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Location of Review
LOCATION OF REVIEW
NON-IU RESEARCHERS
Researchers not affiliated with IU, who wish to come onto the IUSB
campus to conduct research, must either provide an approved application
from an IRB at an institution with a Federalwide Assurance (FWA), or
submit a new application to the IRB. Either type of application must be
sponsored by one or more full-time IUSB faculty, librarian, salaried
clinical rank, or research rank appointee. See the section
Researcher
Responsibility for a list of allowable sponsor ranks.
If you are submitting an approved application from an IRB at an
institution with a Federalwide Assurance, you must also include a copy
of the IUSB Documentation of Review and Approval page from the IUSB
application packet. The entire packet may be downloaded
.
IU RESEARCHERS
All IU researchers must follow the "Institutional Review Board
Policy for Studies Conducted on Multiple Campuses" issued by the
Office of the Vice President for Research in May 2004.
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In order to provide Indiana University researchers
with an efficient and effective process for applying for and obtaining
the necessary institutional review board ("IRB") approvals for human
subjects research conducted on multiple campuses of Indiana University,
the following procedures will now be used at all institutional review
boards on the Indiana University campuses.
1. Except as otherwise provided in the paragraphs
below, the primary IRB responsible for review of a research study
proposed by an Indiana University researcher, whether faculty, student
or staff, shall be the IRB on the campus on which the "principal
investigator" for such study is located (the "Home
Campus").
2. Clinical trials and health facilities
(a) Notwithstanding anything
in this agreement to the contrary, all clinical trial or medical
studies occurring on any IU campus that require the expertise of the
medical IRBs on the Indianapolis campus shall be reviewed by, and
under the oversight jurisdiction of, the IUPUI medical IRBs in
accordance with the procedures of these IRBs.
(b) Subjects to the provisions
of paragraph 6 below, for any study to be conducted in one of the
Indianapolis area health facilities that, pursuant to its federal
assurance, specify use of the IUPUI IRBs, the appropriate IUPUI IRB
shall be the primary IRB for such study.
3. Subject to the provisions of paragraph 6 below, in
instances where an IU researcher proposes to amend a study, previously
approved by the Home Campus IRB pursuant to the principle stated in
paragraph 1 above, in order to extend the study to another IU campus,
the IRB on the Home Campus shall continue to be the primary
IRB.
4. Subject to the provisions of paragraph 6 below, in
instances where an IU researcher wants to conduct a study on any IU
campus other than the researcher's Home Campus, the IRB on the campus
at which the study will be conducted, will serve as the primary
IRB.
5. Subject to the provisions of paragraph 6 below, in
instances where the study will be conducted on more than one IU campus
with no one campus being more involved than the others, the primary
IRB shall be the IRB on the Home Campus.
6. Procedures
(a) The office of the IRB designated as
the primary IRB pursuant to the principles of paragraphs 2(b), 3, 4 or
5 above, shall send a copy of the application or amendment, as the
case may be, to the chair or chairs of the other interested IRB (e.g.,
under paragraphs 2(b) and 4, the Home Campus IRB would be the
interested IRB. Under paragraphs 3 and 5, the interested IRB(s)
would be the campuses at which the study is to be conducted, other
than the Home Campus.)
(b) The chair (or the chair's designee) of
the interested IRB shall have five (5) working days to provide any
comments or recommendations (written or in oral communication) to the
chair of the primary IRB. The chairs shall use their best
efforts to resolve any differences that arise between them. In
the event a difference cannot be resolved, the study shall go to the
full committee of the primary IRB for final resolution (the Chair of
the interested IRB and one other member from the interested IRB shall
be invited to participate in the full committee deliberations of the
study).
(c) In the case of an amendment of a study
as described in paragraph 3 above, the chair of the IRB on the campus
at which the proposed study will be conducted, shall receive in
addition to copies of the amendment and consent form, a copy of the
original file, communications with the researcher and , if the
original study was reviewed by the full committee, minutes of the
meeting(s) at which the study was reviewed.
7. Any amendments to an approved study shall be
submitted to the primary IRB for approval; and continuing reviews will
be done by the primary IRB. The primary IRB shall provide all
other involved campus IRBs with copies of the signed approval page for
any amendment and continuing review and the current and dated consent
documentation.
Nothing herein shall prohibit campus IRBs from consulting with the
IRB on another campus to obtain input on a study to be conducted in part
or in whole on such other campus. Nevertheless, final
decision-making rests with the primary IRB, unless the Vice President of
Research grants in writing a special exception to have a different IRB
serve as the primary IRB.
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