In the Wake of Guatemala: The Case for Voluntary Compensation and Remediation

Abstract

Recently unearthed records reveal that between 1946 and 1948, researchers with the US Public Health Service engaged in nonconsensual inoculation of vulnerable Guatemalan populations with syphilis, gonorrhea, or chancroid.

The US government has issued formal public apologies to the Guatemalan government and its people, and the Presidential Commission for the Study of Bioethical Issues has been tasked with reviewing the historical record and the adequacy of protection of human research participants.

We argue that the US response is insufficient and call for a restitution program directed at the aggrieved parties. We review the lessons of two earlier analogous cases and propose guiding principles upon which such a restitution program could be crafted with the Guatemalan people in mind.

On October 1, 2010, President Obama expressed his profound regret to the Guatemalan people¹ for a recently unearthed study, funded by the National Institutes of Health (NIH) and titled “Investigation of Venereal Diseases in Guatemala,” in which, between 1946 and 1948, vulnerable Guatemalan nationals (including prisoners, prostitutes, and others) were inoculated with syphilis, gonorrhea, and chancroid.^2,3 A statement by Secretary of State Hillary Rodham Clinton and Secretary of Health and Human Services Kathleen Sebelius followed suit in short order.⁴ In response to this revelation, the Presidential Commission for the Study of Bioethical Issues⁵ was asked to conduct

[a] review of human subjects protection to determine if Federal regulations and international standards adequately guard … participants in scientific studies supported by the Federal Government.⁶

In addition, the Presidential Commission was asked to “oversee a thorough fact-finding investigation” into the nature of the study in question.⁶

The recently released report of the Presidential Commission makes it abundantly clear that the nonconsensual experimentation violated research ethics standards in existence at the time.⁷ Indeed, the report concludes that “during this period the basic tenets bearing on informed consent and risk reduction were beginning to be widely recognized and followed in practice.” The report further documents that an individual's legal “right to determine what shall be done with his or her body” was already well established even if “these norms diffused slowly within the medical community.”⁷ This conclusion is supported by the fact that informed consent was routinely used as early as 1943 (in the course of a study at Indiana's Terre Haute penitentiary) by some of the same US Public Health Service (PHS) researchers later found to be involved in the Guatemala study.⁷ Moreover, the Guatemala study occurred at the same time as the issuance of the Nuremberg Code, in which informed consent featured prominently.⁷ Thus, not only should the PHS researchers involved with the Guatemala study have known better, but many of them did.

Although the US government's response is laudatory, we argue that the twin tasks assigned to the Presidential Commission—one prospective and prescriptive, the other retrospective and descriptive—are insufficient and morally abridged. Indeed, hard-earned lessons from past ethical breaches suggest that a morally rounded response should include a compensation and remediation program. Arguments in support of this position abound. First, as a matter of corrective justice, surviving participants or their affected contacts should be made whole (i.e., compensated in full) for injuries sustained. Surviving family members should also be made whole for harm incurred, whether direct (e.g., disease transmission) or indirect in nature. The latter might include emotional distress, loss of consortium, or loss of a family member at a younger age, to name a few possibilities. Second, in keeping with the expressive function of the law,⁸ a compensation and remediation program would more concretely and permanently acknowledge the wrongful nature of the conduct in question. Such a program would also reaffirm the ethical standards undergirding human participant research.

Third, and with an eye toward closure, a case can be made for the imperative of advancing healing and reconciliation. A commitment to provide human and financial capital would constitute an important, and indeed tangible, goodwill gesture to the Guatemalan people. Fourth, a compensation and remediation program could be so tailored to enhance the ethical training of current and future investigators, thereby mitigating potential educational shortcomings and preventing future mishaps. Finally, there is the matter of deterrence. Although imperfect, the recognition that contrition is not enough and that compensation and remediation are expected may obviate gross violations of research ethics in the future.

Examples of voluntary compensation and remediation programs established in the wake of ethics violations are few. Instead, history appears littered with misdeeds characterized by drawn-out, grudging acceptance of responsibility by the alleged perpetrator. In fact, it is rare that the concerns of the aggrieved are recognized absent a lawsuit, frequently of the class-action variety.⁹ Stated differently, the involuntary establishment of compensation and remediation programs appears to constitute the default mode of the offending party. Regrettably, this course of action achieves little but alienation and disaffection. Not unexpectedly, this cycle of inaction is playing itself out yet again with the recent initiation of a class-action suit by those who claim injury from the Guatemala experiments.¹⁰ In recognition of this recurring pattern, the United States would do well in such cases to craft a compensation and remediation program in advance of a possible lawsuit. In the specific case of the Guatemala study, such a compensation system would allow Congress to end the pending litigation, as it has done before in one of the cases that we discuss.¹¹ To inform the crafting of a compensation and remediation program, we discuss two case studies from the annals of US research ethics. Similar lessons could have been gleaned from the aftermath of the chemical warfare experiments carried out with UK nationals at Porton Down.⁹

The compensation and remediation of US nationals exposed to ionizing radiation during nuclear experiments stands out as a leading case study in proactive congressional action. Recognizing its responsibility in the face of a failed class-action lawsuit (Allen v United States),¹¹ Congress passed the Radiation Exposure Compensation Act of 1990¹² to make “partial restitution” to eligible individuals “for the burdens they have borne for the nation as a whole.” Congress further apologized “on behalf of the Nation to the individuals … and their families for the hardships they have endured.” By establishing a Radiation Exposure Compensation Trust Fund with the Department of the Treasury¹³ and a Radiation Exposure Compensation Program with the Department of Justice,¹⁴ Congress in effect established a model compensation and remediation program. To qualify for the Radiation Exposure Compensation Program, claimants were not required to establish causation. Instead, they were obliged to document compensable disease and residence commensurate with the time and place of exposure. At the time of this writing, more than $1.5 billion was disbursed to more than 23 000 approved claimants.¹⁴ This compensation and remediation program could serve as a model for a potential initiative to benefit eligible Guatemalans.

Sadly, study participants of the infamous “Tuskegee Study of Untreated Syphilis in the Negro Male” were never the beneficiaries of a proactive compensation and remediation program. Rather, action was delayed and involuntary, forced by a 1973 class-action lawsuit (Pollard v United States) filed on behalf of study participants and their families.¹⁵ Settled out of court for $10 million, the agreement included a congressionally mandated commitment for the establishment of the Tuskegee Health Benefit Program (THBP) under the jurisdiction of the Centers for Disease Control and Prevention.¹⁶ Designed to ensure lifetime health and medical benefits as well as burial services for living participants and their wives, widows, and offspring, the THBP has stood the test of time. A total of three children and two grandchildren constitute the remaining beneficiaries of the THBP. In addition, federal grants were awarded to Tuskegee University to establish a National Center for Bioethics in Research and Health Care.¹⁷

In retrospect, one wonders if some of the fallout from this infamous episode could have been averted by a more forthright, proactive approach, which might have reduced the lingering distrust of the medical establishment harbored by the African American community. Could such an approach have forestalled the ongoing fear among African Americans of potential medical exploitation, with its resulting single-digit-percentage participation in clinical trials, reluctance to donate blood, or even refusal of routine medical care?

Drawing on the Radiation Exposure and Tuskegee case studies, we suggest that the Presidential Commission consider designing a voluntary compensation and remediation program for the President and Congress to consider. Although many of the details will be subject to political and ethical fine-tuning, the following elements may deserve consideration. First, monetary compensation should be afforded to each documented surviving participant. The spouse or children of surviving participants should be similarly treated subject to documentation of compensable disease and the satisfaction of residence requirements. Second, monetary compensation of a more limited nature should be granted to each surviving spouse, child, or grandchild, or the estate of study participants who cannot document affliction.

Third, a federal grant should be awarded to the Guatemalan government to establish public health programs for the prevention of sexually transmitted infections. These would target vulnerable populations similar to those affected in the study, including female sex workers, male prisoners, and psychiatric inpatients.¹⁸ Fourth, congressional appropriation to the NIH should include such funds to further enhance both research and training in the responsible conduct of global human participant research.

We make this recommendation mindful of several potential difficulties in implementation. First, the poor state of the relevant records may compromise the task of tracking down survivors and their families. Under such circumstances, a program of precisely targeted remediation may have to yield to one that serves individuals with backgrounds similar to those of the victims. Second, poor record keeping may also lead to unmeritorious claims. Under such circumstances, the probability-of-causation model may be more appropriate than the no-causation model undergirding the Radiation Exposure Compensation Act of 1990. Clearly, we do not pretend to offer a ready-to-implement proposal. Instead, we offer some overarching principles, draw on relevant analogs, and, most importantly, press that the issue of remediation be given a serious hearing.

Finally, some may resist endorsing such a compensation and remediation program, preferring instead that the class action be allowed to go forward, thereby producing judicial resolution. Although reasonable minds can differ on the issue, strong counterarguments to a judicial solution abound. Given the state of the Guatemala records, the small extant case law on such claims, the increasingly hostile attitude the Supreme Court has evinced toward class-action litigation,¹⁹ the large portion of any recovery that will go to the lawyers, and the complicated questions of sovereign immunity raised by this case, the plaintiffs’ quest for restitution would be long and uncertain of success.

A legislative settlement along the lines we have outlined offers the opportunity for a swifter and surer form of resolution that can benefit a larger swath of possible victims rather than merely those who bring suit or are represented in the class action. Furthermore, legislative action offers a very public way for the US government to admit and assume responsibility, rather than wait for a federal court to possibly adjudicate it as a violator. Perhaps the balance would be different if judicial proceedings were needed to uncover the facts and determine that the PHS researchers in question violated contemporaneous research ethics standards. However, given the outstanding work of the Presidential Commission, that work has already been done.

The unearthing of the NIH-sponsored study in Guatemala proved jolting and saddening.^2,3 Although the report issued by the Presidential Commission is an essential and indeed commendable first step, we believe that the institution of a voluntary compensation and remediation program for the aggrieved parties is an essential next step. It will help ensure that justice is realized, that healing is initiated, that culpability is tangibly acknowledged, and that a better future is secured through ongoing education and training of investigators. Perhaps most importantly, it will express our collective opprobrium in a manner that reaffirms the cultural norms of a responsible research community.