10/30/2016

GmailRE:complaintaboutIRBoversightatUniversityofMinnesota

CarlElliott<ellio023@gmail.com>

RE:complaintaboutIRBoversightatUniversityofMinnesota
Borror,KristinaC(HHS/OASH)<Kristina.Borror@hhs.gov>
To:CarlElliott<ellio023@gmail.com>

Mon,Mar31,2014at11:03AM

DearDr.Elliott:

WehavereviewedyourJanuary24,2014letterandaccompanyingdocumentsregardingresearchconductedat
UniversityofMinnesota,inwhichyouasktheOfficeforHumanResearchProtections(OHRP)toconsiderwhether
certainactivitiesandrelationshipsofDr.DavidAdson,theinstitutionalreviewboard(IRB)chair,constituteaconflictof
interestthatshouldhaveprecludedDr.AdsonfromparticipatinginthereviewoftheCATIEandCAFstudies.

TheHHSprotectionofhumansubjectsregulations,45CFRpart46,discussconflictsofinterestofIRBmembersas
follows:

46.107IRBmembership.

(e)NoIRBmayhaveamemberparticipateintheIRB'sinitialorcontinuingreviewofanyprojectinwhichthemember
hasaconflictinginterest,excepttoprovideinformationrequestedbytheIRB.

Webelievethataninstitutionreasonablycoulddeterminethattheactivitiesandrelationshipsthatyoumentionedforthe
institutionalreviewboardchair,Dr.DavidAdson,donotconstituteconflictsofinterestundertheHHSprotectionof
humansubjectsregulationsthatwouldprecludehimfromparticipatinginthereviewoftheCATIEandCAFstudies.
Therefore,OHRPanticipatesnofurtherinvolvementinthismatter.

Pleasenotethat,asOHRPspurviewistointerpretandenforcetheHHSprotectionofhumansubjectsregulations,we
consideredtheinformationyouprovidedinthecontextofwhetherDr.Adsonsactivitiesandrelationshipsconstitutea
conflictofinterestunderthoseregulations.WedonotaddresswhetherDr.Adsonsactivitiesandrelationshipscould
constituteaconflictofinterestundertheUniversityofMinnesotasinstitutionalpoliciesoranyrelevantFederalpolicyon
conflictsofinterest.

Weappreciateyourconcernabouttheprotectionofhumansubjects.

Sincerely,

KristinaC.Borror,Ph.D.

KristinaC.Borror,Ph.D.
Director
DivisionofComplianceOversight
https://mail.google.com/mail/u/0/?ui=2&ik=98a0bdf517&view=pt&q=kristina.borror%40hhs.gov&qs=true&search=query&msg=14518e194125284d&siml=14518

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10/30/2016

GmailRE:complaintaboutIRBoversightatUniversityofMinnesota

OfficeforHumanResearchProtections
1101WoottonParkway,Suite200
TheTowerBuilding
Rockville,MD20852
email:kristina.borror@hhs.gov
Phone:(240)4538132
Fax:(240)4536909

From:CarlElliott[mailto:ellio023@gmail.com]
Sent:Monday,March10,20146:30PM
To:Borror,KristinaC(HHS/OASH)
Cc:ellio023@gmail.com
Subject:RE:complaintaboutIRBoversightatUniversityofMinnesota

DearDr.Borror,

IwantedtocheckinaboutthiscomplaintthatIfiledinJanuary.Ithasbeensixweeks,andIwashopingto
hearsomethingsoon.DoyouhaveanyideawhenIwillbehearingmore?

Thanks

CarlElliott

From:Borror,KristinaC(HHS/OASH)[mailto:Kristina.Borror@hhs.gov]
Sent:Friday,January24,20142:34PM
To:CarlElliott
Subject:RE:complaintaboutIRBoversightatUniversityofMinnesota

DearDr.Elliot:

TheOfficeforHumanResearchProtections(OHRP)hasreceivedyourJanuary24,2014emailconcerningIRBoversight
atUniversityofMinnesota.

OHRPhasresponsibilityforoversightofcompliancewiththeU.S.DepartmentofHealthandHumanServices(HHS)
regulationsfortheprotectionofhumanresearchsubjects(see45CFRPart46athttp://www.hhs.gov/ohrp/
humansubjects/guidance/45cfr46.html).Incarryingoutthisresponsibility,OHRPevaluates,atOHRPsdiscretion,
substantiveallegationsofnoncomplianceinvolvinghumansubjectresearchprojectsconductedorsupportedbyHHSor
thatareotherwisesubjecttotheregulations(seeOHRPmemorandumdatedOctober14,2009at
http://www.hhs.gov/ohrp/compliance/ohrpcomp.pdfforanexplanationofOHRPsjurisdiction).

https://mail.google.com/mail/u/0/?ui=2&ik=98a0bdf517&view=pt&q=kristina.borror%40hhs.gov&qs=true&search=query&msg=14518e194125284d&siml=14518

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10/30/2016

GmailRE:complaintaboutIRBoversightatUniversityofMinnesota

Wewillreviewthematerialsandgetbacktoyou.

OHRPappreciatesyourconcernabouttheprotectionofhumanresearchsubjects.Pleasedonothesitatetocontactme
atanytimeshouldyouhaveanyquestionsorwishtoprovideadditionalinformation.

Sincerely,

KristinaC.Borror,Ph.D.
Director
DivisionofComplianceOversight
OfficeforHumanResearchProtections
1101WoottonParkway,Suite200
TheTowerBuilding
Rockville,MD20852
email:kristina.borror@hhs.gov
Phone:(240)4538132
Fax:(240)4536909

From:CarlElliott[mailto:ellio023@gmail.com]
Sent:Friday,January24,20141:45PM
To:Borror,KristinaC(HHS/OASH)
Cc:ellio023@gmail.com
Subject:complaintaboutIRBoversightatUniversityofMinnesota

DearDr.Borror,

IamattachingacomplaintaboutconflictsofinterestinIRBoversightofclinicaltrialsattheUniversityof
Minnesota.Couldyouletmeknowifithasarrivedintact?

Thanks,

CarlElliott

**
CarlElliottMDPhD
Professor,CenterforBioethics
UniversityofMinnesota
410ChurchStSE
MinneapolisMN554550346

https://mail.google.com/mail/u/0/?ui=2&ik=98a0bdf517&view=pt&q=kristina.borror%40hhs.gov&qs=true&search=query&msg=14518e194125284d&siml=14518

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