Updated Application forms

The Exempt and Non-Exempt Protocol Application form has been refreshed to make the process clearer, more user-friendly, and better aligned with current regulations and research practices. While the new form might look different — some things were re-worded, some sections were added or removed — our expectations and regulatory scopes we review against remain unchanged. Revisions were made to address common questions or areas where information was commonly incomplete for review. Sections have been streamlined, expanded, or clarified – and edits focus on new technologies, the evolving landscape of research, and evolving AI & data privacy laws and expectations at NU. Below is a summary of the key changes to both forms and the reasoning behind them. 

Structural and Instructional Changes 

• Updated language with clarifying text to mitigate common misunderstandings or oversights throughout.  

• Added links to guidance and/or resources where appropriate.  

• Updated links throughout the document to fix broken links due to URL change. 

Investigator Information 

• Updated the multi-site section to be more consistent with federal engagement guidance. 

• Removed investigator qualifications as it wasn’t needed in most situations. Investigator qualifications can be requested by the full board if deemed appropriate. 

Research Locations and International Research 

• Clarified expectations and resources for international research. 

Research Summary and Participants 

• Requested information for how sample sizes were determined for non-exempt. This is requested to better collect information that is relevant to non-exempt review. 

• Background section expanded and clarified to minimize unnecessarily long responses.  

Recruitment 

• Revised Recruitment Procedures options to better reflect common methods of recruitment at NU and better prompt for the information needed for review against federal regs. 

• Added a question to address any potential for a perception of coercion in recruitment. This was moved from the Risks section to better reflect that this concern primarily occurs at recruitment.  

Study Procedures 

• Study procedures options were updated to better reflect common methods of data collection/procedures at NU. 

• Addition of clarification relating to consumer grade devices vs custom devices for non-exempt. 

• Addition of an AI form to better collect the information needed when AI is used in research. This section will prompt for this ancillary form.  

• Removed questions relating to research location and frequency of procedures from the Procedures section as it was determined these were redundant with other sections. 

Consent and Assent (non-exempt only) 

• Revised the Consent section to make waivers clearer and better outline expectations for waivers. 

• Removed several paragraphs from the Consent section as it was deemed the sections applied to too few studies at NU. 

• Added an assent section to help clarify assent expectations and streamline the submission process to better collect the information needed for review. Breaks out minor/decisionally impaired assent process with guidance on assent documentation and re-consent at age 18. 

Data Use and Confidentiality 

• Secondary data section was revised to better reflect when tis section should be completed. 

• Identifiers section expanded. 

• Clarification of anonymization vs coding to get more consistent plans.  

• Risks section was revised to add more types of risks to consider to better get a complete risk profile. 

• Data storage categories simplified and revised to focus on the IRB’s scope of review. 

Risks and Benefits 

• Addition of new risks to consider to streamline initial review. 

Future Data Use (non-exempt) 

• Revised to provide clearer guidance on when each category should be checked.