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What Modifications Need IRB Approval?
Types of Modifications
Submitting in iRIS
Information for Continuing Subjects
Exempt Research
Adding or Updating: Investigators or Staff, Funding, Study Sites, Researchers' Financial Interests
What Modifications Need IRB Approval?
All changes to your study, even minor ones, must receive IRB approval before you implement them. For example, changes in inclusion criteria, procedures, recruitment, advertisements, consent forms and questionnaires all require IRB review and approval.
NOTE: Considerable changes to the study’s research plan (e.g., Hypothesis; Aims/Objectives; Procedures; Study design; Scope; Intervention) require the submission of a new study. Modifications to an existing study must fit within the original aims of the study. For example, a No Subject Contact study cannot be modified and made into a Subject Contact study.
Implementing changes without IRB approval is a violation of federal regulations and University policies and can lead to the suspension of IRB approval and other serious consequences for the participants, investigators and University.
Exceptions:
Changes “necessary to eliminate apparent immediate hazards to the subject”
The requirement for prior IRB review and approval is not required when the changes are “necessary to eliminate apparent immediate hazards to the subject” (45 CFR 46.103.b.4, 21 CFR 56.108.a). In such rare cases, report the actions taken to the IRB within 10 working days using the Protocol Violation or Incident Reporting Form. Seek approval for permanent changes to prevent the hazards in the future.
Minor (not significant) changes to exempt research
For exempt research only, you can make minor changes to the study without notifying the IRB. However, you must submit significant changes to the IRB. See examples of minor vs. significant changes below.
Types of Modifications
Evaluate whether your modification is major, minor, personnel change or administrative using the definitions and examples below.
Updated guidance (May 2021)
OHRP and FDA guidance allows the IRB to use an expedited review procedure to review "minor changes in previously approved research." The IRB makes the final determination as to whether study changes qualify as “minor changes in previously approved research.”
Below are definitions and examples to help guide the Principal Investigator in making the initial determination, which is required in the Modification Form.
Also required in the Modification Form, the Principal Investigator must determine if the changes alter the study’s overall risk/benefit ratio.
Broadly, these are changes that adversely affect the overall risk/benefit ratio of the study or make significant changes in study design or procedures. Adding newly discovered risks for a drug/compound/study therapy used in the protocol, or implementing a protocol amendment does not necessarily make a modification “major.”
1. Adding study risks that adversely affect the overall risk/benefit ratio of the study
2. Adding new study drugs or new study drug combinations
3. Adding greater-than-minimal-risk procedures for the first time (e.g, X-rays, CT/MRI with contrast)
4. Adding vulnerable populations to greater-than-minimal-risk studies
5. Adding medical devices that require non-significant or significant risk determinations
If the IRB determines that the changes are more than “minor changes in previously approved research,” the submission will be reviewed by the full committee at a convened meeting. An IRB Outcome Letter is issued.
Minor changes in previously approved research.
1. Adding study risks that do not adversely affect the overall risk/benefit ratio of the study
2. Removing study risks that no longer apply
3. Adding minimal-risk procedures found in OHRP Expedited Review Categories (e.g., questionnaires, non-invasive specimen collection, MRI without contrast)
If the IRB determines that the changes are “minor changes in previously approved research,” the submission will be reviewed by an expedited review procedure. An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110. An IRB Outcome Letter is issued.
Additions or removals of Key Study Personnel (KSP)
1. Change in Principal Investigator (PI)
2. Change in Investigators or staff who are Key Study Personnel (KSP)
Reviewed by a small number of IRB members or staff. Approval letter sent for all Key Study Personnel changes.
Minor changes that do not affect study participants in any way.
1. Changing procedures that do not affect participants (e.g., method of shipping samples)
2. Fixing typographical, grammatical or spelling errors
Reviewed by a small number of IRB members or staff using expedited review procedures. Approval letter sent; however, no letter is sent for optional modifications to change research support staff or study contacts who are not Key Study Personnel.
Submitting in iRIS
Follow these steps to submit a modification after your study is approved. For additional assistance, read the quick guide called "Submitting Post-approval Forms" in the Help section of iRIS or on the iRIS Help webpage.
1. Open the study via IRB Study Assistant
Go to My Studies under the IRB Study Assistant. Open the active study you want to modify.
For Major, Minor, and Administrative modifications, clink on the Modification Form link. If your modifications only involves changes in personnel, click on the Personnel Changes link.
This is a dynamic form that will build automatically based on how you answer each question.
4. Attach new or revised documents or applications
Attach any new or revised documents or applications in the appropriate section (e.g. attach the revised IRB Application in the "Revisions to the Application Form" section). Do NOT track your changes. See the Initial Submission Checklist for a list of documents that require IRB review. Reminder: If you are changing study personnel, revise and attach the IRB Application Form.
Anyone listed on the study can sign off and submit the Modification Form.
Reminders:
You can make several changes to your study at one time — describe each change in detail on the Modification Form. However, in general, do not submit more than one Modification Form at a time, particularly if both modifications involve the IRB Application form or the same document. Hold additional modifications until the first request has been approved. Contact the analyst assigned to the modification with questions.
Some modifications are required based on a report of an adverse event, protocol violation or incident; a DSMB or DMC report; an action letter from a sponsor; or other safety report. Submit the modification at the same time as the report, whenever possible. If the report and the modification are not submitted concurrently, explain in both the report and modification why it is/was necessary to delay the modification submission to a later date.
Information for Continuing Subjects
Per federal regulations, research participants must be informed when there is a significant new finding during the course of research that may affect their willingness to participate [45 CFR 46.116 (b) (5)]. Examples of significant new findings include:
- New risks or previously described risks that are now found to occur with greater frequency or severity.
- Changes to the protocol that may affect a subject’s willingness to participate in the research.
If any significant new findings or protocol changes are included in your modification request:
- Describe how you propose to inform current subjects of this information.
- Attach any additional consent forms (see our consent form addendum template) or contact letters that will be used for this purpose.
The level of urgency will determine how the information is communicated to participants. See the Adverse Event Reporting Requirements for additional information.
Exempt Research
Only for studies that the IRB has certified as exempt, researchers can make minor changes to the study without notifying the IRB. However, significant changes must be submitted to the IRB. See the examples below.
All changes must follow UCSF guidance, and some changes are not allowed in the consent materials.
Examples of significant changes: Submit to the IRB
- Adding a new subject population
- Adding new procedures
- Adding a new funding source
- Adding new collaborators or outside sites (each site must obtain their own Exempt Certification or IRB Approval)
- Adding questions about sensitive aspects of the subjects’ behavior – such as illegal conduct, drug use, sexual behavior or use of alcohol – to a survey or interview
- Change in PI (use the Personnel Changes form)
- Disclosing a new financial interest
- Any change that makes the study no longer eligible for exemption
- Revising aims
- Changes to payment (adding, revising, or removing)
Examples of minor changes: Do not submit to the IRB
- Editorial or administrative revisions to consent documents or other study documents
- Adding non-sensitive questions to a survey or interview or revising current questions
- Adding a new recruitment material that follows IRB guidelines
- Increasing or decreasing the number of subjects, unless you are adding a new subject population
- Study team/personnel changes (except a change in PI) — follow the steps below in iRIS to grant access to new study team members.
Changing or Adding Investigators or Staff
Some of these changes require submission of a modification, while others do not. Click on the role of the individual you are changing for more info.
Submit a Personnel Changes form and attach these items:
- A letter signed by the outgoing PI requesting the change
- IRB Application Form — at a minimum, revise the "Grant Key Study Personnel (KSP) Access to the Study" and "Qualifications of Key Study Personnel" sections
- Revised consent forms and other participant-contact documents that name the PI
Investigators or staff who are Key Study Personnel
Submit a Personnel Changes Form and attach these items:
- IRB Application Form — at a minimum, revise the "Grant Key Study Personnel (KSP) Access to the Study" and "Qualifications of Key Study Personnel" sections
- Revised consent forms and other participant-contact documents that name the individuals being changed
UCSF definition of Key Study Personnel
UCSF Key Study Personnel include the Principal Investigator, other investigators and research personnel who are directly involved in conducting research with study participants or who are directly involved in using study participants’ identifiable private information during the course of the research. Key Personnel also include faculty mentors/advisors who provide direct oversight to Postdoctoral Fellows, Residents and Clinical Fellows serving as PI on the IRB application.
Reminder: Key Study Personnel must complete mandatory CITI human subjects training.
Research support staff or study contacts who are NOT Key Study Personnel
You do not need to submit a modification to change these individuals. Instead, someone already listed on the study should follow these steps:
- Open the study via My Studies.
- From the Submissions page, click on the “Study Management” tab.
- Click on the “Key Study Personnel” link.
- Add or remove the study staff and save.
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Reminder: Only add or remove individuals who are not Key Study Personnel in the Study Management tab. DO NOT add or remove the PI, Other Investigators or other Key Study Personnel here. Making such changes without submitting a modification may result in a PROTOCOL VIOLATION. Exception: As explained above, for exempt research only, you can change Other Investigators or Key Study Personnel (not the PI) in the Study Management tab without submitting a modification. |
Changing or Adding Funding Info
You must submit a modification to the IRB to add a new funding source to an approved study. The IRB must approve the modification before the Office of Sponsored Research (OSR) may accept the new award. OSR administrators have access to iRIS and can verify approval of the new funding source.
Submit a Modification Form and describe the new funding source. Attach the following items:
"Funding" section:
- Add the new funding source. If you are adding a subcontract, list the prime sponsor, such as NIH.
- Provide the RAS Award or Proposal # for funding coming through UCSF.
- If applicable, list the grant title and PI, and explain any significant discrepancies between the IRB application and the grant or contract.
Key Study Personnel sections: The PI of the award must be listed as an investigator on the IRB Application, so update sections 3 and 4, if necessary.
2. Consent documents (if applicable)
Update the consent document(s) if the sponsor info needs to be changed.
Attach a) the Research Plan, including the Human Subjects portion, of your NIH grant;
b) for other federal proposals (contracts or grants), the section of the proposal describing human subjects work; OR
c) the section of your progress report if it provides the most current information about your human subjects work.
Note: If the new funding source is a federal award that does not describe specific plans for human subjects — such as a K award or training grant — you do not need to submit the grant. Explain this in the Significant Discrepancies question in the "Funding" section of the IRB Application.
Removing a Funding Source: Please do not remove a funding source from the IRB Application if funding has ended. You can remove a sponsor if the study was never funded (e.g. a grant was submitted, but not funded).
Changing RAS Proposal numbers (P#) to Award numbers (A#): The IRB requires either a P# or an A#, not both. Do not add the A# to the Sponsor Details page in your IRB Application after the funds have been awarded. The P# from eProposal is sufficient to link the funding source to the IRB approval.
Changing or Adding Sites
Most site additions require changes in the consent form and the Application — especially the "Sites," "Procedures," "Sample Size and Eligibility" and "Recruitment" sections — and completion of an "Outside Site Information" subform. You may also need to change your recruitment documents.
In general, the IRB at the new site must approve the study before work can begin there. See the Working With Other Institutions page for more info.
If you are adding a site that is affiliated with UCSF, see the UCSF Affiliated Institutions page.
Changing Locations within UCSF
If you move to another UCSF campus (e.g., from Parnassus to Mission Bay), the study site and address need to be updated in the consent form. A modification form needs to be submitted, but can be batched with your next, upcoming submission. A separate modification form does not have to be submitted solely to update the address.
Changes in Researchers’ Financial Interests
Report any changes the researchers’ financial interests related to the study to the Conflict of Interest Advisory Committee (COIAC). The COIAC will advise the PI and the IRB if modifications in the study are needed.
If there are changes in researchers’ financial interests that have not yet been reported to the IRB at the time of a modification or continuing review, update the IRB Application and describe the change in the Modification or Continuing Review Form.
