Chapter 3: Ethical Chapter 3: Ethical Issues in Health Issues in Health

Promotion ResearchPromotion Research

Research and EthicsResearch and Ethics

► Research involves testing theories to Research involves testing theories to determine what “works” and what “doesn’t”determine what “works” and what “doesn’t”

► In Health Promotion Research:In Health Promotion Research: Something that “works” may:Something that “works” may:

►Save livesSave lives►Reduce diseaseReduce disease

Something that “doesn’t work” may:Something that “doesn’t work” may:►End livesEnd lives► Increase diseaseIncrease disease

► Thus, Health Promotion Research has Thus, Health Promotion Research has potential to cause serious harmpotential to cause serious harm Particularly to vulnerable populationsParticularly to vulnerable populations

Example: Tuskegee Syphilis Example: Tuskegee Syphilis StudyStudy

► Intended as a study of syphilis in African-Intended as a study of syphilis in African-American menAmerican men Experimentation with different treatmentsExperimentation with different treatments

►During Great Depression resources became During Great Depression resources became scarcescarce Treatment was not made availableTreatment was not made available

► Researchers changed study designResearchers changed study design Study became a natural history study of Study became a natural history study of

untreated syphilisuntreated syphilis Even when treatment became available it was Even when treatment became available it was

still withheld from men in studystill withheld from men in study► Study halted in 1973Study halted in 1973

Tuskegee: Issues, Ramifications Tuskegee: Issues, Ramifications and Resolutionsand Resolutions

► Ethical issues present in Tuskegee studyEthical issues present in Tuskegee study No informed consentNo informed consent Deception of subjects regarding purpose of Deception of subjects regarding purpose of

medical proceduresmedical procedures► RamificationsRamifications

Distrust of research among African-American Distrust of research among African-American communitycommunity►May currently be an issue for AIDS researchMay currently be an issue for AIDS research

► ResolutionsResolutions Led to creation of National Commission for the Led to creation of National Commission for the

Protection of Human Subjects in Biomedical and Protection of Human Subjects in Biomedical and Behavioral Research Behavioral Research ►Wrote Belmont ReportWrote Belmont Report►Basis for many federal regulations oin researchBasis for many federal regulations oin research

Principles of Belmont Report: Principles of Belmont Report: Respect for PersonsRespect for Persons

► People are autonomous beingsPeople are autonomous beings Honoring capacity of individuals to make their Honoring capacity of individuals to make their

own decisionsown decisions Treating individuals as more than a means to an Treating individuals as more than a means to an

endend► Full disclosure of research goalsFull disclosure of research goals

Can not trick subjects into participatingCan not trick subjects into participating Must keep subjects informed throughout studyMust keep subjects informed throughout study

► Increased protection for vulnerable groupsIncreased protection for vulnerable groups ChildrenChildren Persons with cognitive disabilities Persons with cognitive disabilities

Principles of Belmont Report: Principles of Belmont Report: BeneficenceBeneficence

► Beneficence – doing good and avoiding harmBeneficence – doing good and avoiding harm In research – maximizing benefits, minimizing risksIn research – maximizing benefits, minimizing risks

►Health promotion activity should include Health promotion activity should include diverse groups whenever possiblediverse groups whenever possible Federal policies demands that benefits of research Federal policies demands that benefits of research

be extended to women, minorities, children etc…be extended to women, minorities, children etc…► Causing risk to one may offset benefit to manyCausing risk to one may offset benefit to many►Who benefits from a program?Who benefits from a program?

Cannot know for sure until research is conductedCannot know for sure until research is conducted Should consider immediate and future effectsShould consider immediate and future effects

►Future generationsFuture generations

Principles of Belmont Report: Principles of Belmont Report: JusticeJustice

►Fair sharing of risks and benefits among Fair sharing of risks and benefits among groupsgroups

►Cannot study one group to treat anotherCannot study one group to treat another Overseas AIDS research by U.S. Overseas AIDS research by U.S.

►Cannot exclude group from study with Cannot exclude group from study with potential benefitspotential benefits Only studying cardiovascular disease in menOnly studying cardiovascular disease in men

►Findings may not generalize to womenFindings may not generalize to women

Federal Inclusion PoliciesFederal Inclusion Policies

► Balance of Balance of access access and and protection protection ► 1994 “NIH Guidelines On The Inclusion Of 1994 “NIH Guidelines On The Inclusion Of

Women And Minorities As Subjects In Clinical Women And Minorities As Subjects In Clinical Research” Research” Ensure that NIH funded research can elicit Ensure that NIH funded research can elicit

information on both genders, diverse racesinformation on both genders, diverse races► In clinical trials examine differential effectsIn clinical trials examine differential effects

► 1998 “NIH Policy and Guidelines on the 1998 “NIH Policy and Guidelines on the Inclusion of Children as Participants in Inclusion of Children as Participants in Research Involving Human Subjects” Research Involving Human Subjects” Ensure that children are included in studies unless Ensure that children are included in studies unless

there are scientific or ethical reasons not tothere are scientific or ethical reasons not to

Ethical Codes of ConductEthical Codes of Conduct

►Designed to set broad standards for Designed to set broad standards for both research and practiceboth research and practice Can evaluate behavior of individual Can evaluate behavior of individual

professionalsprofessionals Create a code of collective responsibility Create a code of collective responsibility

for professionfor profession Contribute to socialization of new Contribute to socialization of new

professionalsprofessionals Establish standards to judge misconductEstablish standards to judge misconduct

►Belmont Report provides a basis for Belmont Report provides a basis for health practice guidelineshealth practice guidelines

Difference between Research Difference between Research and Practiceand Practice

► Ethical standards apply to bothEthical standards apply to both► Specific federal regulations apply to research Specific federal regulations apply to research

onlyonly► Research is activity intended to contribute to Research is activity intended to contribute to

generalizable knowledgegeneralizable knowledge Direct benefit to subjects is not the goalDirect benefit to subjects is not the goal Understanding how to benefit others is the goalUnderstanding how to benefit others is the goal

► Practice refers to interventions designed solely Practice refers to interventions designed solely to help individual or groupto help individual or group Publication is not the goalPublication is not the goal Surveys, etc.. are used solely to help better treat Surveys, etc.. are used solely to help better treat

groupgroup

Institutional ReviewInstitutional Review

► Research Institutions required to have Research Institutions required to have Institutional Review Board (IRB)Institutional Review Board (IRB) IRB sets standards that must comply with federal IRB sets standards that must comply with federal

regulationsregulations Failure to comply can result in termination of Failure to comply can result in termination of

federal research funding to institutionfederal research funding to institution

► IRB provides ethical review for federally IRB provides ethical review for federally funded research involving human subjectsfunded research involving human subjects Institutions extend review to non federal Institutions extend review to non federal

research as wellresearch as well

IRB FunctionsIRB Functions

► For each study, IRB must:For each study, IRB must: Assess risks and benefits to human subjectsAssess risks and benefits to human subjects Ensure proper informed consent proceduresEnsure proper informed consent procedures Provide protection for vulnerable populationsProvide protection for vulnerable populations

►Pregnant women and fetus, Prisoners, ChildrenPregnant women and fetus, Prisoners, Children►Other populations not specifically listed are often given Other populations not specifically listed are often given

special considerationspecial consideration Persons with disabilities, cognitive impairments, the poor, Persons with disabilities, cognitive impairments, the poor,

etc…etc…

Regulations cover practical matters as wellRegulations cover practical matters as well►Composition of IRBComposition of IRB►Elements of informed consentElements of informed consent

Types of IRB ReviewTypes of IRB Review

►ExemptExempt Little or no risk to human subjectsLittle or no risk to human subjects

►Interviews or surveys, pre-existing dataInterviews or surveys, pre-existing data IRB still must verify exempt statusIRB still must verify exempt status

►ExpeditedExpedited No more than minimal risk to subjectsNo more than minimal risk to subjects

►Non or minimally invasive proceduresNon or minimally invasive procedures►Continuing review of researchContinuing review of research

►Full reviewFull review

Human SubjectsHuman Subjects

►Federal regulations exist to protect Federal regulations exist to protect human subjectshuman subjects Human subjects defined as: Human subjects defined as:

►A living individualA living individual Deceased persons not subject to regulationsDeceased persons not subject to regulations

►About whom an investigatorAbout whom an investigator Professional or studentProfessional or student

►Obtains eitherObtains either Data through intervention or interaction with personData through intervention or interaction with person Identifiable private informationIdentifiable private information

IRB CompositionIRB Composition

► IRB must have five members of IRB must have five members of varying backgroundsvarying backgrounds At least one:At least one:

►ScientistScientist►Non-scientistNon-scientist►Person not affiliated with institutionPerson not affiliated with institution

Should be diverse in terms of race, Should be diverse in terms of race, gender, culture and subject matter gender, culture and subject matter expertiseexpertise

Informed ConsentInformed Consent

► Ensuring that researchers obtain informed Ensuring that researchers obtain informed consent of subjects is a major IRB functionconsent of subjects is a major IRB function

► Informed consent includesInformed consent includes Full information regarding benefits and risksFull information regarding benefits and risks

►Benefits are not compensationBenefits are not compensation►Risks could include loss of privacy, mental or physical Risks could include loss of privacy, mental or physical

distressdistress

Adequate comprehensionAdequate comprehension►Written or explained at appropriate levelWritten or explained at appropriate level

Free choiceFree choice►Lack of coercionLack of coercion

Documenting Informed Documenting Informed ConsentConsent

► Traditional means is to have subject sign Traditional means is to have subject sign consent formconsent form

► In some instances this may be waivedIn some instances this may be waived ImpracticalityImpracticality

►Telephone interviews or internet surveysTelephone interviews or internet surveys►Review of existing health records that pose minimal riskReview of existing health records that pose minimal risk

Loss of anonymityLoss of anonymity►Signature would identify participantSignature would identify participant

► Verbal consent should be obtained Verbal consent should be obtained whenever possiblewhenever possible

Vulnerable PopulationsVulnerable Populations

►Higher level of IRB scrutinyHigher level of IRB scrutiny Less likely to gain exempt or expedited Less likely to gain exempt or expedited

statusstatus

►Restrictions or prohibitions on certain Restrictions or prohibitions on certain types of researchtypes of research Research involving greater than minimal riskResearch involving greater than minimal risk

►Alternative procedures for obtaining Alternative procedures for obtaining informed consentinformed consent May be provided by guardianMay be provided by guardian

Research with PrisonersResearch with Prisoners

►Why extend extra protection to prisoners?Why extend extra protection to prisoners? They are easily abusedThey are easily abused

►Example – Nazi abuse of prisoners during WW IIExample – Nazi abuse of prisoners during WW II

They have diminished autonomyThey have diminished autonomy►Can be easily coercedCan be easily coerced

► Specific IRB regulationsSpecific IRB regulations Must have prisoner or representative on IRB Must have prisoner or representative on IRB

when reviewing research involving prisonerswhen reviewing research involving prisoners Research must be directed at issues related to Research must be directed at issues related to

prisonersprisoners►Not simply using prisoners as a sample of convenienceNot simply using prisoners as a sample of convenience

Research with ChildrenResearch with Children

► Children defined as persons not having Children defined as persons not having reached legal age to give consentreached legal age to give consent Children required to give “assent”Children required to give “assent” Parent / guardian required to give consentParent / guardian required to give consent

►Hierarchy of four categories of research that Hierarchy of four categories of research that may involve children:may involve children: Involves no more than minimal riskInvolves no more than minimal risk Potential for direct benefit to subjectsPotential for direct benefit to subjects Likely to yield generalizable knowledge about Likely to yield generalizable knowledge about

disease or disorderdisease or disorder Allows opportunity to understand, prevent or Allows opportunity to understand, prevent or

alleviate serious health conditionalleviate serious health condition

Research in SchoolsResearch in Schools

►Family Educational Rights and Privacy Family Educational Rights and Privacy Act (FERPA) Act (FERPA) Deals with privacy of student educational Deals with privacy of student educational

recordsrecords►Protection of Pupil Rights Amendment Protection of Pupil Rights Amendment

(PPRA)(PPRA) Deals with administering surveys in schoolsDeals with administering surveys in schools Parents must give consent before students Parents must give consent before students

can be given surveys on eight particular can be given surveys on eight particular topicstopics

Health Insurance Portability and Health Insurance Portability and Accountability Act (HIPAA)Accountability Act (HIPAA)

►Designed to ensure confidentiality of Designed to ensure confidentiality of medical records and private health medical records and private health informationinformation

►May affect health promotion research that May affect health promotion research that takes place in health care delivery settingstakes place in health care delivery settings

►Added protections for children and Added protections for children and adolescentsadolescents

►Some exceptions for public health Some exceptions for public health researchresearch

Risks and BenefitsRisks and Benefits

► Risks in health promotion research are much Risks in health promotion research are much different than in biomedical researchdifferent than in biomedical research Risks to subjects in health promotion research Risks to subjects in health promotion research

often involve:often involve:► Invasion of privacy / embarrassmentInvasion of privacy / embarrassment►Stress / discomfortStress / discomfort►Loss of self esteemLoss of self esteem

► Benefits may be direct or indirectBenefits may be direct or indirect Understanding and / or preventing risky behaviorUnderstanding and / or preventing risky behavior Raising awareness of behavior through filling out Raising awareness of behavior through filling out

surveysurvey

Partnering with CommunitiesPartnering with Communities

► Involvement with community improves Involvement with community improves understandingunderstanding Gives researcher a context for subjectsGives researcher a context for subjects

► Involvement with community may help Involvement with community may help protect subjectsprotect subjects

►Communities can help disseminate Communities can help disseminate findingsfindings Ultimately improve health of communityUltimately improve health of community

►Ethical abuses in past may cause Ethical abuses in past may cause communities to distrust researcherscommunities to distrust researchers

Practical AdvicePractical Advice

► Examine potential risks and benefitsExamine potential risks and benefits Devise and explain plan for protecting subjectsDevise and explain plan for protecting subjects

► Justify requests within context of federal Justify requests within context of federal regulationsregulations

► Strive to understand research from subject’s Strive to understand research from subject’s point of viewpoint of view Make informed consent form comprehensibleMake informed consent form comprehensible

►Maintain confidentialityMaintain confidentiality Remove identifying informationRemove identifying information

►Work with and understand the communityWork with and understand the community

SummarySummary

► Ethical treatment of subjects is important in health Ethical treatment of subjects is important in health promotion researchpromotion research

► Core principles involveCore principles involve HonestyHonesty

► Full disclosure os risks and benefits, non coercionFull disclosure os risks and benefits, non coercion JusticeJustice

► Fair sharing of risks and benefits among groupsFair sharing of risks and benefits among groups BeneficenceBeneficence

► Striving to do good while avoiding harmStriving to do good while avoiding harm

► Federal regulations specify ethical codes of conduct Federal regulations specify ethical codes of conduct for researchfor research Administered through IRB’sAdministered through IRB’s Special protections for vulnerable populationsSpecial protections for vulnerable populations

Questions to Ponder…Questions to Ponder…

►Why are federal regulations not Why are federal regulations not applicable to health promotion practice?applicable to health promotion practice?

►What potential problems might coercion What potential problems might coercion cause?cause?

►What other examples of vulnerable What other examples of vulnerable populations might exist?populations might exist?

►What risks might exist in a health What risks might exist in a health promotion research activity involving a promotion research activity involving a weight loss intervention?weight loss intervention?