ORCI and Federal Guidance
AD: Athletic Department (GVSU)
AM: Administration Manual (GVSU)
BF: Business & Finance (GVSU)
CSCE: Center for Scholarly & Creative Excellence (GVSU)
FDA: U.S. Food and Drug Administration
G-0: Guidance from IRB, GV, Federal and Other Sources
IRB: Institutional Review Board (GVSU)
IT: Information Technology (GVSU)
OHRP: Office for Human Research Protections (DHHS)
OIA: Office of Institutional Analysis (GVSU)
000: Policies issued by authority of the ORCI & IRB
OP: Office of the President or Provost (GVSU)
OP-0: Other Policies and Procedures Issued by GV Entities
ORCI: Office of Research Compliance and Integrity (GVSU)
SACHRPP: Secretary's Advisory Committee on Human Research Protections (DHHS)
IRB Guidance
G-1. Guidance on Determining If IRB Approval Is Required
GVSU Office of Research Compliance and Integrity - 12/8/2021
G-2. HIPAA Compliance, Coded Private Information, and De-Identified Data
GVSU Office of Research Compliance and Integrity - 12/8/2021
G-3. IRB Noncompliance Flowchart
GVSU Office of Research Compliance and Integrity - 2/7/2023
G-4. Raffles/Drawings in Research
GVSU Office of Research Compliance and Integrity - 4/5/2022
G-5. Guidance on Assessing Risk Using Magnitude of Harm in Categorized Risk Level
GVSU Office of Research Compliance and Integrity - 5/29/2012
G-6. Guidance on Assessing Minimal Risk
Secretary's Advisory Committee on Human Research Protections - 3/29/2007
G-7. Guidance on Obtaining Informed Consent
U.S. Office for Human Research Protections
G-8. Guidance on Withdrawal of Subjects from Research & Data Retention
U.S. Office for Human Research Protections, U.S. Food and Drug Administration - 9/21/2010
G-9. Reserved
G-10. Guidance on Working with Older Adult Participants
GVSU Office of Research Compliance and Integrity - 3/16/2023
G-11. Reserved
G-12. Guidance on PI Qualifications, Adequacy of Research Sites, and IND/IDE Requirements
U.S. Food and Drug Administration - 08/2013
G-13. Guidance on Multi-Institutional Collaborative Research Projects
GVSU Office of Research Compliance and Integrity
G-14. Guidance on Transferring Clinical Investigation Oversight to Another IRB
U.S. Food and Drug Administration - 05/2014
G-15. Guidance on the Use of Deception and Incomplete Disclosure in Research
GVSU Office of Research Compliance and Integrity - 3/7/2019
G-16. Guidance on Data Management Requirements for Research Data
GVSU Office of Research Compliance and Integrity - 7/9/2024
G-17. Guidance on FERPA in Human Subjects Research Studies
GVSU Office of Research Compliance and Integrity - 10/12/2020
G-18. Guidance on News Stories about Human Subjects Research Projects
GVSU Office of Research Compliance and Integrity - 6/25/2019
G-19. Guidance on Conducting Human Subjects Research Studies During COVID-19
GVSU Office of Research Compliance and Integrity - 6/15/2022
G-20. ClinicalTrials.gov Registration Guidance
GVSU Office of Research Compliance and Integrity - 8/18/2020
Responsible Conduct of Research (RCR) training is required for all GVSU graduate students and those GVSU undergraduate students who have internal funding (e.g. McNair Scholars, S3-Student Summer Scholars, MS3-Modified Student Summer Scholars, and students paid on GVSU R&D grants). NSF, NIH, and GVSU R&D funded research requires RCR training. All other investigators and personnel that will be in contact with subjects or data that can be linked to subjects are also required to complete RCR training every 3 years.