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Types of Modifications

Submitting in iRIS

Information for Continuing Subjects

Exempt Research

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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.

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”

Minor (not significant) changesto exempt research

Types of Modifications

Evaluate whether your modification is Women's Sandal Flat EileenFisher Sport2 Black Nu Awqnv8dminorpersonnel change or administrative using the definitions and examples below. The type depends on whether risks to participants are increased and the complexity of the changes. Major modifications require more intensive review. Modifications typically are reviewed by the IRB panel that originally reviewed the study. 

Contact us with questions about what type of modification you have.

Minimal risk definition

Major Modifications 

  • Definition
  • Examples
  • Review Process

1. Any increase in risk to participants is more than minimal; OR;
2. Any additional activity or procedure would not be eligible for expedited review if submitted as part of new research, OR 
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3. The research itself involves more than minimal risk and the changes significantly alter the study design. 

1. Increasing major risks or discomforts 
2. Adding or deleting major procedures or diagnostic tests
3. Restarting a study after a hold for safety concerns
4. Changing, adding or deleting drugs, devices or other treatments being studied (substituting approved treatments being used in standard ways may be a minor modification)

Reviewed by the full committee at a convened meeting. Approval letter issued. 

Minor Modifications

  • Definition
  • Examples
  • Review Process

1. Any increase in risk to participants is no more than minimal risk, AND 
2. All additional activities or procedures would be eligible for expedited review if submitted as part of new research, AND;
3. Either the research itself involves minimal riskor the changes do not significantly alter the study design.

1. Changing minor procedures or activities without adding more-than-minimal risks 
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2. Reducing risks or adding minor risks
3. Changing wording in the consent form, application or other documents
4. Adding a new advertisement

Reviewed by a small number of IRB members using expedited review procedures. Approval letter sent.

Personnel Modifications

  • Definition
  • Examples
  • Review Process
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.

 

Administrative Modifications

  • Definition
  • Examples
  • Review Process
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)
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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 Shoe White Scissor Supra Khaki Skate Bw1IqHEn.

1. Open the study via IRB Study Assistant

2. Start a new form

3. Complete the form

4. Attach new or revised documents or applications

5. Submit the form

Reminders:

You can combine several changes to your study in one modification request, but only submit one Modification Form at a time

Submit modifications resulting from an adverse event, violation, incident or other safety report at the same time as that report, when possible

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

Examples of minor changes: Do not submit to the IRB

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.

Principal Investigator

Investigators or staff who are Key Study Personnel

UCSF definition of Key Study Personnel

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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:

1. A revised IRB Application 

2. Consent documents (if applicable)

3. A portion of your grant if you are adding federal funds and UCSF is the prime grant holder (attach as an Other study document)

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 Northside Bag II Waterproof a with Summer Brown Women's Wet Athletic Burke Sandal; Dry Pink qaxrZBRqw page for more info. 

If you are adding a site that is affiliated with UCSF, see the UCSF Affiliated Institutions page.

Changes in Researchers’ Financial Interests

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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.