Examples of Potential Risks to Subjects - Research and ...

Physical risks. Physical risks include physical discomfort, pain, injury, illness or disease brought about by the methods and procedures of the research. Skiptomaincontent OneStop Apply Visit Give Search Searchform Search Search SiteNavigation Plan Apply Manage Facilities PrioritiesandImpact Partners About TakeAction OneStop Apply Visit Give MyMain Breadcrumb Home Manage HumanSubjectsResearch ExamplesofPotentialRiskstoSubjects Potentialrisksfallintofivebroadly-definedcategories.ResearchComplianceServicesandtheCPHS/IRBwillweighthepotentialrisksofresearchagainstthepotentialbenefitsaspartofthereviewprocess.Researchersareexpectedtotakestepstominimizepotentialrisks. Physicalrisks Physicalrisksincludephysicaldiscomfort,pain,injury,illnessordiseasebroughtaboutbythemethodsandproceduresoftheresearch.Aphysicalriskmayresultfromtheinvolvementofphysicalstimulisuchasnoise,electricshock,heat,cold,electricmagneticorgravitationalfields,etc.Engagingasubjectinasocialsituationwhichcouldinvolveviolencemayalsocreateaphysicalrisk. Psychologicalrisks Psychologicalrisksincludetheproductionofnegativeaffectivestatessuchasanxiety,depression,guilt,shockandlossofself-esteemandalteredbehavior.Sensorydeprivation,sleepdeprivation,useofhypnosis,deceptionormentalstressesareexamplesofpsychologicalrisks. Social/Economicrisks Social/Economicrisksincludealterationsinrelationshipswithothersthataretothedisadvantageofthesubject,includingembarrassment,lossofrespectofothers,labelingasubjectinawaythatwillhavenegativeconsequences,orinsomewaydiminishingthoseopportunitiesandpowersapersonhasbyvirtueofrelationshipswithothers.Economicrisksincludepaymentbysubjectsforproceduresnototherwiserequired,lossofwagesorotherincomeandanyotherfinancialcosts,suchasdamagetoasubject'semployability,asaconsequenceofparticipationintheresearch. LossofConfidentiality Inallresearchinvolvinghumansubjects,confidentialityofidentifiableinformationispresumedandmustbemaintainedunlesstheinvestigatorobtainstheexpresspermissionofthesubjecttodootherwise.Subjectshavetherightstobeprotectedagainstinjuryorillegalinvasionsoftheirprivacyandtopreservationoftheirpersonaldignity.Themoresensitivetheresearchmaterial,thegreaterthecarethatmustbeexercisedinobtaining,handling,andstoringdata.Inordertominimizetheriskforlossofconfidentiality,investigatorsshouldonlycollectpersonalinformationthatisabsolutelyessentialtotheresearchactivity.Ifpersonaldatamustbecollected,itshouldbecodedasearlyintheactivityaspossibleandsecurelystoredsothatonlytheinvestigatorandauthorizedstaffmayaccessit.Identitiesofindividualsubjectsmustneverbereleasedwithouttheexpressconsentofthesubject.Inaddition,ifaninvestigatorwishestousedataforapurposeotherthantheoneforwhichitwasoriginallycollectedandthedataarestillidentifiable(e.g.acodelistforthedatastillexists),theinvestigatormayneedtoobtainconsentfromthesubjectsforthenewuseofthedata. Legalrisks Legalrisksexistwhentheresearchmethodsaresuchthatthesubjectorotherswillbeliableforaviolationofthelaw,eitherbyrevealingthatthesubjectorothershaveorwillengageinconductforwhichthesubjectorothersmaybecriminallyorcivillyliable,orbyrequiringactivitiesforwhichthesubjectorothersmaybecriminallyorcivillyliable. Manage QuickLinks