PI QUESTIONNAIRE
For sending research materials under an MTA

Please fill out this questionnaire in connection with your request to send out research materials. CSRL requires all the information in this form before it can review and sign any Material Transfer Agreement. Please direct your questions and return the completed questionnaire with attachments to:
  Renee Tetrault, CSRL
tel: 617-954-9375
fax: 617-954-9361
rtetrault1@partners.org

[To download this form rather than submitting it online, please see below.]
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1.
BWH Principal Investigator providing material:
  Name:
  Title:
  Phone Number:
  Fax Number:
  Email Address:
  Building/Room Number:
  Department/Division:
  Is the Principal Investigator an HHMI (Howard Hughes Medical Institute) Investigator?
Yes No

2.
Scientist requesting the material:
  Name:
  Address:
  Phone Number:
(Institution/Company)
  E-mail Address:
(Institution/Company)

3.
Name and type of material that is to be provided (cDNA, mAb, tissue sample, whole blood, etc.):
(*PLEASE NOTE - If providing Human Samples, please be sure to answer questions 17 - 22.) If the material is a mouse, does the material contain any Cre-Lox Materials?
Yes No

4.
Requesting Scientist's planned use of material:

5.
Was the material made in your own lab at the BWH (you were the Principal Investigator)?
Yes No

If yes, when?

If No , please explain:


6.
Did any other research lab (at BWH, another academic institution, or a company) provide essential components or otherwise collaborate with you in making the material (e.g. clone portions of a plasmid, supply antigen against which you raised Abs, provide a cell line, etc.)?
Yes No

If Yes, please explain:

If Yes, is there any form of written agreement (Material Transfer Agreement, letter of intent, etc.) between you and these providers/collaborators? Yes No


7.
Are there any alternative sources for the material? Yes No

If Yes, please explain:

8.
Has the material been described in a publication?
Yes No

If No, how soon do you intend to publish?
3-6 months
1 year
more


9.
Is the material the subject of an invention disclosure, or a patent application which has been filed by BWH?
Yes No

Is the material licensed to any third party, or the subject of licensing negotiations?
Yes No

If Yes, please explain:


10.
Do you have any special concerns, other than those addressed in these questions, about distributing the material?
Yes No

If Yes, please explain:

11.
Has the material already been sent to the requesting scientist?
Yes No

12.
At the time when the material was made, did your lab receive industrial support for:
(a) the research (clinical or basic science) in which the material was made?
Yes No

(b) any portion of your salary or the salary of individuals working on the project?
Yes No

(c) the purchase of supplies, reagents, animals, tissues or cells required for the research?
Yes No

If Yes to any of the above, please explain:


13.
Please indicate other sources of support in your lab at the time that material was made, e.g. NIH grants, fellowships awarded to you or to individuals who made the material, etc.:
Sponsor(s):

Grant title(s):

Grant number(s), if known:


14.
Do you wish to charge a shipping & handling fee (reimbursement for lab tech's time to material, packaging, FedEx, etc.)?
Yes No $

Do you wish to charge a transfer fee for the material? (reimbursement for lab technician time, material costs)
Yes No $


15.
Is the requesting scientist and/or any other company scientist actively collaborating in research with your lab in which the material will be used?
Yes No

If Yes, please explain:


16.
Please indicate the estimated length of time the research will take (if the requesting scientist indicated a time length for the research).



IF YOU ARE NOT PROVIDING HUMAN SAMPLES / TISSUE, PLEASE GO DIRECTLY TO THE SIGNATURE LINE BELOW

IF YOU ARE PROVIDING HUMAN SAMPLES / TISSUE TO THE REQUESTING SCIENTIST, PLEASE FILL OUT THE FOLLOWING QUESTIONS:

Tissue refers to ANY specimen obtained from patients or human research subjects, e.g.: fixed, frozen or fresh pathology or autopsy specimens, any blood, urine, saliva, semen, breast milk or other biological material obtained from humans, any purified DNA, RNA, proteins, cell lines or clones. This includes tissue that is collected primarily for clinical purposes as well as tissue that is collected specifically for research. Regardless of how the tissue was obtained, the proposed use of this tissue for research must be reviewed by the IRB. (www.healthcare.partners.org/phsirb)


17.
Please provide the protocol number and title, and attach a copy (cut & paste) of the protocol and a copy of the IRB's determination (approval letter, exemption determination, etc.) If you have hard copies, please fax them to Renee Tetrault / CSRL at (617) 954-9361.

18.
Please indicate the estimated length of time the research will take.

19.
Has the IRB specifically approved this use and transfer of these materials to this specific receiving party?
Yes No

If No, please explain why approval is not relevant/required. If the use and transfer has not been specifically reviewed, an amendment to the IRB protocol may be necessary.


20.
Were the samples collected from BWH patients?
Yes No

If No, please explain:


21.
Under what circumstances were the samples collected from the patients?
Surgical procedure
Blood draw
Delivery/obstetric procedure
PI-initiated or BWH-sponsored clinical trial / research
(If "yes", please provide name of the company.)

NIH or company-sponsored clinical trial / research
(If company, please provide company name.)

Other

If Other, Please explain:

22.
What form of consent was obtained from the patients?
BWH standard Procedure Consent
BWH standard Consent for Obstetrical Procedures and Activities
Study-specific written consent (please append)
None or don't know

If "None or don't know", please explain:


23.
Will any patient information or other clinical data be transferred with the samples?
Yes No

If Yes, will the information/data contain any of the following identifiers (please check applicable box(es))?

Name Address by street location Address by town/city/zip code
Telephone number Fax number Electronic mail address
Social security number Medical record number Account number
Certificate / license number Web URL's Full face photographic image
Medical device identifiers and serial numbers Internet protocol (IP) address Biometric identifiers (finger and voice prints)
Dates (except year), e.g., date of birth; admission/ discharge; date of procedure; date of death Health plan beneficiary number Vehicle Identification number and serial number, including license plate number
Any other identifier or combination of identifiers likely to identify the subject

PLEASE NOTE: The transfer of samples with identifiable information may carry additional requirements (e.g., patient consent and authorization) under federal human subjects regulations and/or the HIPAA Privacy Rule. If the identifiers transferred are limited to address by town/city/zip code, dates, and other identifiers not specifically listed above, the provider of the material (if it is a "covered entity" under HIPAA) may require that a data use agreement be put into place before the transfer occurs. Please forward any such data use agreement to CSRL for review.


Please be aware: There may be terms and conditions in the Material Transfer Agreement which preclude your use of the materials in research sponsored by industry, limit your ability to commercialize your inventions or prevent you from obtaining other materials for the same project. Please let CSRL know of any special concerns you may have with respect to the material.


I CERTIFY THAT I HAVE READ THE QUESTIONNAIRE AND THAT ALL INFORMATION PROVIDED IS ACCURATE.

This Information Form will be submitted electronically and validated by electronic signature. I represent that I am the Principal Investigator named in the Information Form and I type my name as an electronic signature.

 
  Signature of Principal Investigator
(no per signatures please) 		Date
Download Form. Principal Investigator must sign the printed form before submitting by fax or interoffice mail.
MTA Out Form.doc
MTA Out Form.pdf