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).
Abbreviation Key
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)
Index
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
000. IRB Operations
010. IRB Composition and Member Responsibilities - 04/12/2022
020. Conducting IRB Meetings - 04/12/2022
030. Operational Support of the IRB - 04/21/2022
040. IRB Review Fees - 11/06/2023
050. Records Retention and Destruction - 04/21/2022
060. Contingency Plans for IRB Operations and Human Subjects Research - 02/06/2023
100. IRB Authority & Responsibilities
110.Ethical & Legal Standards and Practices for Human Subjects Research - 05/23/2018
120.Compliance with Applicable Laws and Regulations - 02/06/2023
121.Review Standards for Research Not Covered by Federalwide Assurance - 10/28/2014
130.Review of Scientific Validity and Scholarly Merit - 05/01/2018
140.IRB Member Conflict of Interest - 09/10/2013
150. [Reserved]
160. Institutional Review Board Policies and Procedures Committee (IRBPPC) - 02/28/2022
200. Determination of Research and Engagement
210. Determination of Human Subject Research - 01/21/2019
220. Determining Engagement in Human Subjects Research - 12/21/2021
300. Researcher Responsibilities, Qualifications & Authorizations
310.Researcher Responsibilities, Qualifications and Training - 04/21/2022
320.Researcher Conflict of Interest - 05/27/2019
321.Researcher Conflict of Interest When Enrolling GVSU Students and Employees - 05/27/2019
330.Authorization to Conduct Human Subjects Research - 09/26/2017
700. Minimizing Risk
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
800. Informed Consent
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
900. Protocol Review and Approval
900. [Reserved]
901. IRB Protocol Review: Expedited Protocols - 05/16/2024
902. IRB Protocol Review: Full Board Protocols - 05/16/2024
910. Continuing Review and Approval of Selected Non-Exempt Protocols - 04/12/2022
911. Exemption Determinations and Research Ethics Standards - 05/27/2019 *This version applies to protocols approved under the Revised Common Rule.*
911. Exemption Determinations and Research Ethics Standards - 05/01/2018 *This version applies to protocols approved under the Pre-2018 Common Rule.*
920. Significant Risk, Nonsignificant Risk, and Exempt Medical Device Studies - 04/06/2020
930. Requirements for Research Involving Investigational Drugs - 04/06/2020
940. Research Involving a Sponsor-Investigator - 11/06/2024
950. Protocol Review Agreements with External Entities Lacking an IRB - 09/23/2011
951. Declaration of Concordance Between Grants and Protocols Submitted to the IRB - 03/26/2019
1000. Post-Approval Monitoring and Actions
1010. Modifications to Approved Protocols - 05/16/2024
1020. Reportable Events: Protocol Deviations, Unanticipated Problems, and Adverse Events - 03/01/2021
1030. Research Noncompliance - 08/30/2024
1040. Post-Approval Compliance Review - 01/21/2019
1050. Suspension or Termination of Research Activities - 08/01/2012
1060. Closure of Approved Research Studies - 05/06/2021
1070. Responding to Concerns and Complaints About Human Subjects Research Activities - 05/01/2018
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
RCR Training
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.