FROEHLICH
LEADS RESEARCH AT IUPUI
Janice Froehlich was appointed Interim
Vice Chancellor for Research at Indiana University-Purdue
University Indianapolis (IUPUI) and Associate Vice
President for Research at Indiana University in November
2005. She provides leadership in the areas of research
development, research compliance, research centers
and institutes, grant and contract submission, and
pre-award negotiation for all schools on the IUPUI
campus. She is the authorized institutional official
signing grant and contract proposals submitted from
the IUPUI campus and from the Centers on Medical Education
system-wide. She coordinates research efforts, promotes
interdisciplinary collaboration, and fosters partnerships
with other institutions and the business community.
Dr. Froehlich is a Chancellor’s
Professor in the Department of Medicine, Division
of Endocrinology and Metabolism, in the School of
Medicine, with joint appointments in the Departments
of Cellular and Integrative Physiology and in Medical
Neurobiology. She serves as a Scientific Co-Director
of the Indiana Alcohol Research Center. Her research
program focuses on the hormonal, neurochemical, behavioral,
and genetic factors that contribute to alcohol abuse
and the development of alcoholism. She has served
on the editorial board of national journals and as
a member of a study section for the National Institutes
of Health. She has authored numerous papers, book
chapters, and review articles, has supervised more
than forty graduate students and postdoctoral fellows,
and serves as Scientific Program Director for the
biennial pre- and postdoctoral trainee workshop of
the National Institute of Alcohol Abuse and Alcoholism
(NIAAA).
BIZILA
OVERSEES RESEARCH COMPLIANCE
Shelley Bizila, Director of Research
Compliance Administration in the IUPUI Office of Research
and Sponsored Programs (R&SP), was appointed Research
Integrity Officer for the IUPUI campus in February
2006 and campus-wide compliance activities have been
reorganized. As the Director of Research Compliance
Administration, Shelley is responsible for assuring
that research on the IUPUI campus is conducted in
full compliance with federal regulations governing
all research with human subjects, recombinant DNA,
biohazardous materials, and laboratory animals. Shelley
also oversees the Institutional Review Boards that
review and approve all human research studies for
IUPUI/Clarian and the Centers of Medical Education.
As IUPUI Research Integrity Officer, Shelley oversees
campus committees that identify, assess, develop,
and implement management plans for conflict of interest,
conflict of commitment, research misconduct and financial
compliance.
JOHNSON
DIRECTS GRANTS AND CONTRACTS
Sponsored
Research Services (SRS) in the IUPUI Office of Research
and Sponsored Programs (R&SP) has undergone reorganization
in order to be more responsive to the needs of IUPUI
investigators. W.S. (Sid) Johnson, JD, has been reappointed
as the Executive Director of Sponsored Research Services.
Sid continues to oversee submission and pre-award
negotiation of grants, contracts, subcontracts, and
other research agreements and provides guidance on
research related policies for the IUPUI campus. Prior
to his appointment as Executive Director of SRS, Sid
was the Director of Corporate Contracts Administration
in the IUPUI R&SP Office.
RESEARCH
DEVELOPMENT
Campus-wide
internal grant funding mechanisms have been expanded
and adjusted to reflect changes in the IUPUI research
mission and to increase the competitiveness of proposals
for external funding. Experienced investigators from
every school on the IUPUI campus, representing more
than 50 disciplines, have been recruited to serve
as reviewers for campus-wide internal grant funding
mechanisms. The Office of Research and Sponsored Programs
is committed to fostering research and scholarship
in all disciplines and to creating new opportunities
for IUPUI faculty.
IRB
SUBMISSIONS STREAMLINED
In
January, the IUPUI Research Compliance Administration
(RCA) began requiring that all human subject research
study applications be submitted electronically to
streamline the review and approval process. Along
with the electronic submission requirement, an electronic
review and approval pilot program was initiated with
one IUPUI IRB (IRB-04). Studies submitted to IRB-04
receive a pre-review from an RCA staff member and
from Dr. C. Conrad Johnston, Jr. (Chair of IRB-04),
in order to answer scientific questions and resolve
potential protocol problems. The Principal Investigator
of the study is given an opportunity to revise and
clarify the protocol prior to formal submission to
the IRB. The goal of this program is to reduce the
time for IRB approval. If successful, this pilot program
will be expanded to include additional IRBs.
UPDATES
CHANGE
IN POLICY FOR ESTABLISHING HUMAN BIOLOGICAL MATERIAL
REPOSITORIES
Based
on recent guidance from the Department of Health and
Human Services (DHHS), the IUPUI Institutional Review
Boards (IRBs) will no longer require that informed
consent to store human biological materials specify
future potential use of the materials. In the past,
the IRBs have required that subjects give informed
consent for a specific future use of human biological
materials at the time of material collection. While
informed consent is still required for collection
and storage of human biological materials, the future
potential use of the materials no longer has to be
specified. This change will become effective immediately
in the IUPUI/CLARIAN IRB system. More information
regarding IUPUI/CLARIAN Standard Operating Procedures
will follow.
OFF-SITE
IRB APPROVED
In
April, the IUPUI Research Compliance Administration
(RCA) established an agreement with the National Cancer
Institute (NCI) to use a central, off-site, IRB (CIRB),
composed of cancer research experts from all over
the country, to review human subject cancer protocols
from the IUPUI campus. This agreement should reduce
the administrative burden on IUPUI IRBs and campus
investigators while continuing to provide a high level
of protection for participants in human research studies.
Off-site IRB reviews should also shorten the total
time required for study review thereby allowing for
more rapid subject recruitment and faster completion
of studies. This new program will be initiated in
the summer of 2006.
HUMAN
SUBJECTS PROTECTION
The
IUPUI Human Research Protection Program (HRPP) received
full accreditation from the Association for the Accreditation
of Human Research Protection Programs (AAHRPP) in
September 2005. In the most recent audit (November
2005) by the U.S. Food and Drug Administration, the
IUPUI/Clarian Institutional Review Board (IRB) system
was given very high marks.
NON-COMPETING
PROGRESS REPORTS
Principal
investigators may submit National Institutes of Health
(NIH) non-competing progress reports electronically
through the NIH eRA Commons (https://commons.era.nih.gov/commons/)
for projects designated to use the Streamlined Non-competing
Application Process. This designation is contained
in the “Terms and Conditions” of the NIH
Notice of Grant Award.
Principal
investigators may delegate authority to another individual
to enter the progress report into the system. After
a report is completed and verified by the principal
investigator, copies should be routed to Sponsored
Research Services (SRS) in the IUPUI Office of Research
and Sponsored Programs using a paper or ERA route
sheet. SRS will review and submit the report on behalf
of the institution. An email from the NIH eRA Commons
will be sent to the principal investigator and to
SRS indicating receipt of the progress report.
Non-competing
progress reports submitted electronically are due
at the NIH 45 days prior to the next budget period
start date instead of the 60 days required for submission
of paper copies of the reports. If the principal investigator
elects to submit the non-competing progress report
in paper format, the face page must include an authorized
institutional signature and is due 60 days prior to
the next budget period start date.
JUST-IN-TIME
APPLICATION PROCESS
Just-In-Time information may now be
submitted electronically through the National Institutes
of Health (NIH) eRA Commons. Just-In-Time, the application
process requiring applicants to send documentation
to the NIH if an award is probable, should only be
submitted when formally requested by NIH staff. The
principal investigator must initiate the Just-In-Time
submission by entering the documents requested in
the NIH eRA Commons. Copies of the information should
then be routed to Sponsored Research Services (SRS)
in the IUPUI Office of Research and Sponsored Programs
using a paper or ERA route sheet. Once reviewed and
submitted by SRS on behalf of the institution, an
email from the NIH eRA Commons will be automatically
sent to the principal investigator and to SRS indicating
receipt of the Just-In-Time information.
eRA
COMMONS
If
you need a National Institutes of Health (NIH) eRA
Commons account, please contact Sponsored Research
Services (SRS) in the IUPUI Office of Research and
Sponsored Programs at 317.278.3473. If you would like
to request an individual or departmental training
session on these topics, or have comments or questions,
please contact Michelle Artmeier, Director of Proposal
Services at 317.278.8644. SRS is committed to assisting
faculty in all matters related to grant submission.
HUMAN
SUBJECT RESEARCH
New
principal investigators involved in research with
human subjects are required to complete the Investigator
101 Course and pass the test, which was developed
by the Office of Human Research Protections on the
appropriate conduct of clinical and non-clinical research.
This requirement, as established by the IUPUI Institutional
Review Board (IRB) Executive Committee in 2004, applies
to new principal investigators that submit protocols
to the IUPUI IRB. This includes both behavioral and
medical protocols and all levels of submission (exempt,
expedited, and full review). The three-hour course
may be completed in multiple sessions. To obtain a
copy of the Investigator 101 Course on a compact disc
(CD) free of charge, contact Research Compliance Administration
at 317.274.8289 or resrisk@iupui.edu.
MONTHLY
REMINDER: LIMITED SUBMISSION GRANT OPPORTUNITIES
Check
the IU Research Web site at http://www.srs.indiana.edu/LimSub/LimSub.asp
for upcoming limited submission program opportunities.
Click on the program name for a summary with links
to the agency guidelines and instructions for applying.
If you have questions contact Etta Ward at 317.278.8427
or emward@iupui.edu.
NSF:
INTERNATIONAL VISIT AND WORKSHOP GRANTS
NSF
grants are available to support the early phases of
developing research and education activities with a
foreign partner. Visit proposals are accepted at any
time. Workshop proposal deadlines are May 20, September
20, and February 20. For additional information, visit
http://www.nsf.gov/funding/pgm_summ.jsp?pims_id=12815.
