IRB Policies, Procedures & Guidance


Find additional information on IRB policies, procedures, and guidance in the drop down menus below. You can also find a list of commonly used abbreviations.  

Note: The "Revised Common Rule" that became effective on January 21, 2019 resulted in some changes to how protocols are regulated. In cases where a policy is affected by these regulatory changes, two versions of the policies are included below: one for protocols falling under the Revised Common Rule and one for protocols falling under the previous regulations (termed "Pre-2018 Common Rule"). The Pre-2018 Common Rule policies apply only to existing protocols approved prior to 1/21/19 that have not been transitioned to the Revised Common Rule. All other protocols will fall under the Revised Common Rule version of the policies. If you need assistance determining which version applies to your protocol, please contact the Office of Research Compliance and Integrity ([email protected]; (616) 331-3197).


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)

GVSU Office of Research Compliance and Integrity 

Policies, Procedures & Guidance

000.     IRB Operations

010: IRB composition

020: Conducting IRB meetings: voting

030: ORCI document retention and maintenance

OP-1:  GV Charge to the IRB. OP

 

100.     IRB Authority & Responsibilities

110: Ethical & legal standards and practices for human subjects research

120: Compliance with applicable laws and regulations

130: Review of scientific validity and scholarly merit

140: IRB member conflict of interest

150: IRB use of outside expertise (consultants)

OP-4:  GV Policy on Conflict of Interest. OP  

 

200.     Determination of Research

210: Determination of human subject research

G-1:  Guidance on distinguishing research from QI and PE activities. OHRP

G-2:  Guidance on research projects involving oral history. ORCI

G-3:  Guidance on research activities not requiring IRB approval. ORCI

G-4:  Guidance on engagement in research. OHRP

G-10:  Guidance on single case reports and case series. ORCI

 

300.     Researcher Responsibilities, Qualifications & Authorizations

310: Researcher responsibilities, qualifications and training

320: Researcher conflict of interest

321: Researcher conflict of interest when enrolling GVSU students and employees

330: Authorization to conduct human subject research

OP-2:  GV Policy on research involving varsity student–athletes. AD

OP-3:  GV Policy on Research Integrity. OP

OP-4:  GV Policy on Conflict of Interest. OP

OP-5:  GV Procedures on payment to research subjects. BF 305

G-12:  Guidance on PI qualifications, adequacy of research sites, and IND/IDE requirements. FDA

 

 

400 (Reserved)

500 (Reserved)

600 (Reserved)

 

700.     Minimizing Risks

710: Assessing risk to research participants

720: Assessing risk to vulnerable participants

730: Collection, management and security of research information

740: Internet mediated research

741: Research involving non-GVSU computer servers and systems (cloud computing)

742: Research involving social media and networks

750: Recruitment, selection & payment of participants

OP-6:  GV Policies on data security. IT

OP-7:  GV Protection of human subject research information. CSCE

OP-8:  GV Procedures for research involving email. OIA

OP-9:  GV Procedure on Confidential Research Information & Investment Act. OP

G-5:  Guidance on assessing risk using magnitude of harm in categorizing risk level. ORCI

G-6:  Guidance on assessing minimal risk. SACHRPP 

G-11:  Guidance on coded private information. OHRP

 

800.     Informed consent

810: Informed Consent – General

812: Informed assent and parental permission

813: Research involving participants with questionable consent capacity

814: Informed Consent for persons not fluent in the primary language of the study

820: Waivers, alternations and exceptions to informed consent process and documentation

830: Voluntary participation, termination and withdrawal in human subject research                

OP-2:  GV Policy on research involving varsity student–athletes. AD

OP-8:  GV Procedures for research involving email. OIA

G-7: Guidance on constructing an informed consent document. ORCI

G-8: Guidance on withdrawal of subjects from research & data retention. OHRP

G-9: Guidance on age of majority in U.S. and foreign countries. ORCI

 

900.     Protocol Review and Approval

910: Continuing review and approval of selected non-exempt protocols

911: Exemption determinations and research ethics standards

950: Protocol review agreements with external entities lacking an IRB

 

1000.   Post-Approval Monitoring and Actions

1010: Modifications to approved protocols

1020: Unanticipated problems and adverse events

1030: Research non-compliance

1040: Research post-approval audits

1050: Suspension or termination of research activities

1060: Closures of approved research studies

1070: Responding to concerns and complaints about human subjects research activities

 

1100.  External, Unaffiliated and Collaborative Research

1110: Collaborating researchers not covered by an FWA

1120: Collaborating research with investigators covered by an external FWA

G-13:  Guidance on multi-institutional collaborative research projects. ORCI

 

Other Policies (OP)

OP-1:  GV Charge to the IRB. OP

OP-2:  GV Policy on research involving varsity student–athletes. AD

OP-3:  GV Policy on Research Integrity. OP (Admin Manual)

OP-4:  GV Policy on Conflict of Interest. OP (Admin Manual)

OP-5:  GV Procedures on payment to human participants. BF 305

OP-6:  GV Policies on data security. IT

OP-7:  GV Protection of human subject research information. CSCE

OP-8:  GV Procedures for research involving email. OIA

OP-9:  GV Procedure on Confidential Research Information & Investment Act. OP

 

Guidance (G)

G-1:  Guidance on distinguishing research from QI and PE activities. OHRP

G-2:  Guidance on research projects involving oral history. ORCI

G-3:  Guidance on research activities not requiring IRB approval. ORCI

G-4:  Guidance on engagement in research. OHRP

G-5:  Guidance on assessing risk using magnitude of harm in categorizing risk level. ORCI

G-6:  Guidance on assessing minimal risk. SACHRPP 

G-7:  Guidance on constructing an informed consent document. ORCI

G-8:  Guidance on withdrawal of subjects from research & data retention. OHRP and FDA

G-9:  Guidance on age of majority in U.S. and foreign countries. ORCI

G-10:  Guidance on single case reports and case series. ORCI

G-11:  Guidance on coded private information. OHRP

G-12:  Guidance on PI qualifications, adequacy of research sites, and IND/IDE requirements. FDA

G-13:  Guidance on multi-institutional collaborative research projects. ORCI

710.Assessing Risk to Research Participants - 10/28/2014

720.Assessing Risk to Vulnerable Participants - 10/02/2020 *This version applies to protocols approved under the Revised Common Rule.*

720.Assessing Risk to Vulnerable Participants - 05/01/2018 *This version applies only to protocols approved under the Old Common Rule.* 

721.Protections for Pregnant Women, Fetuses, and Neonates - 01/21/2019

730.Collection, Management and Security of Research Information - 05/27/2019

740.Internet Based Research - 05/27/2019

750.Recruitment, Selection and Payments to Research Participants - 11/06/2023

760.Research Utilizing HIPAA-Protected Health Information - 05/16/2024

810.Informed Consent: General - 11/06/2023 *This version applies to protocols approved under the Revised Common Rule.*

810.Informed Consent: General - 12/19/2018 *This version applies to protocols approved under the Pre-2018 Common Rule.*

812.Research Involving Children - 08/30/2024

813.Research Involving Participants with Questionable Consent Capacity and/or Legally Authorized Representatives  - 01/21/2019 *This version applies to protocols approved under the Revised Common Rule.*

813.Research Involving Participants with Questionable Consent Capacity and/or Legally Authorized Representatives  - 05/01/2018 *This version applies to protocols approved under the Pre-2018 Common Rule.*

814.Informed Consent for Persons not Fluent in the Primary Language of the Study - 01/21/2019 *This version applies to protocols approved under the Revised Common Rule.*

814.Informed Consent for Persons not Fluent in the Primary Language of the Study - 05/01/2018 *This version applies to protocols approved under the Pre-2018 Common Rule.*

820.Waivers, Alterations, and Exceptions to Informed Consent Process and Documentation - 09/30/2019 *This version applies to protocols approved under the Revised Common Rule.*

820.Waivers, Alterations, and Exceptions to Informed Consent Process and Documentation - 05/23/2018 *This version applies to protocols approved under the Pre-2018 Common Rule.*

830.Voluntary Participation, Termination, and Withdrawal in Human Subject Research - 08/01/2012

KHS at night

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.

Find out more about RCR Training.



Page last modified April 2, 2021