View details on compliance related issues within the Office of Research and Sponsored Projects at KGI.
The role of the Institutional Biosafety Committee (IBC) is to establish and implement policies that provide for the safe conduct of research involving the use of all potentially hazardous biological agents, including but not limited to infectious agents, human and non-human primate materials (including established cell lines and stem cells), CDC/USDA select agents and toxins, recombinant or synthetic nucleic acids, clinical trials involving human gene therapy, genetically modified animals and whole plants and animals or animal specimens known to be reservoirs/vectors of zoonotic diseases.
The IBC ensures that research involving these agents is conducted in a manner that complies with all applicable regulations, policies and standards and does not endanger the researcher, laboratory worker, human research subject, the public or the environment. The IBC is a National Institutes of Health (NIH) mandated committee.
KGI relies on Western University as its IBC of record. Any research involving the materials described above must be reviewed and approved by Western’s IBC via their protocol review process.
The Western University IBC protocol form, instructions and additional information can be found here.
David Sanchez, PhD, is the current Chair of Western University’s IBC and is happy to assist KGI researchers with their protocols. Dr. Sanchez can be reached at 909.469.8479, or via email at firstname.lastname@example.org. The KGI Lab Safety Committee serves as the liaison between KGI and the IBC at Western University. Please contact eithe Larry Grill at 909.607.0175 or Jasmine Yu at 909.607.8698 if you have questions on lab safety or IBC matters.
CITI Training Instructions – Institutional Biosafety Committee Protocols
If you have never accessed CITI, or if you have never affiliated yourself with KGI’s CITI subscription, go to citiprogram.org and click “Register” at the top right-hand side of the page. On the next page, click on “Log-In Through My Institution” and click ”Keck Graduate Institute.” You will be asked to enter your Single Sign-on (SSO) credentials—the same credentials you use to log-in to KGI email or Workday. This will automatically register you in CITI and affiliate you with KGI.
Once you are in the CITI website, go to the bottom of the page, and click on “Add a Course.” Select “Question 5 – Biosafety / Biosecurity” and check “Lab Faculty and Staff.” The modules are available to take at your convenience, and you can log in and out as time permits. You must pass each module with a score of 80% or higher. Completion reports should be attached to your IRB protocol application.
Research conducted at Keck Graduate Institute (KGI) encompasses a variety of fields that, directly or indirectly, involve interacting with and/or collecting data from humans. It is KGI’s policy and practice to uphold the ethical and responsible conduct of such research. KGI holds a Federal Wide Assurance (FWA), issued by the federal Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services (DHHS), in which the Institute has agreed that all activities involving human research subjects conducted at KGI (regardless of school, investigator (faculty, staff or student), funding source (internal or external), teaching activities, master’s and PhD theses, and Team Master’s Projects) will be guided by the Belmont Report and the Declaration of Helsinki, and additionally, all federally-funded research will be in compliance with the Federal Policy for the Protection of Human Subjects (aka “The Common Rule”) and the US Department of Health and Human Services regulations for the Protection of Human Research Subjects: Title 45 of the Code of Federal Regulations, Part 46 (45 C.F.R. § 46).
Claremont Graduate University (CGU) is KGI’s current Institutional Review Board (IRB) of record, meaning that they have the authority to grant approval for studies involving human research subjects, to require modifications to a protocol to secure approval for human research subject studies, and can suspend or terminate approval pursuant to these policies. In infrequent cases, KGI uses the services of an alternate external IRB for reviews of protocols that are highly technical or involve major clinical work. Studies involving human research subjects that have been approved by an IRB may be subject to further review and approval or disapproval by officials of the Institute. However, KGI officials may not approve studies involving human research subjects if it has not been previously approved by an IRB.
CGU has transitioned to an online IRB protocol submission and review system, Axiom Mentor. All KGI IRB protocols must be submitted via this system. To submit a protocol, you must have first taken training in Human Subjects Research via KGI’s subscription to the Collaborative Institutional Training Initiative (CITI).
CITI Training Instructions – Institutional Review Board Protocols
Once you are in the CITI website, go to the bottom of the page, and click on “Add a Course.” Select “Question 2 – Human Subjects Research” and check “Human Subjects – Faculty, Staff and Students.” The modules are available to take at your convenience, and you can log in and out as time permits. You must pass each module with a score of 80% or higher. Completion reports should be attached to your IRB protocol application.
The University of La Verne (ULV) is a USDA registered research facility that is regularly inspected and files all required documentation, including an annual report, with the USDA. In addition, under the provisions of the Public Health Service Policy on the Humane Care and Use of Laboratory Animals, the University files required assurance documents, conducts semi-annual inspections, and submits annual reports to the Office of Laboratory Animal Welfare (OLAW) as required to demonstrate compliance with federal regulations.
KGI has purchased a dedicated rack and bins for our research staff to use.
Investigators interested in using the University of La Verne’s facility need to take CITI / Animal Care & Use training; sign the Memorandum of Understanding (agreeing to fees for protocol review, Principal Investigator set-up, and animal housing/care); verify recent tetanus vaccinations; and complete a ULV protocol.
Forms and information can be obtained by contacting the current Institutional Animal Care and Use Committee (IACUC) Chair and Animal Facility manager Christine Broussard, Professor of Biology. Dr. Broussard can be reached by phone 909.448.4597 or via email at email@example.com. Jeniffer Hernandez, PhD, SPHS, serves as a member of ULV’s IACUC and is available to answer questions on the ULV facilities and protocol process. Dr. Hernandez can be reached at 909.607.0112 or via email at Jeniffer_Hernandez@KGI.edu.
CITI Training Instructions – IACUC Protocols
Once you are in the CITI website, go to the bottom of the page, and click on “Add a Course.” Select “Question 4 – Animal Care and Use” and check the appropriate box (lab staff, students, etc.) as well as “I work with mice…” under the species choices. The modules are available to take at your convenience, and you can log in and out as time permits. You must pass each module with a score of 80% or higher. Completion reports should be attached to your IRB protocol application.
Once you are in the CITI website, go to the bottom of the page, and click on “Add a Course.” Select the appropriate course from the list that corresponds to the type of protocol you will be submitting (i.e., IRB, IBC, or IACUC). The modules are available to take at your convenience, and you can log in and out as time permits. You must pass each module with a score of 80% or higher. Completion reports should be attached to your IRB protocol application.
Once you have completed CITI training, please login to Axiom.
You will again be asked to enter your Single Sign-on (SSO) credentials. You will be taken to Mentor’s main page.
A quick-start guide to using Mentor can be found here.