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. 

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.”