OPO) designated by the Secretary, under which the hospital will contact the OPO in a timely manner about individuals who die or whose death is imminent in the hospital. The OPO will then determine the individual's medical suitability for donation. As well, the hospital must have an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage, and distribution of tissues and eyes, as long as the agreement does not interfere with organ donation. The final rule requires a hospital to ensure, in collaboration with the OPO with which it has an agreement, that the family of every potential donor is informed of its option to donate organs or tissues or not to donate. Discussion and outcome must be noted in the patient's medical record. Under the final rule, hospitals must work with the OPO and at least one tissue bank and one eye bank in educating staff on donation issues, reviewing death records to improve identification of potential donors, and maintaining potential donors while necessary testing and placement of organs and tissues take place.

d. In the absence of anything to indicate that Lloyd would have opposed organ donation, Lurleen is the person under the UAGA who may consent to organ donation. The UAGA, however, requires an organ donor to be declared dead. Thus, the issue is whether Lloyd is dead in accordance with the relevant Determination of Death statute (Texas'). It is stated that he is still breathing, although he needs assistance, so he does not meet the cardiorespiratory criteria for death (irreversible cessation of all spontaneous cardiac and respiratory functions). In addition, although his neocortex may be destroyed, he still has some brain stem function, so he is not brain dead either. He's not dead, so his organs cannot be harvested at this time.

e. A nonheartbeating donor protocol would require cardiopulmonary death B at least the cessation of spontaneous function for 2-5 minutes, depending on the protocol. Although this could happen, it hasn't happened yet. Presumably most NHB donors are on a vent until the moment they are taken off the vent; but there's no reason to believe that Lloyd will stop breathing altogether when he is extubated. The slow downward spiral may eventually lead to a cessation of spontaneous respirations, but not until there's been some damage to his organs due to lack of oxygen. Two other problems: (a) How do the doctors tell he can't breathe on his own when he is on a ventilator? Doesn't the vent interfere with their ability to determine death in accordance with cardiorespiratory criteria? (b) Yet the H&S Code appears to prevent them from discontinuing the ventilator before death has been pronounced. Thus, the statute seems to imply that once a patient is on a ventilator, death can only be determined in accordance with neurological criteria. (Alternatively, this provision might not be applicable if the surrogate is permitted to consent to removal of life-support, after which death could be pronounced. The key to this move would be to limit this provision to determination of death situations, and not consult it when a surrogate is available to consent to withdrawal of life support.) How, under such a statute, could a nonheartbeating donor protocol be implemented? Only for patients not on ventilators would be the apparent answer, unless the doctors are willing to fudge the statutory prohibition and take him off the ventilator before he is dead in accordance with neurological criteria. (Note: NHBD protocol probably fudges the whole question of death, since the determination that cessation of spontaneous respirations is irreversible is made after only 2-5 minutes (depending on the protocol) and without attempting to restart the patient's heart and breathing. In this light, fudging the prohibition against extubation before death is pronounced is probably only one more infraction (and a smaller one) in the service of a pretty large infraction of state standards.) Accordingly, it is unlikely that Lloyd is a candidate for NHBD protocol, at least until his condition worsens materially (to the point of total loss of respiratory drive). Therefore, no change in the analysis.

3.f. NDA: Is Lloyd a qualified patient? Does he have a terminal condition? Yes, since terminal condition includes irreversible condition and death would be imminent (hours or days?) without the application of LSTs. Even if the answers are no, LST could be discontinued, but the NDA's civil and criminal immunities wouldn't be available. DPAHC: Lurleen has the DPAHC, which does not require that Lloyd have a terminal condition, only that he be incompetent, which he is. Artificial life-support includes ventilation; so she is certainly authorized to instruct the physicians to discontinue ventilator support. They (and the hospital) are required by law to follow her instructions, unless they have a hospital policy against it, or if they believe her instructions to be contrary to the values and preferences of the patient. No indication of this on these facts. Substituted judgment: His agent can rely on his directive to physicians to establish that he wouldn't want to be kept alive in this condition (artificial means of support with no chance of recovery). History of suicide attempts (up to an including this one) is a slender basis on which to base substituted judgment, given the possibility of undertreated or mistreated mental illness (depression severe enough to lead him to attempt suicide). If surgeon is not able to comply, transfer should be looked into.

g. This could be characterized as either discontinuation of unwanted life-support or active euthanasia. The former characterization isn't particularly apt, since the procedure has been done (i.e., the airway has been opened) --  something she might not have consented to if asked, but she wasn't there. Since the statute allows the surrogate to consent to a procedure and then to withdraw consent, she could argue that the only way to effectuate a withdrawal of consent to the tracheostomy would be to close up the tracheostomy wound. On the other hand, the doctors presumed consent, as they were entitled to do under emergency (life-threatening) circumstances. To go back and close up the unwanted air-hole is tantamount to putting a pillow over the face of a patient who is breathing on her own B clearly an act of killing. Under this characterization, the trach isn't "treatment" after it's performed, and so there is no treatment to discuss with Lurleen. Similarly, sewing the gauze in place isn't "treatment," either (unless there is some medical rationale for this; not disclosed by the facts of the question). This is homicide, a crime in all 50 states, and not authorized or immunized by either the Natural Death Act or the DPAHC. Transfer option is technically invoked, but chances of transfer are slim to none.

4.h. Although there is no need to inquire as the patient's values and preferences, once confronted with details of an agent's conflict of interest, the physician must at least pause. Here, there is some indication that the wife has a conflict of interest, though it isn't more of conflict of interest than any spouse would have under the circumstances. The basis for this conclusion, however, is weak, because the source of the charge of conflict is three daughters who may themselves have a financial conflict. In any event, does their allegation shed any light on the patient's values and preferences? Everything he has done, including executing the directive, executing the DPAHC, and trying to kill himself on (at least) three different occasions suggests something less than the daughters' suggested standard of "do everything to keep him alive."

5.i. DNRs can be written unilaterally, and even over the objections of the surrogate decision maker, according the AMA standards, if the physician believes that CPR would be futile. (Even without the benefit of the AMA standards, futility policies of a hospital, if they exist, could be invoked under the circumstances of the question.) Here, there are precious few medical facts given in the problem to support that conclusion, but they wouldn't be hard to imagine. A somewhat mechanical resolution would be to recognize that the agent's choice conflicts with the directive to physicians (assuming CPR falls within the definition of LST, and therefore a DNR order would be a decision about LSTs). Whichever one was executed later in time controls, according to the DPAHC statute. If that means Lurleen's choice trumps the directive, the dilemma doesn't go away. If that means the directive trumps Lurleen, that may give legal authority to write a DNR order, but it doesn't solve the human problem of how to deal with the opposition of the spouse. Another way out of this dilemma is to counsel with Lurleen, perhaps through an ethics committee consultation. Her opposition seems petulant and ill-advised, at least, and at worst bizarre. Perhaps with an opportunity to reflect on the implications of DNR vs. CPR, and with a little more confidence that the physicians are only trying to do the right thing, she will go along.

j. The OOHDNR bracelet wouldn't change much. First of all, it probably wasn't executed validly in the first place, since there is no indication on these facts that he had been certified to have a terminal condition, as required by the statute. Second, the OOHDNR doesn't have any force or effect once the patient is admitted to an acute care hospital. This means that once he was out of the ER and into the ICU, the question of DNR has to be independently assessed and decided.

Part II

1 False; principlism is derivable from both

2 True; JCAHO may require it, but not federal law

3 True; many states have such laws (or court decisions interpreting the WD statute)

4 True; the statute only applies to group health insurers

5 True; the only ban (except in Calif.) is on the use of federal funds

6 False; most states have not passed the necessary legislation and have seen prosecutions fail under existing laws

7 B; the better argument is that although the state law would not have allowed abortion at any time during the pregnancy, it's unconstitutional; therefore, the mom would have been legally entitled to terminate the pregnancy, and a wrongful birth claim would exist. Wrongful conception is just wrong on these facts, and wrongful life is a recognized cause of action only in 3 states, not including Texas. Full credit required a discussion of the impact of the state statute on the mom's ability to get a lawful abortion during the first or second trimester.

8 Assuming anencephaly is an incurably fatal condition, there is no need to ventilate. The question comes down to whether artificial nutrition and hydration (AN&H) can be withheld. The statute says "appropriate N&H" may not be withheld. Thus: C is correct, if you place sufficient weight on "appropriate" as a modifier of "nutrition and hydration" in the Baby Doe regs.. Under this theory, nutrition and hydration are never "appropriate" for an anencephalic newborn. If that's the case, though, the effect of the rule is to make AN&H just as "withholdable" as any other treatment, which raises the question why the drafters would have separately addressed AN&H in the first place. And yet, if AN&H must always be provided, why modify it with "appropriate," which should be presumed? B may also be correct; on this theory, "appropriate" does not speak to "whether or not" but to "how much and what kind"; thus, you always have to provide some kind of nutrition and hydration. Full credit for this question required that you at least address this issue, regardless of how you came out.