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
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 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.