IRB
Policy Change Regarding Just-in-Time Procedures
The Just-in-Time procedures, announced by NIH last year, make it no longer
necessary to obtain IRB approval within 60 days of proposal submission. Investigators
are now required to obtain IRB approval when there is evidence that funding
will be received. Previously, IUPUI/Clarian IRBs required investigators to
submit their protocols regardless of where they were in the NIH review cycle.
The original procedure allowed the IRB to review the protocol quickly, without
pressure from the investigator or agency.
Effective immediately, the IRBs will request
that investigators not submit studies until there is evidence that the proposal
is in a fundable range. The new procedure should not be problematic since
the priority score is assigned early and allows adequate time to run the study
through the IRB process. Additionally, the new procedure allows the investigator
to make changes, as requested by the study section, before the study is submitted
to the IRB. This policy is effective for NIH proposals only.
Early
Adopters Use ERA System
Currently, a sample group of early adopters,
representing 27 departments/divisions on the IU campuses at Bloomington and
Indianapolis are using the new ERA system electronic routing form. The education
program for the early adopters was successfully completed in March 2001. A
Web-instructional guide for using the ERA system will soon be available. Watch
for details to be announced on the ERA home page http://www.research.indiana.edu/era.html.
Also, check out the ERA home page for information on ERA system enhancements
and implementation dates.
Department
of Microbiology and Immunology Experiences ERA
Sandra Wilson, Business Manager for the Department of Microbiology and Immunology,
offers the following helpful hints to new Electronic Research Administration
system users, "The first of March, we became early adopters of the new electronic
route sheet in ERA. We found the training to be excellent and easily understood.
We chose to initially limit creation/input into the system to two persons
within the department. Our faculty needs only to go in and approve the sheets
prior to routing. This system worked well since ERA was still undergoing modifications
and some problems. We are training the faculty on an individual level as they
process their grant applications. Hints I would give new users would be: 1.
Maintain a departmental log sheet of your Tracking Numbers. 2. Make sure all
faculty, postdoctoral fellows and students have completed a User Agreement,
prior to implementation. Some 25 applications later, many of our faculty members
have embraced the new system without any major problems. Dr. Janice Blum (Professor
of Microbiology and Immunology who has processed three ERA applications) said,
'It's great! It's a snap! Didn't seem hard and it flowed quickly. I just bookmarked
it and was easily able to get back into it the next time.'"
COS
Tools for Research Administration
IUPUI is a member of the Community of Science,
a leading Web site used by nearly half a million scientists and scholars worldwide.
As members of Community of Science (COS), campus faculty and researchers have
access to a global Internet network of peers in which they can publicize research,
collaborate with peers, find funding and conduct research, all online, 24
hours a day, 7 days a week, at no charge.
COS has developed Web-based services that provide
a universal means of collaboration for researchers, facilitating "virtual
communities" whereby societies and scholars in selected scientific disciplines
can convene on the Web. Presently, the COS Internet community is used by more
than 460,000 members at 700 universities and institutions who communicate
and exchange information with fellow researchers in more than 120 countries.
COS also has established key contacts throughout the R&D community, thus providing
exposure of campus research to a primary interest group. An important COS
service is COS Workbench, a customized Web-based "work space" for professional
development and the means for accessing all of the COS products and services
in one place.
Central to COS' mission of supporting the advancement
of scholarship is to provide access to research funding. Accordingly, COS
offers the largest Internet repository of funding opportunities and provides
access to more than 20,000 grants in all fields of research. A highlight of
COS services is COS Funding Alert, a customized service that automatically
e-mails individual researchers about current funding opportunities that apply
to their research.
As members, you are encouraged to use the COS
portfolio of Web tools with which you can create an online customized working
environment. Principal among these is COS Expertise, in which individual members
supply professional work information and experience, joining a network of
thousands of researchers worldwide. Through COS Expertise, COS publishes first
person profiles on the COS Web site in a secure, standardized, and searchable
format. Researchers can quickly construct a standardized c.v. or NIH 398 Biosketch
with just a few clicks of the mouse.
COS Services are complimented by many powerful
bibliographic databases and interconnected data resources. Researchers have
access to a wide range of comprehensive information including U.S. patents,
and current published work in the biomedical, geological, agricultural and
engineering fields, all drawn from federal agency resources. Comprehensive
meeting and conference schedules including searchable information on hundreds
of professional societies and meetings are provided. The COS Funded Research
Database tracks research activities and projects sponsored by NIH, NSF, USDA,
SBIR and MRC.
COS services are accessible through campus computers.
The COS Web site is http://www.cos.com/
and offers a comprehensive tutorial on how to get started using COS. For more
information, contact the COS campus liaison, Ann Kratz, akratz@iupui.edu
or 278-0249.
Department
of Medicine Takes the Lead Requiring Human Subjects Education
Indiana University Department of Medicine employees
are required to pass the certification exam for The Protection of Human Subjects
in Research Education now offered as a Web-course:
http://www.iupui.edu/~resgrad/Human Subjects/human-menu.htm. David Crabb,
M.D., Chairman of Indiana University Department of Medicine, states "…it is
essential that we remain on the forefront of protecting our patients who have
agreed to participate in our research."
Education/Mentoring
for New Department of Medicine Faculty
According to Dr. Crabb, "We will explicitly provide
a mentor for those doing clinical investigation. Each division will identify
a senior (associate professor or higher) and experienced person to be the
mentor for new faculty for issues related to clinical trials. In most divisions,
I anticipate that this will be a single individual. The mentor will be asked
to assist the new faculty in the preparation of their IRB applications and
in their contacts with industrial sponsors. This would entail a face-to-face
meeting to go over the important points of contracting, routing, human subjects
protection, and IRB regulations. The mentor will provide the IRB with a cover
letter for the first IRB application submitted indicating that they have reviewed
the protocol with the junior faculty member." Included in the mentoring activities
is the requirement for all new faculty to complete the education and test
for The Protection of Human Subjects in Research: http://www.iupui.edu/~resgrad/Human
Subjects/human-menu.htm.
Additional information for clinical investigators
is found on the FDA and CTP Web sites:
http://www.fda.gov/cder/about/smallbiz/clinical_investigator.htm
http://dmed.iupui.edu/ctp/
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Research and Sponsored
Programs
UN 618
General - 274-8285
Research Compliance - 274-8289
Sponsored Program Development - 278-0249
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