As of January 1, 2020, the IRB transitioned to an electronic IRB (eIRB) system. To apply for new study approval or to submit a continuing review, modification or reportable new information (RNI), please do so through eIRB at https://eirb.tuftsmedicalcenter.org.
Below are supplemental forms that you may be required to complete and upload to your eIRB application. These forms are also available on the eIRB Library.
Please also refer to Documents to Upload with eIRB for guidance on which documents to include with your submission and where they should be uploaded in eIRB.
Version Date: 11/18/2019
Required for a new study and continuing review if a research study involves radiation exposure solely for research purposes. The form may be reviewed and approved by the Radiation Safety Officer (RSO) through the “Manage Ancillary Review” function of eIRB prior to submission.
Version Date: 12/2011 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.
Version Date: 12/19/2019 Required for a new study and continuing review submissions if a research study involves sample banking for future unspecified research. A separate optional sample banking informed consent form (ICF) must also be submitted with Form 6.
Version Date: 12/10/2019 Required for any new study submitted for exemption. Can be submitted for exempt studies and uploaded as the protocol for those through eIRB. If completed thoroughly, this form is designed to eliminate the need for a separate protocol.
Version Date: 11/22/2019
Use this form to add a participating site (or multiple sites) that are fully owned by Tufts Medical Center and operating as a Tufts Medical Center location, and are covered by the Tufts Medical Center Federalwide Assurance (FWA00004449).
Version Date: 01/09/20 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.
Version Date: 3/18/2015
Submit for all new Tufts Medical Center studies that utilize an Informed Consent Form. This is a Tufts MC institutional requirement and must be submitted in order to receive IRB approval. This form for posting studies on this recruitment website is optional for Tufts University studies. [Please refer to the List of Conditions when completing this form].
Version Date: 02/10/2020
This form is used to help you fulfill HIPAA accounting requirements when you are granted a research authorization waiver. If you access 50 or fewer records, you must record the names of the records you have accessed. If you access 51 or more records, you may create a profile of the study population (e.g., men over age 70 with glaucoma and a history of hypertension). In either case, it is the responsibility of the PI to report the names or profile to his/her institution’s HIPAA Privacy Officer for Research.
Version Date: 12/03/2019
This form is required when you plan to access PHI for purposes preparatory to research (such as preparing a research protocol, assessing feasibility of a research study, developing a hypothesis, or identifying prospective participants who would meet eligibility criteria for a proposed project). The PI will confirm the following on the Review Preparatory to Research Form:
The use of the PHI is solely for purposes preparatory to research.
The review is necessary for preparation.
No PHI is removed from the covered entity during the course of the review.
Version Date: 01/20/2011 This form is for use when a case report may directly or indirectly identify a patient. An analysis of more than 3 clinical cases meets the definition of research that must receive IRB approval before starting. These cases also require HIPAA authorization from the patient. Please refer to the case report policy for more information.