Renewal of human research

Guidance

Any project that requires renewal, must submit renewal paperwork to continue IRB approval for additional time. Investigators must receive IRB approval prior to the expiration of the study. The IRB decides the frequency of renewal for each human research project to ensure the continued protection of the rights and welfare of research subjects. The IRB may designate a review that is more frequent than annually.

Investigators with projects approved prior to the July 19, 2018 human subject rules are grandfathered under the old rules. This means that any existing project must continue submission of renewal requirements for the life of the project unless the project transitions to the new rules. Projects will be sent instructions for transitioning to the new rules at the time of continuing review.

Research projects reviewed after July 19, 2018 human subject rules removed the requirement for renewals except for projects that are greater than minimal risk (e.g., full committee projects). Northern Arizona University, however, has determined that some minimal risk projects should still have a renewal requirement as identified below.

Exempt research

Human Research projects that are deemed exempt do not have a renewal requirement. However, exempt research will be given a five-year expiration date so that the Human Research Protection Program can update its records. An updated application is required every five (5) years.

Minimal risk research

The July 19, 2018 human subject rules eliminate the requirement to submit renewal paperwork at least annually for minimal risk research. However, the Northern Arizona University has determined that some projects may require more routine monitoring and has identified the following types of projects or instances when a renewal may be required:

• Principal Investigator (PI), co-PI, or Faculty Advisor that have received serious or continuing non-compliance determinations in the past two years;
• Projects that involve deception but do not receive the subject’s prior authorization to be deceived before engaging in the deception; or
• As determined by the IRB on a project basis depending on the risks in the research project, protection or inclusion of subjects, or other concerns that require increased oversight.
• A conflict of interest management plan exists.

The approval letter will identify whether the project has a requirement for a renewal by listing the expiration date as one year or less from approval.

Greater than minimal risk research

Projects deemed greater than minimal risk will have a renewal required at a period determined by the IRB. This renewal will usually be annually; however, it may be more frequent depending on the type of project, risks of the research (e.g. phase 1 studies), or for investigators with a history of serious or continuing non-compliance.

Requirements

Investigators must receive IRB approval prior to the expiration of the study. To obtain continued approval for the study, investigators must:

• Complete the Continuing Review Form.
• Approved list of project personnel and consent materials
• Submit renewal materials between 30 and 45 calendar days prior to the expiration of the study.

NOTE: Email reminders are sent as a courtesy to investigators 60 and 30 calendar days prior to expiration from IRBNet. Ultimately, it is the responsibility of the PI to track the expiration date and ensure appropriate documents are submitted within the required timeline so that the project can receive approval prior to expiration.

The Office for Human Research Protections requires that the review of the project should be as close as possible to the expiration of the study to maintain an accurate representation of the human research project. Therefore, projects submitted more than 45 calendar days prior to the expiration date will be reviewed and granted new expiration dates.

Materials received less than 30 calendar days from expiration may not have enough time to be reviewed prior to the study expiring. If the study expires before re-approval is granted by the IRB, all project activities must stop. The project will be administratively closed by the HRRP and a new application for approval is required.

The administrative closure of a project will not be reversed due to a PI not receiving or reading the renewal reminder notice.

• Maintain copies of all information submitted to the IRB in case revisions are required.

When there are potential delays in submitting materials to the HRRP, please contact the office so that, if possible, arrangements can be made.

Do not submit amendments to previously approved research as part of the renewal! If the renewal involves amendments to previously approved research, submit those amendments separate from the annual renewal by using the Amendment Request form. Remember that the HRRP can only process one submission at a time. Once the renewal is approved, the amendment may be submitted. If there are outstanding circumstances, please contact the HRRP.

For studies overseen by outside IRBs, submit a copy of the IRB renewal letter to the HRRP via IRBNet for record-keeping.

Updated protocols

The IRB is required to review the protocol, in its entirety, to continue to determine that the elements for approval are met. The protocol should be updated regularly so that a current protocol document exists. For sponsored research, a separate protocol is usually updated and supplied by the sponsor of the research throughout the course of the research. Frequently for Social and Behavioral Researchers or for Investigator Initiated studies, the IRB application may be the actual protocol document that is used by researchers to conduct the study.

The IRB understands the logistics of continually updating protocols for each and every change made. Therefore, the IRB has instituted the following requirements for making revision to protocols during the course of the research activity:

1. The IRB will use submitted amendments during the course of the approval period, and the last updated protocol submitted, to determine if the approval requirements in 45 CFR 46.111 have been met.
2. The IRB will require that at least every five (5) years, the protocol (which may be the IRB application, or may be a separate protocol document) be updated to reflect all changes made over the course of the five years, IF an updated protocol has not already been submitted in that time period via an amendment.

Version 2020-11