USA | Should Medical Research Regulations and Informed Consent Principles Apply to States’ Use of Experimental Execution Methods?

New drugs and med­ical treat­ments under­go rig­or­ous test­ing to ensure they are safe and effec­tive for pub­lic use. Under fed­er­al and state reg­u­la­tions, this test­ing typ­i­cal­ly involves clin­i­cal tri­als with human sub­jects, who face sig­nif­i­cant health and safe­ty risks as the first peo­ple exposed to exper­i­men­tal treat­ments. That is why the law requires them to be ful­ly informed of the poten­tial effects and give their vol­un­tary con­sent to par­tic­i­pate in trials.

Yet these reg­u­la­tions have not been fol­lowed when states seek to use nov­el and untest­ed exe­cu­tion meth­ods — sub­ject­ing pris­on­ers to poten­tial­ly tor­tur­ous and uncon­sti­tu­tion­al­ly painful deaths. Some experts and advo­cates argue that states must be bound by the eth­i­cal and human rights prin­ci­ples of bio­med­ical research before using these meth­ods on prisoners.

Nitrogen Gas

Nitrogen gas exe­cu­tion was first pro­posed by an Oklahoma state leg­is­la­tor, based on a doc­u­men­tary by a British TV per­son­al­i­ty — nei­ther of whom had any med­ical train­ing or expe­ri­ence. Veterinarians advise against using nitro­gen gas to euth­a­nize ani­mals based on evi­dence that the ani­mals suf­fer dur­ing the process. But when Alabama sched­uled the first nitro­gen gas exe­cu­tion in his­to­ry for January 25, 2024, vir­tu­al­ly no reg­u­la­to­ry bar­ri­ers stood in its way. The state released a heav­i­ly redact­ed exe­cu­tion pro­to­col that left many details of the method hazy. Lawsuits chal­leng­ing the method by the con­demned pris­on­er, Kenneth Smith, and oth­er death-sen­tenced Alabama pris­on­ers have been most­ly unsuc­cess­ful. Courts have large­ly accept­ed the state’s claims that the method would be ​“humane” and ​“pain­less,” caus­ing uncon­scious­ness in ​“sec­onds.”

By con­trast, Mr. Smith and the sev­en men that have since been exe­cut­ed using nitro­gen gas dis­played a dis­turb­ing pat­tern of reac­tions, sum­ma­rized vivid­ly by Supreme Court Justice Sonia Sotomayor: ​“appar­ent con­scious­ness for min­utes, not sec­onds; and vio­lent con­vuls­ing, eyes bulging, con­sis­tent thrash­ing against the restraints, and clear gasp­ing for the air that will not come.” She wrote in dis­sent in Mr. Smith’s case that Alabama ​“select­ed him as its ​‘guinea pig’ to test a method of exe­cu­tion nev­er attempt­ed before,” and the Supreme Court had allowed the state to ​“experiment…with a human life.” In a dis­sent from the Court’s deci­sion to deny review of Anthony Boyd’s appeal, Justice Sotomayor argued that ​“when a State intro­duces an exper­i­men­tal method of exe­cu­tion that super­adds psy­cho­log­i­cal ter­ror as a nec­es­sary fea­ture of its suc­cess­ful com­ple­tion, courts should enforce the Eighth Amendment’s man­date against cru­el and unusu­al pun­ish­ment.” Mr. Boyd’s exe­cu­tion was lat­er wide­ly described as ​“botched.”

Justice Sotomayor’s con­cerns that nitro­gen gas is tor­tur­ous­ly ​“exper­i­men­tal” have echoed around the world. Following Mr. Smith’s exe­cu­tion, four United Nations Special Rapporteurs point­ed to the International Covenant on Civil and Political Rights (ICCPR), which holds that ​“no one shall be sub­ject­ed with­out his free con­sent to med­ical or sci­en­tif­ic exper­i­men­ta­tion.” The Special Rapporteurs argued that ​“Alabama’s use of Kenneth Smith as a human guinea pig to test a new method of exe­cu­tion amount­ed to uneth­i­cal human exper­i­men­ta­tion and was noth­ing short of State-sanc­tioned tor­ture.” The ​“use, for the first time in humans and on an exper­i­men­tal basis, of a method of exe­cu­tion that has been shown to cause suf­fer­ing in ani­mals is sim­ply out­ra­geous,” they wrote.

Lethal Injection

This is not the first time con­cerns have been raised about exper­i­men­tal exe­cu­tions. In the past two decades, state offi­cials have altered lethal injec­tion pro­to­cols numer­ous times, claim­ing that drug short­ages have forced them to turn to oth­er sources and untest­ed com­bi­na­tions of drugs. Lethal injec­tion is less a sin­gu­lar exe­cu­tion method than an umbrel­la term for dozens of dif­fer­ent drug com­bi­na­tions and dosages — some with lit­tle or no research to sup­port their use. Like nitro­gen gas, some of the drugs used are con­sid­ered inhu­mane for ani­mal euthana­sia. (1) And exe­cu­tion secre­cy laws have allowed states to hide their sources, effec­tive­ly block­ing over­sight of the qual­i­ty, puri­ty, or effi­ca­cy of the drugs. One researcher described lethal injec­tion in 2008 as ​“a nation­wide, gov­ern­ment-spon­sored clin­i­cal tri­al gone horribly awry.”

Regulation of Methods of Execution?

What would it look like for nitro­gen gas, lethal injec­tion, and oth­er meth­ods of exe­cu­tion to be reg­u­lat­ed the same way as drugs and med­ical treat­ments? In a com­pre­hen­sive 2015 arti­cle, Professor Seema K. Shah argued:

“Prisoners are con­sid­ered a vul­ner­a­ble pop­u­la­tion, and exper­i­men­tal exe­cu­tions involv­ing pris­on­ers should abide by the gen­er­al prin­ci­ples that are applic­a­ble to research: respect for auton­o­my, non-malef­i­cence, and jus­tice. Second, legal safe­guards that fol­low from these prin­ci­ples should be applied to exe­cu­tions — in par­tic­u­lar, states should ask for informed con­sent from pris­on­ers to mod­i­fi­ca­tions of lethal injec­tion pro­to­cols, obtain inde­pen­dent review by a reg­u­la­to­ry body like the Food and Drug Administration, and apply a stan­dard requir­ing risk min­i­miza­tion in the choice of drugs and pro­ce­dures. Finally, states should sys­tem­at­i­cal­ly gath­er data as they engage in experimental execution.”

Professor Shah reviewed the dark his­to­ry of exper­i­ments on pris­on­ers, who have been sub­ject­ed to dan­ger­ous research projects for cen­turies; at one point in the 1970s, they com­prised 85% of the sub­jects of phase I clin­i­cal tri­als. For instance, in 1906, sev­er­al death-sen­tenced pris­on­ers in the Philippines died after an American doc­tor inject­ed them with plague serum and withheld food.

In 1973, con­gres­sion­al lead­ers heard con­cerns about ​“exploita­tion, secre­cy, dan­ger, and the impos­si­bil­i­ty of obtain­ing informed con­sent” dur­ing pris­on­er exper­i­ments, and a nation­al com­mis­sion to pro­tect human research sub­jects was sub­se­quent­ly estab­lished. That com­mis­sion has strong­ly advised against exper­i­ment­ing on pris­on­ers in most cas­es because ​“the con­di­tions of social and eco­nom­ic depri­va­tion in which they live com­pro­mise their free­dom.” In oth­er words, the inher­ent­ly coer­cive nature of a prison pre­vents its inhab­i­tants from exer­cis­ing a mean­ing­ful choice to under­go poten­tial­ly harm­ful treat­ments — or to ​“choose” how they will be exe­cut­ed among avail­able meth­ods. The coer­cion is exac­er­bat­ed because of the immi­nent threat of death and secre­cy laws that deny pris­on­ers mean­ing­ful infor­ma­tion about what their decision entails.

Executions have not adhered to the stan­dards of val­i­dat­ing med­ical prac­tice, which would require care­ful extrap­o­la­tion from exist­ing data and/​or rig­or­ous data gath­er­ing in humans to find an effec­tive approach that does not exceed the Eighth Amendment’s restric­tions on risks of pain and suf­fer­ing. States have also failed to take account of the prin­ci­ples and legal require­ments gov­ern­ing bio­med­ical research, includ­ing obtain­ing inde­pen­dent review, informed con­sent, and min­i­miz­ing risks. Adherence to those prin­ci­ples would pro­tect [pris­on­ers] against exces­sive and unnecessary risks.

— Professor Seema K. Shah (2015)

Professor Shah acknowl­edged the pos­si­bil­i­ty that such reg­u­la­tions, if imposed, might pro­hib­it cer­tain meth­ods of exe­cu­tion entire­ly — but argued that fideli­ty to eth­i­cal and human rights prin­ci­ples must take prece­dence over main­tain­ing the via­bil­i­ty of spe­cif­ic meth­ods of pun­ish­ment. It may be that a new reg­u­la­to­ry sys­tem could do more to pro­tect against the use of untest­ed meth­ods of exe­cu­tion than the legal sys­tem can. Justice Sotomayor’s dis­sent in Boyd was full of warn­ing: ​“Allowing the nitro­gen hypox­ia exper­i­ment to con­tin­ue despite mount­ing and unbro­ken evi­dence that it vio­lates the Constitution by inflict­ing unnec­es­sary suf­fer­ing fails to pro­tect the dig­ni­ty of the Nation we have been, the Nation we are, and the Nation we aspire to be.”

(1) For instance, pan­curo­ni­um bro­mide is a par­a­lyt­ic con­demned as inhu­mane by vet­eri­nary asso­ci­a­tions because it masks the animal’s suf­fer­ing, yet it was used for exe­cu­tions by dozens of states and is still autho­rized in Montana and South Dakota today. For more infor­ma­tion, see DPI’s State-by-State Execution Protocols and Adam Liptak’s arti­cle in the sources section. 

Source: Death Penalty Information Center, Leah Roemer, December 12, 2025

"One is absolutely sickened, not by the crimes that the wicked have committed,
but by the punishments that the good have inflicted."

— Oscar Wilde