tuskgees study handouts

8/15/2019 Tuskgees Study Handouts

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all living articiants# The Tuskegee Health 7enefit Progra" 8TH7P was established to rovidethese services# In 19:, wives, widows and offsring were added to the rogra"# In 199:, the rogra" was e-anded to include health as well as "edical benefits# The ;enters for .I


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19"# %SPHS establishes $aid Treat"ent ;enters$ to treat syhilisA "en in study are nottreated, but syhilis declines#

192 7eginning in 19/, 12 black "edical students are rotated through unit doing the study#

198 ;oncern raised about ethics of study by Peter 7u-tun and others#

199 ;


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T$S%E&EE S'()*+*S ST$,'

* don-t kno. .hat they used us /or * .ill neer understand the study

a surior

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In 1933, the %#S Public Health Service in 'acon ;ounty, .lba"a began an investigation to chartthe succession of haseDs syhilis e-hibits when left to itself, unco"licated by other "orbid rocesses and un"olested by active treat"ent# 399 .frican4."erican "en with latent syhilisand 2)1 "en without disease were enrolled in the study based on the results of a 193) venereal

diseases control ro!ects survey# This survey had identified 'acon ;ounty to have the highest revalance of syhilis of the si- southern States e-a"ined# The rural setting of Tuskegee 4 aderived socioecono"ic status,high rates of illiteracy and esecially a aucity of "edical care 4were e-loited by the investigators of the syhilis study who led the oor sharecroers to believe they were being treated for $bad blood,$ a euhe"is" for syhilis# The study, whichlasted for /) years included only soradic clinical ree-a"inations when a PublicHealth hysician ca"e to Tuskegee and denied the individuals any for" of anti4syhilitic theray# In fact, in 19/2 when it was brought to the attention of the then.ssistant Surgeon Eeneral, =onderlehr that so"e of the syhilitic sub!ects were beingcalled for e-a"ination rior to induction into the .r"ed @orces and were being directed toundergo treat"ent syste"atic stes were taken to reserve the investigation# To revent the

draftees fro" receiving anti4syhilitic treat"ent, the investigators rovided the 'acon ;ountySelective Service 7oard with a list of 2:( na"es of "en under the age of /: years who were to be e-cluded fro" the list of draftees needing treat"ent# The 7oard agreed to e-clude these "en#@urther"ore, when the "odern4era of anti4syhilitc theray began in 19/3 with the introductionof enicillin as an effective drug, the Public Health Service did not use the drug on the Tuskegee articiants unless they asked for it# The rationale ublished by the investigators for their decision regarding the lack of treat"ent rovided to the infected $&egro$ oulation was,

"...Such individuals seemed to offer an unusual opportunity to study the untreated syphilitic

patients from the beginning of the disease to the death of the infected person. An opportunity was

also offered to compare the syphilitic process uninfluenced by modern treatment, with the results

attained when treatment had been given." (6)

7y the ti"e the study was e-osed in 192 and ended on &ove"ber 1( th of the sa"e year, 2F

"en had died of syhilis, 1)) others were dead due to syhilis related co"lications, at least /)

wives had been infected and 19 children had contracted the disease at birth#

5n 0uly 23rd, eight "onths after the Tuskegee syhilis study was abandoned, a 61#F billion classaction suit was filed against the institutions and individuals involved# Pro"inent civil rightslawyer, @red Eray, de"anded 63 "illion in da"ages for each living articiant and the heirs of the deceased# The case, however, never ca"e to trial and in


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"...various methods were used to maintain and stimulate their

interest. Free medicines, burial assistance or insurance, free hot

meals on the days of eamination, transport to and from the hospital

and an opportunity tp stop in town on the return trip...all helped."

(!)

7earing in "ind the low educational status of the atients and the

tendency of the average .frican4."erican "an to willingly agree

with a erceived authoritarian figure such as the Public Health Service hysician the "en fro"

Tuskegee beca"e the unassu"ing victi"s of an unethical scientific undertaking#

"...he county health officer shall re#uire persons

infected with venereal disease to report for treatment to

a reputable physician and continue treatment until such

disease, in the $udgment of the attending physician is nolonger communicable..." (%)

This was stated in the venereal disease law enacted by

the .laba"a Cegislature in 192# &otwithstanding the

law the officials of a @ederal .gency, the Public Health

Service, were successful in withholding theray fro" the articiants of the Tuskegee Study, and

the hysicians did not detect an ethical dile""a#

.lthough there were no guidelines in 193) to influence the for"ulation of a rosective study of atients with an untreated chronic disease, when the 0udiciary ;ouncil of the ."erican 'edical

.ssociation issued a reort, on


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T)E 3$RE4BER& 6,E

Wartime E7periments on the *nmates o/ 3ai onentration amps

The idea of, $state before individual$ was tyical of the &aBi era and hysicians began to losesight of their "oral obligations as they were swet into the dehu"aniBing &aBi olitical culture#The slew of e-otic diseases and afflictions, a condition of the war environ"ent, were seen as a,$national threat,$ and it was to these $threats$ that Eer"an doctors began to assu"e the

resonsibility of acting on behalf of the state in order to i"rove the health of the nation# 5n the basis of national thought and utilitarianis" doctors no longer acted as caretakers but as uetsof a govern"ent obsessed with racial and genetic urity# 'edical e-eri"ents co""itted under the disguise of scientific research fell into three basic categoriesG 81 'edico4'ilitary esearchA82 'iscellaneous, .d Hoc -eri"entsA and 83 acially 'otivated -eri"ents# (&)


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The &ure"berg ;ode is the "ost i"ortant docu"ent in the history of the ethics of "edicalresearch and the first of its kind to ensure the rights of sub!ects# @or"ulated :) years ago, in.ugust 19/, by the ."erican !udges heading the trial of &aBidoctors accused of conducting "acabre hu"an e-eri"ents in theconcentration ca"s#


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The duty and resonsibility for ascertaining the uality of the consent rests uon each individualwho initiates, directs or engages in the e-eri"ent# It is a ersonal duty and resonsibility which"ay not be delegated to another with i"unity#

1# The e-eri"ent should be such as to yield fruitful results for the good of society,unrocurable by other "ethods or "eans of study, and not rando" and unnecessary in

nature#2# The e-eri"ent should be so designed and based on the results of ani"al e-eri"entation

and a knowledge of the natural history of the disease or other roble"s under study that theanticiated results will !ustify the erfor"ance of the e-eri"ent#

3# The e-eri"ent should be so conducted as to avoid all unnecessary hysical and "entalsuffering and in!ury#

/# &o e-eri"ent should be conducted where there is an a riori reason to believe that death or disabling in!ury will occurA e-cet erhas, in those e-eri"ents where the e-eri"ental hysicians also serve as sub!ects#

:# The degree of risk to be taken should never e-ceed that deter"ined by the hu"anitariani"ortance of the roble" to be solved by the e-eri"ent#

(# Proer rearations should be "ade and adeuate facilities rovided to rotect thee-eri"ental sub!ect against even re"ote ossibilities of in!ury, disability, or death#

# The e-eri"ent should be conducted only by scientifically ualified ersons# The highestdegree of skill and care should be reuired through all stages of the e-eri"ent of those whoconduct or engage in the e-eri"ent#

F#


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T)E )E+S*3%* ,E+:R:T*63

Ethial (riniples /or 4edial Researh *noling )uman Su;


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(# The ri"ary urose of "edical research involving hu"an sub!ects is to i"rove rohylactic, diagnostic and theraeutic rocedures and the understanding of the etiology and athogenesis of disease# ven the best roven rohylactic, diagnostic, and theraeutic"ethods "ust continuously be challenged through research for their effectiveness, efficiency,accessibility and uality#

# In current "edical ractice and in "edical research, "ost rohylactic, diagnostic andtheraeutic rocedures involve risks and burdens#

F# 'edical research is sub!ect to ethical standards that ro"ote resect for all hu"an beings and rotect their health and rights# So"e research oulations are vulnerable and need secial rotection# The articular needs of the econo"ically and "edically disadvantaged "ust berecogniBed# Secial attention is also reuired for those who cannot give or refuse consent for the"selves, for those who "ay be sub!ect to giving consent under duress, for those who willnot benefit ersonally fro" the research and for those for who" the research is co"binedwith care#

9# esearch Investigators should be aware of the ethical, legal and regulatory reuire"ents for research on hu"an sub!ects in their own countries as well as alicable internationalreuire"ents# &o national ethical, legal or regulatory reuire"ent should be allowed toreduce or eli"inate any of the rotections for hu"an sub!ects set forth in this


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1/# The research rotocol should always contain a state"ent of the ethical considerationsinvolved and should indicate that there is co"liance with the rinciles enunciated in this


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2/# @or a research sub!ect who is legally inco"etent, hysically or "entally incaable of givingconsent or is a legally inco"etent "inor, the investigator "ust obtain infor"ed consentfro" the legally authoriBed reresentative in accordance with alicable law# These grousshould not be included in research unless the research is necessary to ro"ote the health of the oulation reresented and this research cannot instead be erfor"ed on legally

co"etent ersons#

2:# ?hen a sub!ect dee"ed legally inco"etent, such as a "inor child, is able to give assent todecisions about articiation in research, the investigator "ust obtain that assent in additionto the consent of the legally authoriBed reresentative#

2(# esearch on individuals fro" who" it is not ossible to obtain consent, including ro-y or advance consent, should be done only if the hysical>"ental condition that reventsobtaining infor"ed consent is a necessary characteristic of the research oulation# Thesecific reasons for involving research sub!ects with a condition that renders the" unable togive infor"ed consent should be stated in the e-eri"ental rotocol for consideration andaroval of the review co""ittee# The rotocol should state that consent to re"ain in the

research should be obtained as soon as ossible fro" the individual or a legally authoriBedsurrogate#

2# 7oth authors and ublishers have ethical obligations# In ublication of the results of research,the investigators are obliged to reserve the accuracy of the results# &egative as well as ositive results should be ublished or otherwise ublicly available# Sources of funding,institutional affiliations and any ossible conflicts of interest should be declared in the ublication# eorts of e-eri"entation not in accordance with the rinciles laid down inthis


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32# In the treat"ent of a atient, where roven rohylactic, diagnostic and theraeutic "ethodsdo not e-ist or have been ineffective, the hysician, with infor"ed consent fro" the atient,"ust be free to use unroven or new rohylactic, diagnostic and theraeutic "easures, if inthe hysician+s !udge"ent it offers hoe of saving life, re4establishing health or alleviatingsuffering# ?here ossible, these "easures should be "ade the ob!ect of research, designed to

evaluate their safety and efficacy# In all cases, new infor"ation should be recorded and,where aroriate, ublished# The other relevant guidelines of this


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The codes consist of rules, so"e general, others secific, that guide the investigators or thereviewers of research in their work# Such rules often are inadeuate to cover co"le- situationsAat ti"es they co"e into conflict, and they are freuently difficult to interret or aly# 7roader ethical rinciles will rovide a basis on which secific rules "ay be for"ulated, criticiBed andinterreted#

Three rinciles, or general rescritive !udg"ents, that are relevant to research involvinghu"an sub!ects are identified in this state"ent# 5ther rinciles "ay also be relevant# Thesethree are co"rehensive, however, and are stated at a level of generaliBation that should assistscientists, sub!ects, reviewers and interested citiBens to understand the ethical issues inherent inresearch involving hu"an sub!ects# These rinciles cannot always be alied so as to resolve beyond disute articular ethical roble"s# The ob!ective is to rovide an analytical fra"ework that will guide the resolution of ethical roble"s arising fro" research involving hu"an sub!ects#

This state"ent consists of a distinction between research and ractice, a discussion of the three basic ethical rinciles, and re"arks about the alication of these rinciles#

(art : Boundaries ;et.een (ratie > Researh

*. Boundaries between 2ractice and 5esearch

It is i"ortant to distinguish between bio"edical and behavioral research, on the one hand, andthe ractice of acceted theray on the other, in order to know what activities ought to undergoreview for the rotection of hu"an sub!ects of research# The distinction between research and ractice is blurred artly because both often occur together 8as in research designed to evaluate atheray and artly because notable deartures fro" standard ractice are often callede-eri"ental when the ter"s e-eri"ental and research are not carefully defined#

@or the "ost art, the ter" ractice refers to interventions that are designed solely to enhancethe well4being of an individual atient or client and that have a reasonable e-ectation of success# The urose of "edical or behavioral ractice is to rovide diagnosis, reventivetreat"ent or theray to articular individuals# 82 7y contrast, the ter" research+ designates anactivity designed to test an hyothesis, er"it conclusions to be drawn, and thereby to develo or contribute to generaliBable knowledge 8e-ressed, for e-a"le, in theories, rinciles, andstate"ents of relationshis# esearch is usually described in a for"al rotocol that sets forth anob!ective and a set of rocedures designed to reach that ob!ective#

?hen a clinician dearts in a significant way fro" standard or acceted ractice, the innovationdoes not, in and of itself, constitute research# The fact that a rocedure is e-eri"ental, in the

sense of new, untested or different, does not auto"atically lace it in the category of research#adically new rocedures of this descrition should, however, be "ade the ob!ect of for"alresearch at an early stage in order to deter"ine whether they are safe and effective# Thus, it is theresonsibility of "edical ractice co""ittees, for e-a"le, to insist that a "a!or innovation beincororated into a for"al research ro!ect# 83

esearch and ractice "ay be carried on together when research is designed to evaluate thesafety and efficacy of a theray# This need not cause any confusion regarding whether or not the

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http://ohsr.od.nih.gov/guidelines/belmont.html#go2http://ohsr.od.nih.gov/guidelines/belmont.html#go3http://ohsr.od.nih.gov/guidelines/belmont.html#go2http://ohsr.od.nih.gov/guidelines/belmont.html#go3


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activity reuires reviewA the general rule is that if there is any ele"ent of research in an activity,that activity should undergo review for the rotection of hu"an sub!ects#

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