Purdue ExtensionPurdue ExtensionHuman SubjectsHuman Subjects

TrainingTraining

Based on CITI Based on CITI

Course in the Protection of Course in the Protection of Human Subjects ResearchHuman Subjects Research

Fall 2004Fall 2004

Topics To Be CoveredTopics To Be Covered

History and Ethical History and Ethical PrinciplesPrinciples

Defining Research Defining Research with Human with Human SubjectsSubjects

Regulatory Overview Regulatory Overview Assessing RiskAssessing Risk Informed ConsentInformed Consent

Privacy and Privacy and ConfidentialityConfidentiality

Research with Research with PrisonersPrisoners

Research with Research with ChildrenChildren

Research in Public Research in Public SchoolsSchools

Internet ResearchInternet Research

History and Ethical PrinciplesHistory and Ethical Principles

Provides a Structure for Analysis and Provides a Structure for Analysis and Decision makingDecision making

Supports – Reminds to Protect Supports – Reminds to Protect Human subjectsHuman subjects

Aids in Assessing Risks and BenefitsAids in Assessing Risks and Benefits

Historical InfluencesHistorical Influences

Nuremberg CodeNuremberg Code Resulted from Nazi Doctors AtrocitiesResulted from Nazi Doctors Atrocities The Code didn’t Impact U.S. ScientistsThe Code didn’t Impact U.S. Scientists

Declaration of HelsinkiDeclaration of Helsinki Broadened Nuremberg CodeBroadened Nuremberg Code

Historical Case StudiesHistorical Case Studies

Obedience to Authority StudyObedience to Authority Study Involved Deception of SubjectsInvolved Deception of Subjects

Caused Some Emotional ProblemsCaused Some Emotional Problems

Public Health Service Syphilis StudyPublic Health Service Syphilis Study 1932-19721932-1972 Withheld Available TreatmentWithheld Available Treatment Led to Establishment of National Led to Establishment of National

Research ActResearch Act Current Protections for Human SubjectsCurrent Protections for Human Subjects

Ethical ProblemsEthical Problems

Lack of Informed ConsentLack of Informed Consent CoercionCoercion Use/Exploitation of Vulnerable Use/Exploitation of Vulnerable

PopulationsPopulations Withholding information including Withholding information including

about risksabout risks Failure to Assess Risks vs. BenefitsFailure to Assess Risks vs. Benefits DeceptionDeception Violation of RightsViolation of Rights

The Belmont ReportThe Belmont Report

1974 National Commission formed to 1974 National Commission formed to study Human subjects concernsstudy Human subjects concerns

1979 Belmont Report1979 Belmont Report Respect For PersonsRespect For Persons BeneficenceBeneficence JusticeJustice

No One Principle “Trumps” AnotherNo One Principle “Trumps” Another All must be weighed equallyAll must be weighed equally

From Principles to PracticeFrom Principles to Practice RespectRespect

BeneficenceBeneficence

JusticeJustice

Informed ConsentInformed Consent VoluntarinessVoluntariness

Risks/BenefitsRisks/Benefits Privacy/Privacy/

ConfidentialityConfidentiality = Burdens = Burdens

=Benefits=Benefits DiversityDiversity

Regulatory OverviewRegulatory Overview

Common Rule (45 CFR 46)Common Rule (45 CFR 46) Department of Health and Human Department of Health and Human

ServicesServices All Institutions that Receive DHHS FundsAll Institutions that Receive DHHS Funds Subparts to Common RuleSubparts to Common Rule Special Protections forSpecial Protections for

Prisoners- Subpart CPrisoners- Subpart C Children – Subpart DChildren – Subpart D Pregnant Women (when their pregnancy Pregnant Women (when their pregnancy

affects their ability to participate) fetuses, affects their ability to participate) fetuses, neonates -Subpart Bneonates -Subpart B

The Common RuleThe Common Rule

Dictates What an IRB Should doDictates What an IRB Should do The basic criteria for IRB review of The basic criteria for IRB review of

protocolsprotocols Description of the types of reviewDescription of the types of review Composition of the IRBComposition of the IRB

Primary PurposePrimary Purpose Protect the rights and welfare of Protect the rights and welfare of

research subjectsresearch subjects

Institutional Review Board (IRB)Institutional Review Board (IRB)

Evaluates ResearchEvaluates Research According to Belmont Report PrinciplesAccording to Belmont Report Principles Respect for PersonsRespect for Persons BeneficenceBeneficence JusticeJustice

Federal Regulations derived from itFederal Regulations derived from it Common RuleCommon Rule

IRB Committee Decision is FinalIRB Committee Decision is Final No one can override a decision of the No one can override a decision of the

IRBIRB

Defining Research Defining Research

A Systematic InvestigationA Systematic Investigation Research Development, Testing, EvaluationResearch Development, Testing, Evaluation

Contributes to Generalizable KnowledgeContributes to Generalizable Knowledge Will it be Disseminated?Will it be Disseminated?

Will it be Read by others outside of Purdue Will it be Read by others outside of Purdue Extension?Extension?

Poster SessionsPoster Sessions Journal ArticlesJournal Articles Impact StatementsImpact Statements

Human SubjectsHuman Subjects

DefinitionDefinition ““A living Individual about whom an A living Individual about whom an

investigator conducting research obtains:investigator conducting research obtains: Data through intervention or interaction with Data through intervention or interaction with

the individualthe individual Identifiable private information”Identifiable private information”

Private InformationPrivate Information Reasonable Expectation of PrivacyReasonable Expectation of Privacy Provided for Specific Purpose – not to be Provided for Specific Purpose – not to be

made publicmade public

BenefitBenefit

A positive value to the individual of A positive value to the individual of participating in a studyparticipating in a study Direct BenefitsDirect Benefits Indirect BenefitsIndirect Benefits Benefits to Science and societyBenefits to Science and society

RiskRisk Harms that may occur to individualHarms that may occur to individual

Probability and MagnitudeProbability and Magnitude May be:May be:

PhysicalPhysical SocialSocial EconomicEconomic LegalLegal PsychologicalPsychological

Weigh Risks against Potential BenefitsWeigh Risks against Potential Benefits Not all Risks and Benefits may be Not all Risks and Benefits may be

knownknown

Assessing RiskAssessing Risk Falls into 3 General CategoriesFalls into 3 General Categories

Invasion of PrivacyInvasion of Privacy Information accessed without knowledge or Information accessed without knowledge or

consentconsent Breach of ConfidentialityBreach of Confidentiality

May be unintentionalMay be unintentional Information disclosed outside to research Information disclosed outside to research

settingsetting Study ProceduresStudy Procedures

Just participating can cause stress or issues of Just participating can cause stress or issues of privacyprivacy

Can be culturally determinedCan be culturally determined

Managing RisksManaging Risks Collect Data without IdentifiersCollect Data without Identifiers Remove all Direct IdentifiersRemove all Direct Identifiers Code DataCode Data Keep code lists and data separatelyKeep code lists and data separately Aggregate Data so as not to identifyAggregate Data so as not to identify Secure Technology/computersSecure Technology/computers Minimize risks of exposure from Minimize risks of exposure from

ParticipationParticipation Sensitive to Psychological RisksSensitive to Psychological Risks

Privacy in ResearchPrivacy in Research Privacy/of participantPrivacy/of participant

About the personAbout the person Identifying and Recruiting subjectsIdentifying and Recruiting subjects Covert observationCovert observation Privacy of Third partiesPrivacy of Third parties Sensitive QuestionsSensitive Questions Limits to ConfidentialityLimits to Confidentiality

Child/Elder Abuse ReportingChild/Elder Abuse Reporting Focus GroupsFocus Groups

Research with PrisonersResearch with Prisoners

Definition:Definition: Some one in the legal systemSome one in the legal system

Consent Issues with PrisonerConsent Issues with Prisoner Free ChoiceFree Choice Undue InducementsUndue Inducements Breach of ConfidentialityBreach of Confidentiality Sensitive Questions when there is no Sensitive Questions when there is no

supportsupport IRB must include an Prisoner Advocate IRB must include an Prisoner Advocate

when reviewingwhen reviewing

Research with ChildrenResearch with Children

Definition:Definition: Persons who have not yet attained the Persons who have not yet attained the

legal age of consent. In IN it is 18legal age of consent. In IN it is 18 In Commonly Accepted Educational In Commonly Accepted Educational

SettingsSettings Research about educational TestsResearch about educational Tests

““Is your survey to find out what they Is your survey to find out what they learned, or what behavior changed?”learned, or what behavior changed?”

Not ExemptNot Exempt

Studies with Children cannot be Studies with Children cannot be Exempt when:Exempt when:

Interviews and or surveys outside of Interviews and or surveys outside of an educational experiencean educational experience

Observations when the researcher Observations when the researcher participates in the activities observedparticipates in the activities observed

Will require an Expedited or Full Will require an Expedited or Full ReviewReview

Issues with ChildrenIssues with Children

Potential Coercion Potential Coercion Peer PressurePeer Pressure Child Abuse/Neglect ReportingChild Abuse/Neglect Reporting Age AppropriatenessAge Appropriateness CompensationCompensation

Written Informed ConsentWritten Informed Consent

Required for Expedited and Full Required for Expedited and Full ReviewsReviews

Include:Include: Purpose of the ResearchPurpose of the Research Procedures to be FollowedProcedures to be Followed Risks or DiscomfortsRisks or Discomforts BenefitsBenefits How records will be MaintainedHow records will be Maintained Compensation if anyCompensation if any Contact InformationContact Information Voluntary Statement/Ability to WithdrawVoluntary Statement/Ability to Withdraw

Issues of Informed ConsentIssues of Informed Consent RecruitmentRecruitment Language/Cultural AppropriatenessLanguage/Cultural Appropriateness

Reading LevelsReading Levels Rights and Welfare SubjectsRights and Welfare Subjects Potential CoercionPotential Coercion Waivers of parental consent may be Waivers of parental consent may be

granted:granted: Parent’s knowledge of situation my Parent’s knowledge of situation my

cause harmcause harm Child is emancipatedChild is emancipated

Research in Public SchoolsResearch in Public Schools Regulations affecting schoolsRegulations affecting schools

Common RuleCommon Rule Common Rule –Subpart D for ChildrenCommon Rule –Subpart D for Children Family Education Rights and Privacy Act Family Education Rights and Privacy Act

FERPAFERPA Educational RecordsEducational Records

Protection of Pupil Rights Amendment Protection of Pupil Rights Amendment PPRA-PPRA-

Written Notification to Parents for SurveysWritten Notification to Parents for Surveys No Child Left Behind ActNo Child Left Behind Act

Surveys containing sensitive TopicsSurveys containing sensitive Topics

Internet ResearchInternet Research

Observing On-Line CommunicationsObserving On-Line Communications Are they Public or Private?Are they Public or Private?

Technical IssuesTechnical Issues Email is not secureEmail is not secure IP Addresses can be used to Identify IP Addresses can be used to Identify

SubjectsSubjects Ensure Servers are secureEnsure Servers are secure Encrypt Data Encrypt Data Storage of data must be protectedStorage of data must be protected

Issues with Internet ResearchIssues with Internet Research

Ensuring ComprehensionEnsuring Comprehension Underage ParticipantsUnderage Participants WithdrawalWithdrawal Documenting ConsentDocumenting Consent PrivacyPrivacy IdentifiersIdentifiers Breach of ConfidentialityBreach of Confidentiality Assessing RisksAssessing Risks

WorkersWorkers Some Argue that Workers are a Some Argue that Workers are a

Vulnerable populationVulnerable population Issues of workers as subjectsIssues of workers as subjects

Effects of individual entitlementsEffects of individual entitlements Impairment of Family RelationshipsImpairment of Family Relationships Possible threats to job retentionPossible threats to job retention Peer PressurePeer Pressure Constraints to Job AdvancementConstraints to Job Advancement Findings may affect individuals, Findings may affect individuals,

corporations, unions, governmentcorporations, unions, government

Exempt ResearchExempt Research

Educational SettingsEducational Settings Surveys, Interviews, and Surveys, Interviews, and Observation Observation

of Adults of Adults Research on Public OfficialsResearch on Public Officials Existing DataExisting Data Federal Govt. Public BenefitFederal Govt. Public Benefit Consumer Evaluation/Taste TestingConsumer Evaluation/Taste Testing Implied Consent- VoluntaryImplied Consent- Voluntary

Expedited ReviewExpedited Review

No More than Minimal RiskNo More than Minimal Risk Falls into one of the 9 eligible categoriesFalls into one of the 9 eligible categories

Medical drugs and devices approved by FDAMedical drugs and devices approved by FDA Collection of biological specimensCollection of biological specimens Collection of data from audio, video, or Collection of data from audio, video, or

image recordingimage recording Non-exempt research using surveys, Non-exempt research using surveys,

interviews, observationsinterviews, observations OthersOthers

Full ReviewFull Review

Greater than Minimal RiskGreater than Minimal Risk Use of a Vulnerable PopulationUse of a Vulnerable Population

Must be present at IRB Committee Must be present at IRB Committee meetingmeeting

Continuing Reviews will go back to Continuing Reviews will go back to the full committee for approvalthe full committee for approval

Continuing Reviews/RevisionsContinuing Reviews/Revisions

Approval is for 364 DaysApproval is for 364 Days Continuing Review for Exempt ApprovalContinuing Review for Exempt Approval Approximately 10 months after approvalApproximately 10 months after approval Email continuing review formEmail continuing review form Complete and send backComplete and send back Same process for an Expedited or Full ReviewSame process for an Expedited or Full Review Revisions- for allRevisions- for all Complete the Revision form for all revisions,Complete the Revision form for all revisions, Send to IRB who approvedSend to IRB who approved

CITI Site for QuizCITI Site for Quiz

https://www.citiprogram.org/default.asp

Log –inLog –in Choose “Purdue Extension Educators” Choose “Purdue Extension Educators” Click on Basic CourseClick on Basic Course Complete IntroductionComplete Introduction Complete Extension Institutional PageComplete Extension Institutional Page Scroll down to complete the quizScroll down to complete the quiz

If you pass, download a completion reportIf you pass, download a completion report If not, try again, using the CITI ModulesIf not, try again, using the CITI Modules

Extension Exempt ProcessExtension Exempt Process

Complete X-HS-03-1Complete X-HS-03-1 Attach Instrument and PublicityAttach Instrument and Publicity Send Electronically to DDSend Electronically to DD He/she will Forward to IRB coordinatorHe/she will Forward to IRB coordinator Reviewed by Extension Human Subjects Reviewed by Extension Human Subjects

Comm.Comm. Sent to Three ReviewersSent to Three Reviewers

When all agree, approval is Emailed, withWhen all agree, approval is Emailed, with Official notification sent from Director’s Official notification sent from Director’s

officeoffice

Process for Expedited and Full Process for Expedited and Full ReviewsReviews

Complete Application on IRB websiteComplete Application on IRB website Write a Narrative Describing ResearchWrite a Narrative Describing Research Develop a Consent FormDevelop a Consent Form Send to Director’s office to sign as P.I.Send to Director’s office to sign as P.I. Will be sent to Purdue IRB for reviewWill be sent to Purdue IRB for review IRB will review the research component of IRB will review the research component of

the projectthe project IRB will review and asks for clarificationIRB will review and asks for clarification Plan ahead for QuestionsPlan ahead for Questions

Questions????Questions????

If you have questions, please contact Janet Bechman, If you have questions, please contact Janet Bechman, Extension Plan of Work & Accountability Coordinator, Extension Plan of Work & Accountability Coordinator,

jcb@purdue.edujcb@purdue.edu

Prepared by Prepared by Catherine E. Burwell, Ph.D.Catherine E. Burwell, Ph.D.

Extension IRB and Reporting CoordinatorExtension IRB and Reporting Coordinator ceb@purdue.educeb@purdue.edu