Signatory Money Transfer Agreement Template Made Easy

Signatory money transfer agreement template

read thank you very much for joining us for the FTP data transfer and use agreement template 101 webinar and hopefully all the information you need for a successful kickoff of the DQ a template pilot starting November 1st my name is Melissa Cerf I'm the Associate Director for grants and contracts at Harvard Medical School and my co-presenter today is Martha Davis associate director at Brandeis University we're going to start with a little bit of an overview of the templates for those of you who may not have had an opportunity to use them before but before that we'll dive into a little bit of the background that led to the template development some of the work that we did to create the templates and then we'll get into a little bit more of the details of a pilot we'll discuss the overall goals of the pilot what we're calling the rules or what we're asking pilot participants to do the timeline and then of course well answer any questions that you may have about the templates or a pilot or GTO is generally we will pause briefly in between the sort of two general sections so after we go over the templates what we'll pause and see if there's questions on specifically that content then we'll go into the to the pilot content and then similar then have an opportunity for a question and answer on that section so what is a DTU a-anyway what are we talking about so broadly speaking it's a contractual agreement used to define how exchanged data may be access and/or used there's a lot of different labels that we see attached to these data youth agreement which is what both might be a little bit more accustomed to seeing a nondisclosure agreement a confidentiality agreement a Memorandum of Understanding an information transfer agreement these are all labels that are attached to an agreement whereby an investigator is receiving a data set or information that they intend to use in a research project and we intend to capture all of those when we say data transfer and use agreement and you all might be thinking well data use agreement is a more common term that's how people refer to them you know most of the time so why are we calling this Aditi way why not just dua and under HIPAA the Health Information Portability and Accountability Act under HIPAA dua or data use agreement is specifically defined as that agreement that you use to transfer a limited data set for research and we wanted the template that we were creating for it to be clear that the intention was for it to be usable for a broad range of data types and so we chose data transfer and use agreement so as to be clear that it wasn't just an agreement for a limited data set and we thought that it was a pretty accurate description of what we're doing we're setting out an agreement that governs the transfer and use of research data so what is research data anyway it's recorded factual material it it isn't actual material it isn't cells it isn't lab notebooks it's the recorded factual material commonly accepted in the scientific community as necessary to validate research findings and in surveys and discussions with STP member organizations we found that the volume and complexity of DTU A's is really going through the roof lately i've heard from a number of colleague institutions who said you know we went to having almost none to having like you know 100 in a year we've seen a three 300% increase in our data transfer in use agreements and you know i know at my own institution i see you know 20 to 30% increase annually in our inner volume and each one when each one is different you have to read each one and you have to negotiate the terms and you have to communicate differently with a faculty member so that they know where to find the terms that are relevant to them and you know make sure they know where to look so that they know what they need to do to comply with a data transfer and use agreement in addition to that you know we have a lot of faculty now in the era of big data that are combining different data sets for a research project they might be getting a data set from a collaborator at institution a and then from an insurance company and maybe from an NIH repository and combining them all together and when those days all have widely varying terms it becomes very difficult for that faculty member to understand what they need to do for compliance with that whole data set so we embarked on the effort to create a data transfer and use template use agreement template as a first step towards improving the quality of those agreements so sometimes we also see a one-page agreement that doesn't actually cover all of our obligations than using a data set and creating greater consistency in terms and format to reduce associate administrative burden we are hoping that the DT way will have a very similar effect of something like the UVM ta the universal biological material transfer agreement aside for NTAs or that the FDP sub award agreement template has had four sub award agreements we're really driving towards some consistency in the format and terms has greatly improved turnaround time and you know reduced negotiation effort and time associated with those agreement types even outside of FTP number institutions we can see that some of those templates even when they're not adopted in their entirety but they're there and they provide some sort of model for consistent language actually helps us at better language or start to see better language from other foot for not using the whole template but our borrowing pieces and those of you who pay attention to the let the latest breaking news on data sharing like I do will have seen that NIH published their RFI for information that will help them in the final stages of development of the NIH wide data sharing policy so we see the agencies you know encouraging and creating more policies you know NIH is just the latest in the in large federal funders not to mention the foundation funders that are developing data sharing requirements so the requirement to share the data is there which means there's more data out there to be shared more data that our faculty are needing and a low burden method for sharing that data that we can't just post on a website is going to be really critical in helping us comply with those obligations when there's more data there's more dua z' and if we're having to negotiate each one of those separately and review on each separately and develop different compliance methods for for widely different terms it will really make that harder on our faculty and harder on ourselves so hopefully this template will be that first step towards creating a low burden method for that and actually help remove one of the potential roadblocks to data sharing so when we were starting barking on creating the template we opted to to go after sort of a low-hanging fruit initially the simplest paradigms for data sharing are you know we have a provider institution who has a data set another recipient institution who would like to access that data set for use in a project at their own institution so it's a single directional flow of information from the provider institution to the recipient institutions it assumes no collaboration between the two entities it doesn't really contemplate bi-directional flow of information we wanted to start with this simple paradigm so that we could try to make sure that we were getting things right and then try to roll out potentially different face pages that might help accommodate these other kinds of scenarios or as some of you may have heard working with the sub-awards group to develop a specific attachment that could be incorporated into a sub-award agreement that would cover these terms but for right now it's just we're going for the the simplest scenarios and in that same vein we have created attachments that work for de-identified data about human subjects or a limited data set or of course if you are sharing a data set that doesn't require by regulation or law additional requirements beyond what would be the standard terms in any data transfer and use agreements then you can use the face page without any additional special terms and an attachment to so for the pilot purposes and because quite honestly it's what we've published so far those are the data types that would be covered right now by published documents and under the pilot so like I said the the template currently isn't designed for bi-directional flow of information I've heard from some institutions that were able to easily make a few tweaks and have it work for that it isn't designed for sharing of materials so if you're sharing data human cells or humans human tissue samples or something like that it doesn't really contemplate the sharing of physical materials doesn't really work for a repository where one entity has a collected data from a broad number of institutions or where third-party rights that are inconsistent with the template terms attached to the data set so if you've obtained the data from a colleague institution and you know you may be some modifications to it and then you want to share or you added your own data to it and you want to share the full dataset with a third collaborator where you have terms and obligations to the original data provider the the DTU a template in its current form would require some tweaks potentially to work in that scenario so what are we talking about when we talk about de-identified data about human subjects or a limited data set so if we're talking about a covered entity under HIPAA in that case we would be looking for all 18 of the identifiers enumerated under HIPAA to be removed from the data set and if the provider is not a covered entity we would look for identifying information such as meme or social security number that would invent that would enable anyone with access to the data set to readily identify the subjects to have been removed so you know de-identified from a common rule or an IRB perspective when we're talking about a limited data set it's a very specific definition under HIPAA and basically all but two of those 18 identifier 's have to be removed in order for something to be considered a limited data set and we'll get into how to handle the limited data set from a covered entity to a non covered entity or those kinds of questions in a little bit so the template structure when we were working on creating the template we talked about a few different options and because we were trying to create something for data that was you know very similar to what the UVM ta did for MTA's we considered that model where there is a an overarching agreement Master Agreement that institutions have signed on to and then as each sample is shared or as each material is shared there is an implementing letter that's executed for that specific transfer but we realized that when we're talking about data it requires a little bit more flexibility in the terms because based on the flavor or the type of data that's being shared you need by law or regulation you need some slightly different terms you need some slightly different terms for DNA fi data versus a limited data set versus you know pH I pull pH I and we wanted to create something that would be flexible enough to accommodate that and so we looked to the FDP sub-award Agreement format in that it provides the flexibility to be issuing sub wards that are at their core very similar but under you know awards from a varying set of agencies that require flow down of slightly different terms and we looking at that model we created a face page which is actually several pages but you know for sake of consistency of face page that includes the information in terms that we feel needed to be included in every data and transfer and use agreement regardless of the data type and then an attachment one that includes information related to the project specifics the description of the data the description of the project that you're obtaining the data for you're sharing the data for are there any kind of specific transfer requirements that that both parties need to be aware of and in regards attachment one I've actually heard from some institutions that faculty actually find that to be a really useful tool as they're planning for sharing of certain data like oh I should think about those things I should think about how I'm going to to get you this data set while we're planning for this transfer so it can actually be a very nice tool in helping faculty plan their data sharing scenarios attachment 2 is where you would incorporate any additional terms that are required by law or regulation so that's where you would see the couple additional terms that are usually added in when you're dealing with de-identified data or limited data set or other types of data and attachment 3 there's a there's a lot of data providers that might might want each individual institution who's going to access the data to find their own separate data use agreement and some institutions at site naw man I want to only share this with one institution and you take responsibility for whoever else needs to access it for your project and you take responsibility for getting them access to that data and the liability for them accessing the data through you and so we wanted to provide enough flexibility for both providers where if the provider wanted to allow access by third-party collaborators at other institutions and the recipient institution they could indicate that on attachment 3 so you can either say none on attachment 3 or provide a definition of who you're authorizing where can I find these template documents Melissa they're all available off of both the dated stewardship and contracts subcommittee pages on the FTP website I guess one of the things that I didn't mention when we were talking about the background is that this is a collaborative effort between the data stewardship subcommittee under their research compliance committee and the contract subcommittee under the research administration committee because it really kind of covers both aspects there's an agreement aspect and there's an aspect of ensuring appropriate data stewardship and security of the data that's being shared the components that are currently available are a single PDF document that includes the face page components as well as attachments one and three because those are the attachments or the documents that are going to be consistent regardless of which type of data you're sharing and unfortunately we're just not to the police where we have kind of consistency in the language to consider doing some of the really fancy programming that the sub-awards group has done so we have to have the versions of attachment to be separate PDF documents for right now it is a thing that we're hoping to maybe get to where we could do some of the programming that you could just click a little a little radio button and have it pull in the right attack meant two terms but for right now we're a little lower tech and there is a separate PDF document of the attachment two for de-identified data about human subjects a separate PDF document for DTU a four attachment for limited data set and a separate PDF document for four other and can talk a little bit more about what we envision the other attachment to be used for in a few minutes and so one one quick point on this is I believe it's one of the pitfalls that folks have seen with folks who have already started using the templates is that an attached of or any a version of attachment two must be incorporated in the final agreement package so even if you're comfortable totally with all the facepage terms you don't feel that you need to add additional terms for the type of data that you're sharing you do need to include attachment to other and mark none because otherwise it looks like maybe a document just got left out or something along those lines so just an important reminder that some version of attachment 2 should be incorporated in every full agreement package as I mentioned they are PDF documents and their form syllable in places where we feel that people would need to be adding additional information especially in attachment one weathers large text boxes for things like a description of the data or description of the project we have included instructions should the drafter with the type of information that the working group felt one should consider when completing this section and then we do ask that language that's not where a text box isn't provided for special language to be included that the form not being modified the whole point you know as was the sub award agreement templates is to create some consistency and thereby get some reduction in administrative burden and some streamlining and so where the text is not intended to be altered we ask that it not be so if the technological gods are with me today I am going to pull up the the PDF documents here give you one second so while I have this screen up I also did just want to show what the data stewardship page looks like and so this is where all of the documents right here are available via the website and on the contracts website it looks very much the same all the documents are just posted in a format like this underneath the the templates and we will talk a little bit more about some of these documents in a few minutes are some of the guidance documents that we've developed already and of course the FAQ documents that we've circulated for the pilot Melissa I'm not sure this is Martha I'm not seeing that but maybe it's just my screen I don't know if other folks are seeing that this again I'm not saying it as well do you mind going back to the slice and REE sharing your screen and seeing a bat pulled it up surely see [Music] you you you how's that yeah better yeah yeah you can see that now okay yeah and can you see the data stewardship page now mm-hmm yeah okay so sorry about that so now you can see where we have the documents posted and in the same format on the contracts website and then there are the guidance documents below that and then below that documents related to the pilot which right now is just the essay cues but as we get closer to launch additional documents might be posted there okay and now we can all see the face page hopefully so you can see that this is a mate 2017 version that is when the templates were originally posted on the website so some of you may have already started using this template or you may have seen an agreement come in on this template from another institution that has already started using it so please feel free if you want to use it before the pilot kicks off or you want to suggest it to your friends who are ftp member institutions this is this is out there for anyone who would like to use it to use it we have included a little text box here for an agreement ID some institutions my own is just launching use of the hero and agreements module so some institutions may use a system that will assign an agreement ID and so if you have one you can put that here and it's helpful because we are have several pages that constitute the full agreement it might be helpful just to make sure that you've but you've got all the right pages in the right document and then provider and recipient so provider we define as the entity that is sharing the data set and the recipient is intensity that is receiving it this terminology is mirrored off the terminology that's in the UVM ta template as we try to we we mirrored the FTP sigil or template but where we could also incorporate some consistency of terms in the UVM ta we try to do that as well and then rather than having a separate attachment for contact information as there is in this award agreement we felt that there was really a few enough contacts that were needed for the data transfer and use agreement that we put boxes right under the name of the institution for the provider scientists name and email or the recipient scientists name and email and I've heard from some institutions that have said well you know what if what if we don't really have a PI that's in charge of the data set that we're sharing and I would say whoever then is really the programmatic contact for that data set would be the appropriate person to list there we have a place here for a project title which we construe as the title of the project that the recipient will be performing with the data set and a box for agreement term and these are text boxes so you can change them but we have pre typed in in the start date date of last signature below in in the working groups experience most institutions are not willing to share a data set with the recipient until that data transfer and use agreement is executed so it seemed to make the most sense that the earliest possible start date would be the date of last signature and then we provided for the end date to be an amount of time after the start date for that reason usually you need the data for awhile my project is going to take three years so you need it you need the data for that three years whenever it gets signed but that is also a text box and so editable but we typed in three sets seemed like a pretty average length of time for data use agreements and then the final box in that header is a drop down menu for attachment to type and that's where you would select which which data type and much attachment to type the reviewer can anticipate to see when they get to that point of the document now there is an option here for fully identifiable human data though that attachment to version is not yet published so for right now with published components it would really just be de-identified data about human subjects limited data set or the other see attachment to options you so like I said these terms and conditions here are what we felt as a working group would be needed for any agreement that is being executed for sharing of research data so here in article one you know provider is going to provide the data to the recipient and a reinforcement that the provider retains full ownership rights in the dataset and in section two we've introduced the concept that it's possible that the provider will incur some cost in preparation or transfer of the data set if for example it's a very large data set and the best way to transfer the data is to purchase a server or an external hard drive download the data and ship that to the recipient the cost of perhaps purchasing the external storage or the shipping costs may be the types of costs that the provider would seek reimbursement for a reminder an article 3 that the recipient won't use the data except is set forth under the agreement and then the remainder of section 3 is where we get into the definition of authorized persons and so if someone is or if a provider is going to permit collaborate or personnel this is where we see that that concepts introduced into who's actually authorized to use the data for we cover that the recipient has obligated to retain control over the data and put in place appropriate administrative technical and physical safeguards to prevent any unauthorized use or poor access to the data and in general comply with whatever additional requirements are set forth in that attachment to that gives those sort of data specific type terms a general compliance with law statement and article 5 that we will generally use the data in a way that complies with applicable laws and then a publication section in article 6 we had a lot of conversations about this because it seemed that including the 30-day review period maybe shouldn't be necessary and so should we encourage institutions not to include that but at the end of the day we've seen you know some inconsistency in this section and wanted to put out their language that is broadly acceptable to most institutions so rather than leaving it out and haven't have a lot of institutions feel but they couldn't use the template because this wasn't addressed or try to insert something that wouldn't be consistent with what's you know usually expected by academic institutions we felt that it was wise to insert something here so we cover permission to publish and then a 30-day review period for the provider provider in which to identify if any section of the data has been inadvertently included also on the second page here too we see that the agreement ID would carry through so on the first page if you inserted there just carries through the rest of the documents in this in this PDF document seven we agreed to recognize the contribution of the provider and if there is a specific publication or other citation that should be used for the data set that can be included in attachment one here in eight we cover termination provisions and that attachment one may provide further information on disposition of the data upon termination nine is a pretty standard disclaimer of warranties and in nine and ten is where we really try to maintain some consistency with the UVM ta because a lot of institutions might prefer to have an indemnification in a data use agreement to ensure that the provider is taking on the liability for their use of the data but a lot of it that our member institutions are also signatories to the ub MTA and so that middle ground space of not an indemnification but the recipient you know taking on responsibility for their actions with the data seem to be a good middle ground or we hoped would be a good middle ground an article 11 we have some pretty standard use of mean language that we we tried to have consistent with the use of mean language that's been inserted in the sub award agreement the FTP sub award agreement and in section 12 because we're all loyally legal agreement types we actually enumerated attachments that constitute the full agreement and then on the final page of what we call the face page we have the signatory boxes so this is where we have some language that reinforces that if you are going to sign this this data transferring use agreement you should be authorized to do so by your institution because I hope I'm not alone in the fact that sometimes faculty might think that day are authorized to sign and in some cases their institutions will authorize them to sign agreements like this but we wanted to just remind people to make sure that they are in fact authorized to sign before they do so and then there's also underneath the signature block for each party to the agreement there's a place for contact information for formal notices so up at the very top of the document start of the document is where we would include programmatic contacts and then this very at the very end here underneath the signature box is where we would provide administrative contacts moving on into attachment one so this is where you see that we have these big text box things like description of the data and have instruct instructions to the draft are so this is very important that second part of that first statement so delete after completion of this section so the text sets in here is really just to give some prompts as to the level of detail that would be appropriate for these sections or the types of information that a faculty member might want to include here so in the description of the data you know a description of the population of human subjects that the date has been obtained from if it's related to human subjects if it's from animal subjects perhaps the species or the number of of animals that were included the name of the study that the data was obtained under and you know as I mentioned when we were going over the face page if there is a particular publication or a grant that needs to be acknowledged in publications that result from use of the data this is a place that that information could be could be provided to the recipient section 2 of attachment 1 the description of the project so we view this is very similar to a statement of work in a sub-award agreement it should be sufficient for both parties to understand the project that the that the recipient will be undertaking and if required by your institution or by regulation should be sufficient for an IRB to understand how the data will be used and determine whether or not it's consistent with consensus the data is about human subjects so we suggest the objective or the purpose of the work a general description of the actions to be performed rather recipient with the data and then in particular if there's any restrictions on linkage of the data with other datasets that information could be included here or if your faculty member knows that they need permission to link it with another data set they might want to include that here so it's clear that that they are going to do that in section 3 you can provide if there is a different contact for someone who should be receiving the data when it's transferred so in some of our departments here at HMS we'll have faculty who have a programmer that helps them out and that's the person who should receive the data set because they're going to make sure it goes where it needs to go and get it ready for the research project so they could put that name here and give some indication as to any special instructions that might be needed by either party in order to make the transfer and in section 4 in the interface page it addresses that if there is any need to reimburse costs that be addressed in this section so in a lot of cases it will probably be done in many cases if we're able to just make a secure file transfer of a research data file that's low or no cost in some cases and so this will be none but if perhaps there are some costs and you know that the way that you need to handle that is by a separate purchase order or something along those lines that could be you can indicate that in the second box or if you you know have just a few instructions like it's going to cost me a hundred dollars to ship you back your external hard drive you can indicate that in the third box and then there's a text box for that information disposition requirements this is we had a lot of conversations about dua s that say at the end of this dua or GT you a you'll either return to destroy the data you know based on however we instruct you to do it and feeling that to the extent possible would be really nice to know ahead of time if you're expected to destroy the data or return it just so that you can make sure that you're storing the data in a way that's appropriate for whichever method so if there's special instructions that you'd like to provide for that that can be included in article 5 on attachment 1 and then here we see attachment 3 which you can either indicate that collaborate or personnel means none so no third-party collaborators are permitted to access the dataset through this agreement or you can check the second box and mutually agree on who that might be so you can either we've provided a suggested definition for collaborator personnel here it might be work better for certain parties to actually list individuals you know if there's going to be some agreement on collaborate or personnel this is really intended to be flexible to meet your needs and then we can take a look at some of the attachments so I've just brought up the attachment to for de-identified data about human subjects Martha do you see that one just to make sure I do okay good so like I said it's very important to make sure that okay hold on one second it's very important to make sure that a version of attachment two is incorporated excuse me and we think that probably the most common we use attachments will be either this one which is de-identified data about human subjects which covers in the first two bullets basically the definition but that your as a provider you're saying you'll either not include any personally identifiable information or if you've covered entity if you're a covered entity that you will have de-identified the data to the HIPAA standard and then some of the standard things we see with the de-identified data set that the recipient won't attempt to identify the subject they won't attempt to notify or or be in touch with the subjects and also that the provider is there is a key the provider won't provide it to the recipient and that will promptly disclose any inappropriate or unauthorized uses of the data the probably most common second type of data set that we see data transfer and use agreements for is a limited data set and this is we very carefully went through the HIPAA regulations and checked off the boxes so either either the element that's required in a data use agreement under HIPAA is included in the face pages or if not it's included in this attachment to we also opted in in section 4 of this attachment to actually list the identifiers that have to be removed because a lot of participants in the working group had found that some investigators would say all know how this is de-identified and then they look at the description of the data and say but I see you need you need this information what do you mean is this de-identified or this is a limited data set and so by providing the identifiers that have to be removed we hot in this attachment we thought that that would help streamline review because the reviewer would have it right there and also as a reference point for faculty members who are trying to determine which data type they have and then otherwise this attachment is very similar to the de-identified in the sense that you know the recipient won't attempt to re-identify the subject will comply with any local regulations relating to IRB approval and insertion of HIPPA references or potentially the need to amend the hip amend to the DTA if HIPAA is amended down the road then we see the other version of attachment 2 so so here this very first box none if you are sharing a dataset that that you really only need the terms that are in the face page make sure that you include this version of attachment 2 and check none so that someone doesn't think the other party doesn't think that you've just forgotten to include the appropriate version of attachment 2 or if there are some minor additional terms and conditions that need to be incorporated in order to comply with a state law so we've heard about a relatively recent law in California that might deal with data privacy and so if California institution is sharing data and just needs to insert reference to that California law they might be able to use this attachment but we ask that the attachment to other not be used as a way to get around or modify the core terms of the data transfer a noose agreement by adding a whole bunch of additional terms that aren't aren't required by some sort of law or regulation you so I think that that covers the templates so I'll pause for a second and see if anyone has questions on that section of the webinar you so what was it oh sorry I'm seeing any questions but there are a couple of questions that people have asked previously mm-hmm and one of them being well actually I think you've covered a lot of some when would a non-covered entity component disclose a HIPAA limited data set I think that's a good question I'm not sure I did cover that so thank you for that Martha I'm in a so and we are working on creating a set of FA cues that will cover some of these kinds of questions but the answer is they wouldn't we wouldn't expect that a non-covered entity or non-covered component of a hybrid entity would have occasion to be sharing a limited data set because it's only meaningful under HIPAA for covered entities we have heard of some institutions that where they are not covered entity but the data set includes some dates like might be in a limited data set that that perhaps they might be inclined to want to insert some additional terms but the limited data set attachment to wouldn't be appropriate for that kind of a flipside question to that is cannon on covered entity receive a limited data set and yes again that the determination whether or not something is a limited data set is based on the nature of the provider so if the provider is a covered entity and providing the data elements that would make up a limited data set then then anyone can receive a limited data set we have a couple other questions that have been coming in about when the fully identifiable attachment to will be released for use and another another question that points out that that there were versions of those that were searched in December so quite some time ago for for feedback and as what my suspect when you get into fully identifiable information and by that we mean you know pH I that is more than a limited data set so you know you couldn't just share it as under a dua as a limited data set personally identifiable information or identifiable information about a person under the common rule or education records under FERPA and we got a lot of feedback on those attachments on a lot of questions so we're really trying to be very careful about designing those and and incorporating all the feedback that we received and we also identified a need to have some fa cues that go along with that and we didn't want to release those attachments without the fa cues to answer some of the questions and answer in particular why we made certain decisions the way that we did and so we're hoping that those will be published unreleased in the next couple months so unfortunately about a year after we last asked for feedback but we really want to make sure that we try to get those as right as possible and what Martha will cover this when we get into the rules of the pilot but because those aren't published yet and because there's a high sensitivity around those you know arguably riskier types of data to share they won't be included in the pilot so we have a question to clarify use of the term collaborator and attachment three and you know part of that question is is this intended to be data collected under a federal grant or contract and not necessarily so this the template is designed to be agnostic to the funding source that generated the data set so you know we're anticipating that this might end up being used for a lot of datasets that were generated under federal funding because those sponsors are the ones that are requiring data sharing but you know if you if you collected a data set under institutional funds you know as long as you have the permission and authority to share the data set and there aren't awkward third party terms that attach to the data set you could use the DTU a our intention is it zqa could be used to share that data set the the template isn't well designed for collaborations between the provider and the recipient I think if that that might be something that we look to do in addition to a bi-directional flow of information so often you'll have you know hey I'll share this data set with you you share that data set with me and we'll collaborate on a project but that is such as future iterations of template components that we might be able to address that kind of a circumstance the the term collaborator in attachment 3 is then intended to cover you know perhaps a closer our custom to DB gap requests where DB gap says if you're collaborating across institutions you know your collaborator at that other institution needs to have their own dua so if you're you know someone from Harvard Medical School is working with someone at Brigham and Women's Hospital for separate legal entities that person over at Brigham Women's Hospital they need to have their own well they call it a did use certification but we have some data providers who say yeah I just I want to have one agreement with one institution and if you have a collaborator at another institution that you need to share it with that's fine you you take care of that and and in the event that a provider wants to permit that so wants to permit one agreement with Harvard Medical School knowing that we're going to share it with our collaborator at Brigham Women's Hospital that could be recorded in attachment three that's the intent there um maybe we'll take this this one more question and then move on to the pilot section of the webinar is there a need to add certificate of confidentiality language that is applicable to data produced from NIH grants to comply with the new NIH policy and that is you know one of the other common questions we get to is what about gdpr do we have to incorporate something from gdpr and certainly on our list of things to consider about future iterations of the template much like the sub award agreement template both through revisions periodically but we wanted to test what we have now and so that we can be collecting information like that on things that we need to add as options so Martha I'll pass this over to you so that you can take us through the pilot great I can hear me yeah yes right okay so as Melissa mentioned the DTU a working group created the templates for the transfer and sharing of research data from provider institutions to the recipient institutions for use in a research project at the recipient institutions so it is going from the provider to the recipient and the purpose of the pilot is to collect data that will help the working group ascertain if the templates create greater consistency in terms of format to reduce associated administrative burden so are the templates working and the pilot is expected have approximately 30 member institutions and from their experience we are hoping to get feedback as to whether the templates succeed in providing this low burden method for sharing non publicly available data if it is evident that some of the terms should be changed the pilot will enable us to know which term should be revisited the aim is to gather information that will result in confirming or highlighting the necessary changes if needed and we're how are we going to collect this data so sorry okay so there we're going to be collecting data in three different ways first we will collect the quantitative metrics using a form like an Excel spreadsheet that will be provided to the participants and will require data submission on a quarterly basis by the participants in addition we're also looking for more detailed information on 1 2 3 D tu as per month and we will have an online questionnaire that the participants will be able to complete and submit to us and then finally we also see seek feedback from the participants on their experiences in general and on the template usability via two surveys one at the halfway point and one at the completion of the pilot for the metrics we'll be looking and collecting the data that's listed on this slide and we were somewhat limited to what the participating institutions collect themselves and what their systems can supply back to us so again since the templates are intended for use when there is data flowing in a single direction from the provider to the recipient the spreadsheet is set up that way let's see we are planning to distribute the spreadsheet to the participants and also upload it to the FTP data stewardship website the data is going to show us how often the templates are used the type of entity receiving the DTU a how long it takes the agreements to be executed in the data type and it will allows for comments to then the qualitative questionnaire will be collected in the form of this online questionnaire and it will talk about ask questions about specific incidences of using the DTU a it'll include whether the standard terms were sufficient or whether they needed to be modified and whether the templates were used or whether the templates were used but the and modified and the FTP moniker was removed access to the online questionnaire will be made available to non-participants too so we encourage everyone to use these and also to provide feedback you see so what is required of lip isla participants so the participants will be expected to use the template for standalone DPAs only when the pilot participant is supervisor as I mentioned and the data type as Melissa mentioned is either de-identified or a limited data set the use of the template should be a starting point in order to participate in the pilot we will collect data on the modifications requested required in these examples so we're hoping that the providers and the recipients if we'll encourage people to use the templates if they're presented with something else where the templates would be have been applicable we will provide pushback language to the participants to use if other institutions are not using the templates this chart on the slide here shows when the template should be used it's available on the data stewardship website and it will it's also available in the FAQ s and will be supplied to the participants so people can read this carefully it's a pretty good summary of when they're applicable participants will also be asked to sign a participation agreement and I'll talk about that further and a little bit and so the start date is November first the term of the pie is expected to be 12 months however we do reserve the right to extend it if we have to collect more data if we don't have enough data and some institutions may not be able to join right now but please do let us know if you're interested and it will reassess at the six-month mark if there's sufficient interest to add more participants the updates will be shared at the FTP meetings and through the listserv and through emails FTP members can sign up for the pilot listserv is that correct Musa we will have a listserv yes for pilot participants only so those suggestions that are formally participating in the pilot will have a listserv and then there is a link available via the FTP website for anyone who would like to sign up for the data stewardship or contracts listserv but the pilot listserv will be closed to formal pilot participants okay but we will be putting information on those other listservs as well so in terms of the participation agreement it will include the participants agreement to use the template when appropriate to complete the metrics data collection sheet and return it quarterly to complete the online questionnaire for one to three d 2 days per month and to complete the semiannual online survey they will also agree to provide their institution contact information and it is consent to the institution's name being included in public listings of participant institutions the agreements are due back October 29th there are a number of resources that are available for everyone and they actually are quite helpful there's the glossary that defines the terms in the DTU 8 templates the guidance chart which I showed you and there's also a tool for classifying human subject data which is very helpful and then the FAQ answer a lot of questions that people may have this webinar will be posted on the website and we also are providing a dqa 101 and pilot slide deck so this slide deck and so that folks can use that to share at their own institutions and then I guess so I could take some questions about the pilot if anybody has any yeah I think we also have time for it folks have other questions that I'd like to ask about the templates as well but I did just want to make one comment on the participation agreement in case there's anyone who is signed up excuse me to participate and is thinking I don't have an agreement to return on the 29th we're just waiting for final approval from the FTP Executive Committee of that agreement and then we'll be sending it out to the folks that we have that reached out to us to express that their institution was interested in participating or whose name we got is the authorized official for one of those institutions so those will be coming soon and I also wanted to maybe say a few words about the you know use of name permission I know that a lot of institutions are very sensitive about how their name is used or maybe I'm biased that way because Harvard is very sensitive about the way its name is used and we just want to make it clear that that's we've had a lot of questions from institutions asking if we could please publish a list of who's participating a so that institutions know if I want to use the dtft PDQ a template who's likely to accept it and also a little bit of safety in numbers you know an institution may be more able to get buy-in from the folks that need to provide approval if they can see a list of the other institutions that have agreed to participate in a pilot or have agreed to use the template so but if we would be very clear that it's not an endorsement it's just a list of names of institutions who've agreed to participate you I'm not seeing any questions at the moment actually here's one so Martha I have I have one question okay if an institution isn't going to participate in the pilot can they still use the template absolutely yes mm-hmm and however if they're going to make any changes to it we ask that the FDP moniker be removed and so here we have a question is it the case then that only pilot participants can use the agreement for now and can you publish the list of those institutions participating in the pilot so I think we already answered that yeah as soon as I know that everyone who's participating has given me permission to do that I will be posting a list so that folks know how about if we have institutions that are a little bit on the fence right now or might be right now working on their roles and responsibilities for D us or putting in place and policies can they be added to the pilot later we're going to reassess in six months to see if they can be added for the short term well they should let us know now just in case because we don't know what the response is going to be with the agreements coming back hopefully they'll come back and signed but if people can let us know now if they're interested but if they can't join till later the answer is it depends how things look in six months so we have one more question here we'll each institution have a main point of contact that we can work with on issues or should we work with the pilot leaders first well that's an interesting question I would say if it's regarding this specific data transfer they should be talking with the contacts at the institution if there's sort of a general question then I think you and I'd be happy to answer them yeah and I think violet yeah you know much like institutions who might have participated in the expanded Clearing House will have experienced sometimes change management is hard yo and it takes a little while for information about new initiatives or pilot initiatives to make it to all the appropriate folks so we will be asking institutions to designate a main point of contact and we would like to in addition to list of participating institutions at least for the other pilot institutions post who the main point of contact is for that institution so that if there are issues you try to work with directly with that institution themselves we also are going to be posting a sample pushback language much like with the expanded Clearinghouse if you are expecting to be receiving the FGB DQ a pilot a template from another pilot institution some sample language that you can use as a starting point for saying did you know that you're part of the pilot and could we please use this template but you know Martha and I are always happy to help out with general questions about how it should work or the rules of a pilot or you know reach out and in the event that there's some confusion about participation we have another question here will pilot institutions be required to use the SDP BTU a template and Martha if you want to pull back up the the chart maybe I think it's slide 15 so you can see in this chart there's only one one use case where we've said that use is required and that's when the pilot participant is the provider the other party is an FTP member institution or other domestic low-risk nonprofit and a data type is de-identified or limited data set and in those circumstances we're saying that from pilot institutions uses the template is required and the reason we've designed it that way is that we acknowledge that the templates not might not work for a tiny NGO that you're sharing data with or company and also because when you are the recipient of data you have less control over the agreement template that gets used it's often the provider of a data set that might decide which which agreement gets used and in other cases we said you know we encourage you or you know we ask that if you're the recipient in that same set of circumstances could you ask the other institution if they'd be willing to use the template but in other than and that circumstance it's not required one more question here for the pilot would we report agreements where we don't use the SDB template because it is a two-way transfer template is just for one-way transfer oh I see so if you've got a dua that's bi-directional flow we would we ask for that to be included in the spreadsheet and I don't think so right actually I'm not sure the answer to that yeah that is a good question and a good one for us to make sure we have on the instructions for the spreadsheet but I going to say no excuse me and the reason is that it's two different it's sort of like we wouldn't ask for a collaboration agreement that happens to include data sharing terms to be reported on the spreadsheet so if you really want to but I think our cleanest data will be looking at the the by the unidirectional transfer using the FTP template or using a different template but I'll make note of that for our instructions I think that's a good question yeah you you but it looks like there are no more questions you so I think if anybody has any questions they should feel free to contact Melissa or myself and Melissa do you have any final comments just to say that the the next step to formally sign up will be that Martha and I will be sending out the agreement to the institution's interested in participating and asking for that to be returned and then making sure that all of the resources that we've talked about today are posted on the website in addition to the recording of the webinar we'll also make sure that we've posted these slides in the event that a participating institution or another institution wants to do a presentation on the the template or the pilot for stakeholders within their institution that you could feel free to take these slides and modify as necessary for your your internal community and as Martha said we're very happy to take any any questions in particular questions about how the metrics reporting tools work or you know as IQs that or content that we're missing from the pilot if they queues any questions that folks have about these final rollout all right it like Martha said it looks like we don't have any other questions and if you do Martha and my contact information is on the final slide thank you very much for joining us today yes thank you for joining us