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Amendment

According to federal regulations, investigators are responsible for obtaining prior approval from the IRB for any modifications to approved research, including modifications to the informed consent process and document. The only exception to this requirement is a change necessary to eliminate apparent immediate hazards to subjects (45 CFR 46.103(b)(4)).


Submission Requirements

If you are submitting an amendment, please see below for the materials you will need to provide to the IRB office in hard copy, with original signatures. Be sure to consider the points below and make sure they are addressed in your submission so your amendment can be processed quickly and efficiently:

When submitting an amendment, use the appropriate sample cover letter:

Use this or the Amendment (Cover Letter) to submit an updated Investigator’s Brochure for your study.

The amendment cover letter

  • Include the following points (using the template Amendment cover letter will ensure all of these points are included, as needed):
    • Description of the amendment
    • Rationale for the amendment
    • Where this amendment originated (Sponsor or PI).  If the amendment did not originate from the Sponsor, provide documentation that the Sponsor is aware of this amendment.
    • The PI should provide assessment of how the amendment alters, or does not alter the risks and benefits of the study. Explain whether the proposed amendment increases or decreases the level of risk to participants (thereby changing the risk/benefit ratio) and, if so, describe. If the level of risk remains the same, state that.
    • Clearly identify all proposed changes in the letter, or, refer to a specific document containing a detailed list of changes (i.e., a sponsor document detailing all changes). It is helpful if you delineate each change made to each document by referring to the section and page number where each change has been made. It is important that no changes are made to documents that have not been listed/ discussed as proposed changes in the amendment. The IRB needs to be sure all components of an amendment are considered and approved.  For example, don’t accidentally change something in a consent form or protocol document that you haven’t listed in your delineated changes. Some changes may require convened IRB review, and the IRB office needs to identify these immediately.
    • Label each document with the document name and updated version date and make sure the cover letter references each of the documents by the same name and version date.
    • This letter must be signed by the PI (original signature on appropriate letter head)
    • Please note that the information in the documents being submitted with an amendment must coincide with the information in the protocol.  If something is being submitted that does not coincide with the existing protocol document, consider whether the protocol needs to be revised/updated to reflect the revisions/new information in the amendment.
    • Consider whether the informed consent form (ICF) should be revised as a result of the amendment, and if so, describe whether or not previously enrolled subjects will be re-consented to this new information.
  • Revised Study Documents
    • Submit a clean and tracked copy of any revised documents
      • If tracked changes are not possible in the documents you are submitting, you must hand note / highlight each of the changes and provide a detailed description of each change made in the document.  This is so the Reviewers can easily distinguish the changes made. The amendment will not be reviewed until tracked changes of revised documents are provided.
    • Update the version date on each revised document
    • Documents should always be paginated (have page numbers at the top or bottom)

Other points to include in the amendment letter, as applicable:

Increase in number of subjects: If you are proposing an increase in the number of subjects to be enrolled, please state this and provide the rationale.

Reportable new information: Include a statement if this amendment is a result of a serious adverse event (SAE), unanticipated problem (UP), non-compliance, protocol deviation, or other reportable new information. State whether this information is being submitted along with the amendment, or specify the date it was submitted/will be submitted to the IRB.

[Investigator’s Brochure (IB):  In addition to the other points described, include the following points for updated/revised IBs, deleting those that are not applicable:

  • Refer to IB revisions summarized on pages [## – ##].
  • State whether the IB revisions contain information that should be included in the ICF [i.e., information that might affect a subject’s willingness to continue to participate in the research study] or revised Protocol [i.e., change in risks, changes in experience with the drug].
  • Alternatively, you may submit the Investigator’s Brochure (Cover Letter) for an updated Investigator’s Brochure.

Revised Documents: Consider whether the protocol, Site-Specific Appendix, and/or informed consent form(s) need to be revised to reflect the proposed changes.

Re-consent: If the ICF is being revised, state whether or not you plan to re-consent previously enrolled subjects to the new information. (Consider whether the new information might affect a subject’s willingness to continue to participate in the research study.)

Pharmacy: If the study has a pharmacy component, please contact the Investigational Drug Service (IDS) (617-636-3202) and provide IDS with updated documents, as needed. Include a statement in the letter to the IRB such as “We have contacted the investigational drug service (IDS) to ensure the most recent protocol, site-specific appendix, and investigator’s brochure are on file with the pharmacy.”

Radiation: If the study involves research radiation, consider whether the Form 4 needs to be updated. If so, please submit a revised Form 4, reviewed and signed by the Radiation Safety Officer.

Specimen Banking: If the study involves tissue banking, consider whether the Form 6 needs to be updated. If so, please submit a revised, signed, Form 6.

Translations: If translated documents are being submitted, please refer to the Tufts MC / TUHS IRB Investigator Manual for document translation policy and submit the Certification of Translation/Back Translation Form and English back translations.

Research team: If you are adding or removing research team members, please include this information. For new research team members, state name and role in the study, and confirm completion of the IRB’s mandatory human subjects’ protection education and the research conflict of interest (COI) form. If the new research team member is not affiliated with Tufts MC/TUHS please refer to the Requests to Cede/Assume IRB Review website to see whether an agreement needs to be put into place.

Funding source: If you are informing the IRB of a new funding source or a change in funding source, please describe these changes and include a copy of the grant, as applicable.

Amendments are generally processed within 7 to 10 business days. The turnaround time depends on the complexity of the amendment and the state of submission.  Contact the IRB office at 617-636-7512 with any questions.