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)).
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.
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:
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.