Overview of key forms for working with the HS IRB.

Forms

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.

IRB Forms

• Certification of Translation
  • Version Date: 10/19/2023
• Drug Decision Tree
  • Version Date: 03/21/2016
    Use this decision tree to help identify whether your study uses a drug that is subject to FDA regulations.
  • To locate current drug labeling – package inserts go to: http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
• Device Decision Tree
  • Version Date: 08/29/2017
    Use this decision tree to help identify whether your study uses a device that is subject to FDA regulations.
• Emergency Use, Compassionate Use, Expanded Access Form 
  • Version Date: 3/21/2024
    Use this form when submitting Emergency or Compassionate Use
• Form 4 (Research Radiation)
  • Version Date: 1/5/2024
    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.
  • Typical Exposure Document
    • 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.
  • Radiation Safety Committee Form
    • If radiolabeled agents are to be used, please complete and submit the above form to the Radiation Safety Office.
• Form 7 (Request for Exemption) 
  • Version Date: 08/14/2024
    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.
• Form 8 has been retired. Use Form 10B (below) for WCG IRB studies.
• Form 10
  • Form 10A – Request to Assume Oversight 
    Version Date: 5/10/2024
    This form is required for requesting that Tufts Health Sciences IRB assume (take on) IRB oversight for research at another institution that has an FWA.
  • Form 10B – Request to Cede Review 
    Version Date: 05/22/2024
    This form is required for requesting that Tufts Health Sciences IRB cede (give up) oversight for research to another IRB.
  • Form 10C – Request for Independent/Institutional Agreement 
    Version Date: 5/10/2024
    This form is required for requesting that Tufts Health Sciences IRB assume (take on) IRB oversight for research for an independent investigator or institution that does not have an FWA.
• Form 11 (Adding Tufts Medical Center Satellite Locations)
  • Version Date: 12/19/2023
    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).
• Form 12 (MelroseWakefield and Lowell General Research)
  • Version Date: 04/25/2024
    Use this form for research conducted at MelroseWakefield Healthcare and/or Lowell General Hospital (including remote activities involving MelroseWakefield/Lowell General personnel or patients).
• Form 13 (Non-Research Projects) 
  • Version Date: 03/14/2024
    Use this form to submit a proposal for a non-research project involving humans, such as quality improvement. If completed thoroughly, this form is designed to eliminate the need for a separate protocol or cover letter.
  • For more information about non-research projects, see the following guidance:
    • Not Human Subjects Research Determinations
    • Quality Assurance / Quality Improvement Projects
• Form 14 (Not Human Subjects Research)
  • Version Date: 04/16/2024
    Use this form to submit a proposal for a research project without human subjects. If completed thoroughly, this form is designed to eliminate the need for a separate protocol or cover letter.
  • For more information about research projects without human subjects, see the following guidance:
    • Not Human Subjects Research Determinations
    • Analysis of Coded / De-identified Data / Specimens
• Form 15 (Engagement Form) 
  • Version Date: 11/08/2023
    Use this form to submit a proposal for a project where Tufts is not engaged in human subjects research conducted by another institution. If completed thoroughly, this form is designed to eliminate the need for a separate protocol or cover letter.
  • For more information about when Tufts is not engaged in human subjects research, see the following guidance:
    • Not Human Subjects Research Determinations
    • Tufts not Engaged in Research
• ​​​​​​HRP-226 – Letter of Support Form – Providing De-identified Specimens or Data
  • Version Date: 12/09/2024
    Use this form if you will receive coded or de-identified data and/or biospecimens from another researcher or institution.
• ​HRP 227 - Letter of Support – Permission to Recruit Employees or Students
  • Version Date: 03/04/2024
    Use this form if you will directly target employees, residents, students, interns and/or fellows for recruitment.
• HRP 228 - Letter of Support – Permission to Conduct Research at Another Institution
  • Version Date: 03/04/2024
    Use this form if Tufts personnel will conduct research and/or quality improvement/quality assurance (QI/QA) at another institution.
• Institutional Profile Form (HRP-815)
  • Version Date: 07/07/2023
    Use this form to request that an institution be added to eIRB, allowing you to select it as an external IRB or a relying site.
• Relying Site Personnel List
  • Version Date: 08/03/2021
    Use this form to list the research team members for an external site relying on Tufts for IRB review, and to obtain a sign-off from the relying IRB/HRPP confirming that the research team has completed their institution’s requirements.
• Short Forms
• Protocol Template
  • Version Date: 8/14/2024
  • Use this template if the Sponsor did not provide a protocol. You can utilize either the form or the MS Word document.
• Site-Specific Appendix (SSA)
  • Version Date: 8/14/2024
    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. You can utilize either the form or the MS Word document for your study.

Other Forms

• Clinical Research Recruitment Website Form [Please refer to the Tufts MC Clinical Research Recruitment Website Form List of Conditions when completing this form]
  • Version Date: 01/26/2022
    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.
• ClinicalTrials.gov Form
  • Version Posted: 6/16/2022
    Submit for all new studies that utilize an Informed Consent Form. This is an institutional requirement and must be submitted in order to receive IRB approval.
• Research Financial Interest Disclosure Form
  • Version Posted: March 2020
    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. Please refer to the Tufts University Conflict of Interest Policy or the Tufts Medical Center Policy on Industry Conflicts of Interest.
• Scientific Review Committee
  • SRC Medical Reviewer Form
    Version Date: 09/14/2017
  • SRC Statistical Reviewer Form
    Version Date: 05/22/2015
  • These forms contain items that will be considered by SRC reviewers in assessing the scientific rigor and merit of a study under review.

HIPAA Forms

• Tracking Form for Disclosure of PHI from Research Records
  • 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.
• Review Preparatory to Research Form
  • Version Date: 06/09/2023
    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:
    1. The use of the PHI is solely for purposes preparatory to research.
    2. The review is necessary for preparation.
    3. No PHI is removed from the covered entity during the course of the review.
• Research on Decedent Form
  • Version Date: 11/15/2019
    This form is required if you plan to conduct research on decedents (a person who has died). The PI will confirm the following on the Research on Decedent Form:
    1. The PHI accessed is solely for research of the PHI on the decedent.
    2. The PHI accessed is necessary for research.
    3. Documentation of death is available upon request.
• Case Report Authorization Form
  • Version Date: 11/10/2023
    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.