Human Research Review Committee

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.

Click here for theHRRC Policies and Procedures Key.

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.

Human Research Review Committee (HRRC) Procedures & Guidelines - Please note that the following procedures are undergoing extensive review and revision this term. Updated documents will be posted by the start of winter term 2012. Information within these procedures may no longer be accurate. Please contact the HRPP with specific questions, 331-3197.

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.

    7-1 Conducting audits of previously approved research 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

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.
    18-1 GVSU employees who conduct human subjects research as part of academic degree requirements from another institute
     18-2 Requests from external entities who lack an IRB