Review Procedures
PROTOCOL SUBMISSION AND REVIEW PROCEDURES FOR RDNA RESEARCH
For all experiments involving recombinant DNA, including those which are considered exempt by NIH Guidelines, Principal Investigators must submit an IBC Protocol Application for (i) exemption determination and documentation or (ii) IBC review and approval of non-exempt experiments. Protocol Applications should be submitted to the Office of Regulatory Services at regulatoryservices@uta.edu or ibc@uta.edu.
The IBC Protocol Application Form is divided into 2 parts. Experiments qualifying for exemption under the NIH Guidelines Section III-F require completion of Part I of the Protocol Application. Experiments that do not qualify for exemption under the NIH Guidelines Section III-F (non-exempt) require completion of both Part I and Part II of the Protocol Application
The Protocol Application will be initially reviewed by the IBC Chairperson to determine if it falls under the 8 categories of exemption as described in the NIH Guidelines Section III-F.
Experiments determined as exempt by the IBC Chairperson will receive an acknowledgement letter from the IBC documenting the exemption and determination. No further action is required by the Principal Investigator unless there is a change in procedures or the use of rDNA that would affect the IBC’s initial determination as exempt.
New protocol applications for experiments that do not meet criteria for exemption as outlined in NIH Guidelines Section III-F will be scheduled for review at the next fully convened IBC meeting. It is strongly recommended that the Principal Investigator attend the meeting to answer any questions or address concerns of the IBC, during the review process.
The IBC will consider the Protocol Application in conjunction the NIH Guidelines’ review requirements including:
(i). The source(s) of DNA.
(ii). The nature of the inserted DNA sequences.
(iii). The host(s) and vector(s) to be used.
(iv). If an attempt will be made to obtain expression of a foreign gene, and if so, the protein that will be produced.
(v). The containment conditions that will be implemented as specified in the NIH Guidelines.
If the IBC requests additional information or modifications to secure approval following review of a Protocol Application , the Office of Research Administration or the IBC Chairperson will summarize these requests and notify the Principal Investigator. Final approval of research protocols will be communicated to Principal Investigators via an approval letter issued by the IBC Chairperson.
Laboratories conducting recombinant DNA or biological research are classified as Biosafety Level 1, 2, 3, or 4 based on the guidelines in CDC’s Biosafety in Microbiological and Biomedical Laboratories.
Recombinant DNA experiments requiring Biosafety Level 2 containment will require certification of the laboratory to ensure appropriate safety practices, equipment, and facility design. Therefore, the Principal Investigator should notify Environmental Health & Safety (EH&S, 817-272-2185 or ehsafety@uta.edu) as soon as possible once determined these levels of containment will be necessary. The laboratory certification process may occur simultaneously with the IBC protocol review process, but final approval of the Protocol Application will not be granted until the EH&S laboratory certification is complete.
Currently, there are no research projects on the UTA campus classified above Biosafety Levels 1 or 2. Use of pathogenic agents classified as Biosafety Levels 3 or 4 will require involvement and approval by UTA Administration. If you are considering using any of the agents classified as BSL 3 or BSL 4, please notify Environmental Health & Safety and/or the Office of Research Administration.
The Principal Investigator is responsible for notifying the IBC of any major changes in approved rDNA experiments before initiation. For example, the PI shall submit an Amendment Form for IBC review before implementation of any of the following:
(i). A change in host or vector.
(ii). A change in the donor species or nature of the DNA segment selected.
(iii). A change of project title.
(iv). A change in funding agency.
(v). A change in the location of work/experiments.
(vi). A change of the Principal Investigator.
Laboratory personnel changes will be handled administratively with verification of all appropriate training. To make a personnel change on your protocol, please email ibc@uta.edu or regulatoryservices@uta.edu.