Institutional RInstitutional RReview BoardsReview Boards · collection of data, ancollection of...

Institutional RInstitutional RInstitutional RInstitutional R

Jerry MJerry M

Review BoardsReview BoardsReview BoardsReview Boards

MenikoffMenikoff

DisclaimerDisclaimer

The views expressed in tThe views expressed in tnecessarily represent tnecessarily represent tDepartment of Health aDepartment of Health aDepartment of Health aDepartment of Health a

this presentation do not this presentation do not the views of the the views of the and Human Servicesand Human Servicesand Human Services.and Human Services.

A Cautionary TaleA Cautionary Tale

StandaStandaard Careard Care


Dr. RDr. RRowseyRowsey


Sutureless Corneal TraSutureless Corneal Tra This invention involvThis invention involv

transplanting corneatransplanting corneatransplanting corneatransplanting corneasafer way with far lessafer way with far lesprevious methods. previous methods.

U S Patent 5 584 881U S Patent 5 584 881U.S. Patent 5,584,881U.S. Patent 5,584,881

ansplant Techniqueansplant Technique::ves a technique for ves a technique for al tissue in a muchal tissue in a muchal tissue in a much al tissue in a much ss complications than ss complications than

1 issued Dec 17 19961 issued Dec 17 19961 issued Dec. 17, 19961 issued Dec. 17, 1996


Studied inStudied in

Began useBegan use

Never filedNever filed

cats cats

e in humanse in humans

d with IRBd with IRB


USA Today, Feb. 26, 2001USA Today, Feb. 26, 2001:: In 1994, eye surgeon JamIn 1994, eye surgeon Jam

medical device that he thomedical device that he thocorneal transplantation sucorneal transplantation sudollars. It did neither. Instedollars. It did neither. Instepaying university job and paying university job and he performed unapprovedhe performed unapproved

l i l di hildl i l di hildpeople, including childrenpeople, including children

mes Rowsey invented a mes Rowsey invented a ought would revolutionize ought would revolutionize urgery and make millions of urgery and make millions of ead, it cost him a highead, it cost him a high--led to federal findings that led to federal findings that

d research on more than 60 d research on more than 60 n.n.


OHRP, Sept 2000:OHRP, Sept 2000: Rowsey proposed Rowsey proposed

didn’t conduct it); udidn’t conduct it); udidn t conduct it); udidn t conduct it); utechnique in 60 peotechnique in 60 peo

b t t f ltb t t f ltabstracts of resultsabstracts of results This is systematic cThis is systematic cThis is systematic cThis is systematic c

openopen--label trial, andlabel trial, andresearchresearchresearchresearch

randomized trial (but randomized trial (but used an untested newused an untested newused an untested new used an untested new ople; presented ople; presented

t tit ti at meetings at meetingscollection of data, ancollection of data, ancollection of data, an collection of data, an d meets def. of doing d meets def. of doing


OHRP, Nov 200OHRP, Nov 200

Must tell patiMust tell patiwere researchwere researchunderwent exunderwent exsurgery.surgery.

00:00:

ents that they ents that they h subjects, and h subjects, and xperimental xperimental


StandardStandardStandardStandard

NonNon--StanStan

ResearchResearch

CareCare Care Care

ndard Carendard Care

hh


Dr. Rowsey’s defDr. Rowsey’s defwasn’t doing reswasn’t doing reswasn t doing reswasn t doing resHe says the techHe says the techHe says the techHe says the tech

used on my patieused on my patiesystematic invessystematic inves

fense was that he fense was that he earchearchearch.earch.nique “was nevernique “was nevernique was never nique was never

ents as part of any ents as part of any stigation.”stigation.”


Why was everyonWhy was everyony yy yproving he was doproving he was do

What if he kept noWhat if he kept nomerely told patienmerely told patienmerely told patienmerely told patienexperimental techexperimental techthought it was thethought it was thethem?them?them?them?

ne so interested in ne so interested in oing research?oing research?o research records, o research records, nts this was a newnts this was a newnts this was a new nts this was a new hnique, and he hnique, and he

ffe best thing for e best thing for


Would this havWould this havwas just was just givinggivingcarecare??P h D RP h D RPerhaps Dr. RoPerhaps Dr. Rocareless and dcareless and dcareless, and dcareless, and d“research“research--like”like”

ve been OK if he ve been OK if he g nong non--standard standard

j tj towsey was just owsey was just did too manydid too manydid too many did too many ” things” thingsgg

A Cautionary Tale (A Cautionary Tale (TT

Consider this paradoxConsider this paradox: if a phy: if a phymethod for treating patients, thmethod for treating patients, thprovided the patients have giveprovided the patients have giveBut if a physician is interested But if a physician is interested controlled trial to determine whcontrolled trial to determine whantibiotics is more effective at antibiotics is more effective at must prepare a formal protocomust prepare a formal protocoi tit ti l i b d di tit ti l i b d dinstitutional review board, and institutional review board, and from potential participants.from potential participants.

Truog, Truog, NEJMNEJM, 1999, 1999))

ysician reads about a new ysician reads about a new he physician may start using it he physician may start using it en general consent for treatment. en general consent for treatment. in performing a randomized, in performing a randomized,

hich of two widely used hich of two widely used treating bronchitis, he or she treating bronchitis, he or she l, obtain approval from the l, obtain approval from the

k itt i f d tk itt i f d tseek written informed consent seek written informed consent

A Cautionary Tale (A Cautionary Tale (TT

Physicians can do almost name of therapeutic innovname of therapeutic innovattempt to gain systematicintervention Or “I neeintervention. Or, . . . I needrug to half my patients bthem ”them.

Truog, Truog, NEJMNEJM, 1999, 1999))

anything they want in the vation but only if there is novation, but only if there is no c knowledge from the ed permission to give a newed permission to give a new ut not to give it to all of


Is it true that: “Physanything they want itherapeutic innovatiotherapeutic innovationo attempt to gain syfrom the intervention

NO! To know why weNO! To know why weunderstand rules for

icians can do almost n the name of on but only if there ison, but only if there is ystematic knowledge n.”e have IRBs need toe have IRBs, need to r non-standard care.


Standard Care: Standard Care: PP

NonNon--Standard CaStandard Ca

ResearchResearch

Patient is #1!Patient is #1!

are: are: Patient is #1!Patient is #1!


What happens if aWhat happens if afollow the “PatienMalpractice!D th f t th tDoes the fact thatconsent fully absoco se t u y absogeneral, No!

a doctor fails toa doctor fails to nt is #1” rule?

t ti tt patient gave olve the doctor? In o e t e docto

An ExampleAn ExampleBarbara Rojas, agBarbara Rojas, ag

lost huge amountlost huge amountlost huge amountlost huge amountShe wanted droopShe wanted droopShe wanted droopShe wanted droopGuillermo FalconiGuillermo Falconi

U.S. license, did bU.S. license, did bShe died, he wentShe died, he went

ge 52, successfully ge 52, successfully ts of weightts of weightts of weightts of weightping skin removedping skin removedping skin removedping skin removedi, Ecuador MD, no i, Ecuador MD, no bedroom surgerybedroom surgeryt to jailt to jail


Dr. Rowsey was suti t l i ipatients claiming m

Rule for non-standRule for non-standof best interests oit reasonable to de

?care?Compare risks v bCompare risks v. b

ued by at least 2 l timalpractice

dard care: in termsdard care: in terms of the patients, was epart from standard

benefits of changebenefits of change

Why Special ResearWhy Special Resear

Standard Care: Standard Care: PP

NonNon--Standard CaStandard Ca

Research: Research: PatienPatien

rch Rules?rch Rules?

Patient is #1!Patient is #1!

are: are: Patient is #1!Patient is #1!

nt is nt is notnot #1!#1!


Research involveResearch involveinterestinterest

Researcher is puResearcher is pu

1 A i1 A i1. Answering res1. Answering res

2 (Sometimes) tr2 (Sometimes) tr2. (Sometimes) tr2. (Sometimes) tr


es a es a conflict of conflict of

ursuing two goals:ursuing two goals:

h tih tiearch questionearch question

reating the patientreating the patientreating the patientreating the patient


Researcher (unlike cResearcher (unlike cdo things that can bdo things that can b1 Randomization1 Randomization1. Randomization1. Randomization2. Standardization2. Standardization3. Non3. Non--disclosure ofdisclosure of4 E t t t d4 E t t t d4. Extra tests and pr4. Extra tests and pr


clinician) is clinician) is allowed to to be be bad for patient:for patient:

f interim resultsf interim resultsddroceduresrocedures


Research regulatioResearch regulatiothat conflict of intethat conflict of inte

They make sure thThey make sure thi thi thanswering the resanswering the res

does notdoes not inappropinappropdoes not does not inappropinapproppatient’s interestspatient’s interests


ons help ons help managemanageerest.erest.

hat the goal of hat the goal of h tih tiearch question earch question

priatelypriately override theoverride thepriatelypriately override the override the s. s.


HighHigh--Altitude ExperimentsAltitude Experiments. . conducted to investigateconducted to investigateconducted . . . to investigateconducted . . . to investigateendurance and existence at endurance and existence at

h i l bjh i l bjThe experimental subjects wThe experimental subjects wchamber and thereafter the chamber and thereafter the was raised. was raised.


[E]xperiments were [E]xperiments were e the limits of human e the limits of human e the limits of human e the limits of human extremely high altitudes. . . extremely high altitudes. . .

l d i ll d i lwere placed in a lowwere placed in a low--pressure pressure simulated altitude therein simulated altitude therein


Freezing ExperimentsFreezing Experiments [E]xp [E]xp Freezing ExperimentsFreezing Experiments. [E]xp. [E]xpto investigate the most effeto investigate the most effe

h h d b h h d b persons who had been sevepersons who had been seveseries of experiments the suseries of experiments the suin a tank of ice water for pein a tank of ice water for peanother series of experimenanother series of experimennaked outdoors for many hnaked outdoors for many hfreezing.freezing.gg


periments were conducted periments were conducted periments were conducted . . . periments were conducted . . . ective means of treating ective means of treating

l hill d f I l hill d f I erely chilled or frozen. In one erely chilled or frozen. In one ubjects were forced to remain ubjects were forced to remain eriods up to 3 hours. . . . In eriods up to 3 hours. . . . In nts, the subjects were kept nts, the subjects were kept hours at temperatures below hours at temperatures below


Sulfanilamide ExperimentsSulfanilamide Experiments. . inflicted on the experimentinflicted on the experimentinflicted on the experimentinflicted on the experimentwith bacteria such as streptwith bacteria such as strept

Ci l i f bl Ci l i f bltetanus. Circulation of blootetanus. Circulation of bloooff blood vessels at both enoff blood vessels at both encondition similar to that of condition similar to that of Infection was aggravated byInfection was aggravated byground glass into the wounground glass into the wounwith sulfanilamide and othwith sulfanilamide and otheffectiveness.effectiveness.


. . . Wounds deliberately . . . Wounds deliberately tal subjects were injected tal subjects were injected tal subjects were injected tal subjects were injected tococcus, gas gangrene, and tococcus, gas gangrene, and d i d b i d i d b i od was interrupted by tying od was interrupted by tying

nds of the wound to create a nds of the wound to create a a battlefield wound. a battlefield wound. y forcing wood shavings and y forcing wood shavings and

nds. The infection was treated nds. The infection was treated her drugs to determine their her drugs to determine their gg


Experiments with PoisonExperiments with Poison. [E. [E i i h ff i i h ff . . . to investigate the effect . . . to investigate the effect

human beings. The poisonshuman beings. The poisonsto experimental subjects into experimental subjects inas a result of the poison or was a result of the poison or worder to permit autopsies.order to permit autopsies.


E]xperiments were conducted E]xperiments were conducted f i i f i i of various poisons upon of various poisons upon s were secretly administered s were secretly administered their food. The victims died their food. The victims died were killed immediately in were killed immediately in

The Nuremberg CodThe Nuremberg Cod

1 1 The voluntary consenThe voluntary consen 1. 1. The voluntary consenThe voluntary consenis absolutely essentiais absolutely essentia

Thi th t th i l d h ldThi th t th i l d h ldThis means that the person involved shouldThis means that the person involved shouldbe so situated as to be able to exercise free be so situated as to be able to exercise free any element of force, fraud, deceit, duress, any element of force, fraud, deceit, duress, constraint or coercion; and should have sufconstraint or coercion; and should have sufconstraint or coercion; and should have sufconstraint or coercion; and should have sufelements of the subject matter involved as elements of the subject matter involved as enlightened decision. This latter element renlightened decision. This latter element raffirmative decision by the experimental suaffirmative decision by the experimental suthe nature, duration, and purpose of the exthe nature, duration, and purpose of the exis to be conducted; all inconveniences and is to be conducted; all inconveniences and effects upon his health or person which maeffects upon his health or person which maexperimentexperimentexperiment.experiment.

dede (1947)(1947)

nt of the human subject nt of the human subject nt of the human subject nt of the human subject l.l.d h l l it t i t h ld d h l l it t i t h ld d have legal capacity to give consent; should d have legal capacity to give consent; should power of choice, without the intervention of power of choice, without the intervention of over over--reaching, or other ulterior form of reaching, or other ulterior form of fficient knowledge and comprehension of the fficient knowledge and comprehension of the fficient knowledge and comprehension of the fficient knowledge and comprehension of the to enable him to make an understanding and to enable him to make an understanding and equires that before the acceptance of an equires that before the acceptance of an ubject there should be made known to him ubject there should be made known to him

xperiment; the method and means by which it xperiment; the method and means by which it hazards reasonable to be expected; and the hazards reasonable to be expected; and the ay possibly come from his participation in the ay possibly come from his participation in the

The Nuremberg CodThe Nuremberg Cod 2. The experiment should be such as to2. The experiment should be such as to

society, unprocurable by other methodsociety, unprocurable by other methodunnecessary in nature.unnecessary in nature.unnecessary in nature.unnecessary in nature.

3. The experiment should be so design3. The experiment should be so designi t ti d k l d f thi t ti d k l d f thexperimentation and a knowledge of thexperimentation and a knowledge of th

problem under study that the anticipatproblem under study that the anticipatthe experiment.the experiment.

4. The experiment should be so conduc4. The experiment should be so conducand mental suffering and injury.and mental suffering and injury.

5. No experiment should be conducted5. No experiment should be conductedbelieve that death or disabling injury wbelieve that death or disabling injury wg j yg j yexperiments where the experimental pexperiments where the experimental p

dede (1947)(1947)o yield fruitful results for the good of o yield fruitful results for the good of ds or means of study, and not random and ds or means of study, and not random and

ned and based on the results of animal ned and based on the results of animal h t l hi t f th di th h t l hi t f th di th he natural history of the disease or other he natural history of the disease or other ted results will justify the performance of ted results will justify the performance of

cted as to avoid all unnecessary physical cted as to avoid all unnecessary physical

d where there is an a priori reason to d where there is an a priori reason to will occur; except, perhaps, in those will occur; except, perhaps, in those ; p , p p ,; p , p p ,hysicians also serve as subjects. hysicians also serve as subjects.

The Nuremberg CodThe Nuremberg Cod6 Th d f i k t b t k h ld 6 Th d f i k t b t k h ld 6. The degree of risk to be taken should nev6. The degree of risk to be taken should nevhumanitarian importance of the problem tohumanitarian importance of the problem to

7 P ti h ld b d d7 P ti h ld b d d 7. Proper preparations should be made and7. Proper preparations should be made andexperimental subject against even remote pexperimental subject against even remote p

8 The experiment should be conducted onl8 The experiment should be conducted onl 8. The experiment should be conducted onl8. The experiment should be conducted onlhighest degree of skill and care should be rhighest degree of skill and care should be rof those who conduct or engage in the expeof those who conduct or engage in the expe

9. During the course of the experiment the 9. During the course of the experiment the the experiment to an end if he has reached the experiment to an end if he has reached continuation of the experiment seems to hicontinuation of the experiment seems to hipp

10. During the course of the experiment the10. During the course of the experiment theterminate the experiment at any stage, if heterminate the experiment at any stage, if hep y g ,p y g ,of the good faith, superior skill and carefulof the good faith, superior skill and carefulcontinuation of the experiment is likely to continuation of the experiment is likely to experimental subject.experimental subject.

dede (1947)(1947) d th t d t i d b th d th t d t i d b th ver exceed that determined by the ver exceed that determined by the

o be solved by the experiment.o be solved by the experiment.

d d t f iliti id d t t t th d d t f iliti id d t t t th d adequate facilities provided to protect the d adequate facilities provided to protect the possibilities of injury, disability, or death.possibilities of injury, disability, or death.

l b scientificall qualified persons The l b scientificall qualified persons The ly by scientifically qualified persons. The ly by scientifically qualified persons. The required through all stages of the experiment required through all stages of the experiment eriment.eriment.

human subject should be at liberty to bring human subject should be at liberty to bring the physical or mental state where the physical or mental state where im to be impossible.im to be impossible.pp

e scientist in charge must be prepared to e scientist in charge must be prepared to e has probable cause to believe, in the exercise e has probable cause to believe, in the exercise p ,p ,l judgment required of him that a l judgment required of him that a result in injury, disability, or death to the result in injury, disability, or death to the


TuskegeeTuskegee: :


19321932--19721972


J i h Ch i DJ i h Ch i DJewish Chronic DJewish Chronic D 1963: Patients injec1963: Patients injec 1963: Patients injec1963: Patients injec

Not told, to avoid “Not told, to avoid “,,


Di H it lDi H it lDisease HospitalDisease Hospitalcted with cancer cellscted with cancer cellscted with cancer cellscted with cancer cells

“anxiety”“anxiety”yy


Cincinnati GeneraCincinnati GeneraCincinnati GeneraCincinnati Genera 19601960--72: Patients wit72: Patients wit 19601960--72: Patients wit72: Patients wit

body radiation Rxbody radiation Rx

Not told purpose waNot told purpose wah dh dmuch radiation is “tomuch radiation is “to

about effects of nucleabout effects of nucleabout effects of nucleabout effects of nucle


l Hospitall Hospitall Hospitall Hospitalth cancer got wholeth cancer got whole--th cancer got wholeth cancer got whole--

s to determine how s to determine how h h l lh h l loo much” to help learn oo much” to help learn

ear bomb on troopsear bomb on troopsear bomb on troopsear bomb on troops


Oregon State PenitOregon State PenitOregon State PenitOregon State Penit 1960s: Prisoners volu1960s: Prisoners volu

testicles irradiatedtesticles irradiated

Part of study was maPart of study was ma“prevent contaminati“prevent contaminatiprevent contaminatiprevent contaminati


tentiarytentiarytentiarytentiaryunteered to have their unteered to have their

andatory vasectomy to andatory vasectomy to ion of genetic pool”ion of genetic pool”ion of genetic poolion of genetic pool


CIA’s MKULTRA CIA’s MKULTRA 1950s1950s--60s: 149 projec60s: 149 projec

Chinese advances in Chinese advances in interrogation techniqinterrogation techniq

Developed “chemicaDeveloped “chemicaDeveloped chemicaDeveloped chemicacapable of employmecapable of employme

ti t t lti t t loperations to controloperations to control Subjects unaware; soSubjects unaware; so


Project Projectcts to counter Soviet & cts to counter Soviet & brainwashing and brainwashing and quesquesl, biological materials l, biological materials l, biological materials l, biological materials ent in clandestine ent in clandestine l h b h i ”l h b h i ”l human behavior”l human behavior”ome diedome died


Belmont Report (Belmont Report (p (p (U.S. rules, had 3 eU.S. rules, had 3 e

1.1. Respect for persoRespect for persoB fiB fi2.2. Beneficence: maxBeneficence: maxminimize risks (hminimize risks (hminimize risks (hminimize risks (h

3.3. JusticeJustice


1979) led to current 1979) led to current ))ethical principles:ethical principles:onsons

i i b fit di i b fit dximize benefits and ximize benefits and arms)arms)arms)arms)

Modern Research RModern Research R

OHRP (CommoOHRP (Commo46) f d ll f46) f d ll f46): federally fu46): federally fu

FDA d dFDA d d FDA: drugs, deFDA: drugs, de

C b d bC b d bCan be under bCan be under b

Rules: SourcesRules: Sources

on Rule, 45 CFR on Rule, 45 CFR d d hd d hunded researchunded research

i bi l ii bi l ievices, biologicsevices, biologics

b th t f lb th t f lboth sets of rulesboth sets of rules


Institutional ReviewInstitutional Reviewcommittees that encommittees that en

There are thousandThere are thousand

S i tit tiS i tit tiSome institutions cSome institutions cIRBs; others hire aIRBs; others hire aIRBs; others hire aIRBs; others hire a


w Boards (IRBs) are w Boards (IRBs) are nforce these rulesnforce these rules

ds of them in U.S.ds of them in U.S.

t th it th icreate their own create their own a “private” IRBa “private” IRBa private IRBa private IRB


Each IRB must haEach IRB must hamembersmembers

The members muThe members muareas: some withareas: some withand some with noand some with noand some with noand some with nobackgroundbackgroundgg


ave at least 5 ave at least 5

ust be from diverse ust be from diverse science training, science training,

onon scientificscientificonon--scientific scientific

Scope of Research RScope of Research R

Rules apply tRules apply ti l ii l i HHinvolving involving HuHu

RulesRules

to to ResearchResearchS bjS bjuman Subjectsuman Subjects

What is Research?What is Research?

Research means aResearch means ainvestigation . . . dinvestigation . . . dor contrib te toor contrib te to gegeor contribute to or contribute to gegeknowledgeknowledge..

a systematic a systematic yydesigned to develop designed to develop enerali ableenerali ableeneralizable eneralizable

When are you usingWhen are you using

Human Subject Human Subject individual aboutindividual aboutresearcher getsresearcher getsresearcher getsresearcher gets(1) data through(1) data through( ) g( ) ginteractioninteraction with with (2) id tifi bl(2) id tifi bl(2) identifiable p(2) identifiable pinformationinformationinformationinformation

g a human subject?g a human subject?

means a means a livinglivingt whom a t whom a ::::

h h interventionintervention or or the individual, the individual, orori ti tprivate private

What About “ExempWhat About “Exemp

If you are doingIf you are doing If you are doingIf you are doinginvolving involving humahumaggoften need to filoften need to fil

That office will dThat office will dstudy is exemptstudy is exemptstudy is exemptstudy is exempt

pt” Studies?pt” Studies?

gg researchresearchg g researchresearchan subjects, an subjects, you you j ,j , yyle somewherele somewheredetermine if your determine if your tttt

What Studies are ExWhat Studies are Ex

Questionnaire sQuestionnaire sQuestionnaire sQuestionnaire sinnocuous quesinnocuous quesqqanonymous.anonymous.

Studying preStudying pre--exexdata, so long as data, so long as linking lists arelinking lists arelinking lists are linking lists are

xempt?xempt?

tudies if either (a)tudies if either (a)tudies if either (a) tudies if either (a) stions, or (b) stions, or (b) , ( ), ( )

isting tissue or isting tissue or no identifiers or no identifiers or keptkeptkept.kept.

What About “ExpedWhat About “Exped

Some studies thSome studies thminimal risk, anminimal risk, an

it i dit i dcriteria, can undcriteria, can undreviewreviewreviewreview

This mainly meaThis mainly measingle person, nsingle person, n

ited” Studies?ited” Studies?

hat are both hat are both d meet other d meet other

d “ dit d”d “ dit d”dergo “expedited” dergo “expedited”

ans review by a ans review by a not the full IRBnot the full IRB

What Criteria does IWhat Criteria does I

1. 1. Informed conseInformed conse

2. 2. Substantive rulSubstantive rulstudy is designestudy is designestudy is designestudy is designe

RB Apply?RB Apply?

entent

lesles about how the about how the edededed

Informed ConsentInformed Consent

I f d tI f d t illill Informed consentInformed consent will will prospective subject orprospective subject or

th i d t tth i d t tauthorized representatauthorized representat Consent is documenteConsent is documente

form.form. Consent must be volunConsent must be volun

and undue influence.and undue influence. These requirements caThese requirements caThese requirements caThese requirements ca

b ht f hb ht f hbe sought from each be sought from each r the subject's legally r the subject's legally tititive.tive.

ed by a signed consent ed by a signed consent

ntary: free from coercion ntary: free from coercion

an sometimes be waivedan sometimes be waivedan sometimes be waivedan sometimes be waived

Informed ConsentInformed Consent

Consent form shouldConsent form shouldConsent form shouldConsent form shouldto allow “enlighteneto allow “enlightene

Nature of subject’s Nature of subject’s

What will happen toWhat will happen to What will happen toWhat will happen to

Risks from participaRisks from participa

Possible benefits frPossible benefits fr

Alt ti t b iAlt ti t b i Alternatives to beinAlternatives to bein

d disclose informationd disclose informationd disclose information d disclose information ed decision”:ed decision”:

problemproblem

o them in the studyo them in the studyo them in the studyo them in the study

ating in the studyating in the study

rom participatingrom participating

i th t di th t dng in the studyng in the study

Substantive Rules ASubstantive Rules A

Risks to subjects aRisks to subjects ajj(i) by using proce(i) by using proce

consistent with souconsistent with souconsistent with souconsistent with souand which do not uand which do not usubjects to risk ansubjects to risk ansubjects to risk, ansubjects to risk, an

(ii) whenever app(ii) whenever appd l dd l dprocedures alreadyprocedures already

the subjects for diathe subjects for diapurposes.purposes.

About the StudyAbout the Study

are are minimizedminimized: : edures which are edures which are und research designund research designund research design und research design unnecessarily expose unnecessarily expose ndndnd nd ropriate, by using ropriate, by using b i f db i f dy being performed on y being performed on

agnostic or treatment agnostic or treatment


RisksRisks to subjects ato subjects arelation to anticiparelation to anticipato subjects and thto subjects and thto subjects, and thto subjects, and ththe knowledgethe knowledge thathabe expected to resbe expected to res


are reasonable in are reasonable in ated ated benefitsbenefits, if any, , if any, hehe importance ofimportance ofhe he importance of importance of at may reasonably at may reasonably sult.sult.


Risks to subjects Risks to subjects

(Benefits to subje(Benefits to subje(Benefits to subje(Benefits to subjesociety)society)y)y)


≈≈

ects) + (Benefits toects) + (Benefits toects) + (Benefits to ects) + (Benefits to


Benefits to society aBenefits to society aBenefits to society aBenefits to society ato quantify. That lto quantify. That lcommon IRB behcommon IRB beh

11 Emphasizing infoEmphasizing info1.1. Emphasizing infoEmphasizing info2.2. Assume benefits Assume benefits

to zero; equation to zero; equation subjectssubjects ≈≈ BenefiBenefisubjects subjects ≈≈ BenefiBenefi


are especially hardare especially hardare especially hard are especially hard leads to two leads to two aviors:aviors:

ormed consentormed consentormed consent.ormed consent.to society are close to society are close yybecomes: Risks to becomes: Risks to ts to subjectsts to subjectsts to subjects ts to subjects


Selection of subjSelection of subjSelection of subjSelection of subj

This means grouThis means grouggbear more than tbear more than tresearch risks, bresearch risks, bincluded to get thincluded to get thincluded to get thincluded to get thbenefitsbenefitsbenefits benefits


jects is equitable.jects is equitable.jects is equitable.jects is equitable.

ups should not ups should not ppheir shares of heir shares of

but also should be but also should be heir share ofheir share ofheir share of heir share of


If subjects If subjects vulnervulnerundue influenceundue influence ((undue influenceundue influence ((pregnant women,pregnant women,persons, or econopersons, or econoeducationally disaeducationally disaeducationally disaeducationally disaadditional safeguadditional safegu


rablerable to to coercion or coercion or (children, prisoners,(children, prisoners,(children, prisoners, (children, prisoners, , mentally disabled , mentally disabled omically or omically or advantaged) needadvantaged) needadvantaged), need advantaged), need ards ards


A i t tA i t tAppropriate proteAppropriate proteto privacy of subjto privacy of subjto privacy of subjto privacy of subjconfidentiality of confidentiality of


ti ith dti ith dections with regard ections with regard ects andects andects and ects and datadata

Problems with IRB SProblems with IRB S

Is system too lax?Is system too lax? Is system too lax?Is system too lax?

July 2011 July 2011 –– AdvanAdvanyyProposed RulemaProposed Rulema

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SystemSystem

? Too strict?? Too strict?? Too strict?? Too strict?

nce Notice of nce Notice of kingking

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THE ETHE EENDEND

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