HRRC Policies & Procedures

GVSU centrally manages all university policies.  Individual academic and service support units manage their own procedures and guidelines.

To find the listing of university wide policies, go here:   http://www.gvsu.edu/gvmanual

To find the Human Research Review Committee procedures and guidelines for research subject protections, please follow these links listed below.

 

Terminology

The term Human Research Review Committee is the designated title of the Institutional Review Board at Grand Valley State University.

The term HRRC Chair shall be understood in these documents to refer to either the permanent Chair or the acting Chair of the HRRC. The acting Chair of the HRRC in most cases will be one of the appointed and named Vice-Chairs.

The term OHRP refers to the Federal office of regulatory interpretation and education pertaining to human subject protections in research activities, the Office for Human Research Protections, located in the Department of Health and Human Services.
 

Regulatory Background

The U.S. Department of Health and Human Services (HHS) regulations at Title 45, Code of Federal Regulations (CFR) 46.103(a) require that each institution engaged in HHS-conducted or -supported human subjects research provide written assurance, satisfactory to HHS, that it will comply with the requirements of the HHS regulations for the protection of human subjects, unless the research is exempt under 45 CFR 46.101(b). Grand Valley State University has an approved Federal-Wide assurance (FWA) registered with the Federal Office for Human Research Protections (OHRP) under the authority of the Secretary, HHS, of compliance with HHS regulations (45 CFR 46.103(a)) for the protection of human subjects.

HHS regulations at 45 CFR 46.103(b) require that each institution engaged in HHS-conducted or -supported human subjects research certify to the HHS funding agency that the research has been approved by the human research review committee (HRRC) designated in the FWA. The designated HRRC at GVSU has agreed to comply with the Common Rule (Subpart A) of the regulations pertaining to human subjects protections for federally funded studies.

GVSU functions under an FWA approved by OHRP as: Grand Valley State University FWA# 00002829, Exp. Date Nov 13, 2018 The HRRC that operates within these assurances is registered with OHRP as:
Grand Valley State University Human Research Review Committee #00002615.
The following procedures outline the standards for conducting research at GVSU. These procedures are updated regularly and are made publicly available on this website.

 

Abbreviation Key

AD: Athletic Department (GVSU) 

AM: Administration Manual (GVSU) 

BF: Business & Finance (GVSU) 

CSCE: Center for Scholarly & Creative Excellence (GVSU) 

HRRC: Human Research Review Committee (GVSU) 

IT: Information Technology (GVSU) 

OIA: Office of Institutional Analysis (GVSU) 

OP: Office of the President or Provost (GVSU) 

RPP: Research Protections Program (GVSU) 

SACHRPP: Secretary's Advisory Committee on Human Research Protections (DHHS) 

FDA: U.S. Food and Drug Administration

OHRP: Office for Human Research Protections (DHHS) 

 

000: Policies issued by authority of the RPP and HRRC

G-0: Guidance from HRRC, GV, federal and other sources 

OP-0: Other policies and procedures issued by GV entities 

 

 

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

121: Review standards for research not covered by Federal wide Assurance

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

G-14: Guidance on transferring clinical investigation oversight to another IRB. FDA

 

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

900: HRRC protocol review

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

G-14: Guidance on transferring clinical investigation oversight to another IRB. FDA

 

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 (Admin Manual) 

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 research subjects. 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 & 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: Guided on PI qualifications, adequacy of research sites, and IND/IDE requirements. FDA

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

G-14: Guidance on transferring clinical investigation oversight to another IRB. FDA

Page last modified September 24, 2014