Research Modifications/Continuing Review

For all studies that were not granted exempt status, changes in approved research may not be initiated without prior IRB review (full or expedited review, as appropriate) and approval, except where necessary to eliminate apparent immediate hazards to human participants. If the investigators change the research in order to eliminate apparent immediate hazards to participants without prior IRB approval, they should report those changes promptly to the IRB Chair and then submit a request to change the research protocol.

Investigators must submit requests for changes to the IRB using the Request to Amend an Approved Protocol form (see here). Upon receipt of the protocol change, the Chair will determine if the revision meets the criteria for minimal risk. If the change represents more than a minimal risk to subjects, it must be reviewed and approved by the full IRB. Minor changes, involving no more than minimal risk to the subject, will be reviewed by the expedited review procedure.

Examples of changes to research protocols:

• Change in the number of participants
• Changes involving the investigational product (e.g., investigational drugs)
• Consent document changes
• Funding changes
• Additions to or subtractions from the research team
• Changes to the research protocol, including research materials (e.g. questionnaires)
• Changes to methods of recruiting participants
• Changes to research site/mode of data collection (e.g., social media platform; in-person versus online data collection)

For all studies that were granted exempt status, researchers may edit project procedures and documents without re-submitting to the IRB so long as the research remains minimal risk and stays within the boundaries of the exemption categories that the IRB found applied to the research. It is a best practice recommendation to create a note-to-file in your research record to document the changes you make and your determination that these updates did not change the scope of the study or risk to participants.  

Examples of changes to exempt protocols that would likely require IRB review:

• Removal of the consent process, or use of deception or incomplete disclosure.
• Significant changes to the recruitment procedures.
• Adding sensitive questions to a survey or interview process (e.g., questions regarding illegal activities; questions causing psychological or emotional discomfort for participants; traumatic events such as childhood, sexual, or domestic abuse; suicide; or other probing questions that could reasonably place participants at risk of criminal or civil liability or be damaging to participants’ financial standing, employability, educational advancement, or reputation).
• Collection of new or additional identifiable information.   
• Changes to the data storage plan that may affect confidentiality.
• Adding any new physiological measures that were not already determined to be exempt. 

The IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year. The IRB's continuing review of research is conducted via the Annual Project Status Report (see here) in which the PI must provide information regarding project status, withdrawals and complaints, summary of findings, adverse events, and risks and benefits.

Principal Investigators will be notified no less than 30 days prior to their approval expiration date, and must submit a completed Project Status Report no less than seven days prior to their project expiration date, even for projects that are no longer active. A protocol that was originally reviewed using the expedited review procedure may receive its continuing review on an expedited basis. Additionally, a full Board review protocol that had no changes during the previous period, or which has not been awarded funding, or which remains open only to data analysis may be reviewed using an expedited review.

If the Project Status Report is satisfactory and an extension has been requested, the IRB will notify the PI of approval for another twelve-month period, based upon the approval anniversary date. As an outcome of continuing review, the IRB may require that the research be modified or halted altogether. The IRB may need to impose special precautions or relax special requirements it had previously imposed on the research protocol.

The IRB may determine that certain projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review.  The IRB may randomly select projects, or may decide that complex projects involving unusual levels or types of risk to subjects should receive an extra measure of scrutiny.  Also, the IRB may engage in full Board discussion of continued approval for projects conducted by investigators who previously have failed to comply with the requirements of the HHS regulations or the requirements or determinations of the IRB.  The IRB may seek information from research participants where concern about possible material changes occurring without IRB approval have been raised based upon information provided in continuing review reports or from other sources.