BUILDING INFORMED CONSENT FOR PESTICIDE HANDLERS IN WASHINGTON Karl F. Weyrauch MD MPH Family Physician Research Consultant UW PNASH Member, Western Institutional.

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


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


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?


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


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


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


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

http://www.georgetown.edu/research/gucdc/nccc/documents/Policy_Brief_1_2003.pdf

http://www.georgetown.edu/research/gucdc/nccc/documents/Policy_Brief_1_2003.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


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


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


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


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


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

BUILDING INFORMED CONSENT FOR PESTICIDE HANDLERS IN WASHINGTON Karl F. Weyrauch MD MPH Family Physician Research Consultant UW PNASH Member, Western Institutional.

Documents

elements of informed

building informed consent

informed participant

contents of consent

competent slide

longcomprehensive slide

improved communication

preventive care