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 of 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 Federalwide 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 the OHRP as: Grand Valley State University FWA# 00002829, Exp. Date Nov 8, 2013 The HRRC that operates within these assurances is registered 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: Athetic 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 Tecnology (GVSU)
OIA: Office of Institutional Analysis (GVSU)
OP: Office of the Provost (GVSU)
RPP: Research Protections Program (GVSU)
SACHRPP: Secretary's Advisory Committee on Human Research Protections (DHHS)
FDA: Federal Drug and Cosmetic Act
OHRP: Office of 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
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
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
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
G-5: Guidance on assessing risk using magnitude of harm in categorizing risk level. RPP
G-6: Guidance on assessing minimal risk. SACHRPP
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
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
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
Other Policies (OP)
OP-1: GV Charge to the HRRC. OP
OP-2: GV Policy on research involving varsity student–athletes. AD (under revision)
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
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
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
Page last modified February 6, 2013
