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BUILDING INFORMED BUILDING INFORMED CONSENT FOR PESTICIDE CONSENT FOR PESTICIDE
HANDLERS IN HANDLERS IN WASHINGTONWASHINGTON
Karl F. Weyrauch MD MPHKarl F. Weyrauch MD MPHFamily PhysicianFamily Physician
Research Consultant UW PNASHResearch Consultant UW PNASHMember, Western Institutional Review BoardMember, Western Institutional Review Board
Informed Consent 1- DefinitionInformed Consent 1- Definition
Is Informed Consent a Form or a Process?Is Informed Consent a Form or a Process?
http://eduserv.hscer.washington.edu/bioethics/topics/consent.htmlhttp://eduserv.hscer.washington.edu/bioethics/topics/consent.html
Informed Consent 1- DefinitionInformed Consent 1- Definition
Both! But mostly a process Both! But mostly a process (Belmont Report 1979)(Belmont Report 1979)
Process is informed by pt’s Process is informed by pt’s legal rights and MD’s ethical legal rights and MD’s ethical duties duties Information exchangeInformation exchange ComprehensionComprehension Voluntary choiceVoluntary choice
Informed Consent 1- DefinitionInformed Consent 1- Definition
Research vs. TreatmentResearch vs. Treatment DifferentDifferent
Intent- Intent- care decision vs. conflict care decision vs. conflict of interestof interest
Forms-Forms- information dictates information dictates short/ “basic” vs. short/ “basic” vs. long/comprehensivelong/comprehensive
Informed Consent 1- SummaryInformed Consent 1- Summary
Pesticide Handlers NeedPesticide Handlers Needappropriate informationappropriate informationunderstandable languageunderstandable language
Informed Consent 2- ElementsInformed Consent 2- Elements
What Are The Elements of What Are The Elements of Informed Consent?Informed Consent?
Informed Consent 2- ElementsInformed Consent 2- Elements
Both federal and state law applyBoth federal and state law apply ResearchResearch- 21 CFR Food and - 21 CFR Food and
Drugs, 45 CFR Public WelfareDrugs, 45 CFR Public Welfare TreatmentTreatment- RCW 7.70.050 proof - RCW 7.70.050 proof
of breach of duty, RCW 7.70.060 of breach of duty, RCW 7.70.060 contents of consent formcontents of consent form
Informed Consent 2- ElementsInformed Consent 2- Elements
Understandable languageUnderstandable language Nature and character of the Nature and character of the
treatmenttreatment Anticipated resultsAnticipated results Alternative treatmentsAlternative treatments Risks and benefitsRisks and benefits
Informed Consent 2- ElementsInformed Consent 2- Elements
Reasonable patient standard-Reasonable patient standard- What would the average patient What would the average patient need to know to be an informed need to know to be an informed participant ? participant ?
To do-To do- Provide the best care Provide the best care and respect the patient as a and respect the patient as a person.person.
Informed Consent 2- CaveatInformed Consent 2- Caveat
Vulnerability to coercion= Vulnerability to coercion= limited autonomylimited autonomy By employee statusBy employee status By minority status, language, By minority status, language,
literacyliteracy
Thus, special considerations Thus, special considerations applyapply
Informed Consent 2- SummaryInformed Consent 2- Summary
Pesticide Handlers NeedPesticide Handlers Needappropriate informationappropriate informationunderstandable languageunderstandable languagealternatives, risks and alternatives, risks and benefitsbenefits
not to be pressured to not to be pressured to participate.participate.
Informed Consent 3- Cultural Informed Consent 3- Cultural CompetenceCompetence
What Is Culturally Competent Informed Consent?What Is Culturally Competent Informed Consent?
http://www.georgetown.edu/research/gucdc/nccc/documents/Policy_Brief_1_200http://www.georgetown.edu/research/gucdc/nccc/documents/Policy_Brief_1_2003.pdf3.pdf
Informed Consent 3- Cultural Informed Consent 3- Cultural Competence-DefinitionCompetence-Definition
Cultural competenceCultural competence Delivers care effectively across Delivers care effectively across
culturescultures Identifies unique needs of Identifies unique needs of
individuals individuals Matches services to these needsMatches services to these needs Determines practice by culturally Determines practice by culturally
preferred choicespreferred choices
Informed Consent 3- Cultural Informed Consent 3- Cultural Competence-How To Competence-How To
Beliefs- “believe”Beliefs- “believe” Attitudes- “feel”Attitudes- “feel” Knowledge- “know”Knowledge- “know” Language- “speak”Language- “speak” Traditions- “practice”Traditions- “practice”
Informed Consent 3- Cultural Informed Consent 3- Cultural Competence- Why?Competence- Why?
Diversity increasing-Diversity increasing- 40% non- 40% non-white by 2030 in US populationwhite by 2030 in US population
Disparities for minorities in Disparities for minorities in health care-health care- increased poverty, increased poverty, cancer, obesity, diabetes; cancer, obesity, diabetes; decreased preventive care, decreased preventive care, immunizations; mental health immunizations; mental health carecare
Informed Consent 3- Cultural Informed Consent 3- Cultural Competence- Why?Competence- Why?
Outcomes are improved-Outcomes are improved- HgbA1c, patient satisfactionHgbA1c, patient satisfaction
Law mandates non-Law mandates non-discriminationdiscrimination: legislation, : legislation, regulation, accreditationregulation, accreditation
Malpractice risk-decreasedMalpractice risk-decreased with improved with improved communicationcommunication
Informed Consent 3- SummaryInformed Consent 3- Summary
Pesticide Handlers NeedPesticide Handlers Need appropriate informationappropriate information understandable languageunderstandable language alternatives, risks and benefitsalternatives, risks and benefits not to be pressured to not to be pressured to
participateparticipate a manner that is culturally a manner that is culturally
competentcompetent
Informed Consent 4Informed Consent 4
How Do You Make A Culturally Competent How Do You Make A Culturally Competent Informed Consent Process For Handlers?Informed Consent Process For Handlers?
Informed Consent 4- MethodsInformed Consent 4- Methods
1. Focus groups to study issues of 1. Focus groups to study issues of cultural competence 2. Test-Retest cultural competence 2. Test-Retest to evaluate productto evaluate product
Confidential, in Spanish, with Confidential, in Spanish, with simultaneous English translation and simultaneous English translation and transcriptiontranscription
Iterative process— “Plan, Do, Study, Iterative process— “Plan, Do, Study, Act”, each iteration is differentAct”, each iteration is different
Test-Retest OngoingTest-Retest Ongoing
Informed Consent 4- FindingsInformed Consent 4- Findings
BeliefsBeliefs- law is on their side, - law is on their side, employer should care for employer should care for employeesemployees
AttitudeAttitude- worry about getting - worry about getting sick from pesticides, fear blood sick from pesticides, fear blood and needles, mistrust and needles, mistrust unexplained changes, afraid to unexplained changes, afraid to take time off work to get testedtake time off work to get tested
Informed Consent 4- FindingsInformed Consent 4- Findings
KnowledgeKnowledge- very little known - very little known about blood tests, ChE test, about blood tests, ChE test, but know that pesticides are but know that pesticides are toxic, safety gear is toxic, safety gear is important, employers important, employers sometimes scrimp on safety sometimes scrimp on safety
Informed Consent 4- FindingsInformed Consent 4- Findings
LanguageLanguage- English is a barrier - English is a barrier to care, many handlers can’t to care, many handlers can’t read, recorded information read, recorded information and consent is betterand consent is better
TraditionTradition- important role of - important role of wives and social institutions wives and social institutions for decision making and for decision making and dissemination of informationdissemination of information
Informed Consent 5- How To Do ItInformed Consent 5- How To Do It
How Do I Get Informed Consent From How Do I Get Informed Consent From Pesticide Handlers In My Office?Pesticide Handlers In My Office?
Informed Consent 5- CaveatInformed Consent 5- Caveat
What Does The Rule Say?What Does The Rule Say? Requires “Declination Requires “Declination
Statement” only after Statement” only after receiving training about receiving training about pesticides and discussing pesticides and discussing risks and benefits risks and benefits with MD with MD or LHCP or LHCP (WAC 296-307-14820)(WAC 296-307-14820)
Informed Consent 5- ToolsInformed Consent 5- Tools
Consent FormConsent Form55thth grade reading level grade reading level Incorporates culturally Incorporates culturally appropriate knowledgeappropriate knowledge
Addresses specific attitudes Addresses specific attitudes Will be available on audiotapeWill be available on audiotape
Informed Consent 5- ToolsInformed Consent 5- Tools
Information Novella- “Jorge”Information Novella- “Jorge” Culturally-appropriate formatCulturally-appropriate format Incorporates culturally Incorporates culturally
appropriate beliefs, attitudes, appropriate beliefs, attitudes, knowledge, languageknowledge, language
Will be available on audiotapeWill be available on audiotape Circulated to wives, communityCirculated to wives, community
Informed Consent 5- ToolsInformed Consent 5- Tools
Context for consentContext for consent No job, benefit, seniority loss for No job, benefit, seniority loss for
participationparticipation Testing done on company timeTesting done on company time Information spread to Information spread to
community by radio, church-community by radio, church-centered events, strategic centered events, strategic information postings e.g. information postings e.g. LaundromatLaundromat
Informed Consent 5- ProcessInformed Consent 5- Process
Pt. reviews Novella, audiotapePt. reviews Novella, audiotape Short Q&A discussion in Short Q&A discussion in
SpanishSpanish Pt. signs consent Pt. signs consent oror declination declination Discussion Leader/ Impartial Discussion Leader/ Impartial
Witness co-signs the formWitness co-signs the form Cc: chart and patient. Cc: chart and patient.
Declination sent to employerDeclination sent to employer
ConclusionConclusion
Building Informed Consent For Building Informed Consent For Pesticide Handlers in Washington Pesticide Handlers in Washington State Is A Process That Includes:State Is A Process That Includes:
Legal, ethical, cultural componentsLegal, ethical, cultural components Participation by health care team, Participation by health care team,
handler, employer, communityhandler, employer, community Specific tools you can useSpecific tools you can use In SpanishIn Spanish