IRB Application Submission Guide

Overview

This webpage includes specific guidance information pertaining to the IRB review process for each of the following phases of human subjects research:

• Before Submitting an Application
• After Submitting an Application
• After an Application is Approved
• After the Research is Completed

Before Submitting an Application

Do I Need to Submit an Application to the IRB?

Research projects involving human subjects must be submitted to the IRB for review before the research may take place. You may NOT begin your project until you have been notified that the study has been approved by the IRB. Please see Do I Need IRB Review? for guidance on what activities require a submission to the IRB.

If you are unsure whether an activity requires IRB approval, you can review the Not Human Subjects Research (NHSR) Determination Form. This form may be submitted to the IRB to receive a formal determination about whether an IRB application is needed for your project.

Should I Submit a Medical or Non-Medical Application? 

What Type of Application Form Should I Use?

For most studies, the application type depends on whether the research may be considered minimal risk.

The following application types are available in eProtocol to submit projects to the Stanford IRB:

When Can I Use the Chart Review Form?

Use of the Chart Review Form type is limited to research involving analysis of STARR data or Stanford/VAPAHCS medical records that have been collected for non-research purposes.

The Expedited or Regular application should be used if the research:

• involves evaluating the safety and effectiveness of a drug or device;
• includes receipt of records from outside of Stanford and/or VAPAHCS;
• includes data collection targeting prisoners or abortuses;
• involves machine learning, or algorithm development or validation;
• involves over 10,000 records;
• obtains or analyzes specimens;
• is creating a data repository or database;
• involves prospective collection of data; or
• includes collaborating sites.

What are the Scientific and Scholarly Validity Review Requirements?

All research (except Chart Review and Exempt research) requires a review of Scientific and Scholarly Validity (SSV). If the research underwent any of the following reviews, the SSV requirement is met:

• Federal agency grant review
• Review of scientific merit by a funding agency such as a foundation or non-profit
• FDA oversight of an IND/IDE
• Clinical Research Unit (CRU) review
• Cancer Center Scientific Review Committee (SRC) review
• VA Research and Development Scientific Review

If none of the above have occurred, the Protocol Director's Division Chief, Department Chair, or their designee must provide SSV review for the proposed research. Provide the link found in the 'Attachments' section of the application to the appropriate person to complete this review. If the Department Chair is a researcher on the protocol, submit the protocol and the IRB Manager will request this review as appropriate.

For research where CRU or SRC review was completed, please attach documentation in the ‘Attachments’ section of your protocol application.  

What are the Academic Sponsor Review Requirements?

Students, Residents, Fellows and Post-Docs must have an Academic Sponsor listed on the protocol. The Academic Sponsor must complete a review of scientific and scholarly validity and protocol oversight. Provide the link found in the 'Attachments' section of the application to the Academic Sponsor to complete this review.

Where Can I Find Guidance on Using eProtocol?

eProtocol is the online submission system for submitting and reviewin IRB protocol applications. Useful resources and guidance can be found under the “Help” menu at the top of the eProtocol homepage, including:

• Getting Started - A summary for new users
• eProtocol Training - eProtocol training videos and information on group training
• eProtocol FAQs - Guidance on getting started, managing protocols, and troubleshooting

You can also see the Stanford IRB Office webpage for information on how to contact eProtocol technical support.

After Submitting an Application

Once your protocol is submitted, it will be assigned to an IRB panel and meeting date. Submissions on the regular application will be reviewed at a convened meeting.  Exempt and expedited applications are reviewed on a rolling basis with the meeting date as the target approval date.   You can view the protocol status in your eProtocol dashboard.

• Action Items - Applications that need an action by the research team
• In Process - Applications under review by the IRB (no action needed from you at this time)
• Active Protocols – Ongoing research with active IRB approval
• Non-Active Protocols – Applications that have been closed, expired or withdrawn

What Should I Do When I Receive Comments from the IRB?

It is important to respond promptly to any comments you receive from the IRB for a protocol under review. A specific deadline may be given for protocols to be presented at an upcoming IRB meeting, otherwise a response to comments is typically requested within 3 days. If you need additional time to respond, reach out to your IRB Manager. If your protocol is withdrawn due to lack of response to comments, you may clone the protocol and re-submit with any previous issues addressed in the new application.

When Can I Expect to Receive IRB Approval?

The IRB review process can vary depending on the type of review and information needed, including required Institutional & Ancillary Reviews. Expected timeframes for IRB review are as follows:

After an Application is Approved

Protocol Directors must maintain appropriate study oversight throughout the study, as described in the HRPP Policy Manual (Ch. 15.3 Research Oversight).

What is Needed if My Research Changes?

All proposed changes to non-Exempt research must be prospectively reviewed and approved by the IRB (except where necessary to eliminate apparent immediate hazards to subjects). Investigators should submit a Modification form for review and approval prior to implementing the proposed changes. See Exempt Research for information on changes made to Exempt studies.

What is Continuing Review by the IRB?

Studies with an expiration date must undergo continuing review by the IRB prior to the study expiration. When applicable, the Protocol Director is responsible for ensuring that protocols are submitted with sufficient time for continuing review and approval by the IRB prior to the study’s expiration date.

Some minimal risk studies do not require annual review and qualify for an Extended Approval Period (EAP).

• IRB Approval letters and consent forms (when applicable) will document that the study qualifies for extended approval and do not expire.
• With extended approval, modifications must still be submitted for IRB approval prior to implementing changes, and events that meet prompt reporting criteria must be reported to the IRB.
• Extended approval does not apply for some minimal risk research (e.g. FDA-regulated research, prisoner studies, stem cell research, etc.)

Protocols that receive extended approval should still be closed by the study team once the research is completed. If there is no IRB activity on the protocol for 3 years, researchers will be notified and asked to confirm the status of the study. If the study is not confirmed to be active within 30 days from the date of the notice, the IRB will administratively close the IRB protocol application.

What Happens When an Approved Protocol Approaches its Expiration Date?

Researchers are notified by email about an expiring protocol two months prior to the expiration date, with a second reminder approximately one month later. If no continuing review form has been received prior to an expiration date, an expiration notice is sent to the study team after the study expires.

What Should I Do if a Protocol Expires?

If the expired study is no longer active, you may ask the IRB staff to administratively close the protocol. If the study is FDA-regulated, submit a final report in eProtocol.

For research that is still ongoing, you can contact the IRB to discuss the best option for re-instating your study approval.

After the Research is Completed

When and How can I Close an Application Once the Research is Completed?

Applications should be closed in eProtocol once the study has been completed, or when the only remaining activity is analysis of de-identified data. The human subjects research is completed when all participants have been enrolled; all participants have completed all research-related interventions, including any protocol required follow-up; all analysis of identifiable data is completed; and all funding and contracting issues have been completed/cleared. The Protocol Director should close the application within 30 days of completion.

See the HIPAA and PHI guidance for more information on de-identification.

Applications are closed via eProtocol, either by submitting a Final Report or by changing the protocol status in eProtocol (see eProtocol instructions.) If the 'Close Protocol' option is not available for your study, a Final Report must be submitted to close the study with the IRB. All FDA-regulated protocols must be closed by the Protocol Director. The following table indicates when a Final Report is require to close a study:

What are Record Retention Requirements?

All data, including all signed consent form documents, must be retained for a minimum of three years past the completion of the research. Additional requirements may be imposed by the funding agency, your department, or other entities (e.g. 7 years for studies conducted under HIPAA). (See also Research Policy Handbook RPH 1.9 - Retention of and Access to Research Data.)