You must submit a Request for Modification (DOC) form for review if the modifications include any of the following:
- New inclusion of participants from a vulnerable population (e.g., children, prisoners, pregnant women, cognitively impaired persons, persons who are institutionalized, etc.)
- A change in study procedures or methods of data collection, including but not limited to
o Substantive changes to the nature or scope of data to be collected (e.g., a change in topic or content of survey or interview questions, etc.)
o Changes in confidentiality measures or how identifiers will be collected or recorded
o The addition of any physical interventions
o The addition of usability testing procedures
o Any changes, in your opinion, increase the risk or discomfort to the participants
- Any change such that the revised procedures are not all included in the exemption categories defined by federal regulations. Note: The specific category or categories for which your research was granted exemption can be found in the approval letter you received when your study was last reviewed
You do not need to submit a modification form for IRB review for modifications that will not alter the exempt status of the research. For example:
- Removing or rearranging questions on surveys, interviews, focus group protocols, etc.
- Rewording of questions on surveys, interviews, or focus group protocols for clarity or readability provided the substantive content of the questions does not change. For example, changing "How frequently do you consume bread?" to "How often do you eat bread?" does not change the content. On the other hand, changing "How frequently do you consume bread?" to "How frequently do you consume alcohol?" is a revision that would require review because the content of the question has changed
- Changes in course assignments that are being collected for analysis for a research study, provided that the assignment is being administered for educational purposes and not solely as part of the research protocol
- Changes in the format of compensation (i.e., from a gift card to cash), provided the amount of compensation remains the same
If you know for certain that the modifications render the project to be no longer exempt, then you must submit a standard application for non-exempt research.
If you believe the modifications are such that the project no longer qualifies for exemption, you do not need to submit the Request for Modification/Continuing Review (Renewal) of IRB Approved Human Subject Research (DOC) form. You must complete an Application for Non-Exempt Research (DOC) and submit it to the IRB for review.
If you're not sure whether or not the modifications could alter the status of the research, then carefully consider whether any proposed modifications to your study could alter the exempt status of the research, and submit a modification form if there is a possibility that the exempt status might be compromised. Conducting non-exempt research without IRB approval may constitute non-compliance with federal regulations and/or academic misconduct according to Davidson College policy. Another option is to contact the IRB and convey your proposed modifications. IRB staff will then communicate with you and offer you advice.
When a protocol receives initial approval, the investigator is advised that any proposed material changes in research activity must be submitted to the IRB for approval. Such changes must not be initiated without IRB review and approval. The only exception to this requirement is when initiation is necessary to eliminate an apparent immediate hazard to the research subject. The protocol on file with the IRB must accurately reflect the manner in which the research is being conducted. Therefore, any revisions to an approved research project protocol must be incorporated into the protocol documentation on file with the IRB, assuring that the research project protocol documentation is up-to-date and current.
A Request for Modification submission must include the following:
- A Request for Modification/Continuing Review (Renewal) of IRB Approved Human Subject Research (DOC) form with the applicable information completed
- All forms and supporting documentation (i.e., Application for IRB Review of Research Involving Human Subjects (DOC), consent forms, questionnaires, recruiting materials, etc.) must be updated with the proposed changes, and submitted to the IRB for approval. All of the proposed modifications must be clearly listed on the Request for Modification/Continuing Review (Renewal) of IRB Approved Human Subject Research (DOC) form
- Training certification documentation must be attached to the modification request or "On File" must be checked on the form, for all personnel, including, if applicable, any new investigators being added (regardless of their institutional affiliation)
- The Request for Modification/Continuing Review (Renewal) of IRB Approved Human Subject Research (DOC) form must be signed (name and date typed in the Investigator's Assurance block on the last page of the form) and emailed to email@example.com
The Davidson IRB typically uses a primary reviewer to review all modification requests. After a favorable review, an email approval of the renewal is emailed to the investigator (and copied to the faculty sponsor, if applicable).
Please note: A modification request approval does not affect the expiration date of the original approval. The date of the modification is noted in the record of the approved protocol.