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Institutional Review Board (IRB)

Standard Operating Procedure
Study Modifications

Purpose | Background | Policies | Procedures | SOP Study Modifications (PDF format)

Purpose

This Standard Operating Procedure (SOP) documents requirements for California Pacific Medical Center (CPMC) principal investigators to report changes in IRB-approved research.

It complies with reporting requirements stated in:

U.S. Department of Health and Human Services (DHHS) 45 CFR 46 (Common Rule);
DHHS 45 CFR 160 and 164 Subpart E, Standards for Privacy of Individually Identifiable Health Information;
U.S. Food and Drug Administration (FDA) 21 CFR 50, 56, 312, 812; and
CPMC Federalwide Assurance (FWA).

Background

IRB review and approval is required before an investigator implements any modification to a study. A modification includes changes in the following:

Study design, methods or procedures;
Study title or sponsor;
Recruitment procedures or strategies;
IRB-approved informed consent process or consent form, authorization, questionnaires, recruitment materials (e.g., advertisements, contact letters/postcards, scripts) or other study-related documents;
Investigators, including the addition or withdrawal of sub-investigators and co-investigators;
CPMC study sites or CPMC sub-sites, including the addition or removal of sites;
Use or disclosure of Protected Health Information (PHI), including changing individuals or entities to whom PHI is disclosed and authorization forms; and
Change in data security measures or sharing of study data.

Federal regulations allow the PI to implement a change without IRB approval when it is essential to protect the safety, rights, or welfare of human subjects. The regulations require that the PI notify the IRB within five business days of implementing the change.

Minor modifications in previously IRB-approved research may be reviewed using an expedited review procedure. This includes minor modifications to IRB-approved consent forms and other study-related documents. Examples of minor modifications that the IRB may be able to review using expedited review include:

Substitution of assessments with alternate assessment that present minimal risk (see the IRB Master Glossary for the definition of minimal risk);
Increase or decrease of enrollment (in some cases, a statistical or risk-benefit justification may be required);
Change in inclusion or exclusion criteria that either reduce risk or do not alter risk;
Decreasing the number or volume of biological sample collections, provided that such a change does not affect the collection of information related to safety evaluations;
Changes to improve clarity of statements or to correct typographical errors;
Addition or removal of investigators;
Addition or removal of CPMC study sites;
Revisions or modifications to the informed consent and/or HIPAA authorization to provide clarification, revised lay language, or inclusion of missing elements; and
Addition of recruitment notices provided there is no change in the risk/benefit determination.

If the modification request does not qualify for expedited review, the proposed modification must go to the next designated IRB meeting.

Policies

The CPMC Principal Investigator (PI) must obtain IRB approval for proposed changes in an IRB-approved study or study-related documents prior to implementation except in cases where it is necessary to protect the safety, rights, or welfare of research subjects.
- If implementation of a modification is required prior to IRB approval, the PI must notify the IRB within five business days of implementing the modification. The report (using the IRB’s modification form) will include a description of the modification, a statement that the modification has already been implemented, and a justification of his/her decision to proceed with the modification prior to obtaining IRB approval.
The PI must submit a CPMC IRB Modification Request to the IRB when notifying the IRB of any planned study modifications.
- The IRB Modification Request Form requires the following information:
  - IRB study number, study title and CPMC PI;
  - Name and contact information of the person filling out the form;
  - Description of the proposed modification;
  - Rational for the proposed modification;
  - An explanation of any increased or decreased risks to research subjects resulting from the modification;
  - A statement stating whether or not revisions are necessary in the approved:
    - Consent form;
    - Privacy authorization; or
    - Other study-related documents;
  - A statement explaining whether currently enrolled subjects should be re-consented or provided with an addendum or letter explaining the nature of the change.
The PI will notify the sub-investigators, external collaborators, and sponsor, as applicable, of IRB decisions regarding study modification requests.
The PI can request an expedited review of a minor modification; however, the IRB will determine whether the requested modification can be reviewed by expedited review.

Procedures

Routine Modification Requests
- The PI will complete a CPMC IRB Modification Request form and append any relevant documents, for example:
  - Protocol or protocol summary (if revised, highlight the proposed modifications);
  - Supporting materials as needed (e.g., questionnaires, Investigator’s Brochure);
  - Tracked and clean versions of the consent form, advertisement, flyer, contact letter, or other IRB-approved document to be modified along with the current IRB-approved document; and
  - Other, as required by the IRB.
- The PI will address any questions, concerns and needed clarifications from the IRB Administrator or staff, IRB Chair, IRB member or convened IRB.
- After the PI has received approval from the IRB and met any required contingencies, the modifications may be implemented.

SOP Study Modifications (PDF format)

You can also download SOP Study Modifications in PDF format.

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v. July 22, 2010
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