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 (rci@gvsu.edu; 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 HRRC, GV, Federal and Other Sources

HRRC: Human Research Review Committee (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 RPP & HRRC

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.     HRRC Operations

010: HRRC board composition

020: Conducting HRRC board meetings: voting

030: RPP document retention and maintenance

OP-1:  GV Charge to the HRRC. OP

 

100.     HRRC 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: HRRC member conflict of interest

150: HRRC 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. RPP

G-3:  Guidance on research activities not requiring HRRC approval. RPP

G-4:  Guidance on engagement in research. OHRP

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

 

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

341: Unapproved 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. RPP

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. RPP

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

G-9: Guidance on age of majority in US and foreign countries. RPP

 

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. RPP

 

Other Policies (OP)

OP-1:  GV Charge to the HRRC. 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. RPP

G-3:  Guidance on research activities not requiring HRRC approval. RPP

G-4:  Guidance on engagement in research. OHRP

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

G-6:  Guidance on assessing minimal risk. SACHRPP 

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

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

G-9:  Guidance on age of majority in US and foreign countries. RPP

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

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. RPP

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

720.Assessing Risk to Vulnerable Participants - 01/21/2019 *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 & Payments to Research Participants - 05/23/2018

810.Informed Consent: General - 01/21/2019 *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.Informed Assent and Parental Permission - 05/01/2018

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 - 01/21/2019 *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

G-8.Guidance on Withdrawal of Subjects from Research & Data Retention - 09/21/2010 OHRP

G-9.Guidance on Age of Majority/Adulthood in US and Foreign Countries - 02/14/2015 RPP

900. IRB Protocol Review - 01/21/2019

910. Continuing Review and Approval of Selected Non-Exempt Protocols - 01/21/2019 *This version applies to protocols approved under the Revised Common Rule.*

910. Continuing Review and Approval of Selected Non-Exempt Protocols - 05/01/2018 *This version applies to protocols approved under the Pre-2018 Common Rule.*

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.*

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

KHS at night

G-1.Guidance on Distinguishing Research from Quality Improvement and Program Evaluation Activities

US Office for Human Research Protections - 09/10/2013

G-2.Guidance on Research Involving Oral History Projects

GVSU Office of Research Compliance & Integrity - 02/14/2012

G-3.Guidance on Research Activities Not Requiring IRB Approval

GVSU Office of Research Compliance & Integrity - 02/14/2014

G-4.Guidance on Engagement in Research

US Office for Human Research Protections - 01/13/2009

G-5.Guidance on Assessing Risk Using Magnitude of Harm in Categorized Risk Level

GVSU Office of Research Compliance & Integrity - 05/29/2012

G-6.Guidance on Assessing Minimal Risk

Secretary's Advisory Committee on Human Research Protections - 03/29/2007

G-7.Guidance on Constructing an Informed Consent Document

GVSU Office of Research Compliance & Integrity - 11/22/2016

G-8.Guidance on Withdrawal of Subjects from Research & Data Retention

US Office for Human Research Protections, US Food and Drug Administration  - 09/21/2010

G-9.Guidance on Age of Majority/Adulthood in US and Foreign Countries

GVSU Office of Research Compliance & Integrity - 02/14/2015

G-10.Guidance on Single Case Reports and Case Series

GVSU Office of Research Compliance & Integrity - 01/29/2013

G-11.Guidance on Coded Private Information

US Office for Human Research Protections - 10/16/2008

G-12.Guided on PI Qualifications, Adequacy of Research Sites, and IND/IDE Requirements

US Food and Drug Administration - 08/2013

G-13.Guidance on Multi-Institutional Collaborative Research Projects

GVSU Office of Research Compliance & Integrity - 2013

G-14.Guidance on Transferring Clinical Investigation Oversight to Another IRB

US 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 - 03/07/2019

G-16.Guidance on Data Management Requirements for Research Data *Coming Soon*

GVSU Office of Research Compliance and Integrity - 

G-17.Guidance on FERPA in Human Subjects Research Studies

GVSU Office of Research Compliance and Integrity - 06/04/2019

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 encouraged to complete RCR training every 3 years.

Find out more here.



Page last modified March 29, 2019