}uly 16, 2u14

Elyse I. Summeis, }B
Piesiuent anu Chief Executive 0fficei
Association foi the Accieuitation of Buman Reseaich Piotection Piogiams
2Su1 N Stieet, NW, Suite Suu
Washington B.C. 2uuS7

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*+-;"6)-3? 02 @-++")037() !")"76.> '603".3-0+) '60A678)

Beai Ns. Summeis:

I want to uiaw youi attention to numeious conflicts-of-inteiest that the Association foi the
Accieuitation of Buman Reseaich Piotections Piogiams anu the 0niveisity of Ninnesota faileu to
uisclose when AABRPP was selecteu to ieview the univeisity's policies anu piactices ielateu to
clinical ieseaich.

0n the Foim 99u that was submitteu to the Inteinal Revenue Seivice in 2u12, AABRPP stateu that
its mission as a non-piofit is "accieuitation of oiganizations that engage in ieseaich with human
paiticipants." This mission uoes not incluue ieviewing piogiams that you also accieuit. Youi
contiact to ieview ieseaich piotections at the 0niveisity of Ninnesota appeais to conflict with
iepiesentations AABRPP has maue to the IRS.

AABRPP iequiies the oiganizations it accieuits to have uetaileu conflict-of-inteiest policies. I
have seaicheu foi AABRPP's own institutional conflict-of-inteiest policy but I have been unable to
finu one anu you have not iesponueu to my iequest foi it. Bowevei, if AABRPP applies to itself
the conflict-of-inteiest stanuaiu that it uses to evaluate the institutions it accieuits, you will see
that youi ieview of the 0niveisity of Ninnesota's ieseaich piotections is compiomiseu by
untenable conflicts-of-inteiests.

The stanuaiu AABRPP uses when accieuiting ieseaich piotections piogiams states, "IRB oi EC
membeis aie piohibiteu fiom paiticipating in the ieview of a ieseaich piotocol oi plan in which
they have a conflict of inteiest." AABRPP is paiticipating in a ieview in which it has numeious
conflicts-of-inteiest. 0nless AABRPP wants to be peiceiveu as an oiganization that fails to meet
the stanuaiu it applies to othei institutions, AABRPP must withuiaw fiom ieviewing the
0niveisity of Ninnesota's ieseaich piotections piogiams. You neeu to ueciue whethei it is woith
exchanging youi ieputation foi the $141,9uu my employei is paying you.
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AABRPP accieuiteu the 0niveisity of Ninnesota's ieseaich piotections piogiams in 2uu4, 2uu7,
anu 2u1u. AABRPP's next accieuitation ieview of the univeisity's ieseaich piotections is
scheuuleu foi 2u1S. Baving accieuiteu the 0niveisity of Ninnesota's ieseaich piotections
piogiams foi a uecaue, AABRPP has a substantial financial pioviuei-client ielationship with the
univeisity. Bespite having a financial ielationship to the 0niveisity of Ninnesota, you anu youi
colleagues at AABRPP aie now claiming that you aie managing an "inuepenuent" ieview of the
univeisity's ieseaich piotections. Bowevei, given that you have alieauy been paiu thiee times foi
the seivice of accieuitation anu will soon be paiu foi a fouith accieuitation ieview, AABRPP is not
an inuepenuent, uisinteiesteu bouy.

AABRPP has a financial stake in maintaining the peiception that the univeisity's ieseaich
piotections piogiams meiiteu accieuitation ovei the last ten yeais. Youi stanuing as an
accieuitation bouy will be uamageu if an investigation at some point ueteimines theie have been
seiious pioblems with the univeisity's ieview anu conuuct of human subjects ieseaich.
Auministiatois at the 0niveisity of Ninnesota use AABRPP accieuitation foi maiketing puiposes
by claiming you awaiueu its ieseaich piotections the equivalent of a "uoou Bousekeeping Seal of
Appioval." A tiuly inuepenuent ieview of ieseaich piotections piogiams at the univeisity will
have to sciutinize how anu why they weie accieuiteu by youi oiganization. You cannot conuuct
an "inuepenuent" ieview of the univeisity's ieseaich piotections anu youi own accieuitation
piocesses. Fuitheimoie, it makes no sense foi AABRPP to yet again "ieview" a piogiam that it
alieauy ieviews uuiing the accieuitation piocess. Anothei oiganization, one with no pie-existing
financial ties to the 0niveisity of Ninnesota oi any piioi ieview of the univeisity's ieseaich
piotections piogiams, must conuuct such an investigation.

In iesponse to oveiwhelming eviuence that AABRPP has a significant financial ielationship to the
0niveisity of Ninnesota, you might want to aigue that AABRPP is meiely "hanuling logistics" oi
"managing the ieview" anu iemaining "at aim's length" fiom the "inuepenuent expeits" who will
conuuct the ieview. Such ihetoiic is uisingenuous. AABRPP chose to biu on the 0niveisity of
Ninnesota's "Request foi Pioposals" anu agieeu to the iestiictive teims that limit the inquiiy to a
ieview of "cuiient" ieseaich piactices anu policies. AABRPP selecteu the ievieweis, will pioviue
ievieweis with uocuments, will aiiange meetings with paiticulai inuiviuuals at the 0niveisity of
Ninnesota, anu will pay the ievieweis foi theii seivices. AABRPP has a financial conflict-of-
inteiest that must piohibit it anu !"#$"% '%()*"+ !' *,' -!*. !+%",' fiom conuucting this ieview.

AABRPP has faileu to uisclose auuitional conflicts-of-inteiest. These conflicts fuithei compiomise
the integiity of the ieview piocess foi which you aie being paiu.

Bi. }eiemy Sugaiman, one of the inuiviuuals selecteu to ieview the 0niveisity of Ninnesota's
ieseaich piotections piogiams, consults foi Quintiles. Accoiuing to Bi. Sugaiman's cuiiiculum
vitae, he is a membei of Quintiles' "Compiehension of Infoimeu Consent Auvisoiy Boaiu."
Quintiles, a contiact ieseaich oiganization, has financial ties to the 0niveisity of Ninnesota's
Bepaitment of Psychiatiy. In fact, Quintiles was the CR0 foi the notoiious CAFE stuuy in which
Ban Naikingson committeu suiciue. A cieuible investigation of allegeu ieseaich misconuuct at
the 0niveisity of Ninnesota neeus to sciutinize not only the conuuct of specific faculty membeis
but also the univeisity's financial ties to Quintiles, AstiaZeneca, anu othei coipoiations involveu
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in funuing psychiatiic clinical tiials. Bi. Sugaiman is also a membei of uenentech's Stiategic
Council. uenentech is anothei company with a financial connection to the 0niveisity of Ninnesota
Bepaitment of Psychiatiy. It is uncleai how competent "uue uiligence" coulu have iesulteu in
AABRPP's selection of a ieviewei with ties to two companies that have commeicial uealings with
the veiy acauemic uepaitment that is the focus of longstanuing allegations of ieseaich
misconuuct.

At the time the ieview was announceu AABRPP also faileu to uisclose that a senioi executive at
Novaitis Phaimaceuticals Coipoiation is a membei of AABRPP's Boaiu of Biiectois. The
0niveisity of Ninnesota has ieceiveu significant funuing fiom Novaitis. Foi example, to select just
one faculty membei, Bi. Baviu Auson, a psychiatiist who appeais to have chaiieu the institutional
ieview boaiu that appioveu the CAFE stuuy, ieceiveu ovei $7uu,uuu fiom Novaitis foi
conuucting a single clinical tiial. Any seiious ieview of the univeisity's "ieseaich piotections"
must examine ties to inuustiy anu auuiess conceins that financial conflicts-of-inteiest aie
compiomising institutional ieseaich piotections. Such an investigation neeus to be conuucteu by
a bouy that has no piofessional oi financial connections to phaimaceutical companies,
biotechnology companies, anu contiact ieseaich oiganizations with financial ties to the
0niveisity of Ninnesota. With a senioi Novaitis executive on AABRPP's boaiu, youi oiganization
is too close to one of numeious phaimaceutical companies whose financial uealings with the
0niveisity of Ninnesota will have to be examineu as pait of ieview of ieseaich piotections.

AABRPP also faileu to uisclose links between youi oiganization anu inuiviuuals connecteu to the
0niveisity of Ninnesota's ieseaich piotections piogiams. Foi example, Bi. Susan A. Beiiy is Chaii
of the 0niveisity of Ninnesota's IRB Executive Committee. Bi. Beiiy also seives as a site visitoi
conuucting on-site evaluations foi AABRPP. As a iesult, AABRPP maintains an ongoing
piofessional anu piesumably financial ielationship with someone who is a key executive within
the 0niveisity of Ninnesota's ieseaich piotections piogiams. AABRPP cannot be uesciibeu as an
"inuepenuent ieview bouy" when it has an ongoing business ielationship with someone whose
conuuct will have to be examineu uuiing the ieview of the univeisity's ieseaich piotections.

Noiia Keane is also listeu as an AABRPP site visitoi iesponsible foi conuucting on-site
evaluations. Ns. Keane has also seiveu as the Chaii of the AABRPP Council on Accieuitation. Piioi
to hei ietiiement in 2u12, Noiia Keane was Executive Biiectoi of the 0niveisity of Ninnesota
Buman Reseaich Piotections Piogiam. She woikeu at the 0niveisity of Ninnesota foi ovei
twenty-five yeais. She also happens to have been ueposeu in the lawsuit biought against the
0niveisity of Ninnesota following the ueath of Ban Naikingson. As you must know, the
univeisity's failuie to conuuct a thoiough investigation of Naikingson's ueath was a uiiving
factoi in the Faculty Senate's appioval of a iesolution suppoiting the establishment of an inquiiy
into the univeisity's ieseaich piactices anu policies. AABRPP has a longstanuing piofessional anu
piesumably financial ielationship with someone whose paiticipation in ieseaich piotections
must be examineu as pait of any seiious investigation of piactices, policies, anu allegeu ieseaich
misconuuct at the 0niveisity of Ninnesota.



4



It is hypociitical of AABRPP to have a conflict-of-inteiest stanuaiu that it applies to the
oiganizations it accieuits while AABRPP violateu this stanuaiu when it signeu a contiact to
ieview the 0niveisity of Ninnesota's ieseaich piotections. Bo you want AABRPP to be iuentifieu
as an oiganization that puts its economic self-inteiest above avoiuing financial anu piofessional
conflict-of-inteiests.

Whatevei futuie success AABRPP has is bounu to whethei youi oiganization possesses a
ieputation foi integiity. In signing this contiact you aie squanueiing what ought to be of
paiamount value to you. I uige you to iecognize the substantial haim you aie causing to youi
own oiganization. Noie impoitantly, by paiticipating in a ieview with such significant conflict-of-
inteiests, you aie putting ieseaich subjects at incieaseu iisk of haim anu violating youi
oiganization's mission, vision, anu values.

Youis sinceiely,

Leigh Tuinei, PhB
Associate Piofessoi
0niveisity of Ninnesota Centei foi Bioethics

cc: Aine B. Cailson, Foimei uoveinoi of Ninnesota
Susan Beiiy, N.B., Chaii, IRB Executive Committee, 0niveisity of Ninnesota
Nichael Caiome, N.B., Biiectoi, Bealth Reseaich uioup, Public Citizen
Bebbie Bykhuis, Executive Biiectoi, Buman Reseaich Piotection Piogiam, 0niveisity of
Ninnesota
Cail Elliott, N.B., Ph.B., Piofessoi, 0niveisity of Ninnesota Centei foi Bioethics
Baibaia Entwisle, Ph.B., vice Chancelloi foi Reseaich, 0niveisity of Noith Caiolina at
Chapel Bill anu Biiectoi, AABRPP
Biian Beiman, Ph.B., vice Piesiuent foi Reseaich, 0niveisity of Ninnesota
Biooks }ackson, N.B., N.B.A., Bean, 0niveisity of Ninnesota Neuical School
Eiic Kalei, Ph.B., Piesiuent, 0niveisity of Ninnesota
Tiuuo Lemmens, LL.N., B.C.L., Associate Piofessoi & Scholl Chaii, 0niveisity of Toionto
Faculty of Law
Beinaiu Lo, N.B., Piesiuent, The uieenwall Founuation anu Biiectoi, AABRPP
}ames R. Nobles, N.A., Ninnesota Legislative Auuitoi
Naisha Rappley, N.B., Bean, College of Buman Neuicine, Nichigan State 0niveisity anu
Biiectoi, AAABRPP
Stephanie S. Spanglei, N.B., Beputy Piovost, Biomeuical & Bealth Affaiis, Yale
0niveisity anu Biiectoi, AABRPP
Siuney Wolfe, N.B., Founuei anu Senioi Auvisoi, Bealth Reseaich uioup, Public Citizen