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For Investigators |
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Material Transfer Agreement (MTA) - A variety from which
to choose |
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A primary goal of research is to attain the widest possible
circulation of research knowledge and material in order to maintain
a cycle of continual learning. To that end, the NIH has developed
multiple methods for transferring materials between research entities,
whether federal or academia, with a minimal amount of documentation.
However, realistically, there are just as many various competitive,
legal, and regulatory interests influencing your research options.
Those influencing interests require definition of such factors,
not exclusive list by any means, such as use, liability, and profit.
Therefore, the day of no paperwork or even little paperwork is rare.
The vast majority of academic and commercial institutes will now
require some type of agreement prior to sending you material. You
should ask if an agreement is required, it can save you possible
headaches later and possibly your fellow researchers job. If they
say no agreement is necessary, enjoy it- it won’t happen often!!!
Take heart however, for the underlying design of Material Transfer
Agreement (MTA) and Simple Letter of Agreement (SLA)
is to be succinct, specific, and easy. While an MTA is not mandated,
the use of such a simple process makes good sense in the administration
of a lab. The terms included in any agreement vary between providers,
and significant differences in structure exist between providers
from an academic and commercial entity, but in general, an MTA and
SLA will address at a minimum, the following:
- Identification of the provider and recipient
- Identification of the material and the volume of material
- Definition of the research, how the material will and will
not be used. The use of the material can be broad or narrow, depending
on what the scientists involved have agreed upon. By documenting
the intended use in writing, the chances of a misunderstanding
between the scientists as to what research will be conducted are
reduced.
- Maintenance of confidentiality of background or supporting
data or information, if any
term of agreement and disposal of material at end of agreement
MTAs specify that the receiving scientist may not transfer the
materials to another scientist without authorization from the
providing scientist. This allows the providing scientist some
assurance that he will be informed if the material is transferred
to another laboratory.
- Indemnification and warranties. MTAs are agreements between
institutions, therefore any liability incurred in using or disposing
of the materials is the responsibility of the institutions and
not the scientists sending or receiving the material.
- Issues of discovery or invention from the use of the material.
- Conformance to applicable statutes, regulations, and NINDS
and NIH policy.
- When materials are transported from the NIH campus, since they
are federal property, one should have either a property pass or
a MTA to avoid complications which could arise from accusation
of mishandling of federal property.
The UBMTA ( Uniform Biological Material) transfer Agreement
is an agreement born out of a desire to streamline the transfer
of materials for research. Amongst those organizations catering
to such a philosophy, regardless of classification, any organization
can be signatory to this agreement as administered by the Association
of University Technology Managers (AUTM). The use of the UBMTA is
not mandatory, so in instances that special circumstances prevail,
a signatory is not bound to the use of only this agreement but can
opt for any agreement of their choice.
A Consortium or Repository MTA may have many of the same
clauses of a standard MTA, but generally will include a special
section dealing with “ background rights” to those materials
being deposited or being requested from the repository. Generally,
the consortiums and repositories have agreements for those contributing
materials and a separate agreement for those requesting materials
Software Transfer Agreements (STA) are still being revised,
simply due to the complex underlying legal issues surrounding software
development and protections. The Office of General Counsel has approved
software transfer agreements as utilized by some of the ICs of the
NIH, and within the near future the PHS Technology Transfer Policy
Board will adopt a version that can be utilized as a Standard.
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Processing an Agreement for the Transfer Material
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An important part of many of your labs is attaining
and distributing materials, compounds, or software from colleagues’
labs. We want to make the process of using any form of the Material
Transfer Agreement (MTA) efficient in assisting you to get materials
into and out of your lab. A few hints to getting this done quickly
is:
- Use your NINDS TTO services to send and receive the agreements
– get them involved early
- Your lab chiefs must be the requestor for the material (NEW)
- Someone from the NINDS TTO must review the agreement before
taking it for signature
To initiate this process, you have three options:
go on the website http://ott.od.nih.gov/forms_model_agreements to attain the form which you
can fill out the information, send it electronically to the NINDS
TTO for review. After review, the NINDS TTO will have you download
and print out in duplicate, sign where appropriate as the investigator,
get the lab or section chief to sign, then send to NINDS TTO via
campus mail. The NINDS TTO will get the appropriate NINDS signature,
then overnight the duplicates to the recipient for their signature.
NINDS TTO will follow up with the firm to get signature in a timely
manner.
Or
you can contact your NINDS TTO office and we will send to you an
electronic copy of the Word form for the appropriate agreement for
your situation. You can fill it in electronically, email it back
to one of the NINDS TTO staff, who will review and approve it, send
it back via email so you can print it out, in duplicate, sign it
as requesting researcher, have your lab chief sign it, then send
it back to the NINDS TTO who will get the NINDS signatory to execute
it. The NINDS TTO will overnight the duplicates to the recipient
for their signature and follow up with the firm to get signature.
Once it is returned to NINDS TTO, we will notify you that the material
can be shipped
Or
You can send the email or fax that you got from the fellow researcher
requesting the material, and forward it to the NINDS TTO including
your name, your lab chief’s name, your address, phone and
email and a brief description and amount of material you plan to
send. We will contact the recipient if necessary, fill in all information,
send you the completed form electronically. You print it out in
duplicate, sign it as researcher, have your lab chief sign it, then
return it to NINDS TTO which will overnight the duplicates to the
recipient for their signature and follow up with the firm to get
signature. When the NINDS TTO receives a fully executed copy back
into our office, we will send you a copy of the fully executed agreement
for your files. At that time, you can ship out the materials.
Processing an Agreement for non-NINDS Entities :
Your NINDS TTO must review all outside agreements. Unfortunately,
simply because the title of the agreement is Material Transfer Agreement
does not mean that it says the same as the NIH form. An MTA is a
good management practice because it helps to prevent misunderstanding
and avoid commitment to non allowed liabilities. We find quite often,
universities and research institutes include articles to which we
cannot agree due to statutes or NIH policy. If you are requesting
material from a commercial firm, quite often their agreement is
listed as a Material Transfer Agreement, but many times it will
have terms we can have only in our MCRADA or Clinical Trial Agreement.
For those agreements that are and should be MTAs, once the NINDS
TTO has reviewed the agreement, if no changes are required, the
TTO will route the agreement for appropriate signatures. If changes
are required, the NINDS TTO personnel will notify you that some
terms are not acceptable and then contact the provider’s appropriate
personnel and negotiate appropriate terms. The signature routing
includes the NINDS investigator sent duplicate copies with a routing
sheet for signature, the signature of the lab chief, and the signature
of the authorized NINDS signatory (NEW) who will send both copies
back to the NINDS TTO. NINDS TTO personnel will send the duplicates
to the provider of the material and follow up with them to attain
their signatures and get one fully executed copy back for NINDS
files.
Note: When staff are leaving your lab’s employment,
they must fill out an MTA for materials which they are taking with
them. They can do this as individuals, or they can have the new
employer sign ( the latter is generally the preferable ).
When materials are transported from the NIH campus, since they are
federal property, one should have either a property pass or a MTA
to avoid complications which could arise from accusation of mishandling
of federal property. |
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