I UNIVERSITY OF ILLINOIS
AT CHICAGO

 

June 30, 2014

Of?ce for the Protection of Research Subjects (MC 672)
Of?ce of the Vice Chancellor for Research
203 Administrative Of?ce Building

1737 West Polk Street

Chicago, Illinois 60612

Dear Parent or Guardian or Adult Subject,

We are contacting you because you or your child has been identi?ed as a participant in one or more of the following research
studies, ?Affective Neuroscience of Pediatric Bipolar Disorder? ?Developing Brain Function in Adolescent Bipolar Disorder?
or ?Brain Networks Modulating Affect Self-Regulation in Pediatric Mania?, conducted by Dr. Mani Pavuluri with the
Department of College of Medicine at the University of Illinois at Chicago.

The University of Illinois at Chicago (UIC) Institutional Review Board (IRB) has examined the conduct of these research
studies. The IRB is an independent oversight committee at UIC that reviews and approves research studies involving human
subjects. This evaluation identi?ed several problems with the conduct of these studies. These problems seen are listed
below. If you or your child participated in these studies as a ?control? or did not have an existing condition or did
not receive lithium, it is unlikely these problems affected you or your child.

1).

2).

3).

Failure of Dr. Pavuluri to clearly separate her roles as a care provider versus medicai researcher.
When the investigator conducting a research study is the Subject?s medical care provider, a con?ict may 
arise between the physician?s desire to successfully complete the study with that of providing medical care
to the individual. To minimize potential harm to the participant,.the research plan reviewed and approved
by the IRB describes how this conflict will be avoided. While the plans for Dr. Pavuluri?s research studies
stated that she would have no involvement in making medical care decisions for the research subjects, this
plan did not appear to have been consistently followed.

Failure to prevent individuals who did not meet the requirements from participating in the study. An
important component of every research plan is describing factors that allow (for example, age range,
speci?c medical condition) or not allow (for example, heart condition, allergic reaction to medication) an
individual to qualify for the study. The purpose of these eligibility factors is to ensure the ?ndings of the
study are valid and to exclude participants at risk for serious untoward effects from the study tests. In the
studies referred to above, Dr. Pavuluri enrolled subjects who did not qualify for the studies for one or more
of the following reasons: age, prior medication exposure, diagnosis, other medical conditions,
or use of illicit drugs or alcohol.

Failure to describe key research activities, alternatives to participating in the research, and the risks
associated with the activities in the informed consent document. A physician in the course of providing
care to a patient may use a medication outside the indications approved by the US. Food and Drug
Administration (FDA), referred to as off-label use, or change the treatment when the physician feels it is in
the patient?s best interest. However, these actions during a research study require a greater level of
scrutiny. Speci?cally, the IRB must approve the procedures associated with these actions and the
procedures and risks described in the informed consent and parental permission forms.

Phone (312) 996?17] 1 - Fax (312) 413?2929 - 

In the research study, ?Affective Neuroscience of Pediatric Bipolar Disorder?, the participants or their
parents were not informed that administration of lithium in children less than 12 years of age was off?label
or that withdrawal of other medications may occur and the risks associated with the
withdrawal.

4). Failure to perform tests described in the IRE-approved research plan. One purpose of the testing performed
during research studies is to prevent or identify the occurrence of any untoward effects. In the studies
referred to above, Dr. Pavuluri failed to perform tests in several subjects intended to minimize therisks of
lithium use. 

These errors may-have placed you Or your child at a greater risk of harm than explained in the informed consent or parental
permission documents signed by you. Although we currently are not aware that study participants have been harmed as a
result of the problems described above, a child who was undergOing a withdrawal of their medications that began
before they entered one of the studies experienced a worsening of their mental health condition requiring hospitalization after
lithium was started. If we do become aware of any untoward effects, we will notify you If you feelyou or your
child may have experienced harm as a result of their participation in these research studies or you have any questions about
your rights as a research subject, please contact the Of?ce for the Protection of Research Subjects (OPRS) at 312-996-1711
(local) or 1-866-789?6215 (toll-free) or email OPRS at uicirb@uic.edu. If you have any questions about the study, please
contact: Ms. Darcel Brothers at 312-996-6243 in the Department of College of Medicine.

The Department of and the IRB have put policies and procedures in place to assure that similar problems with the
conduct of research do not occur in the future.

Further, as a consequence of the discovery of these ?ndings, the IRB stopped Dr. Pavuluri?s research studies and is not
allowing the study results to be published in the medical literature or presented at professional meetings. The University of
Illinois at Chicago realizes that an important bene?t to you for participating in research is to contribute to the advancement of
medical knowledge in this area, and thus believes it is important that you be informed of this decision.

We appreciate your or your child?s participation in research at UIC. Please accept our sincere apologies for the occurrence of
these issues in these studies, and our assurance that we are working to prevent similar problems from occurring in the future.

 

Sincerely,
with
Dimitri Azar, M.D., James FisCher, PharmD
Dean, College of Medicine Human Protections Administrator .

Executive Chair, UIC Institutional Review Boar

UIC