Should I Submit a Modification or a New Study Submission?

When a New Study Submission May Be Warranted

A new study submission may be warranted when the proposed changes are so substantial that they fundamentally alter the nature, design or conduct of the researchwould substantially alter the study such that the existing IRB record no longer clearly reflects the current research plan. Specifically, modification of a combination of the research objectives, design, procedures, or study population may warrant a new study submission.

 Examples may include the following:

• The change would shift the study from a No Contact design to a Contact design.
• The change would add FDA-regulated drug or device activity to a study that did not previously involve FDA-regulated activity.
• The proposed changes would substantially alter the study’s purpose, population, or procedures.
• The revised study would be difficult to review or manage effectively as a Modification because the existing record has become lengthy, inconsistent, or no longer reflects the current research activities.

Additional details about each of these examples are included below.

Return to top

Factors the IRB May Consider

Contact vs. No Contact

Current Fred Hutch IRB study submissions use either the Contact or No Contact version of the IRB Application. The Contact version is used for research involving any interaction with participants. It should be noted that even an online survey is considered contact. The No Contact version is used only for research that consists of obtaining and using data or specimens from a source other than the participants.

If a currently approved study was submitted using the No Contact application, adding Contact activities may require submission of a new study rather than a Modification.

For older studies approved under prior application versions, contact the IRO if you are unsure how the earlier application type maps to the current framework.

 

FDA-Regulated Activity

If proposed changes would add activity designed to evaluate the safety, effectiveness, or performance of an FDA-regulated drug or device, the study may require review of additional regulatory considerations, such as IND or IDE-related requirements. In those cases, a new study submission may be more appropriate than adding the activity through a Modification, in particular if the study was not FDA-regulated originally.

Note that assessment of investigational in vitro diagnostics can involve FDA oversight. 

 

Purpose, Population, and Procedures

As a general guide, the IRB may consider the extent to which the proposed changes affect the study’s purpose, population, and procedures (“the three P’s”). If the changes are limited, a Modification may be appropriate. If the changes substantially alter multiple aspects of the study, a new study submission may be more appropriate.

Exception - Sponsor-Driven Agile Protocols

The IRB recognizes that some sponsors are moving toward “agile” protocols that are revised for new phases or cohorts, rather than creating a new protocol for each phase. When this approach is truly sponsor-driven and not negotiable, the IRB will strive to accommodate it within a single study record, as long as the overall research plan remains coherent and the risks and benefits can be assessed clearly for each cohort. In these situations, the IRB may require separate consent forms or consent sections for different cohorts or phases, to ensure that participants receive information specific to their procedures and risks.

 

Additional Considerations

The IRB may also consider whether:

• The research questions, purpose, or aims have substantively changed.
• The procedures or methods differ substantially from the original research plan.
• The study has been open for many years and the protocol no longer accurately reflects the current research, institutional requirements, or risk information.
• The protocol was originally reviewed under the Pre-2018 Common Rule and should be brought up-to-date with the current regulatory requirements
• Repeated additions to the study have made the record difficult for the study team or the IRB to follow accurately

Return to top

Final Determination

This guidance is intended to provide general considerations and examples, but it is not exhaustive. The IRB has final authority to determine whether proposed changes may be accepted as a Modification or whether a new study submission is required.

Return to top