Data and/or Material Transfer Agreement Questionnaire
Before sending data and/or materials to any third party, including NEIDL or BU, or when receiving data and/or materials from a third party pursuant to a data transfer or material transfer agreement, please (1) complete the below, (2) attach any template agreements that have been provided for review and a list of data variables, as applicable and (3) send to
DUA.MTARequest@bmc.org
.
1. REQUEST SUMMARY
a. High level summary of project
(please include description of approvals already received, e.g., IRB, COVID Human Subjects Research Committee, etc.)
b. Name of Requesting BMC Principal Investigator (“PI”) of the Associated Research Project
i. PI Title & Department
ii. Admin
c. Project Title
d. H# / IRB # (if applicable)
e. IBC # (if applicable)
f. Timing
g. Payment: (Agreement amount, if any associated payments:)
h. Purpose
i. Briefly describe the purpose of the transfer and the anticipated use of the data or materials.
ii. Do you or the recipient anticipate publishing the results of the research using these data or materials?
2. EXTERNAL PARTY(IES) INFORMATION
a. External Party Institution(s) Name(s)
b. External Party Physical Address
c. Recipient PI Name and Title
d. Administrative Contact(s) and Email Address(es)
3. TRANSFER DETAILS
a. Outgoing / Sending OUT of BMC: Are any materials and/or data being sent OUT from BMC to an outside institution? Please list all entities being sent to (e.g., to Y, then to X service provider)
i. What is the purpose of the transfer and the roles of those involved?
i. Has the other party provided a template / draft agreement?
1. *If YES, please provide agreement received from outside institution for review.
b. Incoming / Received BY BMC. Are there any materials and/or data being received by BMC from an outside individual / institution?
Yes
No
c. Method of Transfer. How are the data or materials to be transferred / received?
i. If so, from whom?
ii. Are the materials or data being received from outside of the U.S.? If so, where?
iii. Has the other party provided a template / draft agreement?
1. *If YES, please provide agreement received from outside institution for review.
4. AGREEMENT DETAILS
a. Is this a request to draft a new agreement to cover a proposed data or material transfer?
i. Answer “No” here if you responded “Yes” to the question above about the other party providing a template / draft agreement (3(b)(i) above)
b. Is this request for multiple agreements and/or involve multiple outside institutions:
i. If YES, please list institutions involved:
c. Is this transfer being done in connection with a grant, subaward or subcontract?
i. If YES, what is the status of the grant/subaward/subcontract?
Please provide InfoEd #
5. TYPE OF DATA OR MATERIALS
a. Describe the data and/or materials being sent or received.
i. Data. If data, provide and/or list all variables being transferred, including any potentially identifying information (including dates, ages, zip codes, medical record numbers, etc.) or other sensitive information.
1. Please indicate if the data set contains any of the following, and if so, which:
HIV Status/Testing Results
Social Worker Communications
Consent for Abortion
Domestic Violence Victims’ Counseling
STI / STD Status
Sexual Assault Victims’ Counseling
Genetic Test Results
Alcohol & Drug Abuse Records
ii. Materials. If materials, please describe or attach description.
1. Are the materials proprietary?
Yes
No
2. Are the materials infectious or hazardous? a. If YES, please explain.
2. Will any of the following identifiers be shared? If so, please identify which ones
Names
Geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP code, and their equivalent geocodes
All elements of dates (except year) for dates directly related to a patient or subject, including birth date, admission date, discharge date, death date, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older
Telephone numbers
Vehicle identifiers and serial numbers, including license plate numbers
Fax numbers
Device identifiers and serial numbers
Email addresses
Web Universal Resource Locators (URLs)
Social security numbers
Internet Protocol (IP) addresses
Medical record numbers
Biometric identifiers, including finger and voice prints
Voice print: the visual output of a spectrogram
Health plan beneficiary numbers
Full-face photographs and any comparable images
Account numbers
Any other unique identifying number, characteristic, or code, except as permitted by paragraph (c) of this section (see below) and Clinical trial record number
Clinical trial record number
Device model number unique to the patient’s device
Certificate/license numbers
3. Do the materials involve any of the following:
a. Recombinant or synthetic nucleic acid molecules
b. Hazardous biological agents (virus, bacteria, fungi, parasite, prion, rickettsia etc.)
c. Other potentially infectious materials (human or non-human primate blood, serum, plasma, body fluids, unfixed tissue, organ and cells)
d. Biological toxins including select agent toxins
e. Inactivated Biological Samples derived from BSL-3 or BSL-4 agents
f. Attenuated pathogens derived from BSL-3 or BSL-4 agents
g. Human gene transfer
h. Transgenic animals or plants
i. Sheep and any tissues derived from them (these tissues can transmit Coxiella burnetii, the causative agent of Q-fever)
j. Field studies with wild animals and their tissues inherently infected or would be experimentally infected with BSL-2 or higher agents
4. IBC Review. If the materials involve any of the above (3(a) – 3(j)) – has the protocol been reviewed and approved by the Institutional Biosafety Committee (“IBC”)?
Yes
No
a. See information on IBC review here:
https://www.bu.edu/researchsupport/compliance/ibc/about-the-ibc/application-review-and-approval/
.
b. If YES, please provide IBC review number
i. Were the materials and / or data collected from human subjects?
Include IRB # for any study under which the data/material was generated or will make use of the data / material.
b. Source of Data / Materials.
i. Please (1) provide the BMC IRB
i. Please (1) provide the BMC IRB # for any study under which the data/material was collected or will make use of the data / material and (2) indicate whether the data or materials were obtained pursuant to a signed participant consent form.
ii. Please describe the original source (e.g. BMC clinical data, leftover clinical samples, samples or data obtained from repository, or received by BMC from other institution, etc.).
6. OTHER
a. Any other important information about the transfer?
Any other attachments, please upload them here
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