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1. Items Subject to Review
2. Application Submission and IBC Approval Process
3. Human Gene Transfer Studies
4. Changing an Existing Protocol/Study
5. IBC Membership at the University of Minnesota
6. Disagreements with IBC Decisions
7. Continuing Review
1. Items Subject to Review
Q: What must be reviewed by the IBC?
A: The Institutional Biosafety Committee (IBC) is charged under the NIH Guidelines and University of Minnesota Regents’ Policy with the oversight of all teaching and research activities involving:
- Recombinant DNA
- Artificial Gene Transfer
- Infectious Agents
- Biologically Derived Toxins
This also includes use of biological materials at sites removed from the University of Minnesota by University faculty, staff, researchers, and non-university staff researchers under grants and contracts to the University.
Q: Does research that is exempt from the NIH Guidelines for Research Involving Recombinant DNA Molecules require IBC review?
A: Yes, the University of Minnesota Board of Regents Policy requires that University faculty, staff and students using any potentially hazardous biological agents (rDNA, infectious agents and/or biologically-derived toxins) in research or teaching activities apply to the IBC. Even if rDNA activities are exempt according to Section III-F of the NIH Guidelines, the activities must be reviewed by the IBC.
2. Application Submission and IBC Approval Process
Q: Where should I send my completed IBC application form?
A: Submissions to the IBC should be sent electronically to ibc@umn.edu from the Principal Investigator’s University of Minnesota e-mail account.
Q: Do I need to send a hard copy of my submission with original signatures, as well as my electronic submission?
A: No, the IBC office is prepared to receive all documents electronically and in most cases, requires that correspondence is sent in an electronic format. Submissions must be transmitted directly from the Principal Investigator’s University of Minnesota e-mail account, as this is considered their electronic signature.
Q: Do I need to submit the Decontamination and Spill Clean-up Plan Template and the Biological Waste Disposal Template with my IBC application?
A: Yes. The IBC requires that you use the Decontamination and Spill Clean-up Plan Template and the Biological Waste Disposal Template when creating Standard Operating Procedures (SOPs) for management of accidental spills/exposure and waste disposal. Using these formswill ensure ease in training of laboratory staff and consistency in laboratories. Customization and submission of the templates will help to ensure that the committee receives sufficient information for review. The templates may be located at: http://www.dehs.umn.edu/Docs/WasteTemplate.doc and http://www.dehs.umn.edu/Docs/DecontaminationTemplate.doc
Q: Does the IBC have a template I can use to write Standard Operating Procedures (SOPs) for my laboratory?
A: Department of Environmental Health and Safety (DEHS) offers guidance for writing SOPs on the Bio Basics Fact Sheet entitled, “Writing Standard Operating Procedures.”
Q: Can I submit a single application to be reviewed by the IBC and the IACUC?
A: No, separate applications must be submitted to the IBC and the IACUC in order to be reviewed. HRPP is exploring options to move toward new types of forms in the future; however, we do not have the capability to accept a single form at this time.
Q: I've done this work quite often and have similar protocols with the IBC. Why is the committee so concerned about the details of my most recent application?
A: Each protocol you submit is a "stand alone" document, and you cannot refer to procedures in other protocols or publications, or assume that they are so generally used that everyone will know what you will do. The Committee members do not have access to previous protocols, and references cannot take the place of procedure descriptions. Each protocol must contain details of each procedure performed. Please also note that regulations and practices continue to evolve, so procedures approved in the past may require additional information before committee approval.
Q: How should I respond to stipulations from the IBC?
A: Responses to IBC stipulations should be submitted electronically to ibc@umn.edu. Please submit your response in the form of a letter, addressing each point in the order in which they are presented in the stipulations letter from the IBC. Responses to stipulations should be attached as a Microsoft Word document or PDF and sent directly from the Principal Investigator’s University of Minnesota e-mail account.
Typically, a response to stipulation letter does not need to be reviewed by the entire committee. The Biosafety Officer or individual members of IBC review these letters to ensure rapid turnaround time.
Q: Should I submit a revised IBC Application with my response to stipulations letter?
A: The IBC prefers that you do not submit a revised application with your response to stipulations unless a revised application is explicitly requested in the stipulations.
Q: How long will the IBC approval process take?
A: If an application is received on or before a submission deadline, it will be reviewed at the next IBC meeting, which falls approximately two weeks after the deadline. The Principal Investigator will receive notice of the meeting results approximately 7-10 business days after the meeting. Projects that are assigned stipulations will take an additional amount of time, depending on how quickly the stipulations are met and when they can be reviewed, either by the Biosafety Officer or by the full committee.
Q: When can I expect to hear from the IBC about the status my application?
A: You will receive an e-mail from the IBC within 48 hours of when your application is received. The e-mail will inform you of the IBC Code Number assigned to your application and that your application will be scheduled for the next available meeting. Approximately 7-10 business days after your application is reviewed by the committee, you will receive additional electronic correspondence from the IBC outlining the results of the review.
Q: How can I determine the status of my study?
A: HRPP has developed eResearch Central for University of Minnesota researchers designed to provide online access to study information. Through this tool the research staff can view the action history of their IBC protocols. Access requires an active x500 account or an affiliated researcher x500 guest account.
You may also contact the IBC Office at 612-626-5654 or ibc@umn.edu to inquire the status of any submission.
3. Human Gene Transfer Studies
Q: What is human gene transfer research?
A: Human gene transfer is the process of transferring genetic material (DNA or RNA) into a person. For an experiment involving the deliberate transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA, into human research participants, no research participant may be enrolled until: 1) the RAC review process has been completed; and (2) IBC and IRB approvals and FDA and all other applicable regulatory authorization(s) have been obtained. (Section III-C-1)
Q: What are the requirements for human gene transfer review by the IBC?
A: The NIH Guidelines (Appendix M-I-B-1) require that no research participants be enrolled in a human gene transfer project until:
- The RAC review process has been completed**
- Institutional Biosafety Committee (IBC) approval has been obtained from the clinical trial site
- Institutional Review Board (IRB) approval has been obtained from the clinical trial site
- All applicable regulatory authorization(s) have been obtained.
** The RAC review process must be completed BEFORE the University of Minnesota IBC will review a human gene transfer project. Principal Investigators must submit the following materials to the IBC for review of a human gene transfer project:
- Completed Recombinant DNA and Artificial Gene Transfer Application Form
- A copy of the completed NIH Appendix M
- A copy of the NIH RAC review letter and comments
- A copy of the human subjects consent form
- Any additional items, as required by the Recombinant DNA and Artificial Gene Transfer Application Form
Q: Why are human gene transfer trials reviewed by the NIH?
A: Human gene transfer research raises scientific, medical, ethical, and social considerations worthy of special attention and public discussion. Some of these issues arise from the fact that the techniques being used are relatively new and their risks and benefits are not well characterized.
The NIH review process allows for an in-depth examination of the issues associated with this technology in a setting where public input and comment is encouraged. This open discussion has two important benefits. First, it disseminates this information to scientists who can then incorporate new scientific findings and ethical considerations into the design of trials they may be conducting or planning. The efficiency of the research system is improved by allowing scientists to build on a common foundation of new knowledge emanating from this ongoing process of analysis and assessment. Second, it creates enhanced public awareness and allows for a public voice in the review of the safety and ethics of gene transfer research. This helps assure the public that scientists are attending to these important matters and sustains confidence in the enterprise. Finally, as the major funder of human gene transfer research and the basic science that underpins it, the NIH has an important responsibility for the appropriate stewardship of this area of scientific activity. This stewardship role is both an ethical obligation and a public mandate associated with the tax-derived research funds appropriated to the agency by Congress. (NIH-OBA FAQs)
Q. Is NIH-OBA RAC review required if my project is not funded by NIH?
A: Yes. The University of Minnesota Board of Regents has delegated the IBC to oversee all research and teaching activities involving recombinant DNA in compliance with safety requirements established by the National Institutions of Health in the Guidelines for Research Involving Recombinant DNA Molecules, 51 Fed. Reg. 16, 958 (1986, and as subsequently revised).
Even if your project is funded entirely by private sources, you must submit your protocol to the NIH. The NIH Guidelines apply to recombinant DNA research that is performed at or sponsored by an institution that receives any NIH funding for recombinant DNA research.
Q: What is the RAC?
A: The RAC is the Recombinant DNA Advisory Committee, which issues recommendations to the NIH Director regarding recombinant DNA activities. The recommendations are conveyed through the NIH Office of Biotechnology Activities (OBA), which is responsible for the NIH oversight system of recombinant DNA research.
Q: I am an investigator developing a protocol for a gene transfer clinical trial. What are the first things I need to do to prepare for a review of my trial by the RAC?
A: First, you should read Appendix M of the NIH Guidelines, which outlines points to consider in the design and conduct of these trials. It also includes details about submitting your protocol for review by the RAC.
As part of the packet of materials that you will send to the NIH, you will need to submit responses to Appendices M-II through M-V of the NIH Guidelines, which pose questions concerning the objective and rationale of the proposed research. These sections also explore how you will handle informed consent and privacy for research participants and their families. In addition to these responses, your packet should contain:
- a cover letter on institutional letterhead signed by you (and your colleagues) as the Principal Investigator(s). The letter should
- acknowledge that the documentation submitted to NIH OBA complies with the requirements set forth in Appendix M-I-A, "Requirements for Protocol Submission";
- identify the Institutional Biosafety Committee (IBC) and Institutional Review Board (IRB) at the proposed clinical trial site(s) responsible for local review and approval of the protocol; and
- acknowledge that no research participant will be enrolled (see definition of enrollment in Section I-E-7 of the NIH Guidelines) until the RAC review process has been completed (see Appendix M-I-B, "RAC Review Requirements"), IBC approval (from the clinical trial site), IRB approval, and all applicable regulatory authorizations have been obtained;
- a scientific abstract;
- a non-technical abstract;
- the proposed clinical protocol, including tables, figures, and relevant manuscripts;
- the proposed informed consent document; and
- curriculum vitae of the principal investigator(s).
For additional information and RAC submission instructions, please visit: NIH-OBA FAQs
4. Changing an Existing Protocol/Study
Q: How do I request IBC approval for a change in protocol?
A: The IBC recommends using the Amendment Request Form to request any changes to an approved IBC protocol. Researchers also have the option of providing a cover letter for IBC review. Clearly describe the requested change in a cover letter and indicate what prompted the request. Describe any potential implications the changes may have on health and safety. Provide a copy of all documents revised or added as a result of the proposed change (i.e. SOPs, decontamination/waste disposal templates, vector maps, etc.) with changes highlighted. Both options must be submitted to ibc@umn.edu by the Principal Investigator.
Q: How do I change/add titles to a research protocol already approved by the IBC?
A: Provide a written request or an Amendment Request Form for IBC review. Indicate whether the existing title is to be changed or whether another title is to be added to the existing title, and provide the rationale for doing so (i.e. new funding source, PI assessment, etc.). Additionally, please provide assurance that the new title reflects THE SAME RESEARCH as that already approved by the IBC.
Be aware that the addition or change of a title does NOT reflect IBC approval for any changes to the protocol or—such changes to the protocol must be submitted for review.
Q: How do I reactivate a study which has been filed “Inactive” ?
A: Failure to respond to deferral, to stipulations or continuing review by the stated deadline can result in inactivation of the request. Reactivation requires an explanation for failure to meet the deadline and documentation of fulfillment of the outstanding requirement.
Provide a written request for reactivation of approval (submitted to ibc@umn.edu by the Principal Investigator), and indicate the reason for requesting reactivation. Be aware that upon review, the IBC may also request an updated IBC application along with all associated documents.
5. IBC Membership at the University of Minnesota
Q: How can I find out about becoming an IBC member?
A: If you are interested in becoming an IBC member, please contact the IBC office at (612)-626-5654 or ibc@umn.edu to be directed to the
appropriate person.
6. Disagreements with IBC Decisions
The Human Research Protection Program leadership recognizes that actions of the committee are subject to scrutiny by the research community. The Institutional Biosafety Committee evaluates a wide range of research, and HRPP wants researchers to know there is an avenue to address disagreements regarding committee decisions.
Principal investigators wishing to raise concerns with IBC decisions should first clarify their understanding of the recommendations or requirements with HRPP staff (612-626-5654 or ibc@umn.edu). It is also recommended that researchers familiarize themselves with the specific regulation requirements related to the committee concerns. These references can most often be found on the IBC website.
Q: How do I submit documents for review?
A: If researchers are unable to address concerns through these traditional methods, then a researcher may address controverted issues by meeting with the committee. Before meeting with the committee, researchers should describe their concern and forward any supporting materials to HRPP. The submission should be a scientifically based position outlining the specific concerns, provide references, scientific rationale, and/or supporting material.
The submission will be referred to the committee for discussion. The process may include meeting with the committee at its next meeting if requested and appropriate. The process will include communication with all the relevant parties to collect additional information as well as the transmittal of the findings, recommendations and resultant actions back to the researcher.
Q: Is there anything else I should know?
A: All communication concerning IBC submissions should be submitted directly to the HRPP office, and not to individual committee members or to other University of Minnesota officials.
7. Continuing Review
Q: What is Annual Continuing Review?
A: "Continuing review" refers to the annual reappraisal of an IBC study. The goal of continuing review is to reexamine all IBC approved work and to confirm that work is being performed at appropriate containment levels. Changes in personnel and additional titles may be updated during this process.
Q: How do I know when I need to submit an Annual Continuing Review Form?
A: An e-mailed notice for renewal and a link to the "Annual Continuing Review Form" are sent to the principal investigator, co-investigators, and designated correspondents 8-10 weeks before the expiration date. The form is available at: http://cflegacy.research.umn.edu/ibc/download/IBCAnnualContinuingReview.doc . Please submit the completed form to ibcren@umn.edu as an e-mail attachment by the deadline referenced in the e-mail notice. If you have completed your project, please submit a final continuing review form to the IBC requesting closure of your project.
Q: How do I know when my Annual Continuing Review is approved?
A: You will receive an e-mail if there are any questions regarding your responses. Once approved, you will receive an e-mail indicating the new approval and expiration dates of your protocol. This process occurs the second and third years of your study.
Q: What happens if I don’t complete the continuing review process?
A: If you allow the protocol to expire, the IBC will classify the study as “inactive.” If you would like to continue the study, you will be required to defend the lapse in approval to the IBC and to regulatory and/or funding agencies. Activities involving recombinant DNA, infectious agents and biological toxins may not continue if you have a lapse in IBC approval.
Q: What is the difference between “Annual Continuing Review” vs. “Three-year Renewal”?
A: The annual review process begins one year after the initial protocol was approved by the IBC. Annual continuing review extends your protocol’s approval date for another year. This process is repeated the second year. When three years of the study have passed, the study must be completely reevaluated by the IBC. The Three-year Renewal is the process of resubmitting a new application for a full review of the ongoing study. Please note that the Three-year Renewal application must be a “stand-alone” submission; do not reference information that can only be found in an outdated application.
Q: What do I submit for a Three-Year Renewal?
A: Please submit an IBC Three Year Renewal Form and indicate whether the referenced project will be renewed or closed. Please submit the completed form to ibcren@umn.edu as an e-mail attachment. The form is available at: http://cflegacy.research.umn.edu/ibc/download/IBCThreeYearRenewal.doc.
If you intend to continue your work, a new IBC application must be submitted to the IBC for full committee review. To avoid a lapse in approval, a new IBC application and supplemental documents should be submitted at least two months before the expiration date.
IBC meeting dates and deadlines can be located at: http://cflegacy.research.umn.edu/ibc/meetings/index.cfm
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