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A. RESEARCH
REQUIRING REVIEW
Research involving
Recombinant DNA must be approved by the Institutional Biosafety Committee
(
B. BIOSAFETY PRINCIPLES
1. Definition of Recombinant DNA Molecules
As defined in the Guidelines, recombinant DNA molecules are either (1) molecules which are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (2) DNA molecules that result from the replication of those described in (1) above.
2. Containment Levels
As outlined in the Biosafety in Microbiological and Biomedical Laboratories manual, containment is described as the use of safe methods for managing infectious agents in the laboratory environment where they are being handled or maintained. The three elements of containment include laboratory practice and technique, safety equipment, and facility design.
There are four different levels of physical containment designated as Biosafety levels (BL) 1 through 4, which consist of combinations of laboratory practices and techniques, safety equipment, and laboratory facilities appropriate for the operations performed and the hazard posed by the infectious agents and for the laboratory function or activity. These levels are fully described in the NIH Guidelines.
C. PROTOCOL REVIEW PROCESS
1. Instructions and Forms for Research Submissions
Research applications
and any related documents are to be forwarded to RCA for processing. Copies
of these submissions are then forwarded to members of the Institutional Biosafety
Committee (
The principal investigator will be notified in writing of the results of these reviews.
2. Deadlines
Submission
deadlines are indicated on the Research and Sponsored Programs
website. These deadlines are strictly adhered to. Incomplete submissions will
not be accepted for review. Proposals submitted after the deadline will not
be reviewed until the following month. Exempt registrations and transgenic/knockout
rodent submissions are accepted on a rolling deadline.
3. Committee Actions
The Committee may take one of the following actions in regard to proposed research:
a) Final
Approval - For applications which fall under Section III-E of the NIH Guidelines, the PI may initiate the research simultaneous to submission
of the
b) Provisional Approval - The PI must respond to provisions requested by the Committee and receive final approval prior to initiating the research.
c) Tabled - Deferred for consideration at a subsequent meeting after the PI has responded to significant modifications requested by the Committee.
d) Disapproved - The PI will be notified in writing of reasons for disapproval.
Upon completion
of the review, the investigator will receive a formal response from the
3. Requirements of Funding Agencies
Some funding agencies now require that projects involving the use of recombinant DNA be approved by the applicant's IBC prior to their review of the application. Therefore, timely submission of the research application is essential.
D. RESPONSIBILITIES OF THE INVESTIGATOR
1. Compliance
The PI is responsible for complying fully with the NIH Guidelines and University policy in conducting any recombinant DNA research.
2. Laboratory Safety Procedures
A description
of your laboratory procedures is required; however, the procedures are incorporated
into the various
Investigators
are required to report any significant problems or violations of the NIH Guidelines and any significant research-related accidents or illnesses
to the Biosafety Officer, IBC, and OBA within 30 days.
3. Amendments and Continuing Reviews
Any change
in an approved protocol must be submitted in writing by the principal investigator
and receive written approval by the IBC prior to the initiation of
the change. If the
proposed change is in support of a different set of outcomes or objectives
than those previously approved by the IBC, a new research submission should
be prepared for review.
Changes considered
minor (no increase in risk or Biosafety Level) will be reviewed on an expedited
basis by an IBC reviewer. Submit the
IBC/BHC Amendment form and any necessary supporting documentation for review. Changes considered major (increased risk or
Biosafety Level) will be reviewed by the full Committee in a convened meeting.
Submit the IBC/BHC Amendment form, an updated IBC Protocol Submission
form, and any necessary supporting documentation for review.
Note that any amendment may be brought for full Committee review upon
recommendation from the IBC reviewer.
A status report
must be filed with the
4. 5-Year Resubmission Policy
To
ensure the IBC has the most current information when reviewing studies, and
to remain in line with NIH resubmission requirements, the IBC has established
a 5-year re-review policy for ongoing studies that have been approved at BL1
or higher. This policy requires PIs
to submit a new application to the IBC after 5 years of approval. Studies currently in progress that have reached
or exceeded the 5-year duration will be granted approval for only 6 months
at the time of continuing review. The
investigator must subsequently file a new application with the IBC within
this 6-month time frame. When a new
application is received by the IBC, it will be assigned a new study number
and reviewed by the full Committee. It
is strongly recommended that the new application be submitted to the IBC within
60 days of the study’s review date. By
submitting the study in this time frame, delays will likely be avoided so
that the project’s approval does not lapse or expire. If no new application is received by the IBC
within the 6-month period, the study’s approval will indeed expire, and thus,
the study will be terminated.
5. File Maintenance
It is important for the investigator to keep a copy of every document related to the research study which is submitted the Committee. These documents must be kept for at least three (3) years after terminating the study. RCA will NOT be responsible for duplicating any information submitted to the Committee.
E. RESEARCH CONDUCTED AT OTHER CAMPUSES OR INSTITUTIONS
1. Proposal Routing and Protocol Review Procedures
Research studies
are normally reviewed on a campus specific basis, with the exception of the
2. Research Conducted at Other Institutions
If it is anticipated that the research may be conducted at another site or that another institution may be involved in the research, it is the investigator's responsibility to obtain permission to involve other sites by providing the appropriate individuals or campus IBC with the local IBC approval, as well as a copy of the research submission which outlines the proposed research activities.
F. HUMAN GENE THERAPY
Investigators
are required to submit research applications to both the
If the proposal involves children, special attention should be given to subpart D of the regulations noted above. These regulations may be obtained from R&SP.
The IRB and
IBC may, at their discretion, condition their approval on further specific
deliberation by the RAC.
Serious Adverse
Event reports occurring during the conduct of the study must be submitted
to the Biosafety Committee as well as the OBA.
Refer to Appendix M-I-C-4 of the NIH
Guidelines for reporting requirements.
Research & Sponsored Programs
Last Update: July 17, 2007
http://www.iupui.edu/~resgrad/spon/dnapol.htm
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