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The HRRC Protocol Approval Renewal Process

Exempt Protocols

Protocols approved as eligible for one of the categories specifically designated as exempt in federal regulations (link to 45 CFR 46.102) do not require continuing review and renewal of approval. However, The HRRC confirms on an annual basis that all research continues to meet the criteria for exemption and that there have been no significant changes in activity. 

A change in protocol operations may effect a change in protocol approval status.  To maintain current records, approximately one month prior to the expiration date of the exempt approval an e-mail is sent to the investigators requesting an indication of whether: the protocol has been completed and is permanently closed, the protocol is continuing as originally approved, or    a Change in Protocol form is being submitted for approval. If no response is received by the requested reply date the protocol is marked "closed" and no more research or analysis may be conducted without submitting a new protocol.

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Expedited Protocol Review

Federal regulations and GVSU policies allow the HRRC to approve research protocols for any period of time up to a maximum of one calendar year. If an approved protocol includes research activity extending beyond one year, continuing review and re-approval must be completed by the HRRC. The continuing review and approval must be completed prior to the expiration date of the initial approval. The expiration date is printed at the top of the initial approval letter and one reminder e-mail is sent to the first investigator listed on the protocol approximately two (2) months prior to the expiration date. If no response is received at least three (3) weeks prior to the approval expiration date the protocol is marked "closed" and no more research or analysis may be conducted without submitting a new protocol.

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Full Board Protocol Review

The same regulations and policies apply to protocols reviewed under full board procedures as those reviewed under expedited procedures with one exception. The submission of continuing review materials must be received no later than eight (8) days before to the regularly scheduled full board meeting prior to the expiration date of the protocol approval. Note that the HRRC board does not meet in the month of August. Therefore, 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.

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

If the protocol approval is granted and then expires without timely renewal, the 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 a violation of GVSU policies and the Federalwide assurance GVSU holds with the US federal government.

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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.

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