Anietie Maureen-Ann Akpan
excerpted from: Anietie Maureen-Ann Akpan, Dark Medicine: How the National Research Act Has Failed to Address Racist Practices in Biomedical Experiments Targeting the African-american Community, 11 Seattle Journal for Social Justice 1123-1180, 1136-1152 (Spring, 2013) ( 215 footnotes)
A dark-haired legislator by the name of Edward "Ted" Kennedy sits behind a desk, his hair slightly touched with whispers of gray--indicative of the inherent stress and strain of his career. Across from him sit two elderly African-American men. The young legislator settles himself behind his desk, taps his microphone gently, clears his throat, and asks, "Would you tell us a little about how you heard about this study, how you came to be involved?" This triggers a series of questions that forces the older gentlemen to recall very painful and agonizing periods in their lives.
The beginnings of the NRA were first yielded from the hearings conducted by Senator Ted Kennedy, who was an adamant advocate for the survivors of the Tuskegee syphilis study. Senator Kennedy spearheaded the movement for medical bioethics legislation by the conduction of a series of hearings in the early 1970s in which survivors of the study testified to their experiences. Through these hearings, Senator Kennedy learned from the survivors of the study that the nature of these experiments was nebulously conveyed; therefore, the survivors were unable to properly assess whether or not they should participate. The Senators were alarmed by the survivors' testimony detailing the lack of consent, the menial compensation received by the participants, and the lack of compensation for their spouses and children who caught syphilis due to the subjects remaining untreated for a number of years.
Backed by the testimony at these hearings, Kennedy commenced his expedition to introduce the concept of scientific experiments conducted on humans into the narrative of American law. He first introduced a bill to create a National Human Experimentation Board to regulate biomedical research, but unfortunately, it was unsuccessful. At the wake of his first bill's failure, Kennedy introduced another bill that would be known as the NRA, which was signed into law by President Nixon on July 12, 1974. The NRA created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the Commission). The purpose of the Commission was to serve as an advisory body that creates the ethical and moral framework for medical professionals and scientists conducting experiments that involve human subjects.
Several components of the NRA cover the training of research personnel, which regulates how institutes select members for advisory councils. The NRA also clearly delineates how funds are allocated to research institutions institutions that conduct medical research relating to "the cause, diagnosis, prevention and treatment of the disease or other health problems" are eligible to receive government grants.
A. The NRA's Objectives and Provisions
The NRA also discusses the central role of the secretary of the US Department of Health, Education, and Welfare (now known as the secretary of US Department of Health and Human Services) in ensuring that the provisions of the NRA are properly executed. For example, the secretary is responsible for assessing "current training programs available for the training of biomedical and behavioral research personnel." One of the most important responsibilities of the secretary is the selection of the members of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The careful selection of these members is imperative, as it is the Commission that both "identif[ies] the basic ethical principles which should underlie the conduct of biomedical and behavioral research", and "develop[s] guidelines which should be followed in such research to assure that it is conducted in accordance with such principles."
The unfortunate aspect of this provision (and a large contributing factor to the NRA's deficiencies to be addressed later) is that it never clarifies those guidelines. The NRA also gives the secretary of Health and Human Services power to select members for the National Advisory Council for the Protection of Subjects of Biomedical and Behavioral Research (the Council). Similar to the Commission, the Council functions as an advising entity regarding "the protection of human subjects of biomedical and behavioral research." Although the Commission and the Council fundamentally serve the same purpose, the Commission establishes the moral framework for those conducting experiments, whereas the Council evaluates changes in policies and regulations regarding biomedical research.
The passage of the NRA was historical because it was the first piece of national legislation that recognized the need to protect human subjects in medical and scientific experiments. The fact the NRA's passage was sparked largely by the mistreatment of African-Americans--coupled with its passage during the mid-1970s, when racial tensions were significantly high--illustrates an attempt by lawmakers to protect communities that have historically been seen as more expendable than others. While the creation of the NRA was noble and trailblazing, it unfortunately has both an overflow of provisions that are unnecessary, and a lack of provisions that would ensure the actualization of its intended impact.
The main objective of the NRA is to regulate medical research involving human subjects, and based on the legislative intent of the NRA, it is clear that it is used as a tool to preempt future violations. However, due to its failure to thoroughly address past atrocities, it continues to be inefficient in its execution. There are several components that must be integrated into the NRA in order for it to have its intended impact.
B. The NRA's Inefficiencies
The NRA, though noble in its creation, lacks the necessary provisions to have the impact it seeks. In order to prevent the horrors that it was created to prevent, there are numerous amendments that need to be integrated into the NRA.
1. Absence of the Tuskegee Study
One of the most important and glaringly obvious omissions from the NRA and its notes is the mention of Tuskegee. Although this omission may not seem significant, acknowledging the circumstances that prompted the creation of the legislation plays an integral role in the NRA having a lasting effect, while also appropriately acknowledging those participants in the study who were wronged.
The absence of Tuskegee in the preliminary provisions of the NRA makes for a lack of context as to why the NRA was initially drafted. The NRA was written to protect human subjects targeted due to their race, yet it makes no mention of ensuring that subjects are not selected based on their identification to a specific social group. Until such a provision is written into the NRA, it can never truly give reverence to those who suffered, nor can it reprove the behavior of USPHS officials or others who may conduct future analogous experiments.
2. Absence of Framework for Human Subject Selection
Further, the NRA does not discuss the significance of setting a framework to guide the selection of subjects for any future studies. While it is necessary for doctors to target specific communities when conducting clinical studies, such as a breast cancer study in women where such studies are based on empirical, scientific assertions and not on socialized views of a particular community like the Tuskegee syphilis study, legitimacy in selection of subjects is established. The NRA must address the specificities of how to select subjects, ensuring that selection is not based on biased notions, but rather based on empirically founded hypotheses. Here, the main contention is that the process of selecting subjects must be evidence-based. Such a process ensures that the research being conducted is done so without bias, racial or otherwise, as illustrated by Tuskegee.
3. Absence of Clear "Guidelines" and "Boundaries"
The purpose of the Commission, derived from the NRA, is to "develop guidelines which should be followed in such research to assure that it is conducted in accordance with such [basic ethical] principles." It is not enough to assume that careful, unbiased subject selection falls under these vague "principles," which the Commission must enforce. Rather, guidelines and principles must be clearly and explicitly defined in order to avoid possible future problems.
One can assume that the reasoning behind the broad language used in constructing the NRA was to create an over-inclusive, all-encompassing overtone, ensuring that all similarly situated persons receive its legislative protection. However, comprehending the context in which this act was written, its general, broad language is more harmful than helpful. If the focal point of the NRA is to ensure that humanity is maintained while conducting medical studies or experiments, then specificities must be explained in order to ensure that this objective is upheld.
In particular, section 202 of the NRA exemplifies this glaring lack of specificity. By generally referring to broad "guidelines" and ""boundaries," this portion of the NRA does little to clarify the authors' intentions. If a bright line "boundary" is not defined, it cannot be guaranteed that medical researchers will be aware of crossing it. It then becomes easy to escape liability if negative aftereffects occur.
Section 202 also tasks the Commission with developing guidelines to create the moral framework for physician-scientists to conduct their work. However, there is no discussion in the NRA of exactly how these guidelines will be developed. What will the Commission look to in deciding what the guidelines will be; and how they will be defined?
The NRA also refers to examining the "boundaries between biomedical or behavioral research involving human subjects and the accepted and routine practice of medicine." This again is lacking the specificity necessary in a properly written provision of legislation. While today's doctors have ethics included in their educations, it is unwise to assume that they (or society overall) fully comprehends what such a statement objectively means. An "accepted and routine practice of medicine" is by no means subjective; it is defined by a series of objective and internationally revered set of doctrines. Allowing that portion of the statement to remain as it is welcomes laxity in defining the propriety of physician-scientists' conduct.
The Commission consists of an assortment of experts who all contribute to the task of creating ethical boundaries for biomedical research. The individuals of the Commission are described as people distinguished in various fields of expertise, including medicine, law, theology, as well as behavioral and social sciences. However, the NRA fails to discuss to what extent each expert contributes in creating these boundaries. This Commission may consist of "not more than five" members involved in the biomedical industry. This language is significant because it leaves undecided the question of who the remaining individuals will be in regards to their expertise. If a limit has been placed on the quantity of these particular types of experts, then there should be a clear statement as to how many individuals in law or theology, or any of the mentioned fields of expertise, should or should not be included in the makeup of the Commission as well. Through this type of change, one can ensure that the recommendations made by the Commission are balanced and fair. A well-balanced Commission warrants a well-balanced set of standards, thus at least somewhat guaranteeing that the communities, intended by the NRA, are indeed protected. By eliminating the broad language in sections 201 and 202, the NRA will perform more efficiently in meeting the effects of its objective, and thereby better protecting communities most in need of its legislative protection.
However, there are several other inadvertences that will help make the NRA a stronger remedy for victims of human experimentation. One solution to strengthen remedial measures in the NRA i$ to force researchers to address a study's, or experiment's, definitive purpose. One of the most tragic parts of the Tuskegee study is that the finite objective to the study-- examining possible cures for syphilis--never came to be. A requirement of a finite objective would serve as the most impactful addition made to the NRA. It would ensure that the research entity or agency conducting the study states a definitive and expressly defined purpose to the study. The change would require this purpose to be strictly adhered to. Although it was contended that the rationale behind the Tuskegee study was significant in how it could improve public health, this objective never came to fruition. Over time, a shift occurred in the purpose of the Tuskegee experiment being conducted--from finding a cure for syphilis to examining the effects of syphilis going untreated.
Due to this shift in objectives, the intentions of the USPHS physicians conducting the Tuskegee study went from scientifically-based--with a purpose to benefit general public health--to racially-based, putting one particular community's health in danger. The NRA must include a provision declaring that any research initiated must present a finite, objective purpose to mitigate any possible abuses by researchers. If a change exists in the objectives due to new developments in the experiment, the researching entity must present that new objective and garner the approval of the Commission. This new objective (just as the primary one) must function to benefit the general public and not be used as a way for physician-scientists or researchers to fortify their own personal inquiries.
One of the most glaring omissions from the NRA is its failure to discuss any reprimands for doctors who violate it. Failure to practice medical research in a careful and cautious way is a direct breach of the medical standard of care. For the survivors of the Tuskegee study, breach of medical care resulted in an atrocious aftermath. Wives of the subjects (as well as many of their children) contracted the disease because it went untreated. These results were irreversible, yet despite these facts, no record exists showing that the physicians involved were ever held legally liable for their work or punished in any way.
Although it is true that there are alternative avenues to rebuke doctors and their agencies (e.g., suing for medical malpractice), it is unfair that victims of these past atrocities, as well as the victims of any later breaches of the NRA, were forced to partake in a roundabout path to ensure that medical practitioners were held accountable for their harmful conduct.
Although doctors were held to an ethical standard, this standard during Tuskegee was evidently not strictly enforced or regulated. Lack of regulation, however, by no means releases these physicians from having to conduct themselves ethically. Some scholars suggest that the enforcement of criminal sanctions on physicians is highly unlikely because our dependence on medical professionals is too significant to permit a sudden lack of doctors. It is probable that the medical profession has become so idolized that adjudicators are more resistant to convict. It is also suggested that American law should create motivations for physicians to "see themselves as institutionally embedded." By doing so, doctors would be encouraged to properly analyze the interconnection between "law, medicine, and science as they constantly revisit the challenges of modern medicine."
In response to these proposals, I contend the following: first, criminal sanctions should be imposed on anyone (regardless of their profession) who deliberately endangers someone, as the doctors of Tuskegee did. Physicians are in a position of power and should be held legally liable for conducting any type of study or experiment that takes advantage of that power and would unfairly manipulate or target a specific community over another. Reverence for their profession does not grant medical professionals immunity from legal liability. Second, Professor Larry I. Palmer of Cornell Law School proposes that an institutional analysis is necessary to properly evaluate the issue of human experimentation as opposed to examining individual behavior as "bad professionals." I understand this proposal to mean that the behavior and work of physicians should be evaluated as a corporate body, rather than an individual body.
I do believe it is important to examine the work of medical institutions as a whole (as we see in the example of the USPHS as an agency sponsoring the Tuskegee study) to ensure that medical groups and entities are not conducting themselves in a questionable way. But to propose that physicians are incapable of having even a minor understanding of the nexus between law, morals, and practicing medicine without first seeing themselves as "institutionally embedded" seems a bit overreaching. Yes, the projects of institutions should be examined, but it is individual persons who create the ideas that fuel the projects to begin with. Therefore, individual behavior should be examined in determining legal responsibility. Palmer suggests that supervising the conduct of individual physicians is a job best suited for Congress. I could not agree more with this contention, as this article addresses how properly constructed legislation (in this case, the National Research Act) can shape the behavior of medical personnel to conform to ethical protocol.
Although legislation establishing a universal medical standard of care currently does not exist, one can look to other doctrines that have created a framework for examining human experimentation in a more humane and ethical way. The principles established in the Physician's Oath, and the Nuremburg Code, should be incorporated into the NRA so that the legislation contains a provision that explicitly explains why physicians should be held liable for illegal medical research involving human subjects. No provision is written in the NRA that explains the type of ethical standard that medical professionals should be held to when conducting medical research. While it may be true that most medical professionals hold themselves to strict ethical standards, even without the threat of legal consequences, not having any legally binding provisions that ensure adherence to a certain standard of care would be unwise.
These doctrines are held with well-regarded reverence, and it is expected that all physicians who swear to them will adhere to them. Therefore, it is important that a shift takes place from these doctrines holding no legal weight to those doctrines being the very legal framework by which physicians will be held accountable. Making such doctrines law could yield a universal standard of care to which physicians would be held liable.
Although the ethical standards outlined in these doctrines exemplify what the medical standard of care should be, that alone would not hold physicians legally liable. The only way to ensure that physicians, like those who conducted the Tuskegee study, can be held legally liable is to actually criminalize certain conduct. As no legislation exist that regulated physicians' conduct--illicit or otherwise--the only way to establish liability is by examining their behavior through a criminal law analysis.
The author acknowledges that the terms "African-American" and "Black" are used frequently throughout this article. These words are not used interchangeably, but are deliberately placed in specific portions of the text to reflect each of the terms varying historical connotations.
JD, 2013, St. Mary's University School of Law.