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.
- Request for Exemption
Required for any new study submitted for exemption.
- Form 1
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 2
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 2 if the drug and dose are specified in the protocol.
- Form 3
Required for a new study and continuing review that involves a device in as part of the research study. A separate Form 3 is required for every device employed in a research study. A user manual, operations manual, etc., must be submitted for each device.
- Form 4
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 4.
- 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.
- Radiation Safety Committee Form
If radiolabelled agents are to be used, please complete and submit the above form to the Radiation Safety Office.
- Form 5
Required for continuing review submissions only. A Site-Specific Appendix (see above) may also be required. For additional information about completing the Continuing Review, please refer to the Continuing Review page.
- Form 6
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 6.
- Form 7
Required for medical record/chart reviews only. If completed thoroughly, Form 7 is designed to eliminate the need for a separate protocol, ICF, and HIPAA documentation.
- Form 9
Required for Central IRB Networks: NCI CIRB, NIH StrokeNet, PETAL cIRB, and CEGIR CCHMC IRB submissions. Click here for more information.
- Form 10 (IAA/IIA Request Form)
Use for requesting that Tufts Health Sciences IRB assume or cede IRB oversight for research.
Request for amendment to previously approved research template letter
- Change in Research Team
Notification of changes to research team template letter
- Departing Principal Investigator Checklist
For Investigators who are leaving Tufts Medical Center / Tufts University who have active studies with the Tufts Health Sciences IRB – this checklist will help you close out, identify a new PI for, or transfer your active studies before you leave Tufts Medical Center / Tufts University.
- Subject Wallet Card
This subject wallet contact information card has been approved by the Tufts Health Sciences IRB for use. Please consider providing this wallet card to subjects so they can easily access study contact information.
This card has been approved by the Tufts Health Sciences IRB and can be used in a specific study without further IRB approval, provided the information on the card is restricted to the information in the template (contact name, phone #(s), address/location, e-mail address, and appointment reminder). The size of the card and the font type can be altered without further IRB approval. If you would like to include additional information or make further alterations on the card (beyond the allowed alternations described here), please submit it to the IRB for review and approval prior to use.
- 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.
- Tufts Medical Center Clinical Research Recruitment Website Form
Complete this form to post your study on the Tufts Medical Center Clinical Trials search website. Posting your study on this site does not require IRB approval, and there is no cost associated with posting Tufts Medical Center studies (non-Tufts Medical Center studies cost $250 to post).