IRB Forms

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.

• Checklist
  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 any new study and continuing review that involves the use of a FDA-approved or investigational drug, substance, biologic or nutrient. A separate Form II is to be submitted for every FDA-approved or investigational drug, substance, biologic or nutrient employed in a research study. Package insert information, an Investigator's Brochure, MSDS sheets, etc., are required for each drug, substance, biologic or nutrient.

• 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.

• 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.

• Form VIII
  Required for WIRB submissions. Please click here for more information.

• Adverse Effect Report
  Required for any Serious Adverse Event (SAE), as defined by the research protocol, that occurs during the conduct of the research study. One Adverse Effect Report form must be submitted for each SAE. All SAEs provided to the Principal Investigator by the sponsor (e.g., Safety Reports/MedWatch Reports) and all SAEs occurring in subjects enrolled by the Principal Investigator must be submitted to the IRB with this Adverse Effect Report form.
  

• Request for Exemption
  Required for any new study submitted for exemption.

• Adult Informed Consent Form (ICF)
  Required elements of consent and an adult ICF template for research subjects.
  
  
• Parent/Guardian Permission Form for Enrolling Minors
  Required elements of consent and a minor ICF template for research subjects.
  
  
• Assent Form for Children 7-17 Years Old
  
  
• HIV screening informed consent form (ICF)
  Standard Tufts Medical Center HIV screening ICF. (Only accessible via the Tufts Medical Center intranet.)
  

• U.S. Food and Drug Administration Form 1571

• U.S. Food and Drug Administration Form 1572

• Protocol Template Document
  

• Research COI 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.