Modification

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What Modifications Need IRB Approval?

Types of Modifications

Submitting in iRIS

Information for Continuing Subjects

Exempt Research

Enrollment Exceptions

Adding or Updating: Investigators or StaffFundingStudy SitesResearchers' 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.

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) changesto 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 majorminorpersonnel 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

Minimal risk is the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45.CFR.46.102(i)).

Major Modifications 

Definition

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 
3. The research itself involves more than minimal risk and the changes significantly alter the study design. 

Examples;

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)

Review Process

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

Minor Modifications

Definition 

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.

Examples

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

Review Process

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

Personnel Modifications

Definition 

Additions or removals of Key Study Personnel (KSP)

Examples 

1. Change in Principal Investigator (PI)
2. Change in Investigators or staff who are Key Study Personnel (KSP)

Review Process

Reviewed by a small number of IRB members or staff. Approval letter sent for all Key Study Personnel changes.

 

Administrative Modifications

Definition 

Minor changes that do not affect study participants in any way.

Examples 

1. Changing procedures that do not affect participants (e.g., method of shipping samples)
2. Fixing typographical, grammatical or spelling errors

Review Process

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. 

2. Start a new form

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.

3. Complete the form

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.

5. Submit the form

Anyone listed on the study can sign off and submit the Modification Form.

Reminders:

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

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.

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

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 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

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.

Enrollment Exception

To allow enrollment of a single individual who does not meet the entry criteria of your study, you may submit a request for a one-time enrollment exception as a modification request to the IRB. This enrollment exception request applies only to a single individual. Approval from the IRB is required prior to enrollment.

The request should be rare and justified in terms of serving the best interests of the potential study participant. Changes of entry criteria for more than one individual should be submitted as a regular modification.

What to submit for enrollment exceptions

Submit a Modification Form that includes this request. Include approval from the study sponsor or PI if there is no sponsor (see below). Call the IRB office at 415-476-1814 and ask to speak to the Assistant Coordinator for the committee that approved this study (noted on the approval letter). This person will determine whether the modification can be handled this way, and also will contact one of the IRB Chairs or Vice Chairs to provide speedy review (if needed).

Review process

The Chair can approve the request if it constitutes a minor change to the study. The Chair may decide that the change requires a higher level of review, and additional documentation may be requested.

Sponsor review required

Changes in entry criteria also require approval from the study sponsor or cooperative group. Approval from the study sponsor is required and must be uploaded with the iRIS modification. If there is no study sponsor, confirmation from the PI must be provided.

Data collection

Data collection should be reported using the standard study case report forms and become part of the scientific evaluation of the test article.

Important Note: If a one-time change is needed urgently for subject safety and there is no time to obtain IRB approval, the change should be implemented immediately and then reported to the IRB within 10 working days using the Protocol Violation or Incident Reporting Form in iRIS.  

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

Submit a Personnel Changes form and attach these items:

  1. A letter signed by the outgoing PI requesting the change
  2. IRB Application Form — at a minimum, revise the "Grant Key Study Personnel (KSP) Access to the Study" and "Qualifications of Key Study Personnel" sections
  3. 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:

  1. IRB Application Form — at a minimum, revise the "Grant Key Study Personnel (KSP) Access to the Study" and "Qualifications of Key Study Personnel" sections
  2. 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:

  1. Open the study via My Studies.
  2. From the Submissions page, click on the “Study Management” tab.
  3. Click on the “Key Study Personnel” link.
  4. Add or remove the study staff and save.

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:

1. A revised IRB Application 

"Funding" section:

  1. Add the new funding source. If you are adding a subcontract, list the prime sponsor, such as NIH.
  2. Provide the RAS Award or Proposal # for funding coming through UCSF.
  3. 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.

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)

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.

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.