Submit this completed typed form and other required documents to the IRB office via email, or on a CD/flash drive marked as a WIRB submission (provide instructions for returning the flash drive). Submissions can be emailed to . All Tufts IRB Forms (e.g. 2, 3, 4, and 8) must be signed by the PI and submitted as scanned PDFs. Documents that do not require signature may be submitted in either WORD or PDF format. If documents are password protected, provide the passwords. If this research study has been reviewed by the Tufts Health Sciences IRB, please call the IRB office at ext. 6-7512 before submitting this form.
Refer to WIRBSubmission Instructions for complete information on the submission process at both Tufts IRB and WIRB
Sponsor assigned Protocol Number: / Study Title:
Principal Investigator: / PI Telephone:
PI E-mail:
Research Coordinator: / Research Coordinator Telephone:
Research Coordinator Email:
Institution: / Department/Division:
Location of Research:
Please note: if additional locations are added once the study is active, you need to submit a new Form 8 to the IRB.
Sponsor: / Mailing Address or Box #:
Tufts University funded studies:Provide either the PeopleSoft or Research Administration System (RAS) number:
A.WIRB Submission Eligibility Requirements
If any of the following boxes are not checked, call Tufts IRB staff at 617-636-7512 to determine eligibility to submit to WIRB.
Study will be submitted directly to WIRB [Note: Do NOT submit to Copernicus Group IRB or WIRB-Copernicus]
This research study has NOT been previously reviewed by the Tufts IRB (A research study may only be reviewed by the Tufts IRB or WIRB, not both)
Industry Sponsored or sponsored by a non-federally funded foundation
Sponsor Initiated (Sponsor initiated is defined as sponsor created, designed, and developed.)
Multi-Center
If the research involves an FDA-regulated test article, the following eligibility criteria apply:
Drugs, Biologics, Substances: Study is in Phase II, III or IV (Phase I studies are NOT eligible)
Devices: Study is in pivotal, post-marketing, or equivalent, phase (Pilot or first-in-man studies are NOT eligible)
B. Required Institutional Committee Approval
Check all that apply.
Pharmacy Review / N/A Reviewed*
Radiation Safety Committee / N/A Reviewed* Not Required (No research-related ionizing radiation exposure)
Institutional Biosafety Committee (IBC) / N/A Reviewed*
N/A means there is no research related or standard care test, procedure, or intervention involving drugs/biologics, ionizing radiation or biohazardous material.
* A scanned copy of the review is required. The PI is responsible for ensuring all comments have been addressed and resolved prior to starting the study.
- Mandatory Human Subject Protection Education
List of Research Team Members:
This includes those responsible for the design, conduct, or reporting of the research, such as the PI & Co-Is, research nurses and coordinators, project managers, etc. / Individual’s Role
For example, list PI, Co-I, Research Coordinator. Do not list any research team member as a “Co-PI;” only one person may be listed as PI for a study. / In a Training Position
For example resident, fellow, etc. / Institutional Affiliation
For example Tufts MC, TUSM, HNRCA, etc. / Current CITI Certification: Indicate the expiration
date of each individual’s CITI certification. / Current GCP
Training1:
Indicate the expiration
date of each individual’s GCP Training
Check N/A if this does not apply to this study: N/A
1 GCP training is required for NIH funded clinical trials (NIH funded studies that meet the NIH definition of clinical trial).
As of 01 January 2018, GCP training will be required for allclinical trials, regardless of funding source.
- Blood-borne Pathogen Training
Annual training is required by theOccupational Safety and Health Administration(OSHA) and the International Air Transit Association (IATA) for any research team member who will collect, handle, and/or process human samples capable of transmitting blood borne pathogens.
This does not apply to this research.
This does apply to this research and all research personnel who may come in contact with blood borne pathogens have completed or will complete the required training and, as applicable, annual updates before conducting research.
Documentation attesting to completed trainingis subject to audit. Contact the Tufts MC/TUHS Biosafety Officer at (617) 636-0964 with any BBP training related questions.
- Point of Care Pregnancy Testing
For Tufts Medical Center studies: If this study requires point of care pregnancy testing (i.e., study staff administering a pregnancy test directly with the research subject), please note that in accordance with CLIA regulations, people performing urine pregnancy tests must be trained annually. In addition, use of the ONOM pregnancy test kit is required for point of care pregnancy testing.If you are required to use a different pregnancy test kit by a study sponsor you must perform the tests twice, once with the sponsor’s kit and once with ONOM (and this repeat testing should be explained in the Informed Consent Form). ONOM kits will be provided to you, if necessary, at no cost to the investigator.This does not apply to tests being sent to the Tufts MC laboratory or to a central laboratory.
This does not apply to this research
This does apply to this research and all research personnel who perform point of care pregnancy testing have completed or will complete training and will use the ONOM pregnancy test kit.
Contact: Douglas Reichgott, Research Administration, Tufts Medical Center
- Study-Specific Disclosure of Financial Interest †
Conflict of Interest (COI)
Check to confirm the PI and each research team member have completed the Research COI form and copies of the completed forms have been retained in the study files.
Check to confirm that the following COI forms have been submitted to the Tufts IRB office:
- The PI’s completed COI form (this needs to be submitted regardless of the responses on the form).
- COI forms from research team members who have indicated a “YES” response in any field on the form
- Confirmation of understanding of ICF template language requirement.
I understand that Tufts ICF template language must be utilized at Tufts. I understand that any deviations to Tufts ICF template language require review by the HIPAA Privacy Officer.
- Confirmation of Understanding of Billing/Invoicing Processes for WIRB Studies:
I understand that all WIRB invoices must be sent directly to the study funding source, and I confirm the WIRB application will include the correct invoicing address for the funder in section VI Billing Information (p. 24 question 67). I have made my Research Administrator aware of this new WIRB submission, and I will discuss any questions I have about billing for WIRB studies and completing WIRB application section VI Billing Information with my Research Administrator.
- Submission Checklist (Check only those documents that are applicable to this study)
A completed Form 8 signed by the PI and Department Chair/Division Chief, as appropriate.
The study protocol, including any appendices and supplemental documents, as provided by the sponsor.
A copy of the sponsor’s ICF with Tufts ICF template language or approved deviations as indicated above (and RSO-recommended language, if applicable) included.
If a drug/biologic/substance (including placebo) is involved in the study: Completed and PI-signed Form 2, including a copy of each Investigator’s Brochure, if applicable.
If a device is involved in the study: Completed and PI-signed Form 3, including a copy of each Operator/User Manual, device specifications, etc.
Signed Conflict of Interest form, as indicated above.
Clinicaltrials.gov form – Submitting this form is required for studies that utilize an Informed Consent Form.
Tufts MC Clinical Research Recruitment Website form – Submitting this form is required for Tufts Medical Center studies that utilize an Informed Consent Form. For Tufts University studies, submitting this form for posting studies on this recruitment website is optional.
Documentation of approval (if required) from each required institutional committee or confirmation from the institutional committee (e.g., RSO) that approval is not required (see above).
- Investigator Acknowledgement
I certify that I have read and understand the Tufts MC/TUHS procedures for the use of WIRB and have reviewed them with the research team, that the information provided in this application is complete and accurate, and that this study meets the Tufts MC/TUHS criteria for review by the WIRB. I agree that I will only submit studies to WIRB that meet all internal Tufts MC/TUHS requirements. I also understand that the Institution reserves the right to disapprove any study approved by WIRB.
As Principal Investigator, I have ultimate responsibility for the conduct of this research study, its ethical performance, and the protection of the rights and welfare of human subjects. I agree to conduct this research study in accordance with all applicable federal and state regulations and Tufts MC/TUHS policies and practices governing human subject research.
I confirm that the research team members listed above and I are appropriately qualified and meet the Institutions’ standards for eligibility to conduct research and have completed the Institutions’ research education requirements. I also agree all research team members will complete Institutional continuing education requirements and I will oversee all members of the research team.
I confirm that the amount of time I will spend on the research is adequate to conduct and complete the research.
I understand that only one (1) IRB (i.e., Tufts MC/TUHS IRB or WIRB) may review this study and that if I submit this study to WIRB, I cannot submit the same protocol to the Tufts MC/TUHS IRB or any other IRB at any time in the future, regardless of the outcome of the WIRB review. I also understand that protocols submitted to the Tufts MC/TUHS IRB may not be submitted to WIRB at any time in the future.
I understand if an additional location is added, a new Form 8 is required.
Printed Name of Principal Investigator:
Investigator signature: / Date:
- Department/Division Chair Acknowledgement
I affirm that the enclosed application is within the academic and/or clinical scope of this Department/Division. In addition, I certify that adequate space and resources are available to conduct this research.
I understand that the industry sponsor of the above-referenced research study to be reviewed by WIRB will receive an invoice for the WIRB review fees. I understand that if this fee is not paid within sixty (60) days, my Tufts MC/TUHS department/division may be asked to pay this fee. I will assure that this fee is paid in a timely manner if this situation arises.
Printed name of Department Chair/Division Chief:
Department Chair/Division Chief Signature: / Date:
For Tufts Health Sciences IRB use:
Based on the information provided by the PI for this study, this study may be submitted to WIRB for review:
Printed name of Tufts MC/TUHS designated IRB office staff personnel:
Signature of Tufts MC/TUHS designated IRB office staff personnel: / Date:
WIRB: Please refer to attached Tufts MC / TUHS Institutional Committee Review Comments
VERSION DATE: 08/14/2018 / PAGE: 1 of 3