Ethical issues in recruiting Ethical issues in recruiting Mexican immigrant mothers and Mexican immigrant mothers and

children as research subjectschildren as research subjects

Julia Muennich Cowell PhC, RNC, FAAN, Julia Muennich Cowell PhC, RNC, FAAN, Diane McNaughton, PhD, RN Diane McNaughton, PhD, RN

Sarah Ailey, PhD (c ), RN.Sarah Ailey, PhD (c ), RN.

Rush College of Nursing, Chicago, ILRush College of Nursing, Chicago, IL

R01 NR05008-01, National Institute of Nursing ResearchR01 NR05008-01, National Institute of Nursing Research

IntroductionIntroduction

• Investigators’ responsibilitiesInvestigators’ responsibilities– AssuranceAssurance

• Participants’ rightsParticipants’ rights– Informed consentInformed consent

Ethical theoriesEthical theories

• UtilitarianismUtilitarianism

– benefit to the group benefit to the group

• DeontologyDeontology

– benefit to the individualbenefit to the individual

Ethical principlesEthical principles

• VeracityVeracity• BeneficenceBeneficence• NonmaleficenceNonmaleficence• JusticeJustice

• Autonomy Autonomy

• FidelityFidelity

• Be truthfulBe truthful• Do goodDo good• Do no harmDo no harm• Distribute goods Distribute goods

fairlyfairly

• Individuals’ free Individuals’ free

choicechoice

• Keeping one’s wordKeeping one’s word

PurposePurpose

...address ethical issues related to:...address ethical issues related to:

– recruitment recruitment

– informed consentinformed consent

– assuranceassurance

Mexican American Problem Mexican American Problem Solving Program (MAPS)Solving Program (MAPS)

• mother and child linked problem solving mother and child linked problem solving intervention designed to intervention designed to – meet the individual needs of participants bymeet the individual needs of participants by

• increasing mental health statusincreasing mental health status

• family functioning family functioning

• school adaptation for the child school adaptation for the child

MethodsMethods

• Design…randomized clinical trialDesign…randomized clinical trial– Schools randomly assigned to treatment & Schools randomly assigned to treatment &

control conditionscontrol conditions

• MeasuresMeasures– Measures initially tested and translatedMeasures initially tested and translated– Mexican immigrant advisory reviewMexican immigrant advisory review

Population/SamplePopulation/Sample

• Chicago a point of entry Chicago a point of entry

• Schools A & B in Hispanic communitySchools A & B in Hispanic community

• Schools C & D in multinational Schools C & D in multinational communitycommunity

RecruitmentRecruitment

PeoplePeople

– School based coordinatorsSchool based coordinators

– School nursing coordinatorSchool nursing coordinator

– Research staffResearch staff

RecruitmentRecruitment

ProcessProcess– Flyers to classrooms-CoordinatorsFlyers to classrooms-Coordinators– Flyers to classrooms-School nursing Flyers to classrooms-School nursing

coordinatorcoordinator– Flyers to classrooms-Research StaffFlyers to classrooms-Research Staff– Flyers & meetings with parents and Flyers & meetings with parents and

teachers-Research Staffteachers-Research Staff– Letters to teachers-Research StaffLetters to teachers-Research Staff

Informed consentInformed consent

DefinitionDefinition

...voluntary choice of an individual to ...voluntary choice of an individual to participate in research based on an participate in research based on an accurate & complete understanding of its accurate & complete understanding of its purposes, procedures, risks, benefits, purposes, procedures, risks, benefits, alternatives and any other factors that alternatives and any other factors that may affect a person’s decision to may affect a person’s decision to participate. participate. DHHS, OHRP, 2001DHHS, OHRP, 2001

Informed consentInformed consent

Basic ConceptsBasic Concepts

1. Full disclosure1. Full disclosure

2. Adequate comprehension2. Adequate comprehension

3. Voluntary choice to participate3. Voluntary choice to participate

Informed consentInformed consent

General requirementsGeneral requirements1. Obtained before the research begins1. Obtained before the research begins

2. Information must be understandable2. Information must be understandable

3. Participants must have time to consider3. Participants must have time to consider

4. Consent without coercion4. Consent without coercion

5. Participants must not be required to give up 5. Participants must not be required to give up legal rightslegal rights

6. Competency to consent6. Competency to consent

Informed consentInformed consent

Elements of informed consentElements of informed consent

1. Description of potential risks and benefits1. Description of potential risks and benefits

2. Explanation of confidentiality protection2. Explanation of confidentiality protection

3. Compensation3. Compensation

4. Voluntary nature of participation4. Voluntary nature of participation

5. Program is 5. Program is researchresearch

6. Contacts for questions about research & 6. Contacts for questions about research & participant rightsparticipant rights OHRP, 2001OHRP, 2001

1st wave ethical issues1st wave ethical issuesInformed consentInformed consent

1. Flyer1. Flyer

2. Consent by treatment group2. Consent by treatment group

3. Informed consent as a process3. Informed consent as a process

1st wave ethical issues1st wave ethical issues

Compensation issueCompensation issue

1. Social security numbers1. Social security numbers

2. Preference for grocery certificate2. Preference for grocery certificate

1st wave ethical issues1st wave ethical issues

Referral for mental health problemsReferral for mental health problems

1. Risk of control group contamination1. Risk of control group contamination

2. Benefit of best practices2. Benefit of best practices

Summary of ethical issues, Summary of ethical issues, principles & strategiesprinciples & strategies

Ethical issue Principle Strategy

Translations Beneficence 1.Translations2. Back-Tran.3. Committee

Minorityinclusion

Justice Mexicanimmigrantinclusion

Summary of ethical issues, Summary of ethical issues, principles & strategiesprinciples & strategies

Ethical issue Principle Strategy

Recruitmentflyers

Veracity Adjust flyers

Informedconsent

Autonomy Adjust bycondition

Summary of ethical issues, Summary of ethical issues, principles & strategiesprinciples & strategies

Ethical issue Principle Strategy

Referral BeneficenceNon-male-ficence

Best practice

Availabilityof SocialSecurity id

BeneficenceNon-male-Fficence

Alternativeincentive

ConclusionsConclusions

• Ethical principles illuminate solutionsEthical principles illuminate solutions

• Assurance process is continuousAssurance process is continuous

• Ethical theoretical base guides local IRBEthical theoretical base guides local IRB

• DHHS.govDHHS.gov