Modifications to Approved Research
- When and How to Modify
- Types of Modifications and Examples
- Level of Review for Modifications
- Sponsor Modifications
- Notification
When and How to Modify an Approved Human Research Study
Per federal regulations, once a human research study has received IRB approval, any subsequent changes to the study must be reviewed and approved by the IRB prior to implementation (except when necessary to avoid an immediate, apparent hazard to a subject. See Reporting of Adverse Events, Unanticipated Problems and Violations).
To request approval of a proposed modification, complete and submit an electronic Modification (e-MOD) Request.
Note: If the proposed modification changes any IRB approved documents (e.g., the protocol narrative, the informed consent form, study information sheet etc.), the investigator must submit an updated version of each document for IRB review. Upload two (2) versions of the revised documents with the e-MOD request:
- a clean copy of each revised document (changes not highlighted), and
- a highlighted copy of each revised document (all changes highlighted).
Types of Modifications
Modifications are categorized into minor changes and significant changes.
Minor modification/change - A proposed change in research related activities that does not significantly affect an assessment of the risks and benefits of the study and does not substantially change the specific aims or design of the study.
Significant modification/change - A proposed change in research related activities that significantly affects an assessment of the risks and benefits of the study or substantially changes the specific aims or design of the study.
Examples:
Examples of minor changes to a research study include but are not limited to, the following:
- Addition or deletion of study team members
- Addition of procedures that do not significantly increase risk to subjects, considering the original purpose and study design of the approved study (i.e., new procedures that fall under any of the expedited categories can usually qualify as minimal risk)
- Removal of research procedures that would thereby reduce the risk to no more than minimal (i.e., procedures now meet expedited research categories)
- Addition of non-sensitive questions to unvalidated survey or interview procedures;
- Addition of or revisions to recruitment materials or strategies
- Administrative changes to the approved documents (e.g., correction of typographical errors)
Examples of significant changes to a study may include, but are not limited to, the following:
- Addition of a new and/or separate subject population (e.g., control group, additional cohort, vulnerable population, etc.)
- Addition of research procedures that involve greater than minimal risk to subjects (e.g., addition of a new drug to a treatment regimen; addition of invasive procedures; change in route or frequency of drug administration, etc.)
- Addition of surveys/questionnaires/interview procedures that could have adverse psychological consequences for subjects or damage their financial standing, employability, insurability, or reputation.
- Removal of follow-up visits that appear necessary for monitoring subject safety and welfare.
Level of Review for Modifications
A modification/change to an approved human research study will generally be reviewed at the same level of review in which the study was first reviewed, either by the Expedited review process or by the full Committee.
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Minor changes may undergo Expedited (subcommittee) review.
- Investigators submitting minor modifications are required to submit the following hard copies:
- 1 copy of the updated Sponsor/Master protocol and/or Investigator Brochure (if applicable)
- 1 copy of any required documentation not previously uploaded via the e-MOD process (e.g., no electronic version of permission letter)
- Investigators submitting minor modifications are required to submit the following hard copies:
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Significant modifications/changes require review by the full Committee.
- Changes to the informed consent document for full Committee studies usually require full Committee review.
- There are submission deadlines for Full Committee review of modification requests. Full Committee modifications and all required hard copies must be received in ORA no later then 5 pm of the meeting deadline to be considered for the IRB meeting agenda.
- Investigators submitting full Committee modifications are required to submit the following hard copies:
- 4 copies of the updated Sponsor/Master protocol and/or Investigator Brochure (if applicable)
- 4 copies of required documentation not previously uploaded via the e-MOD process (e.g., no electronic version of permission letter)
Sponsor Modifications
Modifications can be made only to IRB approved studies. A sponsor may modify the research protocol before the study has received final approval from the IRB. If this occurs, it is recommended that investigators await receipt of the IRB approval letter before making changes to the research protocol.
Sponsor generated modifications (or addenda) require review and approval by the UCI IRB. The UCI investigator should provide the IRB with all sponsor documentation and summarize in the e-mod request how the changes affect the UCI approved protocol, recruitment, enrollment, treatment and follow-up of UCI participants. The sponsor documentation can be uploaded via the e-MOD request process; however hard copy documentation (see above) must also be received by ORA. Please reference the HS# and e-MOD number when submitting hard copy documentation.
Notification
Approval of electronically submitted modification requests are documented in an approval letter to the Lead Researcher, and copied to the Faculty Sponsor (if applicable). Approved modifications are appended to the protocol in the official IRB file.
Note: Approved modifications do not extend the approval period of the protocol.
