Ethical Challenge Ethical Challenge & Solution in & Solution in

Social Behavioral Social Behavioral ResearchResearch

Melody LinMelody Lin

December 2012December 2012

ObjectivesObjectives

Apply regulation & ethical principles Apply regulation & ethical principles Develop review parameterDevelop review parameter

Roles & responsibilitiesRoles & responsibilities Do actions protect human subjectsDo actions protect human subjects

45 CFR 4645 CFR 46

Understand regulations’ flexibility Understand regulations’ flexibility and aplly to SBER researchand aplly to SBER research

Ethical principlesEthical principles

The 3 ethical principles are:The 3 ethical principles are: RespectRespect BeneficenceBeneficence JusticeJustice

EP are the basis for the regulationsEP are the basis for the regulations

Primary Ethical Concerns Primary Ethical Concerns (SBER)(SBER)

Informed consentInformed consent ConfidentialityConfidentiality PrivacyPrivacy Risk categoryRisk category

Psychological riskPsychological risk Social riskSocial risk Economic riskEconomic risk

Subject selectionSubject selection

Areas of IRB ReviewAreas of IRB ReviewUse regulations, ethical principles, institutional guidance and Use regulations, ethical principles, institutional guidance and

their expertise to review research for:their expertise to review research for: RespectRespect

RecruitmentRecruitment Informed consentInformed consent Confidentiality proceduresConfidentiality procedures

BeneficenceBeneficence Subject compensationSubject compensation Background literatureBackground literature Investigator experienceInvestigator experience Research designResearch design

JusticeJustice Risks and benefitsRisks and benefits Subject selection practicesSubject selection practices

Application of the Application of the RegulationRegulation

Do not provide direct guidance on each of Do not provide direct guidance on each of these ethical concernsthese ethical concerns

Ethical issues are briefly mentioned:Ethical issues are briefly mentioned: Informed consent requirement (46.116)Informed consent requirement (46.116) Confidentiality Confidentiality

In relation to informed consent (46.116(a)(5)In relation to informed consent (46.116(a)(5) PrivacyPrivacy

IRB approval criteria (46.111)IRB approval criteria (46.111) RiskRisk

IRB approval crietria (46.111)IRB approval crietria (46.111) Meeting or exceeding “minimal risk” (46.102)(i)Meeting or exceeding “minimal risk” (46.102)(i)

Review ChallengesReview Challenges

Regulations do not provide ethical Regulations do not provide ethical guidanceguidance

IRBs are not experienced in IRBs are not experienced in application of the regulations to non-application of the regulations to non-medical researchmedical research

A one-size fits all approach may not A one-size fits all approach may not workwork

Lack of guidance creates confusion Lack of guidance creates confusion and tensionand tension

Regulations Allow for Regulations Allow for FlexibilityFlexibility

Exempt statusExempt status Expedited review via subcommitteeExpedited review via subcommittee Waiver of informed consent and Waiver of informed consent and

documentationdocumentation General open-mindedness in General open-mindedness in

consideration of various research consideration of various research design choicesdesign choices

Exempt Review ExamplesExempt Review Examples

Use of biological samplesUse of biological samples Involvement of school children in Involvement of school children in

educational researcheducational research Survey gathering non-sensitive dataSurvey gathering non-sensitive data

Expedited Review: Expedited Review: ExamplesExamples

Effect of stride frequency on oxygen Effect of stride frequency on oxygen uptake while running uphilluptake while running uphill

Knowledge and attitudes on Knowledge and attitudes on contraception and reproductive contraception and reproductive health in residents of a small health in residents of a small Mexican townMexican town

A comparison of standard vs. A comparison of standard vs. hearing aid processing in cell hearing aid processing in cell phones for the hearing impairedphones for the hearing impaired

Full Committee: Full Committee: ExamplesExamples

Interviews with law enforcement Interviews with law enforcement agents, armed group leaders, drug agents, armed group leaders, drug users, and drug dealers on the drug users, and drug dealers on the drug trade in several Asian Countriestrade in several Asian Countries

Testing weight-reduction strategies Testing weight-reduction strategies for breast cancer survivorsfor breast cancer survivors

Study of social rejection and Study of social rejection and depression using deceptiondepression using deception

So, We UnderstandSo, We Understand

IB member responsibilities are highly IB member responsibilities are highly complexcomplex

Social and behavioral sciences studies are Social and behavioral sciences studies are highly complexhighly complex

Each study must be reviewed case by caseEach study must be reviewed case by case Regulations allow for flexibilityRegulations allow for flexibility IRB members and administrative staff IRB members and administrative staff

should be well-trained and supported by should be well-trained and supported by the institutionthe institution

What to Do?What to Do?

Improve understanding and relevant Improve understanding and relevant applicationapplication

Streamline process and complianceStreamline process and compliance Determine whether actions actually Determine whether actions actually

protect subjectsprotect subjects Where to focus?Where to focus?

Where Do We Begin?Where Do We Begin?

PI creates a good protocolPI creates a good protocol Produces valid, worthwhile scienceProduces valid, worthwhile science Responds ethically, not Responds ethically, not

bureaucratically, to regulationsbureaucratically, to regulations Demonstrates sensitivity to the context, Demonstrates sensitivity to the context,

culture and needs of subjectsculture and needs of subjects Shows understanding of the consent Shows understanding of the consent

process, risk & benefit privacy & process, risk & benefit privacy & confidentiality, and the consultative role confidentiality, and the consultative role fo the IRBfo the IRB

Demonstrate Ethical Demonstrate Ethical PracticesPractices

Conduct valid research (using accepted Conduct valid research (using accepted scientific methods)scientific methods)

Appropriate sampling (to get valid results)Appropriate sampling (to get valid results) Respect people and their communitiesRespect people and their communities Protect research participantsProtect research participants Benefit individuals and societyBenefit individuals and society Create a basis for socially beneficial Create a basis for socially beneficial

policespolices Disseminate findings effectivelyDisseminate findings effectively Facilitate the application of findingFacilitate the application of finding

StakeholdersStakeholders

RegulatoryRegulatory InstitutionsInstitutions Research subjectsResearch subjects

Shared ResponsibilitiesShared Responsibilities

Stakeholders have complementary Stakeholders have complementary and competing goals:and competing goals: Legal concernsLegal concerns Academic freedomAcademic freedom Human rightsHuman rights

Perception of the IRBPerception of the IRB

Supportive?Supportive? Controlling?Controlling? Inconsistent?Inconsistent? Fearful?Fearful? Restrictive?Restrictive? Helpful?Helpful?

Powerful?Powerful? Arbitrary?Arbitrary? Facilitative?Facilitative? One dimensional?One dimensional? Mysterious?Mysterious? Uninformed?Uninformed?

See JERHRE, March 2006 for results of study perceptions of iRBs

Opportunities or Opportunities or Challenges?Challenges?

Collaborate – us/them or Collaborate – us/them or team team approachapproach??

Communicate – challenge or Communicate – challenge or FacilitateFacilitate??

Cooperate – problem or Cooperate – problem or solutionssolutions??

Collaboration, Collaboration, Communication and Communication and

CooperationCooperation Increase collaborationIncrease collaboration Minimize confrontationMinimize confrontation Improve communicationsImprove communications Reduce barriersReduce barriers Value added decisionsValue added decisions Shared visions and responsibilityShared visions and responsibility Opportunities to partner in research Opportunities to partner in research

endeavorsendeavors

Tips for the IRBTips for the IRB

Organizational perceptionOrganizational perception IRB composition/supportIRB composition/support Educate, guide and consultEducate, guide and consult StreamlineStreamline Meet the investigatorsMeet the investigators Appropriate flexibiltyAppropriate flexibilty

Identify ChallengeIdentify Challenge

Protocol review/approvalProtocol review/approval Appropriate consent Appropriate consent

process/documentationprocess/documentation Appropriate risk assessmentAppropriate risk assessment Turn around timeTurn around time Consent form detailsConsent form details Knowledge of research designKnowledge of research design Use of exempt and expedited reviewUse of exempt and expedited review Providing educationProviding education

The Review ProcessThe Review Process

Does one size fit all?Does one size fit all? Consider methodologyConsider methodology Disciplines involvedDisciplines involved Risk assessment/managementRisk assessment/management Infomred consentInfomred consent

Proactive Site VisitsProactive Site Visits

Create an opportunity to see the Create an opportunity to see the research in actionresearch in action Create an environment where on-site Create an environment where on-site

monitoring is accepted/valuedmonitoring is accepted/valued Enhance IRB awareness of practical Enhance IRB awareness of practical

issues from the investigator’s perspectiveissues from the investigator’s perspective Promote communication between Promote communication between

researchers and the IRBresearchers and the IRB Increase opportunities for training of Increase opportunities for training of

ethical/responsible research practicesethical/responsible research practices

Tip for InvestigatorsTip for Investigators

Take RESPONSIBILITY become Take RESPONSIBILITY become EMPOWEREDEMPOWERED Knowledge is power – know the Federal Knowledge is power – know the Federal

regulations, institutional policy / regulations, institutional policy / guidanceguidance

Opportunities to learnOpportunities to learn Protocol submissionProtocol submission CommunicateCommunicate Ethical awarenessEthical awareness Use resourcesUse resources

ResourcesResources

Both NIH and NSF have developed Both NIH and NSF have developed guidance specific to SBER research guidance specific to SBER research http://obssr.od.nih.govhttp://obssr.od.nih.gov http://www.nsf.gov/bfa/dias/policy/hshttp://www.nsf.gov/bfa/dias/policy/hsfaqs/jspfaqs/jsp

National listserveNational listserve irbforum@irbforum.orgirbforum@irbforum.org