Human Research Review Committee
Revised Common Rule Changes
Further Revised Common Rule Delay: The Department of Health and Human Services (DHHS) announced the effective date and compliance date of the revised Federal Policy for the Protection of Human Subjects (a.k.a. the “Common Rule”) will now be Monday, January 21, 2019.
For more information about the upcoming changes, click here: http://www.gvsu.edu/hrrc/changes-to-common-rule-75.htm
IRBManager is now live university-wide!!
Quick access: https://gvsu.my.irbmanager.com/
Additional information about the system and the roll-out process, including an instruction manual and details regarding the transfer of IRBNet data, can be found here.
Questions? Please contact email@example.com or call 616-331-3197.
The Human Research Review Committee (HRRC), an entity of the Office of Research Compliance and Integrity, ensures that the basic rights and welfare of research participants are fostered and protected. The HRRC supports researchers through its coordinated activities in education, regulatory compliance oversight, and post approval-monitoring. All research involving human subjects performed at GVSU and/or by GVSU students, staff, and/or faculty must be reviewed and authorized by the HRRC prior to the beginning of the research.
The HRRC is comprised of GVSU faculty, staff and community members, who review proposed research studies involving living persons.
If you are looking for Epigeum training, click here:
Note: This will take you to a protected webpage showing instructions for how to setup an Epigeum account, as well as further information related to using Epigeum at GVSU. When prompted on the next screen, enter your GVSU user name and password to access this information.
Are you looking to conduct human research? The information below will quickly get you started.
Informed Consent Document Templates
Below are informed consent document templates you can use for your HRRC submission. The proper template to use will depend upon the level of review for your protocol (exempt or expedited/full board) and whether or not your study falls under the purview of the General Data Protection Regulation (GDPR). If you are collecting identifiable information AND the data is being collected either electronically or in-person in a country belonging to the European Economic Area, your consent form must include GDPR language unless steps are taken to ensure participants are not providing data from a GDPR-regulated area. If you have any questions about which template to use, please contact the Office of Research Compliance and Integrity.
- Exempt Review without GDPR: Informed Consent Document Template
- Exempt Review with GDPR: Informed Consent Document Template
- Expedited/Full Board Review without GDPR: Informed Consent Document Template
- Expedited/Full Board Review with GDPR: Informed Consent Document Template
If you are conducting a clinical study, do not use the templates above. Please contact the Office of Research Compliance and Integrity directly.
Application Forms and Other Forms
If you are looking for application forms, they are now housed on IRBManager, with the exception of the Individual Investigator Agreement Form and HIPAA forms listed below. Forms that are found in IRBManager include the New Protocol Submission, Continuing Review, Change in Approved Protocol, and Closure Forms. Please log into IRBManager to access those forms.