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 Application should be submitted to the Office of Research Administration:
• E-mail to email@example.com
• Drop off at 202 E. Border St., Suite 214
• Mail to Box 19188
• Fax to 817-272-5808
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
EXEMPT rDNA EXPERIMENTS
The Protocol Application will be initially reviewed by the IBC Chairperson to determine if it falls under the 6 categories of exemption as described in the NIH Guidelines Section III-F:
(i). rDNA molecules that are not in organisms or viruses.
(ii). rDNA molecules that consist entirely of DNA segments from a single nonchromosomal or viral DNA source, though one or more of the segments may be a synthetic equivalent.
(iii). rDNA molecules that consist entirely of DNA from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host (or a closely related strain of the same species), or when transferred to another host by well established physiological means.
(iv). rDNA molecules that consist entirely of DNA from a eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain of the same species).
(v). rDNA molecules that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent. See Appendix A, Exemptions Under Section III-F-5--Sublists of Natural Exchangers, for a list of natural exchangers that are exempt from the NIH Guidelines.
(vi). rDNA molecules that do not present a significant risk to health or the environment (see Section IV-C-1-b-(1)-(c), Major Actions), as determined by NIH. **See Appendix C, Exemptions under Section III-F-6 for other classes of experiments which are exempt from the NIH Guidelines.**
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 (allowable exemptions are outlined in NIH Guidelines Section III-F).
NON-EXEMPT rDNA EXPERIMENTS
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 aProtocol 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.
LABORATORY CERTIFICATION AND SAFETY
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, 5th edition.
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 firstname.lastname@example.org) 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.
PERIODIC REVIEW OF APPROVED rDNA EXPERIMENTS
In accordance with the NIH Guidelines, Section IV-B-2, the IBC will periodically review approved recombinant DNA research to ensure compliance with the NIH Guidelines. Periodic reviews will be scheduled at the discretion of the IBC and communicated to the Principal Investigators. Typically, periodic reviews take place on an annual basis. Principal Investigators are responsible for submitting information requested via the Annual Report Form in a timely manner, meeting the deadlines established by the IBC.
REVIEW OF MODIFICATIONS TO APPROVED rDNA EXPERIMENTS
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 (hyperlink to 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 or laboratory personnel.
COLLABORATIVE rDNA RESEARCH
When research covered by the NIH Guidelines is conducted at or in cooperation with another entity, all provisions remain in effect for that research. The UT Arlington IBC may accept, for the purpose of meeting IBC review requirements, the review of an IBC established under another policy of compliance with the NIH. Such acceptance must be in writing, approved and signed by UT Arlington’s IBC Chairperson, and approved and signed by correlative officials of each of the other cooperating institutions.