Does My Research Require Institutional Committee Oversight?
Please review the questions below and assess whether you need to obtain review from any of the following committees:
Conflict of Individual Interest in Research (COIIR)
Embryonic Stem Cell Research Oversight (ESCRO)
Institutional Animal Care and Use Committee (IACUC)
Institutional Biosafety Committee (IBC)
Institutional Review Board (IRB) Committee
Radiation Safety Committee (RSC)
Research Integrity Committee (RIC)
Technology Transfer/Intellectual Property (TT/IP) Committee
The following questions will guide you in determining which Regulatory/Oversight Committee's might apply to your research:
1. Do any of the research personnel participating in your study or anyone else, including immediate family (spouse/significant other/dependent children ) have a financial and/or intellectual property interest in the sponsor or products used with this study?
If yes, complete and submit the "Statement of Financial Interests "RESEARCH" form and transmit to the Office of Research Integrity and Regulatory Affairs. (COIIR)
2. Will your research involve humans? (IRB)
If yes, submit your study to the Rush Institutional Review Board
3. Will your research involve animals? (IACUC)
If yes, submit your study to the Rush Institutional Animal Care and Use Committee
4. Will your research include the use of radiation (including x-rays, CT-scans, PET scans, radioactive materials, etc.) at any time? (RSC)
If yes, submit your study to the Rush Radiation Safety Committee (RSC) or contact Manjeet Hansra.
5. Do you work with recombinant DNA? (IBC)
If yes, review the information and answer the questions below to determine whether Institutional Biosafety Committee (IBC) review is required. The following questions determine whether you need to submit your proposed research to the Institutional Biosafety Committee (IBC) and/or the Biological Safety Officer (BSO).
Typically, answering yes to one or more of questions 1-4 means that you will need to submit an application. If uncertain whether your work qualifies for IBC review you may wish to consult with the BSO first. Answering yes to questions 5-7 means that you should discuss your activities with the BSO.
5a. Do you work with recombinant DNA molecules in any form?
5b. Do you infect experimental animals, whether or not transgenic, with?microorganisms?
5c. Does your work involve recombinant toxins? The IBC is especially concerned if the toxin molecule differs in?molecular structure from the native molecule.
5d. Will you generate transgenic or knockout rodents? Obtaining such rodents from commercial sources or from colleagues, requires BSO notification, but does not require an IBC application. However, if you are creating a transgenic/knockout animal, you must apply to the IBC regardless of whether or not you are receiving assistance of a service, such as the UIC Transgenic Production Service (TPS). The BSO should be notified of crossbreeding of existing transgenic strains, but such crossbreeding does not require IBC application.
6. Do you use the chemical MPTP (1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine), most frequently employed to induce a Parkinsonian syndrome in experimental animals? If yes, you must file a Rush MPTP Handbook including Standard Operating Procedures with the BSO. You and your co-workers must co-sign the "Rush MPTP Workers Informed Consent", which applies to students, technicians, postdoctoral fellows, or any other persons working with MPTP under your direction. (IBC)
7. Do you use carbon fiber nanotubes or other materials of nanomolecular scale? As these materials may evade filtration by conventional HEPA air filtration in a biosafety cabinet or hood, bring your research or planned research to the attention of the BSO as early as possible. (IBC)
8. Check all toxins of biological origin and microbiological agents currently in use against the Select Agents list (insert Link).? If you plan to order a new agent in this category, check that agent against the same list. If your agent is listed, contact the BSO immediately. (IBC)
Please Note: Defined small quantities of Select Agents may be obtained and used without special administrative regulations, but larger quantities will require the activation by Rush of a Select Agents program. Activation of the program and obtaining the necessary approvals for yourself and your lab personnel will require several months.
9. The following question pertains to your use of human embryonic stem cells (hESCRO). Have you acquired, or do you plan to acquire, hESC directly from WiCell or from any other source?
Notify the Senior Director of Research Integrity by signed letter from the P.I. of your possession of such cells or your intention to obtain them. Briefly describe your intended application for these cells, and attach written documentation of the cell origin and their method of acquisition. You will require a written acknowledgement of this notification from the Director to obtain IACUC approval to use such cells in experimental animal models. (hESCRO)
10. Do you have any concerns about the conduct of research by a Colleague, Post Doc, Resident or Student at Rush or elsewhere? Do you have concerns that falsification, fabrication or plagiarism may be a factor in some aspect of the work? (RRIC)