Biological Research Approval

When a new Institutional Biosafety Committee (IBC) application is submitted, it may be reviewed by one of three processes, depending on its scope:

1. Review by IBC Chair

   Biosafety Level 1 or exempt rDNA activity will be reviewed by the IBC Chair. The Chair will notify the PI in writing of the determination of his review and a copy of the determination along with the application will be maintained in the Office of Research Compliance and Integrity for documentation. As long as the activity does not significantly change, no additional action is required by the IBC or the PI.

2. Designated Review

   Blood draws by fingerstick: At least one member of the IBC, designated by the IBC chair and qualified to conduct the review, will be assigned to review the protocol and be given the authority to approve, request modifications, or recommend full committee review. All IBC members receive a copy of these protocols and have the opportunity to comment. Any IBC member may call for a review of the protocol by the convened IBC.

   Designated review for additional protocols may be used under exceptional circumstances, as determined by the IBC chair, as permitted by federal regulations.

3. Full Committee Review

   Protocols involving non-exempt rDNA activity (as per the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules), or Biosafety Level 2 and higher biocontainment levels (except blood draws by fingerstick) will be reviewed at the next available IBC meeting. Annual continuation and new applications every three years are also required. Blood draws using venipuncture require a Full Committee review

Possible Outcomes Upon IBC Review

• Approved –The new protocol submission satisfactorily addresses all issues and the submission is fully approved. No modification is necessary on the part of the principal investigator.
• Provisionally Approved – Minor issues remain that must be addressed by the principal investigator prior to approval. The revised protocol submission is reviewed by the primary reviewer and may be approved outside of the full IBC if changes are deemed satisfactory. Multiple revisions are allowed and may be necessary in some cases.
• Tabled –Significant issues remain that require full IBC review upon the principal investigator's response to the requested revisions.
• Rejected –The protocol submission is not approved and has not been recommended for further consideration by the IBC.

Amendments

Minor changes to a protocol, such as a change in personnel (not including the PI), need only notification to the IBC. Major changes, such as a change in previously described procedures, PI, quantity of material, organism or cell lines used, must be submitted to the IBC committee for review before the requested change is implemented

Select Agents

In addition to IBC approval, research involving Select Agents, a subset of pathogenic organisms or toxins, requires the submission of an application to the CDC as well as the submission of a background check through Human Resource Services, (including an FBI background check), prior to the initiation of research. Contact the Biosafety Officer for more details

Dual Use Research of Concern:

Dual use research is any research that can be used for positive as well has harmful purposes. The subset of research that is the heart of this policy is dual use research "of concern.” This is defined as "life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, projects, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to publichealth and safety, agricultural crops and other plants, animals, the environment, material, or national security." Although the general definition is broad, the recently released Federal policy is more specific. A list of organisms and toxins, as well as seven categories of experiments are the items of concern . An example of research that is classified as DURC is the sequencing of the 1918 flu strain. Someone could easily, (with current technology) build this flu from the information obtained from the research and use it for nefarious purposes.