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 - 12/08/2021

G-2. HIPAA Compliance, Coded Private Information, and De-Identified Data

        GVSU Office of Research Compliance and Integrity - 12/08/2021

G-3. IRB Noncompliance Flowchart

        GVSU Office of Research Compliance and Integrity - 01/05/2022

G-4. Guidance on Engagement in Research

        U.S. Office for Human Research Protections - 10/16/2008

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. Reserved

G-11. Reserved

G-12. Guided 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 - 6/25/2019

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 - 4/2/2021

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.

Find out more about RCR Training.