What Materials Require IRB Review?
The NIH IRB reviews study documents and materials that are necessary to evaluate the research or that provide or collect research-specific information from participants. Other administrative, operational, or informational materials generally do not require IRB review when they are consistent with the IRB-approved protocol and documents and do not contain new information that could affect a participant's willingness to take part in the research. This page provides examples of materials that generally require IRB review and materials that generally do not.
The NIH IRB reviews study documents and materials that are necessary to evaluate the research or that provide or collect research-specific information from participants. Other administrative, operational, or informational materials generally do not require IRB review when they are consistent with the IRB-approved protocol and documents and do not contain new information that could affect a participant's willingness to take part in the research. This page provides examples of materials that generally require IRB review and materials that generally do not.
Materials That Require IRB Review
Submit the following materials to the NIH IRB for review, as applicable to your study.
Study Documents
- Protocol
- Protocol addendum, if applicable
- FDA approval information and correspondence from the FDA
- Device specifications
- Investigator Brochures and Package Inserts
NOTE: Study Manuals or SOPs do not need to be submitted to the IRB for review.
Materials Participants Will See, Hear, or Complete
These generally include:
- Consent forms, assent forms, consent addenda, and verbal or online consent scripts
- Recruitment materials
- Questionnaires, surveys, and interview questions
- Interview and focus group guides or scripts
- Drug diaries and other participant-completed diaries
- Tracking logs completed by participants
- Study-specific assessments
- Other materials used to collect research data directly from participants
Research-specific communications provided to participants also require IRB review when they:
- Provide research-specific information, including risks
- Disclose the study condition, treatment, or study arm to which a participant was assigned after unblinding
- Describe new information about study progress or study procedures
- Provide individual research results or unpublished study results, including findings from initial data analyses
Recruitment Materials
Most materials used to recruit potential participants require IRB review and approval before use. Recruitment materials include information that potential participants may see or hear as part of the recruitment process.
| Generally Requires IRB review | Generally Does NOT require IRB review |
|---|---|
| Flyers and posters | Certain neutral public study listings e.g., ClinicalTrials.gov - see Public Study Listings below |
| Recruitment letters and emails | |
| Social media advertisements | |
| Radio or television advertisements | |
| Recruitment videos | |
| Recruitment websites containing more than basic study information | |
| Telephone and in-person recruitment scripts |
For information about developing a recruitment plan and recruitment materials, see:
Materials That Generally Do Not Require IRB Review
Do not submit the following materials for IRB review when they are consistent with the IRB-approved protocol and other approved study documents and do not contain new information that could affect a participant's willingness to take part in the research:
- Appointment reminders
- Case report forms
- Established course curriculum, when the course content will not be altered for purposes of the research
- Internal data collection forms completed by the study team
- Eligibility determination sheets, forms, or checklists completed by the study team
- Limited instructional materials for participants that provide only technical instructions for procedures or medications already described in the protocol and do not include information about study risks
- Newsletters, press releases, or other participant communications limited to the number of participants enrolled, study status, and/or published study results
Important
Surveys, questionnaires, interviews, and other instruments used to collect research data directly from participants require IRB review. Internal data collection forms completed by the study team generally do not.
Screening scripts used with potential participants require IRB review. Internal eligibility determination sheets, forms, or checklists completed by the study team generally do not.
Public Study Listings
Neutral public study listings generally do not require IRB review when they are limited to basic descriptive information, such as:
- Study title
- Study purpose
- Basic study procedures
- Basic eligibility criteria
- How to contact the study team
The method used to recruit participants must still be described in the protocol or IRB application.
A public study listing generally requires IRB review if it goes beyond basic descriptive information - for example, by including information about risks, potential benefits, or reasons someone may want to participate in the study.
This distinction applies to ClinicalTrials.gov and other public study listings.
When New Materials Are Added or Changed
IRB review requirements apply throughout the study, not only at initial submission.
If you add or revise a document or material that requires IRB review - including consent forms, recruitment materials, study instruments, or translated documents - submit the new or revised material as a Modification (MOD) in PROTECT.
Do not use the new or revised material until it has been approved by the NIH IRB, unless a change is necessary to eliminate an immediate hazard to a participant.
If You Are Unsure
Depending on the study, the NIH IRB may request additional documents needed to make regulatory determinations.
If you are unsure whether a document or material requires IRB review, contact OHSRP before submitting or using the material.