The IRB of Tufts Medical Center/Tufts University Health Sciences employs internal forms that are required for certain submissions.
Principal Investigators (PI) are reminded that all submissions, should be accompanied by a cover letter signed by the PI. The letter should detail the nature of the submission and provide any necessary pertinent information for review. The absence of a PI-signed cover letter may result in a delay in the review of the materials.
This checklist is designed to help guide PIs as submissions are prepared. It should not be sent in place of a cover letter, as noted above.
- Form I
Required for all new studies submitted for full IRB review or expedited review.
- Site-Specific Appendix
Required for all new and continuing review submissions if the protocol does not already detail aspects of the study as they will occur specifically at this site (e.g., consent process including who conducts the consent interview, specific location of document storage, operational details of recruitment methods). This form will typically be used for those studies that are multi-center or industry sponsored and the protocol document cannot be tailored to this site.
- Form II
Required for a new study or continuing review application that involves a drug, substance, biologic, or nutrient administered for research purposes. Ancillary or supportive drugs administered in a study require a Form II if the drug and dose are specified in the protocol. A detailed instruction sheet has been created to help answer questions related to the form.
- Form III
Required for a new study and continuing review that involves a device in as part of the research study. A separate Form III is required for every device employed in a research study. A user manual, operations manual, etc., must be submitted for each device.
- Form IV
Required for a new study and continuing review if a research study involves radiation exposure solely for research purposes. The form must be reviewed and signed by the Radiation Safety Officer (RSO) prior to submission to the IRB office. At the time of continuing review, if the amount of radiation exposure has not changed since the Form IV was last reviewed and signed by the RSO, a copy of the most recent RSO-signed Form IV and a letter signed by the PI stating that there has been no change in radiation exposure may be submitted to the IRB office in place of a newly signed Form IV.
- Typical Exposure Document
This document lists typical effective whole body radiation doses from common medical imaging procedures, including their related increase in lifetime cancer risk and the period of natural background radiation that delivers the equivalent radiation dose.
- Form V
Required for continuing review submissions only. A Site-Specific Appendix (see above) may also be required.
- Form VI
Required for a new study and continuing review if a research study involves sample banking. A separate optional sample banking informed consent form (ICF) must also be submitted with Form VI.
- Form VII
Required for medical record/chart reviews only. If completed thoroughly, Form VII is designed to eliminate the need for a separate protocol, ICF, and HIPAA documentation.
- Request for Exemption
Required for any new study submitted for exemption.
- Research Conflict of Interest Form
The PI and each research team member are to complete this form. The PI is to submit his/her completed COI form to the IRB office. Any form(s) from research team members with “YES” responses are also to be submitted to the IRB office by the PI. The PI is to retain in his/her study files the completed form(s) for research team members who answer “no” to all questions. Please refer to the Tufts University Conflict of Interest Policy or the Tufts Medical Center Policy on Industry Conflicts of Interest.