3.2.6A__Ethics DesignPPSSPPT30  mBINࡱ>   !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvw|}~RdO)dtyPowerPoint Document(pSummaryInformation({%DocumentSummaryInformation8<( / 0DTimes New Roman`Cp?lV{9|~yrp?lVDComic Sans MSn`Cp?lV{9|~yrp?lV DArialSans MSn`Cp?lV{9|~yrp?lV0DTimesSans MSn`Cp?lV{9|~yrp?lV@DHelvetica MSn`Cp?lV{9|~yrp?lVPDTahomaca MSn`Cp?lV{9|~yrp?lV`DCentury Gothic`Cp?lV{9|~yrp?lV ` .  @n?" dd@  @@`` (D&> "#$% !     &C x1?@8 g4adad?VlI9x/?ppp@ <4BdBd?`Cʚ?.xg49d9d?Vl`C? ?p@ pp<4!d!d?`Cʚ?.xuʚ;܋ :ʚ;<4dddd?uʚ;܋ :ʚ;.xR___PPT94,h___PPT2001D<4XV? %O =f2 z DESIGNING RESEARCH WITH THE HUMAN SUBJECT IN MIND Erica Heath, MBA, CIP President IRC - Independent Review ConsultingX7KD!K6 ! Three Common Study ProblemsHidden risks Beyond the physical Presumptiveness What is best for whom? Shared information? Consent Limitations The Therapeutic Misperception Diminished autonomy Minimized consent ZZZ+ZZDZ +D  "Problem 1: Hidden RisksVWhat is a risk? A probability statement About a possible harm Of an unknown magnitude BZFZZF&'Risk Reduction - Build into the design('Risks Define and attribute the known risks Recognize Build in reminders to look Resolve Treat the subject Report Tell of event - PI to whom? Review Who should examine each report Reconcile Who evaluates the varied reports? Respond What action can be taken? Report Is the IRB or FDA to be told? When? Repair Can the study be repaired? Restitution Plan who will pay for what and how !Z(1Injury and Compensation Resolution & Restitution21 rWhat is the policy? Who is being protected most? Is it an ethical policy? Is it limited to physical harm? Why? Are there multiple policies? Site, Sponsor, Insurer, (federal grants will not cover injury!?) Who is in charge? Who knows what? How is the funding guaranteed? What does the subject need to know? If I am injured, how can I get treatment and Do I have to pay for my treatment? I don t care who pays - just not me or my insurer!Z]ZZBZgZPZ3Z]BgP  3$Problem 2: Presumptiveness Attitudes I am your doctor and I would not suggest this were it not in your interest. All of my patients are literate. I can tell. I know what I am doing, don t you?  This is a simple questionnaire. I finished it in 10 minutes so I bet you can too. B  S%#Combating Presumptiveness by design$#A.  Corporate Culture of Concern B. Separation of roles C. Shared information d=!!!!=*@A. Reflect a  Corporate CultureConcern emanates from the TOP Can it be seen in the protocol? Are policies clear? Concern balances business and ethics Where there is a dilemma is it discussed? Concern is contagiousj4%*4%*,.Separation of Roles Conflict(s) of Interest(s)"/" .Each person (PI, subject, sponsor) has interests. Missions Contracts Altruism Money Do the various interests conflict? Who is getting paid? Are the interests and the conflicts transparent and managed?B2Z"ZwZ2"w/B. Separation of RolesTherapeutic misperception Subject conflict - believing that the research is being done to benefit him or her rather than to answer a question. Does the consent form say,  The purpose is to treat your diabetes? Is the purpose and benefit clear - to everyone? l0 0  0 B. Separation of Roles+,Presumption C. Myths of Shared information-,Everyone is  in the know. You lived and breathed it - others did not. PIs and their staff comprehend the protocol Each may comprehend something different! The IRB is included in the information flow Does the chain of communication include everyone? Subjects are informed before giving consent As with everyone, learning is a constant process.,-),2,2,-),2,  2 Problem 3: Informed Consent *The informed consent of the subject is absolutely essential (Nuremberg Code) Individuals should be treated as autonomous agents; persons with diminished autonomy are entitled to protection. (Belmont Report, Respect for Persons)\>ZZsZ&Z>s&1!Lack of evidence of thoughtThe recruitment process is rarely mentioned in a protocol. The process of obtaining consent is rarely mentioned in a protocol. Prospective planning of the logistics and education and discussion necessary to gain consent are not formalized or consistent.$Definition How are these addressed?A) The agreement B) with full information C) of a person with competence and capacity D) made without force, fraud, deceit, duress, coercion or undue influence. See the Nuremburg Code - Principle #14!Z&Z&   A) AgreementOf (or between) whom? Does the study make any demands of investigators? At what point in time Is the process included in the study procedures? For how long? Does the protocol have built-in check-ins with the subject?21<21<   B) With full informationRequired elements of information is information written? Is there any assistance (e.g. videos, diagrams, pictures)? Optional elements of information too often elevated to required position Reasonable elements of information What would you want to know?!V!n)#!V!)#   C) of a competent person Who is competent? Who is  vulnerable ? Legal limits Emotional limits Mental limits Financial limits Social limits Educational limits .(Z_Z(_!BD) Without force, fraud, deceit& " Why might a person agree? Belief in a cure? (misperception?) Money? A warm bed and 3 squares a day? Desire to please? The only way to get medical care? Altruism?*KThere is an Inverse Proportion between competence and consent requirements LJ Why have a consent document?It s required. It helps subject s recall. It helps stimulate questions It helps compliance.\\ Consent and Study Design8Critical Path and Planning Expect multiple edits on the consent form Allow time for a nave reader What tests come before or after consent? What refusal rate is anticipated? Who provides the final version of the consent? Is translation needed? Is there time to get a  second opinion? * Consent and DesignHow can the design alter voluntariness? Amount and schedule of payment to subjects Amount and schedule of payment to site Dependence on site Alternative treatments? Alternative providers? Recent diagnosis (ZfZ/ZZZZ(f/ -Review - Common ProblemsHidden risks Beyond the physical Presumptiveness What is best for whom? Consent Limitations The Therapeutic Misperception Diminished autonomy Minimized consent concern ZZZZZLZ L  Design and Subject ProtectionRA Culture of Concern is essential. Everyone should understand their role, and obligations should understand the protocol, subjects, risks should be ready and willing to do the right thing. Informed Consent is essential It is a process plus a form that documents it The process should be clear in the protocol Consent is a sign of respect.~,ZZZxZx' ~ You have lived and breathed your protocol. 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Hhgֳgֳ ? p  W#Click to edit Master subtitle style$ $  Z1 ?``  D* 2  ZH1 ?`   F*(2  Z1 ?`   F*(2N  6޽h? ? f330 `<((  < <  f(w1 ?P    T*   <  fȑw1 ?    V*  d < c $ ?  L <  fw1 ? @  RClick to edit Master text styles Second level Third level Fourth level Fifth level!     S < # l(w1 ?`P   T*    < # lhw1 ?`   V*  H < 0޽h ? ̙33 l (   l l  fz1 ?P    B*  l  fy1 ?    D*  l # l8{1 ?`P   B*  l # lz1 ?`   D* H l 0޽h ? ̙33g  @((  (r ( S h   ( 3 r81?xW S!Challenges in Protecting Subjects""H ( 0޽h ? f33" k pJ(  r  S Ȕw      C Ȏw P@<$<  H  0޽h ? f33j      (  r  S w    l  C wP` 0   l P   P ,$D,!  3 r(w1?P:  w1HARM Medical Social Emotional Financial Legal*2-   S ~wG~Hn(1? P  :   # lw1?"P  p,$D, r- A 5% chance - of my neighbor hearing my diagnosis in the elevator and telling my boss leading to my being fired.*D/-q&  # l1?" Pp 0kl  p  p,$D,Q  3 rhw1?   ,$D, s;- A 20% chance - of getting a headache - that is really bad<:   f1? pH  0޽h ?  f33  V(  l  C w     C Hw@<$<   *H  0޽h ? f33  D(  l  C      C ش<$<  H  0޽h ? f33  ( wY r  S     l  C   H  0޽h ? f33  (  r  S X    l  C X  H  0޽h ? f33  9(  r  S     l  C      3 r1? 9,$D, =)What culture is reflected by the writers?H  0޽h ? f33  ,( }   S 8 `   l  C   H  0޽h ? f33  (  r  S     l  C X  H  0޽h ? f33     & ( . r  S     8  p  p  3 rغ1?")^ F k{B  # lD1?"pB  # lD1?"  lB  # lD1?" ``B  # lD1?" P P     fx1?0 `0 MPatient Subject   3 r81?`  Q Physician Investigator    f1?P 2  r8CONGRUENT Common goal is treatment of individual patient98*   fX1?   ZNOT CONGRUENT MD is providing care to a person who is volunteering and expecting free drug[Z    f1?  "  v<NOT CONGRUENT Patient is unaware that MD is an investigator.=<"   f1? `  8CONGRUENT Common understanding about study requirements 988H  0޽h ? f33  (  l  C ȋw    l  C 80  H  0޽h ? f33   h$( ( hr h S 0    r h S x2  H h 0޽h ? f33  0 (   r   S 2    l   C 3  H   0޽h ? f33  @,B(  ,r , S 83     , S x5@  *zRH , 0޽h ? f33  P0$(  0r 0 S 5    r 0 S 6  H 0 0޽h ? f33  TL` 8(  8r 8 S 6    r 8 S 86Pp   8  fX71?1  f&First impressions made via advertising$'& 8  f81? @  : 2   8 3 rx81?&    8  WGnRd1[ ?FREEArial,$D,  8 c  W31D[?$$$$$KidprintP  ,$D,H 8 0޽h ? f33D  p4(  4r 4 S 9    r 4 S X:  X 4  f:1?@ x ,$D, XDoes the protocol leave this assessment up to the investigator without any assistance? WH 4 0޽h ? f33  (  l  C (P   l  C   H  0޽h ? f33  WOX(   X*8 f; Xf0 X 3 r貕1?"@ :    X # lH1?"  n<When there is lots of competence, little support is required==  X S ~@1?"f.  G COMPETENCE X C xh1?" ; Q! SUPPORT""B X  fD1?@5  X  f(1?  ,$D, k7When there is less competence, more support is needed. 88l ^ pP X^ pP,$D, X  f1?^ <  GNormal wealthy genius X  fH1?W P JStandard consent formB X  `D? p B X  `D?p p@1l zjp Xzj,$D,  X 3 r1?6:    X 3 rh1?j    X  fȷ1? hUnconscious jogger + stroke  X  f1?O; 950.24B X  `D?VVB X  `D?zzpr X S 踕    H X 0޽h ? f33  ~v(  r  S     l  C h   &   fȺ1?`,$D, \,Is the template Organized? Simple? Stylish?--   f(1? o,$D,  WHO does the consent form protect? How is that signified? Does the protocol treat it as a good legal defense against the subject . . . ?80Z(H  0޽h ? f33  (  l  C P   l  C 軕  H  0޽h ? f33  (  r  S h    l  C ;  H  0޽h ? f33. k V( } x  c $8#      S X$PPp<$<  H  0޽h ? f33  ( `%. r  S #    l  C # @  H  0޽h ? f33  z0( <Hf l  C   f  3     H  0޽h ? f33A\ `X @(  tidtsaMt re txe @X @ C <   X @ C r< @   The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity. @ H @ 0޽h ? ̙33A\ ~0D(  DX D C <   ~ D C x< @    H D 0޽h ? ̙33A\ @H>( +, HX H C <    H C xz< @   F Element 1 - purpose, procedures  !H H 0޽h ? ̙33A\ ~PL( +, LX L C <   ~ L C t< @    H L 0޽h ? ̙33 A\ ~t(  tX t C <   ~ t C ~< @    H t 0޽h ? ̙33A\ ~Px( +, xX x C <   ~ x C w< @    H x 0޽h ? ̙33A\ x(  R  3 <   ~  C {< @    H  0޽h ? ̙33A\ `(  X  C <     S xt< @    H  0޽h ? ̙33r0<rJ`x lٶ@Ps9T"^`>Zz}$@Y$y_%"1  ՜.+,0    +'On-screen ShowPIRCp "Times New RomanComic Sans MSArialTimes HelveticaTahomaCentury Gothic ContemporaryPowerPoint PresentationThree Common Study ProblemsProbl Oh+'0% px  < H T `lt'No Slide Titleo Erica HeathQErica HD:x Applications:MS Office 98:Templates:Presentation Designs:ContemporaryesEricaHD12cMicrosoft PowerPointns:@^/@: 5@,𺤿@-GH$PICT$@ @@ HH Zyrd ff ffˁfˁffˁˁfˁffˁ ff ff ffˁfˁffˁ ff ff ffˁfˁޙˁޙˁfˁޙˁޙfܙ́ܙfܙ́ܙfܙ́ܙfܙ́ܙfܙ́ܙfܙ́ܙyfΙΙ3fۙۙ6fٙٙHfۙۙ f ۙ ۙ.fҙԙΙҙԙΙfܙ́ܙfܙ́ܙfܙ́ܙfܙ́ܙfܙ́ܙ ff ff ff ff ff ff ff ff ff ff ff ffffffffffffffffffffffffffffffffffffffffffffffffffffffff  fff fffffffffffffffffffffff fffffff  ffffffffffffffffffffffffffffffffffffffffffffffffffffffff ff ff ff ff ffAffffffffffffffffffffffffffffffffffffffz  ffffffffffffff fffffffffffff fffffffffffffffffffffffffff  S fffffffffffff ffffffffffffffffffffffffffffffff }fffffffffffffffffffffffffffffffffffffffffffffffffffffffGfffffffffffffffffffffffffffffffffff ff ff ff ff ff ff ff ff ff ff ff ff ff ff ff ff ff ff ff ff ffoffffffffffff fffffffffffffff ffffffffffff fffffffffffffffffffff ffffffff ffffffff ffffffffff fffffffffffffffffff ff ff ff ff6fffffifffffffffffffffWffffffffffiffffffffffffffNfffffff ff ff ff fffffffffffffffffff& ffffffffffffffffff ffffffffffffffffffff Mfffffffffffffffffffffffffffffffffffffffffff\ ffffff ffffffffffffffffffffffffffffffffffffffffffff #fffffffffffffffffffffffffffffffffffff ff ff ff ff ff ff ff ff ff ff ff ff ff ff ff ff ff ff ff ff ffff̼wffff f f fҙfҙff̼ff̼ff̼ffffffffff̼ff̼em 1: Hidden Risks(Risk Reduction - Build into the design2Injury and Compensation Resolution & RestitutionProblem 2: Presumptiveness$Combating Presumptiveness by design!A. Reflect a Corporate Culture/Separation of Roles Conflict(s) of Interest(s)B. Separation of RolesB. Separation of Roles-Presumption C. Myths of Shared informationProblem 3: Informed Consent Lack of evidence of thought%Definition How are these addressed?A) AgreementB) With full informationC) of a competent person"D) Without force, fraud, deceit LThere is an Inverse Proportion between competence and consent requirements Why have a consent document?Consent and Study DesignConsent and DesignReview - Common ProblemsDesign and Subject ProtectionPowerPoint Presentation  Fonts UsedDesign Template Slide Titles_LEricaCurrent User%RdO)yPowerPoint Document(pSummaryInformation({%DocumentSummaryInformation8  !"#$%&'()*+,-./0123456789:;<=>?@ABCDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvw|}~Current User%  With full informationC) of a competent person"D) Without force, fraud, deceit LThere is an Inverse Proportion between competence and consent requirements Why have a consent document?Consent and Study DesignConsent and DesignReview - Common ProblemsDesign and Subject ProtectionPowerPoint Presentation  Fonts UsedDesign Template Slide Titles_LvErica