News
IMPORTANT: HRRC Policy/Procedure Changes
May 03, 2017
*This information will affect all researchers conducting human subjects research. Please read carefully.*
The Office of Research Compliance and Integrity (ORCI), in conjunction with the Human Research Review Policy and Procedure Committee, would like to announce the following HRRC policy and procedure changes. These changes are being implemented to help ensure the university and its researchers remain in compliance with current federal and university regulations when conducting human subjects research.
1. HRRC Policy/Procedure Changes Effective July 1, 2017
a. Only faculty and staff will be allowed to serve as the Principal Investigator (PI) on HRRC protocol submissions. [HRRC Policy 310]
Reason for change: To ensure study PIs are appropriately qualified to carry out all PI responsibilities, including complying with continuing review and audit requirements, as well as long-term data storage requirements.
b. New training/documentation requirements for all individuals named on HRRC protocols submitted after June 30, 2017. [HRRC Policy 310, specifically Procedures section 1a, subsections i and ii.]
1. Individuals who have not previously been named on an approved GVSU human subjects protocol will be required to complete:
i. Epigeum Responsible Conduct of Research (Concise Course) (~45 min)
ii. Epigeum full Human Subjects Protections Course (~150 min)
2. Individuals who have previously been named on an approved GVSU human subjects protocol will be required to complete:
i. Epigeum Responsible Conduct of Research (Concise Course) (~45 min)
ii. Epigeum Human Subjects Protection Module (located within the Concise Course) (~15 min)
Note: Training certificates will be valid for three years, after which point the training will need to be repeated prior to submission of a new HRRC protocol. While GVSU supports the use of the Epigeum Impact system for its Research Compliance training program, CITI training certificates will continue to be accepted after July 1, 2017, for individuals who complete the analogous CITI training course(s).
Reason for change: To ensure all researchers are appropriately qualified to conduct human subjects research and to ensure GVSU has proper compliance training and documentation in place.
c. A GVSU Investigator Conflict of Interest Disclosure and Certification Form must be completed and submitted for each researcher listed on a new HRRC proposal application. Further details and link to the Disclosure Form can be found here. [GVSU Conflict of Interest in Research Policy]
Reason for change: To ensure proper documentation of compliance with federal regulations and university policy.
d. Clarified roles and responsibilities of Authorizing Officials (AOs). [HRRC Policy 330, specifically Procedures section 1c.]
Reason for change: To ensure AOs fully understand their roles and responsibilities when approving human subjects research projects performed by faculty members within their unit.
2. New HRRC Policy, Effective immediately: All requests from unaffiliated (non-GVSU) researchers seeking data collection and/or recruitment of GVSU faculty, staff, and/or students must be reviewed by ORCI. [HRRC Policy 1130]
Reason for change: To ensure and protect the safety of our university participants and to determine if GVSU is engaged in the research activity per federal human subjects research regulations.
Thank you in advance for working with us as we strive to improve the university’s research compliance program.
As always, ORCI staff are available to help answer any questions you might have about these upcoming changes and/or any other research compliance concerns. For questions, please contact ORCI via phone (1-9453) or email ([email protected]), or stop by our office, JHZ 049.