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Informed Consent in the Practice of Pathology

2001; American Medical Association; Volume: 125; Issue: 11 Linguagem: Inglês

10.5858/2001-125-1425-icitpo

1543-2165

Jack R. Bierig,

Healthcare cost, quality, practices

In examining the doctrine of informed consent in the context of pathology practice, it is useful to begin by examining the conceptual underpinnings of the doctrine generally. Why must a physician obtain informed consent from a patient? Is informed consent a statutory obligation imposed by a legislature? Is it an ethical obligation flowing from the fiduciary relationship between physician and patient? Or, is it something even more fundamental?In general, informed consent is not a legislative requirement. Of course, it reflects a judicial concern about the fiduciary responsibility of a physician to the patient, but the doctrine is grounded in something more. That “something more” was first articulated 87 years ago in a case called Schloendorff v Society of New York Hospital (105 NE 92 [NY 1914]). That case involved a physician who discovered a lump in the plaintiff's stomach. The physician advised the patient that he could not diagnose the lump without an ether examination.The patient consented to the examination, but explicitly forbade any operation to remove the lump. The physician performed the examination, diagnosed the lump as a fibroid tumor, and performed an operation to remove the tumor while, as T. S. Eliot wrote in “The Love Song of J. Alfred Prufrock,” the patient was etherized upon the table. Subsequently, when gangrene developed in her arm and some of her fingers had to be amputated, the patient sued.The case reached the highest court of the State of New York. The decision was written by a justice of that court who later went on to serve on the Supreme Court of the United States, Benjamin Cardozo. Significantly, Justice Cardozo did not discuss whether the surgical procedure had been performed negligently. Rather, he noted that the wrong asserted was not merely negligence. It was trespass. He then wrote these words, which are generally thought to summarize the basis for the informed consent doctrine:Or, as the Supreme Court of Kansas put the point 46 years later in 1960, “Anglo-American law starts with the premise of thorough-going self determination. It follows that each man is considered to be master of his own body…” (Natanson v Kline, 350 P2d 1093, 1104 [Kan 1960]). In other words, the need to obtain informed consent arises out of the basic American commitment to individual autonomy.Having touched on the underlying rationale for the doctrine of informed consent, this article explores application of the doctrine in 2 contexts that are of particular importance to pathologists: (1) the autopsy and (2) the use of tissue of a living patient for research purposes. The article concludes with a discussion of a recent Supreme Court case that addresses informed consent in a very interesting context.With respect to autopsy practice, informed consent issues generally arise in 2 areas: (1) consent to perform an autopsy and (2) consent to harvest organs for transplantation.In addressing the need for consent to perform an autopsy, it is necessary at the outset to distinguish between autopsies that are authorized by law and those that are not. Most, if not all, states have laws authorizing the medical examiner or coroner to perform an autopsy in certain, enumerated categories of death. Generally, these categories involve suspicious or unexplained causes of death.Where an autopsy is performed by a medical examiner pursuant to a statute that explicitly authorizes the procedure, consent is generally not required. There is, however, a very important exception. This exception relates to performance of an otherwise legally required autopsy when the decedent or the next of kin has a religious objection. In that situation, consent may be required.An illustrative case is You Van Yang v Sturner (728 F Supp 845 [D RI 1990]). In that case, the chief medical examiner of Rhode Island performed an autopsy on a 23-year-old man who died after suffering a seizure while sleeping. Governing state law authorized an autopsy if the medical examiner had a reasonable belief that the cause of death was attributable to, among other things, (1) an infectious agent capable of spreading an epidemic or (2) suspicious circumstances. The examiner concluded that both of these criteria were satisfied.However, the decedent and his parents were Hmongs. The Hmong religion prohibits any mutilation of the body, including autopsies. The parents of the decedent sued the medical examiner for violating their rights and those of their son to the free exercise of their religion. Notably, Rhode Island, unlike some other states, did not at the time have a law requiring medical examiners to refrain from performing autopsies over religious objections.Nevertheless, the court ruled against the medical examiner. It held that “a ‘reasonable’ medical examiner … would know that certain people and religions abhor autopsies as a violation of their deeply held beliefs. Such an examiner would know which religions and people hold those beliefs” (You Van Yang, 728 F Supp at 855). This decision strongly suggests that, in the absence of a compelling need to perform an autopsy, a medical examiner should obtain consent from the next of kin before performing even an autopsy that is authorized by statute, if the examiner has even the slightest reason to suspect a possible religious objection. See Weberman v Zugibe (394 NYS2d 371, 372 [S Ct NY 1977]), enjoining performance of autopsy “over the religious, ethical or philosophical objections of a decedent's family, absent a showing of genuine necessity therefor.”As of 1997, at least 7 states—California, Louisiana, Maryland, New Jersey, New York, Ohio, and Rhode Island—had specific statutes requiring the medical examiner to take into account the religious beliefs of the decedent and next of kin before performing an autopsy. Clearly, in those states, the medical examiner should determine whether there may be a religious objection and obtain consent from the next of kin. Even in the absence of a statute, the medical examiner is well advised to check out religious issues before performing an autopsy, as You Van Yang demonstrates.For autopsies that are not required by statute, the law is absolutely clear: an autopsy cannot be performed without the informed consent of the next of kin. But, consider this question: if informed consent is based on the right of every human being of adult years and sound mind to determine what to do with his or her body, why does informed consent even enter into the picture when the individual is dead—and thus not of sound mind?The answer is that, in the autopsy context, the doctrine of informed consent arises out of a very different set of values. Those values are summed up as the right of the next of kin to bury a deceased family member in the condition that the body was in at the time of death, that is, without mutilation. See, eg, French v Ochnsner Clinic (200 So2d 371 [La App 1967]); Grad v Kaasa (314 SE2d 755 [NC App 1984]); Scarpaci v Milwaukee County (292 NW2d 816 [Wis 1980]). To secure that right, our society requires informed consent prior to the performance of an autopsy. To be sure, the legislature has determined that, in some situations, competing considerations, such as the need to detect and prosecute wrongdoing or the need to avoid epidemics, override that right. However, in general, informed consent is required.What level of detail is needed in securing informed consent? If the consent authorizes an autopsy of only one part of the anatomy but the autopsy extends to other parts, it is likely that a court will find that consent was not given for the autopsy that was performed. Similarly, consent to an autopsy does not authorize use of the decedent's organs for any purpose other than the autopsy. Thus, consent to an autopsy does not authorize harvesting of organs unless the consent includes specific permission for such harvesting. The bottom line here is that the consent should be as specific as possible in terms of the scope of the autopsy and any uses that might be made of the decedent's organs.With respect to the harvesting of organs for transplantation or other purposes, the rule is generally the same as with respect to the autopsy generally; that is, informed consent must be obtained either from the decedent while alive or from the next of kin. Or, to paraphrase a slogan that was popular in the American colonies before the Revolutionary War, “No transplantation without representation.”The complication here is that some state laws explicitly authorize medical examiners to harvest organs without consent if they have no knowledge of any objection to the harvesting. These laws are designed to effectuate the important social policy of increasing the number of organs available for living persons who are desperately in need of such organs.It would seem that, in states which have such laws, the medical examiner need not obtain consent. However, in 2 cases, the United States Court of Appeals in Cincinnati has ruled that even in a state that has such a law, a medical examiner may be violating federal law by harvesting corneas without the consent of the next of kin. One of these cases, Brotherton v Cleveland (923 F2d 477 [6th Cir 1991]), arose in Ohio. The other, Whaley v County of Tuscola (58 F3d 111 [6th Cir 1995]), arose in Michigan.In the final analysis, the medical examiner may win these cases under a legal doctrine called “official immunity,” but the exposure is significant. That is why medical examiners should recognize that harvesting organs without consent can involve risk, even when a state law seems to permit this practice.Let's move on to informed consent requirements in the context of obtaining tissue of a living person for research. For analytical purposes, this topic is best divided into 2 subjects: (1) state law requirements for obtaining informed consent for use of tissue in research and (2) federal requirements imposed by recently issued regulations implementing the privacy provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).A good way to review state law requirements is to consider 2 important cases. The first is the well-known case of Moore v Regents of the University of California (793 P2d 479 [Cal 1990]), decided by the Supreme Court of California in 1990. There, John Moore was diagnosed with hairy cell leukemia. Even before his spleen was removed, his physician at the University of California, Los Angeles (UCLA) had ascertained that Moore's spleen had T lymphocytes with certain unique characteristics that permitted development of a cell line with potential therapeutic value. The physician and his colleagues at UCLA proceeded to develop this line, which was estimated to have a market value of $3 billion in 1990. However, in order to nurture and develop the cell line, they periodically needed Mr Moore to provide samples of his blood, blood serum, skin, bone marrow aspirate, and sperm.The university obtained informed consent for the removal of Moore's spleen. At no time, however, did UCLA obtain his consent to develop the cell line. Quite to the contrary, the physicians told Moore that they needed to take blood samples in order to follow his medical progress. However, when Moore moved to Seattle, Wash, and UCLA offered to pay him to come to Los Angeles periodically, he became suspicious and hired a lawyer.After the facts came to light, Moore sued for a share of the profits in the cell line that had been developed using his spleen. He made 2 basic claims. First, he asserted that his physician had violated the physician's fiduciary duty in failing to disclose that Moore's spleen would be used to culture a cell line. Second, he asserted that the defendants had misappropriated his cells and tissues. The university's basic defense was that Moore had no further interest in his spleen because he wanted it removed—and was willing to have it discarded.The case went up to the Supreme Court of California. On the first theory, the Court held that “a physician who is seeking a patient's consent for a medical procedure must, in order to satisfy his fiduciary duty and to obtain the patient's informed consent, disclose personal interests unrelated to the patient's health, whether research or economic, that may affect his medical judgment.” The Court acknowledged that there may be some information that is so remote from the patient's decision that it would not need to be disclosed. However, in its view, intentions related to research would not fall into this category.Rather, in the opinion of the Supreme Court of California, a physician who has an interest in research on tissue taken from a patient has potentially conflicting loyalties. Specifically, there is at least a theoretical risk that, either consciously or unconsciously, the physician might recommend a procedure in part to further the physician's personal interest in research. Therefore, disclosure of the research interest is required.On the claim of misappropriation, the Court found that a patient does not have a property interest in his or her cells. Although it acknowledged that a patient does have rights of privacy and autonomy with respect to his or her body, the Court felt that these rights would be adequately protected under the right of the patient to receive all relevant information as part of the informed consent process. Thus, over 2 strong dissents, the Court did not permit the misappropriation claim.The Court did not address the issue of what happens if a physician has no research interest at the time that the tissue is taken but develops that interest later. Of course, if the physician has to continue collecting specimens from the patient, as the UCLA physicians did with Mr Moore, a need for informed consent will arise at that point. But what if there is no need to see the patient again?The Moore case does not reach this question. In my view, however, with 2 potentially significant exceptions, there should be no need to obtain consent to perform research on excised tissue if the decision to do the research is formed after the tissue is taken. In these circumstances, there can be no allegation that a desire for a research specimen influenced a recommendation for a medical procedure. Moreover, the patient generally has little interest in the tissue.The first exception arises when it appears that the research may yield significant economic value. In that situation, the patient may have a financial interest, and the right course, both ethically and legally, is to inform the patient. To be sure, the Moore Court held that a patient has no property interest in his or her cells. But as already noted, there were 2 strong dissents on that issue. Thus, it is possible that if the issue were to arise in a state other than California, a very different result may be reached.The second exception occurs when the nature of the research may be offensive to the patient whose tissue is involved. Such a case might arise, for example, if tissue of an aborted fetus were involved. In this situation, use of the tissue for research purposes might offend the religious beliefs of the woman from whom the tissue was taken. In these circumstances, I believe that informed consent should be obtained.Somewhat related issues are currently being litigated in a case pending in federal court in Chicago, Ill. The case, Greenberg v Miami Children's Hospital, is brought by a group of parents who had children with Canavan disease, a fatal genetic disorder that occurs most frequently in Ashkenazi Jews.In the 1980s, there was no test to identify a carrier of the recessive gene for Canavan disease and no test to identify a fetus with the disease. At that time, the parents interested a medical geneticist in trying to isolate the gene for Canavan disease. They assisted this physician by providing information, financial resources, and tissue samples from themselves and their children, including autopsy samples from their deceased children. They identified other individuals around the world who could contribute information, samples, and financial resources to the research. Their intent was to attempt to find a diagnostic test or a treatment for the disease. However, they imposed no written restrictions on the researcher.The researcher and his team used the information and samples provided by the parents and ultimately isolated the Canavan disease gene. However, without the parents' knowledge, Miami Children's Hospital, where the researcher was on staff, applied for and received a patent on a method for carrier and prenatal testing. The researcher was listed as the inventor. Miami Children's Hospital used the patent to restrict access to the diagnostic test for Canavan disease to a few laboratories around the country.The parents, of course, had consented to use of the donated specimens in research. In fact, they had encouraged the research. They were furious, however, when they discovered that Miami Children's Hospital was profiting from the discovery and restricting access to the test. So, the parents sued. They alleged a breach of a duty to provide informed consent. Specifically, they alleged that the researcher should have disclosed that the hospital intended to obtain and enforce a patent. The parents claimed that if the researcher had made that disclosure, they would not have consented to his research. Instead, they would have found a different researcher.It has been said that to be legally valid, consent must have 4 characteristics: it must be competent, voluntary, informed, and understanding. The decision in the Miami Children's case should shed new light on the third of these elements; that is, in the research context, what sort of disclosure is needed to make consent informed?Specifically, if the plaintiffs prevail in the Miami Children's case, it will not be sufficient for a physician to ensure that the patient is aware that his or her samples will be used in research. Rather, the physician will also need to make sure that the patient understands the researcher's intent with respect to the use of the results of the research. As illustrated by the Miami Children's case, at least for some people, this information is a critical piece of the informed consent decision-making process.Turning to federal law, HIPAA requires health care plans, health care clearinghouses, and certain health care providers who transmit health care information electronically to establish privacy protections for all individually identifiable health information—even information transmitted on paper or orally. Pathologists, researchers, laboratories, hospitals, and most other covered entities will have to be in compliance by April 14, 2003. With respect to research, HIPAA will impact both the way researchers obtain informed consent from participants in research and the way that they use protected health information in their studies.It is important to understand that the HIPAA regulations are predicated on fundamentally different values than are state informed consent requirements. Although both may loosely be said to be designed to protect a right of privacy, that right has 2 major branches: a right to autonomy in decision making and a right to confidentiality of personal information. State law advances the former interest. The HIPAA regulations protect the latter.Thus, the threshold question in evaluating whether HIPAA will apply to a particular research project is to determine whether the information involved in the research is individually identifiable health information that is protected under HIPAA. Information is not subject to HIPAA if it does not identify an individual and there is no reasonable basis to believe that it could be used to identify an individual (45 CFR §164.502[d] and §164.514[a]–[c]).The HIPAA regulations provide 2 different ways for a laboratory or pathologist to classify information as not individually identifiable, or “de-identified.” The first option is to obtain a determination from a person with appropriate statistical and scientific knowledge and experience that the risk of re-identification is very small (45 CFR §164.514[b][1]). For many pathologists, however, obtaining this type of approval may be impractical.Alternatively, information is de-identified if it lacks any type of unique identifying characteristics, including 18 identifiers designated in the regulations (45 CFR §164.514[b][2]). The identifiers listed in the privacy regulations include common identifiers, such as names, addresses, telephone numbers, fax numbers, e-mail addresses, social security numbers, medical record numbers, health plan membership numbers, and zip codes. They also include less common identifiers, such as specific age information on any individual older than 90 years.Therefore, even if a pathologist has eliminated the patient's name, but the sample indicates that the patient is “92 years old” or that the patient lives in a certain zip code, the specimen is considered to contain identifiable information. The most effective way to de-identify a sample would be to strip it of all of the listed identifiers. For example, a sample would not be subject to HIPAA if it were labeled generically, such as “35-year-old white male.” Another option is to label information with a code and to guard the key so that no third party could identify the patient.For use of a patient's protected health information for treatment, payment, or something called “health care operations,” most health care providers must obtain written consent from the patient (45 CFR §164.506). Significantly, however, this consent requirement does not apply to providers, such as laboratories or pathologists, that have an “indirect treatment relationship” with patients (45 CFR §164.506[a][2][i]). An indirect treatment relationship exists when a laboratory or pathologist delivers health care to an individual based on orders from another provider and reports the results back to the provider rather than to the patient (45 CFR §164.501).Although laboratories and pathologists will generally not be subject to the consent requirement under HIPAA for uses of protected health information for treatment, payment, or health care operations, they will have to obtain a special kind of consent called “authorization” if they wish to use a patient's identifiable protected health information in connection with research purposes (45 CFR §164.508[a]). An authorization under HIPAA must provide 3 pieces of information: (1) a description of the information to be used or disclosed, (2) identification of who is permitted to make use of or disclose the information, and (3) a description of who is permitted to receive the information (45 CFR §164.508[c][1][i]–[iii]). These descriptions should be specific and meaningful. They must be written in plain English so that they are understandable; they cannot be hidden behind medical jargon (45 CFR §164.508[c][2]).For example, the description of the information to be used or disclosed may be explained as “all pathology samples obtained in July 2000,” or “all pathology samples obtained by Dr Smith,” or “the patient's entire medical record.” The description of who may use or disclose the information should indicate a specific person or persons, or a specific class of people. For example, the authorization may state that the information may be used by Dr Jones, or that it may be used by all pathologists at a certain hospital, or even that it may be used by all pathologists, nurses, and other medical practitioners at a specific hospital. Similarly, the description of who may receive the information should list all expected recipients or classes of expected recipients. For example, the authorization may state that as part of the research, the information may be disclosed to hospital administrators, organizations providing grant funds, academic journals publishing articles on the research topic, and pharmaceutical companies that are interested in manufacturing drugs to use in treating the disease.Quite apart from consent and authorization requirements, HIPAA requires that all uses and disclosures be tailored as narrowly as possible to provide the maximum amount of privacy protection. With certain exceptions, a pathologist must limit uses and disclosures of protected health information to the minimum amount necessary to accomplish the purpose of the use or disclosure (45 CFR §164.502[b] and §164.514[d]). For example, even if the authorization would permit the pathologist to disclose a patient's entire medical record, if the purpose of the disclosure can be accomplished by disclosing just a portion of the record, the pathologist should not disclose any portion of the file that would be irrelevant to the recipient's purpose.The HIPAA regulations provide 3 significant exceptions to the authorization requirement. Most importantly, the authorization requirement may be waived or altered by either an Institutional Review Board or a privacy board that meets certain requirements (45 CFR §164.512[i][1][i]).Second, an authorization is not necessary if the research will be limited to reviewing information in preparation for research (45 CFR §164.512[i][1][ii]). For example, a researcher may use protected health information without authorization to assist in the development of a hypothesis or research protocol or to aid in the recruitment of research participants. If authorization is waived pursuant to this provision, the researcher must ensure that no protected health information is removed from the location during the course of review.Finally, an authorization is not required if the research will relate solely to protected health information belonging to deceased persons (45 CFR §164.512[i][1][iii]). For example, a pathologist will not need to obtain authorization if the research is limited to autopsy samples. Although the information of deceased individuals is protected under the privacy rules in other circumstances, it may be used for research purposes without obtaining an authorization to do so.Remember, however, that even if a pathologist's research does not require authorization because it meets one of the exceptions above, the pathologist must still comply with the other requirements under HIPAA, as well as state law requirements relating to the research.In short, once the HIPAA regulations become effective in 2003, obtaining the informed consent required under general state law may not be sufficient. Instead, physicians using individually identifiable health information for research purposes will in many cases need to obtain authorization forms that will also meet HIPAA's strict content requirements. It will be important to identify whether research will meet one of HIPAA's exceptions. If not, the researcher will need to obtain an informed consent that will meet the requirements in HIPAA.Finally, the Supreme Court recently decided an interesting informed consent case, Ferguson v City of Charleston (_US_, 69 USLW 4184 [March 21, 2001]). That case involved a program of the Medical University of South Carolina for testing the urine of maternity patients who were suspected of using cocaine. Under the program as it has existed since 1990, a woman whose urine tested positive either could consent to substance abuse treatment or would be referred to the police for criminal prosecution. The purpose of the program was to get at the problem of “crack babies” by giving pregnant women a strong incentive to obtain treatment for their drug problem.Ten women who received obstetrical care at the Medical University and who were arrested after testing positive for cocaine sued the university. They alleged that using drug tests for criminal investigative purposes violated their rights to be free from unreasonable searches and seizures. One of the defenses of the hospital was that the women had consented to the tests as part of their maternity care. In response, the patients made 3 arguments:The Supreme Court, over 3 dissents, sent the case back to the trial court to enable the jury to decide whether informed consent had been given. However, the Court did make this rather telling observation:Thus, the Court has reemphasized the value that society places on medical privacy in the laboratory context and the importance of obtaining informed consent before a patient's tissue can be used for law enforcement purposes.Pathology departments and pathology groups are well advised to put procedures in place addressing the need to obtain informed consent before performing an autopsy, harvesting organs, or using tissue for research purposes. The procedures should outline both the circumstances in which consent is needed and the scope of the consent in the various contexts. These procedures should reflect the requirements both of applicable state law and of the federal HIPAA regulations. In drafting the procedures, the pathology department or group may want to seek the input of an attorney knowledgeable about these issues. Similarly, if a difficult question arises in implementing the procedures, it may be useful to obtain the advice of a knowledgeable attorney.