FAQ - The HRRC Protocol Approval Renewal Process

 

Exempt Protocols

The application forms are different for exempt and non-exempt studies. Be sure to complete the correct form and indicate which exemption category you believe best fits your proposed research.

Protocols determined by the HRPP to be eligible for one or more of the six categories in the federal regulations (45 CFR 46.102) do not require continuing review and renewal.

Any major change in an exempt protocol that alters the risk/benefit ratio or affects eligibility for inclusion in an exempt category requires notification of the HRRC and a request for approval of the change before it is instituted in the research study. For assistance call the office at 331-3197 or email hrrc@gvsu.edu

 

Expedited Protocol Review

GVSU policies allow the HRRC to approve certain expedited research protocols for up to a maximum of two calendar years before continuing review and re-approval must be completed. Certain restrictions apply. See HRRC policies # 110 and #120. Policies may be accessed from the HRRC home web page.

 

 

Full Board Protocol Review

The same federal regulations and university policies apply to protocols reviewed under full board procedures as those reviewed under expedited procedures except that the entire board reviews the protocol rather than two expedited reviewers.

Protocols that require full board review are those that are not eligible for the six exempt categories or the nine expedited categories. Virtually all research involving greater than minimal risk requires full board review.

Note that the HRRC board does not meet in August. Any full board approved protocol whose expiration date falls between the July and September board meetings must be reviewed no later than the July meeting to avoid a lapse in approval, which constitutes non-compliance.

 

 

What happens if I do not renew my HRRC approval prior to the expiration date of initial approval?

If the protocol approval expires without on time renewal, the HRRC approval lapses and the research activities are no longer approved to be conducted, including enrolling subjects, collecting study data, or conducting data analysis. Conducting unapproved research is non-compliance with GVSU policies and the Federalwide assurance .

 

 

Are there any exceptions to the requirement that all research related activities cease if the protocol approval lapses?

There is only one such exception. If the investigator immediately contacts the HRRC Chair and petitions the HRRC that a significant risk of harm to the enrolled subjects may occur if some research activities are required to cease, the HRRC may grant a temporary relief pending full protocol review. The investigator must submit written provisions to ensure the ongoing safety of enrolled subjects. Under no circumstances may new subjects be enrolled in the research protocol until approval is established.