HRRC Policies & Procedures

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.

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 full range of regulations pertaining to human subject protections for all authorized research, regardless of the source of funding.

GVSU functions under an FWA approved by the OHRP as: Grand Valley State University FWA# 00002829, Exp. Date Nov 3, 2007 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.

Human Research Review Committee (HRRC) Procedures & Guidelines
1-0 Federalwide Assurance
    1-1 Research Investigators Defined
    1-2 Investigator Responsibilities
    1-3 Establishment and revision of HRRC Policies and Procedures

2-0 Authorization to initiate proposed research activity
    2-1 Authorization to conduct research activities on human subjects
    2-2 Investigator Training
    2-3 Responding to reports of possible unapproved research activity involving human subjects

3-0 HRRC Voting

4-0 Review of protocol application with partial/sample test materials submitted.

5-0 Inclusion of subjects with limited English proficiency in minimal risk research

6-0 Privacy and confidentiality of personal data information

7-0 Continuing review and lapse of HRRC approval.

8-0 HRRC-required changes to protocols following initial review
    8-1 Investigator-initiated changes to an approved protocol
    8-2 Changes to an exempt protocol that may entail changes in protocol status

9-0 Resolution of disagreements among reviewers of expedited protocol reviews

10-0 Use of currently enrolled students as research subjects

11-0 Closed protocols

12-0 Retaining research records

13-0 Unanticipated problems
    13-1 Complaints

14-0 Suspension or termination of research activities.

15-0 Research conducted in non-U.S. institutions and locations.

16-0 Research on children

17-0 Research on prisoners

18-0 Investigators not otherwise affiliated with GVSU in GVSU-authorized research activities.
       18-2 Requests from external entities who lack an IRB

19-0 Informed Consent
        
20-0 Review of Protocols Involving Research on Vulnerable Populations

21-0 GVSU Email Survey Policy