Location of Review
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 theIUSB Documentation of Review and Approval page from the IUSB application packet.
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.
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.
(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.