Jean Giddens 2024 STUVIA
Holdspthatppersonsphaveptheprightptopself-
determinationpandpthepfreedomptopparticipateporpnotpparticipatepinpresearchp-
pPrincipalpforprespectpforppersons
Thepprinciplepofprespectpforppersons
Thepprinciplepofpjustice
Principlepofpbeneficencep-pEthicalpprincipalsp(thereparepthree)
Holdspthatphumanpparticipantspshouldpbeptreatedpfairlyp-pPrincipalpofpjustice
Requirespthepresearcherptopdopgoodpandpavoidpcausingpharmp-pPrinciplepofpbeneficence
DHHSpregulationsparepknownpaspthisp-pCommonprule
Justifiablepclaimspandpdemandspthatparepnecessarypforpthepselfprespectpdignity,pandpfreedo
mpofpchoicepforpanpindividual.p-pHumanprights
Ispbasedponpthepethicalpprinciplepofprespect.pForppersons.
Respectpforppersonspmeanspthatphumansparepcapablepofpself-
determinationporpmakingptheirpownpdecisions.p-prightptopself-determination
prospectivepsubjectspwhoparepinformedpaboutpapproposedpstudypandpwhopcanpvoluntarilypc
hoosepwhetherptopparticipatep-pAutonomouspagents
subjectsparepunawarepthatpresearchpdataparepbeingpcollected
Researcherspdopthispbecausepthepstudypinvolvespcollectingpdatapaboutpnormalpactivityporpr
outinepofphealthpcare.p-pcovertpdatapcollection
misleadingpparticipantspaboutptheptrueppurposepofpapstudyporpthepeventspthatpwillpactuallyptr
anspirep-pDeception
Whenponeppersonpintentionallyppresentspanotherpwithpanpovertpthreatpofpharmporptheplurepof
pexcessiveprewardptopobtainphisporpherpcompliance.p-pCoercion
Thepabilityptopmakepapvoluntarypdecisionpbasedponpcomprehendingpinformationpaboutptheps
tudy.p-pAutonomy
Personsparepsaidptopbepincompetentpifpapqualifiedphealthcarepproviderpjudgespthemptopbepu
nableptopcomprehend.p-pDiminishedpautonomy
, Prisoners
Terminallypillpparticipants
Pregnantpwomenpandpfetuses
Neonates
Childrenpandpadolescentsp-pGroupspneedingpadditionalpprotection
Apchild'spaffirmativepagreementptopparticipatepinpresearch,pispanpexamplep(whenppossible).
Permissionpfrompapparentporpguardianpmustpbepobtained.p-pAssent
Meanspthatpthepparentporpguardianpagreesptopthepparticipationpofpthepchildporpwardpinpresea
rchp-pPermissionptopparticipatepinpapstudy
Ispanpindividual'sprightptopdetermineptheptime,pextent,pandpgeneralpcircumstancespunderpwh
ichppersonalpinformationpispsharedpwithporpwithheldpfrompothers.p-pprivacy
Occurspwhenpprivatepinformationpispsharedpwithoutpanpindividual'spknowledgeporpagainstphi
sporpherpwillp-pinvasionpofpprivacy
Informationpthatpispapsubsetpofphealthpinformation,pincludingpdemographicpinformationpcolle
ctedpfrompanpindividualpand
p1.pIspcreatedporpreceivedpbyphealthcarepprovider,phealthpplan,porphealthcarepclearinghouse
p2.pIsprelatedptoppastppresent,porpfuturepphysicalporpmentalphealthporpconditionpofpindividuals
,porppastporppresent,porpfutureppaymentpforpthepprovisionpofphealthpcareptopanpindividual,pand
pthatpidentifiespthepindividual:porpwithprespectptopwhichptherepispapreasonablepbasisptopbeliev
epthatpthepinformationpcanpbepusedptopidentifypthepindividualsp-
pIndividuallypidentifiablephealthpinformationp(IIHI)
Consistspofpremovingp18pitemspfromppatientprecordspbeforeptheyparepreleasedptopotherpage
nciesporpresearchers.
Thep18pitemspincludepname,pcontactpinformation,pidentificationpnumbers,pphotographs,pbio
metrics,pandpotherpelementspbypwhichpapparticipantpcouldppotentiallypbepidentified.
Becausepde-identificationpincludespremovingpdates,presearcherspusingpde-
identifiedpdatapmaypnotpbepableptopanswerpsomepresearchpquestionspsuchplengthpofphospit
alpstaypandpseasonalppatternsptopdiseasesp-pDe-Identification
Certifyingpthatpthep18pelementspforpidentificationphavepbeenpremovedporprevisedptopensurept
hepindividualpispnotpidentified.p-pSafepharbor
limitsphowpthepdatapsetpmaypbepusedpandphowpitpwillpbepprotected.p-pDatapusepagreement
thepprocesspofpsearchingpforpinterpretingpexistingpinformationprelevantptopthepresearchptopi
c