Streamline and Simplify Your Addgene Work
Introduction
Scientists wishing to share their plasmids are often faced with several logistical and administrative hurdles. For some scientists, the demand for their plasmids greatly outpaces their labs’ ability to fulfill each request. This leaves many requesting scientists--all of whom are eager to start their own experiments--without reliable access to useful, research tools. For other scientists, the prolonged series of administrative paperwork and negotiations is deemed too confusing or prohibitively time-consuming. Rather than wading through the appropriate administrative channels, they transfer their materials without executing any paperwork or securing the relevant permits. In most cases, neither outcome is ideal for the scientists or their institutions.
For over ten years, Addgene has dedicated itself to making it easier for scientists to share plasmids. By operating a plasmid repository on behalf of the international research community, Addgene provides resource-limited labs and their respective institutions / technology transfer offices (TTO(s)) with a ready solution to several logistical and administrative hurdles. 1 In the last five years, Addgene has seen a steady growth in both depositing and requesting institutions.
While many TTOs have an efficient means of processing Addgene deposits and/or requests, there are other TTOs (both new and old Addgene partners) that have expressed interest in streamlining their steadily increasing workload. This piece will provide some real-life examples of how Addgene’s Master Deposit and Master Reception Agreements have helped TTOs of all sizes.
Streamlining Deposits
Basic Deposit Process
Scientists wishing to deposit their plasmids with Addgene must provide technical data as well as general information such as the plasmids’ and/or their components’ origins, toxicity, and, in some cases, funding sources. Once Addgene has obtained the relevant information, Addgene sends a deposit agreement to the depositing scientist’s institution for review and signature, typically within one or two business days. The agreement states, among other things, that the plasmids will be distributed on the institution’s behalf to other nonprofit research institutions for academic and teaching purposes only pursuant to the terms of the Uniform Biological Material Transfer Agreement (UBMTA)--a widely accepted agreement intended to facilitate easy inter-academic sharing of materials.
Upon receiving a deposit agreement, an institution may occasionally reach out to the depositing scientist for more information. If the institution requires that certain questions be addressed for every deposit, Addgene can save the TTO some time by sending these questions directly to the depositing scientist upon receipt of the technical data and information. The institution will then review the scientist’s responses, the terms of the deposit agreement and the material-to-be deposited and then decide whether to sign the deposit agreement. Depending on the nature of these reviews and an institution’s levels of signature authority, this process can sometimes take months to complete. Meanwhile, the depositing scientist must continue to set aside time and resources to respond to material requests from his or her colleagues. The table below illustrates the basic deposit process for many institutions.
Institute Review : The review process varies widely amongst institutions. In some cases, a single person reviews the deposit agreement terms, questionnaire responses (if any) and the nature of the material (collectively the “deposit packet”). In other cases, more than one person must review the deposit packet--either in its entirety or in parts. Occasionally, this second (or third) person resides in a separate office at the institution or at an outside law firm.
Institute Signature . Once the deposit packet has been reviewed, the deposit agreement is signed by the authorized signatory who may or may not be the one who reviewed the deposit packet. For most TTOs, the authorized signatory is somebody or somebodies other than the reviewer(s). In some instances, the deposit agreement may be signed by multiple signatories in multiple offices.
Available for Distribution . After the deposit agreement has been fully executed, Addgene can begin sharing the depositing scientist’s materials with his or her colleagues.
Master Deposit Process
Overview
Master Deposit Agreements (MDA) can significantly reduce the time between a depositing scientist making a deposit request and Addgene distributing a depositing scientist’s materials on her/his behalf. Once an MDA is executed, TTOs and/or their outside counsel/administrators no longer need to review any legal terms nor track down authorized signatories. Review of the submitted deposit is limited to the material itself and, if applicable, the questionnaire responses. If the TTO has no concerns with the material being shared with other nonprofit research institutions for academic and teaching purposes, then someone within the TTO can approve the material for deposit online through an Addgene-provided account. The table below illustrates the streamlined deposit process.
Review of Material . The TTO reviews the material to be deposited and, if applicable, the questionnaire responses. The review of the material and responses, if any, may occasionally be done by multiple people (for example, if there is a funding related response).
Available for Distribution . If the review yields no outstanding issues, someone within the TTO can log into their Addgene-account and approve the specific item for distribution online.
Some TTOs have determined that even this limited review is unnecessary since plasmids are simple research tools. These TTOs have chosen to pre-approve any material that a depositing scientist submits for deposit with Addgene. In which case, after a depositing scientist has submitted their technical data and information, the material becomes immediately available for distribution. 2
Examples of Universities and TTOs that have benefitted from an MDA
Small Office:The TTO at University A consisted of two to three people who handled a wide range of issues for the university beyond technology transfer. Due to their size, any documents that required legal review were handled by outside counsel. Once the attorney approved the document, the TTO would then submit the document for signature to a vice provost. By executing an MDA, the TTO not only reduced the deposit turnaround time but also reduced their costs in engaging outside legal counsel.
University with Few Deposits:University B did not have a heavy concentration of scientific faculty. Accordingly, deposit requests for plasmids were few and far between. However, when such requests did arise, the deposit process was particularly disruptive for University B administrators. To mitigate the effect of these disruptions, University B administrators executed an MDA so that the administrators could readily handle future deposits with a few simple mouse clicks.
University with Frequent Publications and Deposits:University C was a large research university whose faculty frequently published in top tier journals. Unsurprisingly, University C received many requests for their scientists’ materials. In addition to the many Addgene deposit agreements that had to be reviewed and executed continually, the TTO also had its own inter-academic material transfer agreements to review and (often) negotiate. Looking for an easy solution to streamline some of their work, the TTO executed a MDA, which allowed them to spend more time on negotiating other agreements.
University with Open Sharing Policy:University D’s sharing policy regarding basic, non-hazardous, non-clinical research materials, such as plasmids, embodied many of the sharing principles put forth by the National Institutes of Health. Whenever a University D scientist received a request for materials, the scientist was authorized by the TTO to share the materials without a material transfer agreement (MTA), thereby avoiding potential rounds of negotiations and other barriers to sharing basic research tools. In order to implement this policy through Addgene, the TTO executed an MDA and chose to auto-approve all deposits to Addgene. While the materials would still be distributed under the terms of the UBMTA, the TTO found these terms to be acceptable for their purposes.
Streamlining Requests
Basic Request Process
Scientists wishing to receive plasmids from Addgene’s repository must first read, understand and acknowledge the terms of the UBMTA and any additional terms affecting third party rights 3 in the material. In some cases, a requesting scientist’s institution has asked that Addgene host a questionnaire on its behalf. Unlike a deposit questionnaire which Addgene manually sends after a deposit request has been submitted, a request questionnaire is hosted directly on Addgene’s website and can be completed by the requesting scientist at the time of “checkout”. Once the requesting scientist or the requesting scientist’s principal investigator (if required by the scientist’s institution) have acknowledged the terms of the UBMTA, the third party terms (if any), and completed the questionnaire (if applicable) (collectively, the “MTA packet”), the MTA packet is sent to the requesting scientist’s TTO for review and execution of the UBMTA. Similar to the deposit process, the review of the MTA packet can vary widely amongst institutions. The table below illustrates some of the common practices.
Institute Review of MTA . The review process varies widely amongst institutions. In some cases, a single person reviews the MTA packet. In other cases, more than one person must review the MTA packet--either in its entirety or in parts. Occasionally, this second (or third) person resides in a separate office at the institution or at an outside law firm.
Institute Signature . Once the MTA packet has been reviewed, the MTA packet is signed by the authorized signatory who may or may not be the one who reviewed the packet. For most TTOs, the authorized signatory is somebody or somebodies other than the reviewer(s). In some instances, the MTA packet may be signed by multiple signatories in multiple offices and may even include the recipient scientist’s principal investigator.
Researcher Receives Plasmid . After Addgene has received a signed copy of the MTA packet, Addgene sends the request to its lab for fulfillment and ships the plasmid to the requesting scientist.
In addition to the various review procedures across institutions, the method of signature may also prolong the MTA packet turnaround time. Not all institutions sign MTAs electronically. Some require hard copies while others will accept scanned PDF signatures. In either case, both require the physical printing, signing and mailing/scanning of the MTA packet. Most requesting institutions, however, use Addgene’s electronic MTA (eMTA) system for reviewing and signing the MTA packet. Addgene provides the requesting institution’s TTO a unique and secured link to the MTA packet hosted on Addgene’s servers. The TTO can review the MTA packet as necessary and subsequently forward the link to the respective signatory for signature--thereby reducing the time taken to physically print the packet, track down the signatory and execute the MTA. Institutions choosing to sign the MTA electronically generally reduce their turnaround time by two days, which allows their researchers to begin their experiments all the sooner.
Master Request Process
Overview
Like MDAs, a Master Reception Agreement (MRA) can help TTOs significantly reduce their workload and MTA packet turnaround times. Since Addgene materials are always distributed under the terms of the UBMTA and the terms of the UBTMA are readily accepted by most institutions, many TTOs find MRAs extremely helpful in streamlining their work. For many, the time and expense spent in having multiple people repeatedly review and sign the same, acceptable terms does not make sense. Other TTOs, notwithstanding the ease of the eMTA system, find that they are simply “rubber stamping” incoming Addgene MTAs and wish to avoid going through the motions of clicking through the eMTA system. By executing an MRA, TTOs can obtain all the requisite reviews and signatures upfront, so that future requests are not slowed by simple procedural policies. Moreover, TTOs can choose to have any future material requests automatically approved by pre-approving certains terms within their Addgene-provided accounts. TTOs that have chosen to execute a MRA with pre-approval options have reduced their MTA packet turnaround time to less than a day. The table below illustrates this streamlined request process.
Auto-Approval Check . After the scientist completes the MTA packet, Addgne’s system determines if the terms have been pre-approved by the Institution. If all of the terms have not been pre-approved (UBMTA and any additional third party terms) by the Institution, then the TTO is notified that the MTA packet requires review and approval [ See Table 5. Institute Review of MTA and Institute Signature ]. If all of the terms have been pre-approved, then Addgene’s system notifies the TTO that the request has been pre-approved pursuant to the Master Reception Agreement and the TTO’s pre-approval preferences.
Researcher Receives Plasmid . Once the MTA packet is approved, Addgene sends the request to its lab for fulfillment and ships the plasmid to the requesting scientist.
While currently applicable agreements and terms of use are made available to TTOs for pre-approval through an Addgene-provided account, there is always the possibility that new terms will be added or current terms may be modified. Any third party terms that are later added or modified will require approval or reapproval by the TTO before future requests can be automatically approved. The table below illustrates this pre-approval check.
*Uniform Biological Material Transfer Agreement
Table 7. In the example above, use of this plasmid is subject to three agreements--the UBMTA (entire plasmid), Third Party “X” Additional Terms (orange portion), and Third Party “Y” Additional Terms (purple portion). The pre-approval preferences of each institute will determine whether or not a request of this plasmid will be auto-approved by the respective institute.
(1) Recipient Institute A has pre-approved the UBMTA terms only. Therefore, if a scientist at Institute A requests the plasmid above, then the request will not be auto-approved, and the MTA packet containing the UBMTA, “X” and “Y” terms will require the review and signature of Institute A.
(2) Recipient Institute B has pre-approved the UBMTA and “X” Terms only. Therefore, if a scientist at Institute B requests the plasmid above, then the request will not be auto-approved, and the MTA packet containing the UBMTA, “X” and “Y” terms will require the review and signature of Institute B.
(3) Recipient Institute C has pre-approved the UBMTA, “X” and “Y” Terms. Therefore, if a scientist at Institute C requests the plasmid above, the request will be auto-approved. NOTE: If the third party additional terms should change after they have been pre-approved, then the institution’s TTO will have to re-approve the modified terms within their Addgene-provided account.
Example of Universities and TTOs that have benefitted from an MRA
Small Office:Similar to an MDA, MRAs also provide smaller offices a way to reduce their outside counsel costs and request turnaround times. The TTO at University A executed both an MDA and MRA.
University with Frequent Requests:University E was a large research institution that had, on average, 70 plasmid requests per month. Rather than forwarding and signing the UBMTA 70 times each month, the TTO executed an MRA, which reduced the administrative workload of several individuals at the University. Moreover, because the TTO had repeatedly reviewed and signed the UBMTA and various third party terms, the TTO chose to pre-approve all available agreements. Accordingly, while Addgene continues to provide email notifications to the TTO each time a request for plasmids is made, the TTO rarely has to take any action. If the TTO ever has need for a specific request or MTA, they can access individuals records within their account. By executing an MRA, the TTO cut MTA turnaround times to mere minutes thereby allowing their researchers to get their requested materials as quickly as possible as well as giving the TTO and other university administrators more time to focus on other pressing matters.
University with Multiple Authorities:University F was a non-US institution that consisted of several colleges and departments--each with its fair share of researchers requesting plasmids from Addgene. Initially, Addgene did not have a central contact or signatory for the university. According to various university administrators, several officials were authorized to sign MTAs, including college deans, department heads, presidents and provosts. However, requesting scientists were never certain who they should be forwarding their MTA to for review and signature. In order to simplify and centralize the request process, the university executed an MRA. Not only did the MRA streamline the request process by reducing the number of email exchanges but, by consolidating the requests into a centralized Addgene provided account, it also improved the university’s recordkeeping and tracking of statistics.
Summary
One of the ways Addgene is making it easier for scientists to share and to receive plasmids is by working closely with its academic partners and their respective TTOs to address their MTA-related concerns and to optimize their Addgene-related workflows. Addgene-hosted questionnaires, for example, can save TTOs days of email communications. Addgene-TTO accounts provide TTOs consolidated and readily accessible distributions inventory and request logs, which can expedite internal record keeping. And by implementing an MDA and/or an MDA, TTOs can reduce their agreement turnaround times, save money on external expenses and have more time to focus on complicated matters, such as licensing deals or regulatory issues. Further, by reducing agreement turnaround times, scientists can better focus on their own research experiments rather than on fulfilling the material requests of others or on waiting for multiple internal or external offices to approve their own material requests. As Addgene grows, it will continue to work with its TTO partners and institutions to develop beneficial solutions to ensure that scientists have the materials they need as soon as they need them.
Endnotes
- See Addgene, Benefits of Depositing Plasmids at Addgene ,https://www.addgene.org/deposit/benefits/(last visited Jan. 1, 2016; describing benefits for depositng labs); and Addgene, Technology Transfer Benefits ,https://www.addgene.org/technologytransfer/ttopage/benefits/(last visited Jan. 1, 2016; describing benefits for technology transfer offices and admnistrators).
- Practically speaking, there will be some lag time as Addgene will require time for replication, growth and sequencing of the deposited plasmids.
- Plasmids can consist of several different parts, which may come from a variety of sources. For example, specific fluorescent protections are very popular to build into plasmids for flagging/labeling purposes.