MIME-Version: 1.0 Content-Type: multipart/related; boundary="----=_NextPart_01C63F94.B5F9BB30" This document is a Single File Web Page, also known as a Web Archive file. If you are seeing this message, your browser or editor doesn't support Web Archive files. Please download a browser that supports Web Archive, such as Microsoft Internet Explorer. ------=_NextPart_01C63F94.B5F9BB30 Content-Location: file:///C:/4809C636/Ethical_issues_research_Vayena_2006.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Ethical issues in research: informed consent - Effy Vayena

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------=_NextPart_01C63F94.B5F9BB30 Content-Location: file:///C:/4809C636/Ethical_issues_research_Vayena_2006_files/master04.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252"
PGC-2004
Training Course in Reproductive Health/
Sexual Health Research
Geneva 2006
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Click to edit= Master subtitle style
PGC-2003
Training Course in Reproductive Health/
Sexual Health Research
Geneva 2006
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‹date/time›
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------=_NextPart_01C63F94.B5F9BB30 Content-Location: file:///C:/4809C636/Ethical_issues_research_Vayena_2006_files/pres.xml Content-Transfer-Encoding: quoted-printable Content-Type: text/xml; charset="utf-8" ------=_NextPart_01C63F94.B5F9BB30 Content-Location: file:///C:/4809C636/Ethical_issues_research_Vayena_2006_files/slide0018.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Ethical issues in research: informed consent - Effy Vayena
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PGC-2= 003
= Training Course in Reproductive Health/
Sexual Heal= th Research
Geneva 2006=
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  ETHICAL ISSUES IN RESEARCH
- informed consent-
Effy Vayena
Department of Reproductive Health and Research
World Health Organization
Geneva, Switzerl= and
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PGC-2= 004
Objectives of this session
review need for research ethics
highlight key = issues in research ethics
<= span class=3DBB style=3D'position:absolute;left:-4.2%;top:-.15em'>•focus on and analyse the issue of informed consent
=
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PGC-2004
Funding & publishing requirements? =
Importance of ethics in research
------=_NextPart_01C63F94.B5F9BB30 Content-Location: file:///C:/4809C636/Ethical_issues_research_Vayena_2006_files/slide0090.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Ethical issues in research: informed consent - Effy Vayena
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PGC-2004
Importance of ethics in research
Human participants
Risks/ benefits not always predicted
Harm
Abuses in research
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PGC-2004
Ethical Issues in Research
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Nazi experiments
Nuremberg tria= l- Nuremberg code 1947
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3D"Text
PGC-2004
Ethical Issues in Research
Tuskegee syphilis experiment :     1932-1972
<= span style=3D'font-size:86%;visibility:hidden'>
Jewish chronic disease hospital cancer experiments 1963-1966
<= span style=3D'font-size:86%;visibility:hidden'>
<= span style=3D'font-size:86%'>WIll= owbrook state school hepatitis experiments 1955-1970
<= span style=3D'font-size:86%;visibility:hidden'>
agreement about these abuses =
------=_NextPart_01C63F94.B5F9BB30 Content-Location: file:///C:/4809C636/Ethical_issues_research_Vayena_2006_files/slide0091.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Ethical issues in research: informed consent - Effy Vayena
3D"Text
PGC-2004
Nuremberg cod= e
1= 947 =
Ethical Issues in Research
<= /div>
Declaration of Helsinki
= 1964/1975/2000
CIOMS Guideli= nes
= 1982/2002
<= span style=3D'font-family:Arial;font-size:83%'>Respect for persons <= /span>
= <= /span>
Beneficence
= <= /span>
Justice
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3D"Text
PGC-2004
Fundamental Ethical Principles in Research
Respect for persons
Beneficence
Distributive justice
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PGC-2004
Respect for persons
<= /span>
          Respect for persons =
Respect for autonomy
i)Requirement that those who are capable of deliberating pers= onal = choices should be treated with respect for their capacity of self-= determination; =
ii)Persons with diminished or impai= red autonomy or those in dependent or vulnerable positions should be protected against harm or abuse.
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PGC-2= 003
Ethi= cal Issues in Research
<= /span>  informed consent, and
<= /span>  informed decision-making
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PGC-2003
Informed decision-making =
Informed decision-making requires: <= /span>
=   information from the investigator to be:
<= span style=3D'font-family:Arial;text-shadow:auto'> comprehensive (complete)
<= span style=3D'font-family:Arial;text-shadow:auto'> comprehensible (simple language)
=   the decision by the subject to be: = ;
<= span style=3D'font-family:Arial;text-shadow:auto'> based on competence (ability to understand)
=  voluntary (free of coercion, undue infl= uence or
  inducement, or intimidation)
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PGC-2= 004
Ethical Issues in Research
<= span style=3D'color:#3333CC;mso-color-index:5'>Content of informed consent
<= span style=3D'font-size:114%;color:#3333CC;mso-color-index:5'>Who obtains consent
<= span style=3D'color:#3333CC;mso-color-index:5'>How is consent obtained
<= span class=3DBB style=3D'position:absolute;left:-6.68%;top:-.04em'>•How = is consent = recorded
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PGC-2004
Barriers
= Con= fusion
= Cult= ure
= Coer= cion
= Time=
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PGC-2= 003
Con= sent Form
=
THE CONSENT FORM
=   documents the consent process =
=   it cannot substitute for the consent information and
   discussion
=   it is not to provide legal protection for researchers!
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PGC-2003
Ethi= cal Issues in Research
Research description
Risks
Benefits
Alternatives
Confidentiality
Compensation
Contacts
Voluntary participation
What informati= on must be
disclosed?=
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file:///C:/4809C636/Ethical_issues_research_Vayena_2006_files/slide0060.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Ethical issues in research: informed consent - Effy Vayena
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PGC-2= 004
Ethi= cal Issues in Research
= Research description  4
= = Risks
= = Benefits
= = Alternatives
= = Confidentiality
= = Compensation
= = Contacts
= = Voluntary participation
Proposed study = is research
Objectives of t= he study
=
Expected responsibilities
=
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto'>= Pr= ocedures involved (including methodological aspects, such as randomization,
predetermined assignment, etc.)
=
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto'>= St= udy duration(time commitment)
=
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto'>= St= udy sponsors
<= span style=3D'font-family:Univers;font-size:67%;color:red;visibility:hidden'>=
<= span style=3D'font-family:Univers;font-size:67%;visibility:hidden'>= &= #13;
<= span style=3D'font-family:Univers;font-size:67%;visibility:hidden'>= &= #13;
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PGC-2= 003
Points to remember&= #13;
=
=
Points to remember:
=   use simple, nontechnical language that subjects
   can understand
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<= span style=3D'font-family:Univers;font-size:67%;visibility:hidden'>= &= #13;
<= span style=3D'font-family:Univers;font-size:67%;visibility:hidden'>= &= #13;
<= span style=3D'font-family:Univers;font-size:83%'>Level of literacy&= #13;
<= span style=3D'font-family:Univers;font-size:67%;visibility:hidden'>= &= #13;
<= span style=3D'font-family:Univers;font-size:67%;visibility:hidden'>= &= #13;
<= span style=3D'font-family:Univers;font-size:83%'>Cultural beliefs for disease aetiology  =
<= span style=3D'font-family:Univers;font-size:67%;visibility:hidden'>= &= #13;
<= span style=3D'font-family:Univers;font-size:67%;visibility:hidden'>=
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PGC-2003
<= /div>
= ;
<= /div>
Language: = ;
&= #13;
Examples from US study
Waggoner , W.  And Mayo D. "Who understands?  A Survey of 25 Words of Phrases = Commonly Used in Proposed Clinical Research  Consent Forms,&qu= ot; IRB: A Review of Human Subjects Research, vol. 17, No 1 (1995), 6-9
Language
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PGC-2= 004
1.<= /span>If you were to us= e the = barrier method for birth control, what would this involve?
= ;
Greater than 12th grade: <= /b>
a)25% b)79% = c)90%
<= /div>
12th grade or less:
a)70% b)35% = c)58%
Ethi= cal Issues in Research
------=_NextPart_01C63F94.B5F9BB30 Content-Location: file:///C:/4809C636/Ethical_issues_research_Vayena_2006_files/slide0109.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Ethical issues in research: informed consent - Effy Vayena
3D"Text
PGC-2004
1.<= /span>If you were to us= e the = barrier method for birth control,
what would this involve?
= ;
Greater than 12th grade: <= /b>
a)25% b)79%= c)90%
<= /div>
12th grade or less:
a)70% b)35%= c)58%
Ethi= cal Issues in Research
------=_NextPart_01C63F94.B5F9BB30 Content-Location: file:///C:/4809C636/Ethical_issues_research_Vayena_2006_files/slide0110.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Ethical issues in research: informed consent - Effy Vayena
3D"Text
PGC-2004
2.= What does the ter= m = efficacy mean?
<= /div>
Greater than 12th grade: <= /b>
a)39% b)82%= c)59%
<= /div>
12th grade or less:
a)29% b)13%= c)49%
= ;
Ethi= cal Issues in Research
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3D"Text
PGC-2004
2.= What does the ter= m = efficacy mean?
<= /div>
Greater than 12th grade: <= /b>
<= /div>
a)39% b)82%= c)59%
<= /div>
12th grade or less:
a)29% b)13%= c)49%
Ethi= cal Issues in Research
------=_NextPart_01C63F94.B5F9BB30 Content-Location: file:///C:/4809C636/Ethical_issues_research_Vayena_2006_files/slide0112.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Ethical issues in research: informed consent - Effy Vayena
3D"Text
PGC-2004
3.<= /span>If the drug you w= ere to take was chosen randomly, what does = = this mean?
<= /div>
Greater than 12th grade: <= /b>
a)39% b)64% = c)49%
<= /div>
12th grade or less:
a)38% b)13% = c)4%
Ethi= cal Issues in Research
------=_NextPart_01C63F94.B5F9BB30 Content-Location: file:///C:/4809C636/Ethical_issues_research_Vayena_2006_files/slide0113.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Ethical issues in research: informed consent - Effy Vayena
3D"Text
PGC-2004
3.<= /span>If the drug you w= ere to take was chosen randomly,
what does this mean?
<= /div>
Greater than 12th grade: <= /b>
a)28% b)64%= c)49%
<= /div>
12th grade or less:
a)38% b)13%= c)4%
Ethi= cal Issues in Research
------=_NextPart_01C63F94.B5F9BB30 Content-Location: file:///C:/4809C636/Ethical_issues_research_Vayena_2006_files/slide0114.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Ethical issues in research: informed consent - Effy Vayena
3D"Text
PGC-2004
4.= What does = double-blind mean?
5. = ;
Grader than 12th day:
a)65% b)37%= c)21%
<= /div>
12th grade or less:
a)29% b)3% = c)17%
4. = ;
Double-blind
------=_NextPart_01C63F94.B5F9BB30 Content-Location: file:///C:/4809C636/Ethical_issues_research_Vayena_2006_files/slide0115.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Ethical issues in research: informed consent - Effy Vayena
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PGC-2004
4.= What does = double-blind mean?
5. = ;
Grader than 12th day:
a)65% b)37%= c)21%
<= /div>
12th grade or less:
a)29% b)3% = c)17%
4. = ;
Double-blind
------=_NextPart_01C63F94.B5F9BB30 Content-Location: file:///C:/4809C636/Ethical_issues_research_Vayena_2006_files/slide0073.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Ethical issues in research: informed consent - Effy Vayena
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PGC-2= 003
Ethi= cal Issues in Research
=
=
Points to remember:
=   describe fully what the subject will have to do,
   before, during, and following the research,
   includ= ing the amount of time required
=   include= mention of home visits when relevant 
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PGC-2= 004
Ethi= cal Issues in Research
= Re= search de= scription
= = Risks 4
= = Benefits
= = Alternatives
= = Confidentiality
= = Compensation
= = Contacts
= = Voluntary participation
= <= /span>
=
Anticipated or foreseeable
Physical, socia= l, psychological
=
= Po= ssible discomforts or inconveniences =
=
<= span style=3D'font-family:Arial;font-size:38%;color:red;visibility:hidden'>=
= <= /span>
<= span style=3D'font-family:Arial;font-size:38%;visibility:hidden'>= <= /span>
<= span style=3D'font-family:Univers;font-size:67%;color:red;visibility:hidden'><= /span>
<= span style=3D'font-family:Univers;font-size:67%;color:red;visibility:hidden'><= /span>
<= span style=3D'font-family:Univers;font-size:67%;visibility:hidden'><= /span>&= #13;
<= span style=3D'font-family:Univers;font-size:67%;visibility:hidden'><= /span>&= #13;
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PGC-2= 003
Ethi= cal Issues in Research
=
Points to remember:
=    avoid misle= ading or deceptive statements
e.g. "There are no risks to this research”
=   avoid unduly alarming statements =
 
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PGC-2= 004
Ethi= cal Issues in Research
= Re= search de= scription
= Risks
= = Benefits    4
= = Alternatives
= = Confidentiality
= = Compensation
= = Contacts
= = Voluntary participation
possible benefi= ts to subjects themselves
=
reasonably expected, no exaggeration
=
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto'>= possible benefits to others, or just contributi= ons to scientific
knowledge
= <= /span>
=
<= span style=3D'font-family:Arial;font-size:38%;color:red;visibility:hidden'>=
= <= /span>
<= span style=3D'font-family:Arial;font-size:38%;visibility:hidden'>= <= /span>
<= span style=3D'font-family:Univers;font-size:67%;color:red;visibility:hidden'><= /span>
<= span style=3D'font-family:Univers;font-size:67%;color:red;visibility:hidden'><= /span>
<= span style=3D'font-family:Univers;font-size:67%;visibility:hidden'><= /span>&= #13;
<= span style=3D'font-family:Univers;font-size:67%;visibility:hidden'><= /span>&= #13;
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PGC-2= 003
Ethi= cal Issues in Research
=
Points to remember:
=   do not overstate the benefits to subje= cts of the
   research
e.g. "This new treatment will improve your condition"
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PGC-2= 004
Ethi= cal Issues in Research
= Re= search de= scription
= Risks
= = Benefits
= = Alternatives  = 4
= = Confidentiality
= = Compensation
= = Contacts
= = Voluntary participation
= <= /span>
Alternative procedures or treatment
=
Advantages and disadvantages
=
Availability= 3;
=
=
<= span style=3D'font-family:Arial;font-size:38%;color:red;visibility:hidden'>=
= <= /span>
<= span style=3D'font-family:Arial;font-size:38%;visibility:hidden'>= <= /span>
<= span style=3D'font-family:Univers;font-size:67%;color:red;visibility:hidden'><= /span>
<= span style=3D'font-family:Univers;font-size:67%;color:red;visibility:hidden'><= /span>
<= span style=3D'font-family:Univers;font-size:67%;visibility:hidden'><= /span>&= #13;
<= span style=3D'font-family:Univers;font-size:67%;visibility:hidden'><= /span>&= #13;
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PGC-2= 003
Ethi= cal Issues in Research
=
=
Points to remember:
=   distinguish clearly between the research = ;
   manoeu= vers and any therapeutic or diagnostic
   proced= ures subjects would undergo if not
   enroll= ed in the research
<= /span>
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PGC-2003
Ethi= cal Issues in Research
=
=
Points to remember:
=   avoid a therapeutic misconception
<= /span>
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PGC-2= 004
Ethi= cal Issues in Research
= Re= search de= scription
= Risks
= = Benefits
= = Alternatives
= = Confidentiality   4
= = Compensation
= = Contacts
= = Voluntary participation
= <= /span>
Degree of confidentiality
<= span style=3D'font-family:Arial;font-size:33%;text-shadow:auto;visibility:hidde= n'>=
Persons, organizations who may have access to the information =
<= span style=3D'font-family:Arial;font-size:33%;text-shadow:auto;visibility:hidde= n'>=
= How confidentiality will be maintained =
<= span style=3D'font-family:Arial;font-size:33%;text-shadow:auto;visibility:hidde= n'>=
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto'>= Can confidentiality be maintained (legal situation regarding mandatory disclosure to authorities)
<= span style=3D'font-family:Arial;font-size:33%;visibility:hidden'>=
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto'>= Where and how information will be stored and f= or how long
=
=
=
=
<= span style=3D'font-family:Arial;font-size:38%;color:red;visibility:hidden'>=
= = <= /span>
= <= /span>
<= /span>&= #13;
<= /span>&= #13;
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PGC-2004
Ethi= cal Issues in Research
= Re= search de= scription
= Risks
= = Benefits
= = Alternatives
= = Confidentiality
= = Compensation   4
= = Contacts
= = Voluntary participation
<= span style=3D'font-family:Arial;font-size:83%;visibility:hidden'>= <= /span>
Available money= or other forms of material goods in return for = pa= rticipation
Available compensation in case of injury
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto'>= Tr= avel cost or other expenses
<= span style=3D'font-family:Arial;font-size:83%;visibility:hidden'>= <= /span>
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto;visibility:hidde= n'>=
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto;visibility:hidde= n'>=
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto;visibility:hidde= n'>=
<= span style=3D'font-family:Arial;font-size:83%;color:red;visibility:hidden'>=
<= /span>
<= span style=3D'font-family:Arial;font-size:83%;visibility:hidden'>= <= /span>
<= /span> <= /span>
=
=
= &= #13;
= &= #13;
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PGC-2004
Ethi= cal Issues in Research in
Reproductive Health
= Re= search de= scription
= Risks
= = Benefits
= = Alternatives
= = Confidentiality
= = Compensation
= = Contacts 4
= = Voluntary participation
<= span style=3D'font-family:Arial;font-size:83%;visibility:hidden'>= <= /span>
Contact for research-related questions
Contact for con= cerns about participant’s rights
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto;visibility:hidde= n'>=
<= span style=3D'font-family:Arial;font-size:83%;visibility:hidden'>= <= /span>
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto;visibility:hidde= n'>=
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto;visibility:hidde= n'>=
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto;visibility:hidde= n'>=
<= span style=3D'font-family:Arial;font-size:83%;color:red;visibility:hidden'>=
<= /span>
<= span style=3D'font-family:Arial;font-size:83%;visibility:hidden'>= <= /span>
<= /span> <= /span>
=
=
= &= #13;
= &= #13;
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PGC-2004
Ethi= cal Issues in Research
= Re= search de= scription
= Risks
= = Benefits
= = Alternatives
= = Confidentiality
= = Compensation
= = Contacts
= = Voluntary participation 4
<= span style=3D'font-family:Arial;font-size:83%;visibility:hidden'>= <= /span>
Absolutely volu= ntary = pa= rticipation
Right to withdr= aw from the study at any time without any = co= nsequences
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto'>= No= penalty for refusal to participate
<= span style=3D'font-family:Arial;font-size:83%;visibility:hidden'>= <= /span>
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto;visibility:hidde= n'>=
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto;visibility:hidde= n'>=
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto;visibility:hidde= n'>=
<= span style=3D'font-family:Arial;font-size:83%;color:red;visibility:hidden'>=
<= /span>
<= span style=3D'font-family:Arial;font-size:83%;visibility:hidden'>= <= /span>
<= /span> <= /span>
=
= &= #13;
= &= #13;
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3D"Text
PGC-2= 003
Ethi= cal Issues in Research
=
Points to remember:
=   avoid subtly coercive statements =
= = e.g. "We trust that you will agree to participate= and
         remain in this stu= dy in order to help us find a
         cure for your disease"
<= /span>  do not include a line for the spouse´s signature,
   except= under certain specific and clearly defined
   circumstances
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PGC-2003
Who obtains consent
=
=
Who obtains consent
Investigator / physician
Third party (healthcare worker, interpreter) =
<= /span>
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PGC-2003
How to obtain consent
=
=
How to obtain consent
<= span style=3D'font-family:Arial;text-shadow:auto'>refra= in from unjustified deception, undue influence
<= /span>
“How useful is the issue of informed consent in the Philippines and other developing countries, since i= t is always the poor in trials who cannot afford the drugs on the marke= t? It is their only realistic form of treatment and they are not= truly free to decide not to participate.”
Quoted in Nuffield Council of Bioethics Report, 2002, p.= 79
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3D"Text
PGC-2003
Ho= w to obtain consent
=
=
How to obtain consent
<= span style=3D'font-family:Arial;text-shadow:auto'>refra= in from unjustified deception, undue influence
<= span style=3D'font-family:Arial;text-shadow:auto'>seek consent after comprehension
in ge= neral obtain signed consent (how to record)
renew= the consent of each subject if changes in conditions or procedures
renew= the consent in long term-studies at pre-deter= mined intervals
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PGC-2003
Ho= w to record consent
How to record consent
signed form as evidence -investigators to justify any exceptions to = this general rule and obtain approval from the ethical review <= /span>= committee.
<= span style=3D'font-family:Arial;font-size:83%;text-shadow:auto;visibility:hidde= n'>=
minimal risk
subjects unwilling to sign because of fear, mistrust
       or suspicion
signed conse= nt forms may identify subjects in
    sensitive research (HIV/AIDS, CSWs, etc.)
verbal consent/ witnessing conse= nt
------=_NextPart_01C63F94.B5F9BB30 Content-Location: file:///C:/4809C636/Ethical_issues_research_Vayena_2006_files/slide0080_image024.png Content-Transfer-Encoding: base64 Content-Type: image/png iVBORw0KGgoAAAANSUhEUgAAAeMAAADxCAYAAAD4Ht8cAAAAAXNSR0ICQMB9xQAAAAlwSFlzAAAI NgAACDQBvpAePAAAABl0RVh0U29mdHdhcmUATWljcm9zb2Z0IE9mZmljZX/tNXEAAANFSURBVHja 7dWxCYBADIbRTGNl4YrZz1GEGyGSQkeICO/gwZHyb77Y9qMiAgAY1P3NzGj96rwKABjU/RVjABBj ABBjMQYAMQYAMRZjABBjABBjowCAGAOAGAMAYgwAYgwAiDEAiDEAIMYAIMYAgBgDgBgDAGIMAGIM AIgxAIgxACDGACDGAIAYA4AYAwBiDABiDACIMQCIMQAgxgAgxgCAGAOAGAMAYgwAYgwAiDEAiDEA IMYAIMYAgBgDgBgDAGIMAGIMAIgxAIgxACDGACDGAIAYA4AYAwBiDABiDACIMQCIMQAgxgAgxgCA GAOAGAMAYgwAYgwAiDEAiDEAIMYAIMYAIMZiDABiDABiLMYAIMYAIMZiDABiDABiLMYAIMYAIMZG AQAxBgAxBgDEGADEGAAQYwAQYwBAjAFAjAEAMQYAMQYAxBgAxBgAEGMAEGMAQIwBQIwBADEGADEG AMQYAMQYABBjABBjAECMAUCMAQAxBgAxBgDEGADEGAAQYwAQYwBAjAFAjAEAMQYAMQYAxBgAxBgA EGMAEGMAQIwBQIwBADEGADEGAMQYAMQYABBjABBjAECMAUCMAQAxBgAxBgDEGADEGAAQYwAQYwBA jAFAjAFAjMUYAMQYAMRYjAFAjAFAjMUYAMQYAMRYjAFAjAFAjI0CAGIMAGIMAIgxAIgxACDGACDG AIAYA4AYAwBiDABiDACIMQCIMQAgxgAgxgCAGAOAGAMAYgwAYgwAiDEAiDEAIMYAIMYAgBgDgBgD AGIMAGIMAIgxAIgxACDGACDGAIAYA4AYAwBiDABiDACIMQCIMQAgxgAgxgCAGAOAGAMAYgwAYgwA iDEAiDEAIMYAIMYAgBgDgBgDAGIMAGIMAIgxAIgxACDGACDGAIAYA4AYA4AYizEAiDEAiLEYA4AY A4AYizEAiDEAiLEYA4AYA4AYGwUAxBgAxBgAEGMAEGMAQIwBQIwBADEGADEGAMQYAMQYABBjABBj AECMAUCMAQAxBgAxBgDEGADEGAAQYwAQYwBAjAFAjAEAMQYAMQYAxBgAxBgAEGMAEGMAQIwBQIwB ADEGADEGAMQYAMQYABBjAPhpjFcfAIBR643x8wEAvnEDaeA43D/Wp3EAAAAASUVORK5CYIJ= ------=_NextPart_01C63F94.B5F9BB30 Content-Location: file:///C:/4809C636/Ethical_issues_research_Vayena_2006_files/slide0074.htm Content-Transfer-Encoding: quoted-printable Content-Type: text/html; charset="windows-1252" Ethical issues in research: informed consent - Effy Vayena
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PGC-2= 004
Other issues/concerns
respect of autonomy   informed decision making
individual versus community
»community leader
»council of elders
»another designated authority<= /b>
»
In no case, may the permission of a community leader
or other authority substitute for individual infor= med consent
(CIOMS)
Other issues/concern= s
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PGC-2004
<= span style=3D'color:#3333CC;mso-color-index:5'>autonomy and locus of decision-m= aking authority
Who is
making the
decision?
<= span style=3D'font-family:Arial;color:#3333CC;mso-color-index:5'>= n= otion of personhood
= p= erson versus community
= w= omen
= i= ndividual consent versus community consent
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PGC-2004
Sensitivity to cultural
requirements,
customs  traditions
Ethi= cal Issues in Research
= Requirement for respect
= for persons
in= some cultural contexts it may be appropriate to obtain agreement from the =
co= mmunity or assent from from a senior family member before a prospective participant
is approached. If a prospective participant does not wish to take part in research this
mu= st be respected. Researchers must not enrol such individuals and have a duty to faci-
li= tate their non-participation.                                   Nu= ffield Council of Bioethics Report, 2002
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PGC-2004
Other issues/concerns
respect of autonomy   informed decision making
impaired capacity to give adequately informed consent
–= low risk standard
responsible family member or legally authorised representative (case of mental or behavioural disorder) <= /span>
–= ethical review committee to approve
Ethi= cal Issues in Research
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PGC-2= 003
Ethi= cal Issues in Research
Remember - the primary ethical objective is: =
=   to protect the research subject from harm
<= span style=3D'font-family:Arial;text-shadow:auto'>  physical
<= span style=3D'font-family:Arial;text-shadow:auto'>  psychological
<= span style=3D'font-family:Arial;text-shadow:auto'>  social (stigmatization, community exclusion)
<= span style=3D'font-family:Arial;text-shadow:auto'>  legal (fines)
=   not to prote= ct the investigator from claims
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PGC-2= 004
Ethical Issues in Research
In research on man, the interest of science and society should never = take precedence over considerations related to the wellbeing = of the subject.
»= Declaration of Helsinki
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Respect fo= r persons incorporates two considerations: A)respect for autonomy and B) protection of persons with impaired or diminished auto= nomy Beneficence: ethical obligation to maximize benefit and to minimize harm. This principle gives rise to norms requiring that the risks of research be reasonable in the light of expected benefits, research design is sound, investigator= s are competent to conduct the research and safeguard the welfare of research subjects. Justic= e:  treat each person in accordance with what is morally right and proper= , to give each person what is due to him or her. – distributive justice=3D equitable distribution of both burdens and the benefits in participation
 
 
 
 
 
 
 
 
 
 
 
 
 
The notions of personhood, individual autonomy and decisional capability are clearly embedded in and depended within the social and cultur= al patterns of family ties and community obligation= s In western cultures personal autonomy is emphasised but that = is not the case for all countries and definitely for so= me non-western countries. Research on informed decision making has shown that in some cases the individual transfers the decision making authority to the tribal elders, community leaders, religious authorities etc. Other examples : In one African country (Uganda) by law an 18= year old has the right to make his own decisions, how= ever is customary that he asks for his father approval prior to entering into any obligations, contracts etc.
In these cases, family consent was the issue- fami= ly versus the individual.
Then you have the rural versus urban communities, in ma= ny rural communities in Africa countries it was sho= wn that an individual’s decision is a family matter= . In cases like that the investigator has to take these cultural differences into consideration and perhaps appro= ach community leaders as well. Researchers and philosophers have done a lot of work in this area and what seems to be the most reasonable approach is that it is essent= ial to obtain informed consent but it is naïve to to pr= esume that consent represents a completely autonomous decision in cultural setting where there is pressure to seek permission from spouses or community elders. One way to = look at it is to develop forms and procedures that safeguard the person’s autonomy but also respect= the unique qualities and the cultural diversity of the communities.
 
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parent.GoToPrevSld(); } }function DocumentOnClick() { if( IsNts() || parent.HideMenu() ) return; if( ( g_allowAdvOnClick && (window.name=3D=3D"PPTSld") && !parent.IsFrames= Mode() ) || (event && event.keyCode=3D=3D32) ) { =09 if( g_animUseRuntime && g_animMainSequence && g_animMainSequence.cangonex= t ) return; parent.GoToNextSld(); } } var g_supportsPPTHTML =3D SupportsPPTHTML(), g_scaleInFrame =3D 1, gId=3D""= , g_bgSound=3D"", g_scaleHyperlinks =3D false, g_allowAdvOnClick =3D 1, g_showInBrowser = =3D 0, gLoopCont =3D 0, gUseSldTimings =3D 1; var g_showAnimation =3D g_supportsPPTHTML && SupportsPPTAnimation() && ( (w= indow.name=3D=3D"PPTSld" && !parent.IsFramesMode()) || g_showInBrowser );va= r g_animManager =3D null; var g_animUseRuntime =3D false; var g_animItemsToHide, g_animInteractiveItems, g_animSlideTime; var g_animMainSequence =3D null; var ENDSHOW_MESG=3D"End of slide show, click to exit.", SCREEN_MODE=3D"Fram= es", gIsEndShow=3D0, NUM_VIS_SLDS=3D49, SCRIPT_HREF=3D"script.js", FULLSCR_= HREF=3D"fullscreen.htm"; var gCurSld =3D gPrevSld =3D 1, g_offset =3D 0, gNtsOpen =3D gHasNts =3D gO= tlTxtExp =3D 0, gHasNarration =3D 0, gOtlOpen =3D true window.gPPTHTML=3DSupportsPPTHTML() var gMainDoc=3Dnew Array(new hrefList("slide0018.htm",1,-1,0),new hrefList(= "slide0083.htm",1,-1,1),new hrefList("slide0086.htm",1,-1,1),new hrefList("= slide0090.htm",1,-1,1),new hrefList("slide0085.htm",1,-1,1),new hrefList("s= lide0084.htm",1,-1,1),new hrefList("slide0091.htm",1,-1,1),new hrefList("sl= ide0087.htm",1,-1,1),new hrefList("slide0089.htm",1,-1,1),new hrefList("sli= de0031.htm",1,-1,0),new hrefList("slide0097.htm",1,-1,0),new hrefList("slid= e0094.htm",1,-1,1),new hrefList("slide0116.htm",1,-1,1),new hrefList("slide= 0033.htm",1,-1,0),new hrefList("slide0059.htm",1,-1,0),new hrefList("slide0= 060.htm",1,-1,1),new hrefList("slide0068.htm",1,-1,0),new hrefList("slide01= 07.htm",1,-1,1),new hrefList("slide0108.htm",1,-1,1),new hrefList("slide010= 9.htm",1,-1,1),new hrefList("slide0110.htm",1,-1,1),new hrefList("slide0111= .htm",1,-1,1),new hrefList("slide0112.htm",1,-1,1),new hrefList("slide0113.= htm",1,-1,1),new hrefList("slide0114.htm",1,-1,1),new hrefList("slide0115.h= tm",1,-1,1),new hrefList("slide0073.htm",1,-1,0),new hrefList("slide0061.ht= m",1,-1,1),new hrefList("slide0069.htm",1,-1,0),new hrefList("slide0062.htm= ",1,-1,1),new hrefList("slide0070.htm",1,-1,0),new hrefList("slide0063.htm"= ,1,-1,1),new hrefList("slide0071.htm",1,-1,0),new hrefList("slide0081.htm",= 1,-1,0),new hrefList("slide0064.htm",1,-1,1),new hrefList("slide0065.htm",1= ,-1,1),new hrefList("slide0066.htm",1,-1,1),new hrefList("slide0067.htm",1,= -1,1),new hrefList("slide0046.htm",1,-1,0),new hrefList("slide0082.htm",1,-= 1,0),new hrefList("slide0076.htm",1,-1,0),new hrefList("slide0096.htm",1,-1= ,0),new hrefList("slide0080.htm",1,-1,0),new hrefList("slide0074.htm",1,-1,= 1),new hrefList("slide0098.htm",1,-1,1),new hrefList("slide0075.htm",1,-1,1= ),new hrefList("slide0078.htm",1,-1,1),new hrefList("slide0049.htm",1,-1,0)= ,new hrefList("slide0095.htm",1,-1,1)); /********************************************* Frameset functions These functions control slide navigation and state of the frameset. **********************************************/ function FullScrInit() { g_allowAdvOnClick =3D GetCurSld().mAdvOnClk document.body.style.backgroundColor=3D"black" document.oncontextmenu=3Dparent._CM; document.onkeydown =3D _KDH; document.ondragstart=3DCancel document.onselectstart=3DCancel self.focus() } function Redirect( frmId ) {=09 var str=3Ddocument.location.hash,idx=3Dstr.indexOf('#'), sId=3DGetSldId() if(idx>=3D0) str=3Dstr.substr(1); if( window.name !=3D frmId && ( sId !=3D str) ) { obj =3D GetObj("Main-File") window.location.href=3Dobj.href+"#"+sId return 1 } return 0 } var MHTMLPrefix =3D CalculateMHTMLPrefix();=20 function CalculateMHTMLPrefix() { if ( document.location.protocol =3D=3D 'mhtml:') {=20 href=3Dnew String(document.location.href)=20 Start=3Dhref.indexOf('!')+1=20 End=3Dhref.lastIndexOf('/')+1=20 if (End < Start)=20 return href.substring(0, Start)=20 else=20 return href.substring(0, End)=20 } return ''; } function GetTags(base,tag) { if(g_supportsPPTHTML) return base.all.tags(tag); else return base.getElementsByTagName(tag); } function UpdNtsPane(){ if(frames["PPTNts"]) PPTNts.location.replace( MHTMLP= refix+GetHrefObj( gCurSld ).mNtsHref ) } function UpdNavPane( sldIndex ){ if(gNavLoaded) PPTNav.UpdNav() } function UpdOtNavPane(){ if(gOtlNavLoaded) PPTOtlNav.UpdOtlNav() } function UpdOtlPane(){ if(gOtlLoaded) PPTOtl.UpdOtl() } function SetHasNts( fVal ) { if( gHasNts !=3D fVal ) { gHasNts=3DfVal UpdNavPane() } } function ToggleOtlText() { gOtlTxtExp=3D!gOtlTxtExp UpdOtlPane() } function ClearMedia() { // Clear any sounds playing before launching another browser window. Other= wise, // in fullscreen mode, you'll continue to hear the sound in the frames mod= e. if (PPTSld.pptSound) PPTSld.pptSound.loop =3D 0; } function FullScreen() {=20 if ( PPTSld.g_animUseRuntime ) PPTSld.document.body.pause(); ClearMedia(); var href =3D ( document.location.protocol =3D=3D 'mhtml:') ? FULLSCR_HREF = : FULLSCR_HREF+"#"+GetHrefObj(gCurSld).mSldHref; if(PPTNav.event.ctrlKey) { var w =3D (window.screen.availWidth * 1.0) / 2.0 var h =3D w * (PPTSld.g_origH * 1.0) / PPTSld.g_origW win =3D window.open( MHTMLPrefix+href,null,"toolbar=3D0,resizable=3D1,top= =3D0,left=3D0," + "width=3D"+ w + ",height=3D" + h ); if( win.document.body && PPTSld.g_animUseRuntime ) win.document.body.PPTSldFrameset=3Dwindow; } else { win =3D window.open( MHTMLPrefix+href,null,"fullscreen=3Dyes" ); if( win.document.body && PPTSld.g_animUseRuntime ) win.document.body.PPTSldFrameset=3Dwindow; } } function ToggleVNarration() { rObj=3DPPTSld.document.all("NSPlay") if( rObj && !PPTSld.g_animUseRuntime ) { if( (rObj.playState =3D=3D 1)||(rObj.playState =3D=3D 0) ) rObj.Play() else if( rObj.playState =3D=3D 2 ) rObj.Pause() else return; } else if( PPTSld.g_animUseRuntime ) { narObj =3D PPTSld.document.all("narrationID") if( narObj ) narObj.togglePause() } } function GetCurSldNum() { =20 obj=3DGetHrefObj(gCurSld) if( obj.mOrigVis =3D=3D 1 ) return obj.mSldIdx else =20 return gCurSld } function GetNumSlds() { =20 if( GetHrefObj(gCurSld).mOrigVis =3D=3D 1 ) return GetSldList().mNumVisSlds; else return GetSldList().mList.length } function GetSldNum( href ) { for(ii=3D0; ii 1 ) PopSldList(); else if( !IsFramesMode() ) { if( gLoopCont ) GoToFirst() else EndShow() } } function GoToPrevSld() { ii=3DgCurSld-1 if( ii > 0 ) { obj=3DGetHrefObj(ii) while ( obj && ( obj.mVis =3D=3D 0 ) && ( ii>0 ) ) obj=3DGetHrefObj(--ii) if( ii =3D=3D 0 ) ii=3D1 GoToSldNum(ii) } } function GoToFirst(){ GoToSld( GetHrefObj(1).mSldHref ) } function GoToLast() { ii=3DGetSldList().mList.length if( ii !=3D gCurSld ) GoToSld( GetHrefObj(ii).mSldHref ) } function GoToSldNum( num ) { if( PPTSld.event ) PPTSld.event.cancelBubble=3Dtrue obj =3D GetHrefObj( num ) obj.mVis=3D1 gPrevSld=3DgCurSld gCurSld =3D num; PPTSld.location.replace(MHTMLPrefix+obj.mSldHref) if( IsFramesMode() ) { UpdNavPane(); UpdOtlPane(); UpdNtsPane() } } function GoToSld( href ) { if( PPTSld.event ) PPTSld.event.cancelBubble=3Dtrue GetHrefObj( GetSldNum(href) ).mVis=3D1 PPTSld.location.replace(MHTMLPrefix+href) } function SldUpdated( id ) { if( id =3D=3D GetHrefObj(gCurSld).mSldHref ) return gPrevSld=3DgCurSld gCurSld=3DGetSldNum(id) if( IsFramesMode() ) { UpdNavPane(); UpdOtlPane(); UpdNtsPane() } } function PrevSldViewed(){ GoToSld( GetHrefObj(gPrevSld).mSldHref ) } function HasPrevSld() { return ( gIsEndShow || ( gCurSld !=3D 1 && GetHrefO= bj( gCurSld-1 ).mVis =3D=3D 1 )||( GetCurSldNum() > 1 ) ) } function HasNextSld() { return (GetCurSldNum() !=3D GetNumSlds()) } function CloseWindow() { if( HideMenu() ) return; =09 var event =3D PPTSld.event; if( !IsFramesMode() && event && (event.keyCode=3D=3D27 || event.keyCode=3D= =3D32 || event.type=3D=3D"click" ) ) window.close( self ); CatchNumKeys( self, event ); } function Unload() { gIsEndShow=3D0; } function SetupEndShow() { gIsEndShow=3D1; PPTSld.document.body.scroll=3D"no"; PPTSld.document.onkeypress=3DCloseWindow; PPTSld.document.onclick=3DCloseWindow; PPTSld.document.oncontextmenu=3D_CM; } function EndShow() { if( IsFramesMode() ) return if( PPTSld.event ) PPTSld.event.cancelBubble=3Dtrue doc=3DPPTSld.document var dir =3D doc.body.dir if( dir !=3D "rtl" ) dir =3D "ltr"; doc.open() doc.writeln('


' + ENDSHOW_MESG + '

') doc.close() } function SetSldVisited(){ GetSldList().mList[gCurSld-1].mVisited=3Dtrue } function IsSldVisited(){ return GetSldList().mList[gCurSld-1].mVisited } function hrefList( sldHref, visible, advDelay, advClk ) { this.mSldHref=3D this.mNtsHref =3D sldHref this.mOrigVis=3D this.mVis =3D visible this.mVisited=3D false this.mAdvDelay=3D advDelay this.mAdvOnClk=3D advClk } function SldList(arr,curSld,fEnd) { this.mCurSld =3D curSld; this.mList =3D new Array(); var idx =3D 1; for(ii=3D0;ii 0) { PushSldList(sldList,fEnd); gCurSld =3D 1; } else if( PPTSld.event ) PPTSld.event.cancelBubble=3Dtrue } function PushSldList(arr,fEnd) { var ii =3D gSldStack.length; gSldStack[ii] =3D new SldList(arr,gCurSld,fEnd); GoToSld( gSldStack[ii].mList[0].mSldHref ); } function PopSldList() { if (gSldStack[gSldStack.length-1].fEndShow) EndShow() else { gCurSld =3D gSldStack[gSldStack.length-1].mCurSld; gSldStack[gSldStack.length-1] =3D null; gSldStack.length--; var sldList =3D gSldStack[gSldStack.length-1]; GoToSld( sldList.mList[gCurSld - 1].mSldHref ); } } var custShowList=3Dnew Array(); /********************************************* Navigation button implementation There are 2 types of buttons: ImgBtn, TxtBtn implemented as function objects. They share a similiar interface so the event handlers can call SetActive, for example, on a button=20 object without needing to know exactly=20 what type of button it is. **********************************************/ //---------------------------------- function ImgBtn( oId,bId,w,action ) //---------------------------------- { var t=3Dthis t.Perform =3D _IBP t.SetActive =3D _IBSetA t.SetInactive=3D _IBSetI t.SetPressed =3D _IBSetP t.SetDisabled=3D _IBSetD t.Enabled =3D _IBSetE t.ChangeIcon =3D null t.UserAction =3D action t.ChgState =3D _IBUI t.mObjId =3D oId t.mBorderId=3D bId t.mWidth =3D w t.mIsOn =3D t.mCurState =3D 0 } function _IBSetA() { if( this.mIsOn ) { obj=3Dthis.ChgState( gHiliteClr,gShadowClr,2 ) obj.style.posTop=3D0 } } function _IBSetI() { if( this.mIsOn ) { obj=3Dthis.ChgState( gFaceClr,gFaceClr,1 ) obj.style.posTop=3D0=20 } } function _IBSetP() { if( this.mIsOn ) { obj=3Dthis.ChgState( gShadowClr,gHiliteClr,2 ) obj.style.posLeft+=3D1; obj.style.posTop+=3D1 } } function _IBSetD() { =20 obj=3Dthis.ChgState( gFaceClr,gFaceClr,0 ) obj.style.posTop=3D0=20 } function _IBSetE( state ) { var t=3Dthis GetObj( t.mBorderId ).style.visibility=3D"visible" if( state !=3D t.mIsOn ) { t.mIsOn=3Dstate if( state ) t.SetInactive() else t.SetDisabled() } } function _IBP() { var t=3Dthis if( t.mIsOn ) { if( t.UserAction !=3D null ) t.UserAction() if( t.ChangeIcon ) { obj=3DGetObj(t.mObjId) if( t.ChangeIcon() ) obj.style.posLeft=3Dobj.style.posLeft+(t.mCurState-4)*t.mWidth else obj.style.posLeft=3Dobj.style.posLeft+(t.mCurState-0)*t.mWidth } t.SetActive() } =20 } function _IBUI( clr1,clr2,nextState ) { var t=3Dthis SetBorder( GetObj( t.mBorderId ),clr1,clr2 ) obj=3DGetObj( t.mObjId ) obj.style.posLeft=3Dobj.style.posLeft+(t.mCurState-nextState)*t.mWidth-obj= .style.posTop t.mCurState=3DnextState return obj } //----------------------------------------- function TxtBtn( oId,oeId,action,chkState ) //----------------------------------------- { var t=3Dthis t.Perform =3D _TBP t.SetActive =3D _TBSetA t.SetInactive=3D _TBSetI t.SetPressed =3D _TBSetP t.SetDisabled=3D _TBSetD t.SetEnabled =3D _TBSetE t.GetState =3D chkState t.UserAction =3D action t.ChgState =3D _TBUI t.mObjId =3D oId t.m_elementsId=3D oeId t.mIsOn =3D 1 } function _TBSetA() { var t=3Dthis if( t.mIsOn && !t.GetState() ) t.ChgState( gHiliteClr,gShadowClr,0,0 ) } function _TBSetI() { var t=3Dthis if( t.mIsOn && !t.GetState() ) t.ChgState( gFaceClr,gFaceClr,0,0 ) } function _TBSetP() { if( this.mIsOn ) this.ChgState( gShadowClr,gHiliteClr,1,1 ) } function _TBSetD() { =20 this.ChgState( gFaceClr,gFaceClr,0,0 ) this.mIsOn =3D 0 } function _TBSetE() { var t=3Dthis if( !t.GetState() ) t.ChgState( gFaceClr,gFaceClr,0,0 ) else t.ChgState( gShadowClr,gHiliteClr,1,1 ) t.mIsOn =3D 1 } function _TBP() { var t=3Dthis if( t.mIsOn ) {=20 if( t.UserAction !=3D null ) t.UserAction() if( !t.GetState ) return if( t.GetState() ) t.SetPressed() else t.SetActive() } =20 } function _TBUI( clr1,clr2,lOffset,tOffset ) { SetBorder( GetObj( this.mObjId ),clr1,clr2 ) Offset( GetObj( this.m_elementsId ),lOffset,tOffset ) } function Offset( obj, top, left ){ obj.style.top=3Dtop; obj.style.left=3Dle= ft } function SetBorder( obj, upperLeft, lowerRight ) { s=3Dobj.style; s.borderStyle =3D "solid" s.borderWidth =3D 1=20 s.borderLeftColor =3D s.borderTopColor =3D upperLeft s.borderBottomColor=3D s.borderRightColor =3D lowerRight } function GetBtnObj(){ return gBtnArr[window.event.srcElement.id] } function BtnOnOver(){ b=3DGetBtnObj(); if( b !=3D null ) b.SetActive() } function BtnOnDown(){ b=3DGetBtnObj(); if( b !=3D null ) b.SetPressed() } function BtnOnOut(){ b=3DGetBtnObj(); if( b !=3D null ) b.SetInactive() } function BtnOnUp() { b=3DGetBtnObj() if( b !=3D null ) b.Perform() else Upd() } function GetNtsState(){ return parent.gNtsOpen } function GetOtlState(){ return parent.gOtlOpen } function GetOtlTxtState(){ return parent.gOtlTxtExp } function NtsBtnSetFlag( fVal ) { s=3Ddocument.all.item( this.m_flagId ).style s.display=3D"none" if( fVal ) s.display=3D"" else s.display=3D"none" } function _BSetA_Border(){ b =3D gBtnArr[this.mObjId]; if( b !=3D null ) b.S= etActive() } function _BSetI_Border(){ b =3D gBtnArr[this.mObjId]; if( b !=3D null ) b.S= etInactive() } function _BSetP_Border(){ b =3D gBtnArr[this.mObjId]; if( b !=3D null ) b.S= etPressed() } function _BSetA_BorderImg() {=20 b =3D gBtnArr[this.mBorderId]=20 if( b !=3D null && this.mIsOn && !b.GetState() ) { obj=3Dthis.ChgState( gHiliteClr,gShadowClr,2 ) obj.style.posTop=3D0 } } function _BSetI_BorderImg() {=20 b =3D gBtnArr[this.mBorderId] if( b !=3D null && this.mIsOn && !b.GetState() ) { obj=3Dthis.ChgState( gFaceClr,gFaceClr,1 ) obj.style.posTop=3D0 } } var gHiliteClr=3D"THREEDHIGHLIGHT",gShadowClr=3D"THREEDSHADOW",gFaceClr=3D"= THREEDFACE" var gBtnArr =3D new Array() gBtnArr["nb_otl"] =3D new TxtBtn( "nb_otl","nb_otlElem",parent.ToggleOtlPan= e,GetOtlState ) gBtnArr["nb_otlElem"] =3D new TxtBtn( "nb_otl","nb_otlElem",parent.ToggleOt= lPane,GetOtlState ) gBtnArr["nb_nts"] =3D new ImgBtn( "nb_nts","nb_ntsBorder",10,parent.ToggleN= tsPane ) gBtnArr["nb_nts"].SetActive =3D _BSetA_BorderImg; gBtnArr["nb_nts"].SetInactive =3D _BSetI_BorderImg; gBtnArr["nb_ntsBorder"] =3D new TxtBtn( "nb_ntsBorder","nb_ntsElem",parent.= ToggleNtsPane,GetNtsState ) gBtnArr["nb_ntsElem"] =3D new TxtBtn( "nb_ntsBorder","nb_ntsElem",parent.To= ggleNtsPane,GetNtsState ) gBtnArr["nb_prevBorder"] =3D gBtnArr["nb_prev"]=3D new ImgBtn( "nb_prev","n= b_prevBorder",30,parent.GoToPrevSld ) gBtnArr["nb_nextBorder"] =3D gBtnArr["nb_next"]=3D new ImgBtn( "nb_next","n= b_nextBorder",30,parent.GoToNextSld ) gBtnArr["nb_sldshw"]=3D new ImgBtn( "nb_sldshw","nb_sldshwBorder",18,parent= .FullScreen ) gBtnArr["nb_sldshwBorder"] =3D new TxtBtn( "nb_sldshw","nb_sldshwBorder",pa= rent.FullScreen,null ) gBtnArr["nb_sldshwBorder"].SetActive =3D _BSetA_Border; gBtnArr["nb_sldshwBorder"].SetInactive =3D _BSetI_Border; gBtnArr["nb_sldshwText"] =3D new TxtBtn( "nb_sldshw","nb_sldshwText",parent= .FullScreen,null ) gBtnArr["nb_sldshwText"].SetActive =3D _BSetA_Border; gBtnArr["nb_sldshwText"].SetInactive =3D _BSetI_Border; gBtnArr["nb_voice"] =3D gBtnArr["nb_voiceBorder"] =3D new ImgBtn( "nb_voice= ","nb_voiceBorder",18,parent.ToggleVNarration ) gBtnArr["nb_otlTxtBorder"] =3D gBtnArr["nb_otlTxt"]=3D new ImgBtn( "nb_otlT= xt","nb_otlTxtBorder",23,parent.ToggleOtlText ) gBtnArr["nb_ntsBorder"].m_flagId=3D "nb_nts" gBtnArr["nb_ntsBorder"].SetFlag =3D NtsBtnSetFlag gBtnArr["nb_otlTxt"].ChangeIcon=3D GetOtlTxtState /********************************************* Context menu implementation _CM() is the function that's hooked up to the oncontextmenu event. Once we're asked to show the menu, we first build it by creating DIVs on-the-fly. Then we position it=20 within the screen area so it doesn't get clipped. Creating the DIVs using createElement() means we don't have to write out any extra HTML into the slide HTML files. **********************************************/ var sNext=3D"Next",sPrev=3D"Previous",sEnd=3D"End Show",sFont=3D"Arial",sAr= row=3D"Arrow",sFreeform=3D"Freeform",sRect=3D"Rectangle",sOval=3D"Oval" function ShowMenu() { BuildMenu(); var doc=3DPPTSld.document.body,x=3DPPTSld.event.clientX+doc.scrollLeft,y= =3DPPTSld.event.clientY+doc.scrollTop m =3D PPTSld.document.all.item("ctxtmenu") m.style.pixelLeft=3Dx if( (x+m.scrollWidth > doc.clientWidth)&&(x-m.scrollWidth > 0) ) m.style.pixelLeft=3Dx-m.scrollWidth m.style.pixelTop=3Dy if( (y+m.scrollHeight > doc.clientHeight)&&(y-m.scrollHeight > 0) ) m.style.pixelTop=3Dy-m.scrollHeight m.style.display=3D"" } function _CM() { if( !parent.IsFullScrMode() ) return; if(!PPTSld.event.ctrlKey) { ShowMenu() return false } else HideMenu() } function BuildMenu() { if( PPTSld.document.all.item("ctxtmenu") ) return var mObj=3DCreateItem( PPTSld.document.body ) mObj.id=3D"ctxtmenu" mObj.style.visibility=3D"hidden" var s=3DmObj.style s.position=3D"absolute" s.cursor=3D"default" s.width=3D"120px" SetCMBorder(mObj,"menu","black") var iObj=3DCreateItem( mObj ) SetCMBorder( iObj, "threedhighlight","threedshadow" ) iObj.style.padding=3D2 CreateMenuItem( iObj,sNext,M_GoNextSld,M_True ) CreateMenuItem( iObj,sPrev,M_GoPrevSld,M_HasPrevSld ) =09 CreateSeparator( iObj ) CreateMenuItem( iObj,sEnd,M_End,M_True ) mObj.style.visibility=3D"visible" } function Cancel() { window.event.cancelBubble=3Dtrue; window.event.returnVa= lue=3Dfalse } function Highlight() { ChangeClr("activecaption","threedhighlight") } function Deselect() { ChangeClr("threedface","menutext") } function Perform() { e=3DPPTSld.event.srcElement if( e.type=3D=3D"menuitem" && e.IsActive() ) e.Action() else PPTSld.event.cancelBubble=3Dtrue } function ChangeClr( bg,clr ) { e=3DPPTSld.event.srcElement if( e.type=3D=3D"menuitem" && e.IsActive() ) { e.style.backgroundColor=3Dbg e.style.color=3Dclr } } function M_HasPrevSld() { return( parent.HasPrevSld() ) } function M_GoNextSld() { if( gIsEndShow ) M_End(); else GoToNextSld() } function M_GoPrevSld() { if( gIsEndShow ) { gIsEndShow=3D0; history.back();= PPTSld.event.cancelBubble=3Dtrue; } else GoToPrevSld() } function M_True() { return true } function M_End() { window.close( self ) } function CreateMenuItem( node,text,action,eval ) { var e=3DCreateItem( node ) e.type=3D"menuitem" e.Action=3Daction e.IsActive=3Deval e.innerHTML=3Dtext if( !e.IsActive() ) e.style.color=3D"threedshadow" e.onclick=3DPerform e.onmouseover=3DHighlight e.onmouseout=3DDeselect s=3De.style; 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 No= tes
Slide Show
Outline
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