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11/15/2013

Does Execution by Lethal Injection Violate the Ethics of Human Research?

by Arthur L. Caplan, PhD

The Governor of Ohio has been wrestling with the question of whether a prisoner soon to be executed can donate his organs.  Ronald Phillips, 40, is scheduled to be executed in the next few days for the 1993 rape and murder of 3-year-old Sheila Marie Evans.  He says he would like to donate his heart and kidney to his family members who may need them.  In fact, execution by electrocution, gassing and lethal injection in an execution chamber do not go well with organ donation.  Execution deliberately tries to get vital bodily organs to stop working.  Organ procurement requires brain death with vital organs undamaged.  They don’t mix.

Rather than worry about organ donation, the Ohio Governor and the growing chorus of commentators on the issue of getting organs from prisoners might want to focus on another more serious question that merits thought and debate.

Ohio prison officials say they do not have enough of the drug pentobarbital to carry out Phillips scheduled execution.  The authorities say they will turn to a combination of two drugs that have never been used before for this purpose in the United States.

Ohio is the latest of several US states looking to new drugs or combinations for use in lethal injections. With major pharmaceutical companies discouraging the use of their products in executions, states are turning to either new drugs for executions or concoctions whipped up by lightly regulated compounding pharmacies.   Reports of botched executions and methodological improvisations by executioners raise a question that few seem willing to seriously entertain—are executions at this point experiments involving prisoners?  If they do meet the US Health and Human Services (HHS) definition of human research then do executions both informed consent and review by a research ethics committee?

Is execution using untested methods research?  Maybe.  The use of new drugs or drug combinations for execution may meet the HHS definition of human research because: 1) it involves collecting data through intervention or interaction with a living individual; 2) is a systematic investigation involving testing and evaluation; and 3) is designed to develop or contribute to generalizable knowledge.

There is no question on 1; data are not only collected, but details are also often reported in the press. It is systematic because it involves documented processes designed to achieve specific endpoints—in this case death.  New methods and “improvements” are considered in the context of extant data. And the novel use of drugs for execution is designed to contribute to generalized knowledge in two ways. First, methods and outcomes are generalized by virtue of knowledge sharing among executioners in every state where executions are being done. Second, generalizable knowledge is generated because details of execution by lethal injection is codified in state laws, which are designed in part as a deterrent to would-be evildoers.

If lethal injection experiments meet the HHS definition of Human Research, the activity is outside the purview of the Office of Human Research Protection (OHRP – the HHS office responsible for oversight and enforcement of human research regulations), because the executions are not research studies funded by HHS (funding determines their purview). On the other hand, many of the drugs used in execution via lethal injection are regulated by the US Food and Drug Administration (FDA). Thus, even though the activity does not meet FDA’s definition of a Clinical Investigation, research involving FDA-regulated drugs is required to undergo review by an Institutional Review Board (IRB).  It may also require informed consent from the would-be test subject –in this case the executee.

If reviewed by an IRB there is a pretty good chance they would deem the new drug or drugs posing “greater than minimal risk”.  If so their use would likely be disapproved, because the risks outweigh the potential benefits to the individual or the knowledge gained. Moreover, the ‘research’ involves prisoners, a vulnerable population entitled to additional protections given the long history of prisoner abuse in medical research.

On the other hand some may consider this to be “minimal risk” research. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.  If “daily life” refers to a healthy individual (ie, the absolute standard), the risks outweigh the benefits. However, if it refers to the daily life of the research subject – who is condemned to execution – it could be argued that the risks involving lethal injection might pose only a minimal risk.  But that seems to stretch the concept past any realistic interpretation.

As for informed consent, well good luck with that.

If no one is sure how to use the drugs that are available to humanely execute prisoners then capital punishment is getting awfully close to human experimentation.  And if that is so then the future of capital punishment may be in grave jeoperdy since it is unlikely to be able to secure the kind of external approval needed to continue the killing of inmates.

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