Update December 10th: A sorry update to this post is that despite the many groups questioning the ethics and legality of the new protocol, Biros was executed on Tuesday morning. Many questions however still remain over the use of this experimental protocol.
A horrific subversion of human subjects’ research appears to be about to happen in the US state of Ohio in the execution of Kenneth Biros. Much has been written in the past about lethal injection protocols and the likelihood that they do not cause a swift painless death; by contrast researchers have suggested they are more likely to cause suffocation while awake. So instead Ohio appears poised to try a new one drug method of a huge intravenous dose (5g) of sodium thiopental. If that fails then apparently two other sedatives—midazolam and hydromorphone—will be injected intramuscularly.
According to one news report “A three-judge panel of the court ruled last week that the execution could proceed, because the state adopted a new method that Biros had not previously challenged. The full court upheld that decision Friday.” This is legal catch 22 at its worst. By the same argument the court could equally decide that any one of a number of untried methods could be acceptable and deny the defendant the right to challenge the decision.
In defending the state’s right to try new methods, Charles Wille, an assistant Attorney General in Ohio said “Somebody has to be first”.
Leaving aside the legal debate however, this is a clear violation of human subjects’ research and the principles of The Declaration of Helsinki. To cite just a few of the clauses that this decision seems to violate:
Item 9: “Medical research is subject to ethical standards that promote respect for all human subjects and protect their health and rights. Some research populations are particularly vulnerable and need special protection. These include those who cannot give or refuse consent for themselves and those who may be vulnerable to coercion or undue influence.”
The prisoner is clearly refusing consent.
Item 12: “Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation.”
No evidence that I could find has been presented for the scientific basis for this new method.
Item 14 “The design and performance of each research study involving human subjects must be clearly described in a research protocol.”
If such a protocol exists it must be made publicly available.
Item 15 “The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins.”
Did a research ethics committee approve this research?
To allow ad hoc experimentation such as this shames the US justice system. The Judge who allowed the ruling to go ahead was quoted as saying that it was unlikely “those risks [of the new method] rise to the level of violating the United States Constitution”. Whether or not it violates the US constitution, it clearly violates the Declaration of Helsinki, and anyone, especially a physician, who participates in developing or administering this protocol should expect to be held accountable.