ࡱ> e fbjbj z4h]bh]bu DDDDDXXX8<<Xi2:BXXX1111111$O472D2DDXX4#2DXDX11.|h0Xy"'&l/1920i2~/7~7$h07Dh0l222Zi27 B : Standard Operating Procedures: Human Research Protection Program (HRPP) 1. Purpose The purpose of this document is to describe the process that should be followed by the Principal Investigator (PI) as the recipient of a sponsored award involving human subjects. Additionally, this procedure lists the actions that must be taken by the Office of Sponsored Projects to ensure that all required approvals are in place prior to the expenditure of funds for any award involving human subjects. 2. Scope These procedures are relevant to any sponsored award involving human subjects. 3. Prerequisites The PI is the recipient of a federal or private award involving human subjects. 4. Responsibilities Principal Investigators (PIs) are responsible for the following: Ensuring completion of their HRPP CITI training as well as that of any other faculty, staff and/or students involved in their research. Providing a copy of all completed HRPP CITI certificates to the HRPP. Obtaining HRPP approval for any sponsored program involving human subjects and in which they are PI. If unsure as to whether your project requires HRPP approval, the PI must contact the IRB Administrator or complete a Human Subjects Research Determination form in OSPPortal. Department Chairs (DC) are responsible for the following: Reviewing and approving Institutional Review Board (IRB) applications prior to submission through OSPPortal. Office of Sponsored Projects (OSP) is responsible for the following: Confirming that the PI has the required HRPP approval for their sponsored program/project in place prior to any expenditure of funds. 5. Procedure 1) The PI completes LIUs HRPP CITI training. 2) The PI provides a copy of their CITI certificate to the campus HRPP. 3) The PI submits a copy of their HRPP approval for any award involving human subjects to the Office of Sponsored Projects. 4) Upon receipt of the PIs HRPP approval, OSP approves the expenditure of funds. 6. References  HYPERLINK "https://liu.edu/about-LIU/administrative-departments/academic-affairs/Institutional-Review-Board/Training-Resources" HRPP Policies  HYPERLINK "https://liu.edu/about-LIU/administrative-departments/academic-affairs/Office-of-Sponsored-Projects/Research-Training" CITI Training  HYPERLINK "http://www.liu.edu/ospportal" OSPPortal 7. Definitions PI: Principal Investigator of a sponsored project; responsible for overseeing and certifying the effort of all individuals working on his/her grant(s). Research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Human Subject: defined as a living individual about whom an investigator conductingresearch(i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the informational or biospecimens; or (ii) obtains, uses, studies, analyzes, or generate identifiable private information or identifiable biospecimens. Intervention: includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subjects environment that are performed for research purposes. Interaction: includes communication or interpersonal contact between investigator and subject. Identifiable Private Information: private information for which the identity of the subject is or may be readily ascertained by the investigator or associated with the information. Identifiable Biospecimen: a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.     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