The Nuremberg Code

The Nuremberg Code was introduced in August 1947, after the Nuremberg trials. In these trials, Nazi doctors were con icted of the crimes committed during human experiments on concentration cam! !risoners. It attem!ted to gi e clear rules about what was legal and what was not when conducting human e"!eriments. The code consists of ten !oints. The first and most im!ortant is that an#one !artici!ating in an e"!eriment must gi e informed consent. This means nobod# can be forced to !artici!ate in human e"!eriments. All !artici!ants must understand the !otential ris$s. The code also gi es rules for running the e"!eriments. %or e"am!le, !artici!ants can lea e the e"!eriment if the# want. &octors must sto! the e"!eriment if the# realise it can harm the !atient. Also, no e"!eriment can be made where the ris$s outweigh the benefits that can be had from it. The Nuremberg Code is a set of research ethics !rinci!les for human e"!erimentation set as a result of the 'ubse(uent Nuremberg Trials at the end of the 'econd )orld )ar. BACKGROUND *n August 19, 1947, the +udges deli ered their erdict in the ,&octors- Trial, against .arl /randt and se eral others. The# also deli ered their o!inion on medical e"!erimentation on human beings. 'e eral of the accused had argued that their e"!eriments differed little from !re0war ones and that there was no law that differentiated between legal and illegal e"!eriments. In A!ril of the same #ear, &r. 1eo Ale"ander had submitted to the Counsel for )ar Crimes si" !oints defining legitimate medical research. The trial erdict ado!ted these !oints and added an e"tra four. The ten !oints constituted the ,Nuremberg Code,. Although the legal force of the document was not established and it was not incor!orated directl# into either the American or 2erman law, the Nuremberg Code and the related &eclaration of 3elsin$i are the basis for the Code of %ederal 4egulations Title 45 6olume 47 which are the regulations issued b# the 8nited 'tates &e!artment of 3ealth and 3uman 'er ices go erning federall#0funded human sub+ects research in the 8nited 'tates. In addition, the Nuremberg code has also been incor!orated into the law of indi idual states such as California and other countries Nuremberg code includes such !rinci!les as informed consent and absence of coercion9 !ro!erl# formulated scientific e"!erimentation9 and beneficence towards e"!eriment !artici!ants. THE NUREMBERG CODE %rom Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10 !ol. " pp. 1#1$1#". )ashington, &.C.: 8.'. 2o ernment ;rinting *ffice, 1949. The great weight of the e idence before us is to the effect that certain t#!es of medical e"!eriments on human beings, when $e!t within reasonabl# well0defined bounds, conform to the ethics of the medical !rofession generall#. The !rotagonists of the !ractice of human e"!erimentation +ustif# their iews on the basis that such e"!eriments #ield results for the good of societ# that are un!rocurable b# other methods or means of stud#. All agree, howe er, that certain basic !rinci!les must be obser ed in order to satisf# moral, ethical and legal conce!ts. 1. The oluntar# consent of the human sub+ect is absolutel# essential. This means that the !erson in ol ed should ha e legal ca!acit# to gi e consent9 should be so situated as to be able to e"ercise free !ower of choice, without the inter ention of an# element of force, fraud, deceit, duress, o erreaching, or other ulterior form of constraint9 and should ha e sufficient $nowledge and com!rehension of the elements of the sub+ect matter in ol ed as to be enable him to ma$e an

understanding and enlightened decision. This latter element re(uires that before the acce!tance of an affirmati e decision b# the e"!erimental sub+ect there should be made $nown to him the nature, duration, and !ur!ose of the e"!eriment9 the method and means b# which it is to be conducted9 all incon eniences and hazards reasonabl# to be e"!ected9 and the effects u!on his health or !erson which ma# !ossibl# come from his !artici!ation in the e"!eriment. The dut# and res!onsibilit# for ascertaining the (ualit# of the consent rests u!on each indi idual who initiates, directs, or engages in the e"!eriment. <. The e"!eriment should be such as to #ield fruitful results for the good of societ#, un!rocurable b# other methods or means of stud#, and not random and unnecessar# in nature. =. The e"!eriment should be so designed and based on the results of animal e"!erimentation and a $nowledge of the natural histor# of the disease or other !roblems under stud# that the antici!ated results will +ustif# the !erformance of the e"!eriment. 4. The e"!eriment should be so conducted as to a oid all unnecessar# !h#sical and mental suffering and in+ur#. 5. No e"!eriment should be conducted where there is an a !riori reason to belie e that death or disabling in+ur# will occur9 e"ce!t !erha!s, in those e"!eriments where the e"!erimental !h#sicians also ser e as sub+ects. 7. The degree of ris$ to be ta$en should ne er e"ceed that determined b# the humanitarian im!ortance of the !roblem to be sol ed b# the e"!eriment. 7. ;ro!er !re!arations should be made and ade(uate facilities !ro ided to !rotect the e"!erimental sub+ect against e en remote !ossibilities of in+ur#, disabilit#, or death. >. The e"!eriment should be conducted onl# b# scientificall# (ualified !ersons. The highest degree of s$ill and care should be re(uired through all stages of the e"!eriment of those who conduct or engage in the e"!eriment. 9. &uring the course of the e"!eriment the human sub+ect should be at libert# to bring the e"!eriment to an end if he has reached the !h#sical or mental state where continuation of the e"!eriment seems to him to be im!ossible. 1?. &uring the course of the e"!eriment the scientist in charge must be !re!ared to terminate the e"!eriment at an# stage, if he has !robable cause to belie e in the e"ercise of the good faith, su!erior s$ill and careful +udgement re(uired of him that a continuation of the e"!eriment is li$el# to result in in+ur#, disabilit#, or death to the e"!erimental sub+ect. HISTORY The Nuremberg Code is the !roduct, or might we sa# residue, of the !ost0)orld )ar II trials that were held to !ro ide some degree of accountabilit# for the crimes against humanit# committed during the war. *f course, this introduction is unnecessar# as the historical significance of the e ents that !reci!itated the Nuremberg trials is not lost to an# of us. *ne outcome of the Nuremberg !rocess that is not commonl# $nown was the creation of the Nuremberg Code. )e onl# became aware of !articular s!ecifics of the Code recentl# during the u!roar o er the uninformed e"!osure of humans during arious nuclear radiation e"!eriments. *thers might ha e a longer0term $nowledge of the finer details of the Code. 1et us consider the en ironment in which the Code was created. At that time and !lace there was a s!ecific set of circumstances and acts under scrutin#. Those acts were !rimaril# !erformed b# !h#sicians. @ en so, the resulting Code does not s!ecificall# address the res!onsibilities of !h#sicians. Instead, the Code is more general and refers to human e"!eriments, human sub+ects and scientific e"!erimenters in the most general of terms. At that time there was no awareness or concern of hazards from electromagnetic energ# e"!osure. To our $nowledge no electromagnetic radiation e"!eriments were conducted in the cam!s. And e en had the# been

it would be of no conse(uence as the Nuremberg Code is silent with res!ect to an# !articular t#!e of e"!eriment, !rocedure, e"!osure, or treatment. The Code, b# its generalit#, broadl# encom!asses all human testing. The Code is s!ecific onl# in terms of what must be done to inform human test sub+ects and to guard against the !ossibilit# of harm. The !reamble to the Code, while mentioning medical e"!eriments, !ro ides no indication that the Code should be a!!licable onl# to medical e"!eriments !erformed b# !h#sicians. The !reamble to the Code is, in fact, little more than a general re iew of the incidents that !rom!ted the trials in the first !lace. Certainl#, after ha ing considered the unethical and, in some instances, barbaric actions of the Nuremberg &efendants we cannot infer that the framers of the Code would limit the a!!licabilit# of these basic tenets of fundamental human rights onl# to human test sub+ects about to undergo e"!erimental testing at the hands of !h#sicians. As a matter of fact, the tenets of the Code are silent with res!ect to medical testing9 the Code is entirel# general in the sense that it refers to human sub+ects, human testing, and human e"!eriments. In one instance the Code Aat B1?C refers to ,the scientist in charge,. That-s certainl# not indicati e of a restricti e ,medical e"!eriments onl#, iew. At the time that the Nuremberg Code was drafted the creators could not ha e antici!ated human test sub+ects being sub+ected to radiofre(uenc# A4%C radiation or 4% energ# being !um!ed into the human sub+ectsheads and brains. At that time there were neither cell !hone towers nor !ortable cell !hones9 there were no !ersonal com!uters and no 4% energ# radiating )1ANs in classrooms. The framers could not ha e concei ed of the biological and damaging effects of radiofre(uenc# radiation e"!osure that we ha e learned of since that time. )e must conclude from its er# general !hraseolog# that the Code should a!!l# to all human testing of an# !rotocol that establishes an interaction with the human organism and ma# result in a !h#siological res!onse. Dust as the 8nited 'tates Constitution has been found to include and embrace man# of the circumstances and conditions of !resent societ# unantici!ated b# the crafters of that document, so too must the Nuremberg Code be iewed as a li ing document intended to embrace the conditions of a changing world. The changing conditions at issue toda# include the ca!abilit# of cor!orations to e"!ose humans to thera!eutic doses of 4% radiation and 4% energ# that induces a !h#siological res!onse in those who are e"!osed. 8nder an# conce!t of e"!erimentation such an e"!osure constitutes human testing. In iew of the re elations of the cellular tele!hone industr#, this testing is, in realit#, e"!erimental human testing.