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FDP Data Transfer and Use Agreement (DTUA) Template and Pilot

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Presentation on theme: "FDP Data Transfer and Use Agreement (DTUA) Template and Pilot"— Presentation transcript:

1 FDP Data Transfer and Use Agreement (DTUA) Template and Pilot
Webinar: October 11, 2018 Presenters: Melissa Korf, Harvard University Martha Davis, Brandeis University

2 Agenda Session Agenda DTUA Background
Template Structure and Instructions for Use Goals of the Pilot “Rules” for the Pilot Pilot Timeline Discussion/Questions Survey Results and relieves burden What is needed to evaluate DTUA Facepage, Att 1, Atts 2, Att 3 Mid October, metrics spreadsheet, example DTUA experience questionnaire, survey

3 So, what is a DTUA, anyway? A contractual agreement used to define how exchanged data may be accessed and/or used. These may have many different labels: Data Use Agreement, Non-Disclosure Agreement, Confidentiality Agreement, Memorandum of Understanding, Information Transfer Agreement, etc. Data Transfer and Use Agreement (DTUA) is the label chosen by the FDP to capture all agreements executed for the sharing of research data.

4 What do we mean by “research data”?
2 CFR (e)(3) defines research data as “the recorded factual material commonly accepted in the scientific community as necessary to validate research findings, but not any of the following: preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues. This “recorded” material excludes physical objects (e.g., laboratory samples). Research data also do not include: (i) Trade secrets, commercial information, materials necessary to be held confidential by a researcher until they are published, or similar information which is protected under law; and (ii) Personnel and medical information and similar information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, such as information that could be used to identify a particular person in a research study.”

5 DTUA Template Aims to Relieve Burden
The volume and complexity of DTUAs executed to share research data are increasing. The DTUA template has been created as a first step towards improving quality and creating greater consistency in terms and format to reduce associated administrative burden. A low-burden method for sharing data that cannot be made publicly available will be especially critical in helping institutions comply with sponsors’ data sharing requirements.

6 Current DTUA designed for these data sharing scenarios:
The transfer/sharing of research data from the provider institution to a recipient institution for use in a research project at the recipient institution. Transfer/sharing of data types which do not require terms beyond those in the facepage, de-identified data about human subjects, or a Limited Data Set. (Versions which can be used in sharing Personally Identifiable Information will be forthcoming soon!) Currently not designed for bidirectional flow of data, use in transferring materials, sharing data from a repository, or where third party rights inconsistent with the template terms are likely to attach to the data.

7 Categories of Data De-Identified Data about Human Subjects
If the Provider is a Covered Entity, all 18 of the personal identifiers specified by HIPAA have been removed. If the Provider is not a Covered Entity, identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertains has been removed. Definition of Limited Data Set Protected Health Information that excludes the following: Names; Postal address information, other than town or city, State, and zip code; Telephone numbers; Fax numbers; Electronic mail addresses; Social security numbers; Medical record numbers; Health plan beneficiary numbers; Account numbers; Certificate/license numbers; Vehicle identifiers and serial numbers, including license plate numbers; Device identifiers and serial numbers; Web Universal Resource Locators (URLs); Internet Protocol (IP) address numbers; Biometric identifiers, including finger and voice prints; Full face photographic images and any comparable images; and Any other unique identifying number, characteristic, or code except as specifically permitted by HIPAA. See FDP Tool for Classifying Human Subjects Data and DTUA Glossary for more information

8 DTUA Template Structure
Face Page includes the information and terms that need to be incorporated into every DTUA, regardless of the data type. Attachment 1 includes information related to the project specifics, such as a description of the data being transferred, a description of the Project for which use of the data is being authorized, and information regarding reimbursement of costs, if any is required. Attachment 2 includes terms required based on the specific type of information being transferred, if any.   Attachment 3 includes information on the involvement of any third party collaborators approved by the Provider. Attachment 1 example: For example, this attachment includes any specific requirements for IRB approval related to the use of human data or an obligation not to attempt to re-identify subjects in the case of de-identified human data.

9 Where can I find the template?
All template documents available on both the Data Stewardship and Contracts subcommittee pages Components Currently Available DTUA Face Page with Attachments 1 and 3 DTUA Attachment 2: De-identified Data about Human Subjects DTUA Attachment 2: Limited Data Set DTUA Attachment 2: Other

10 How does the template work?
Form-fillable pdf documents Included instructions to the drafter within the text boxes to indicate the type(s) of information intended to be included Language that is not included within a form text box should not be altered Walk through of the template documents Note that we request that any questions about potential changes to the actual terms included in the template be held until after the session.

11 Pilot Time!

12 DTUA Pilot Goals Gather information on how the forms best accomplish their purposes Confirm whether the template has the desired outcome of reducing the administrative burden of data sharing Gather feedback on what changes to the templates and/or methods of use may be needed to optimize the benefits. If we hear that the same terms need to be modified with great frequency, we will prioritize efforts to update those terms to increase effectiveness

13 Metrics – Quarterly Report
Information Collected DTUA reference number (optional) Receiver Name Receiver Type Issue Date Fully Executed Date Choose one from these options: FDP DTUA Used – No Modification, FDP DTUA Used – With Modification, or Non-FDP DTUA Used Data Type: De-identified or Limited Data Set Notes/Comments (Optional)

14 Qualitative Questionnaire
On-line Qualtrics questionnaire that will be used to collect information how to enhance usability, such as: Did any standard terms need to be modified? If so, which ones? Is there any information you needed to include in Attachment 1 but could not place in an existing form field? Pilot participants will be expected to complete at least one per month in which the institution executes a DTUA Questionnaire will be made available to non- participants to collect feedback from a broad audience

15 Pilot “Rules”

16 DTUA Pilot Timeline Start date will be November 1, 2018
Initial pilot expected to last 12 months Additional institutions may be invited to participate at the 6-month mark if sufficient interest Updates and results will be shared with the community at FDP meetings and via the Data Stewardship and Contracts listservs communication was sent to institution representatives , which included an explanation of the template and Pilot, and a request for a response if interested in participating.

17 Participation Agreement
Participating Institutions will soon receive a formal agreement for signature by their authorized representative Key terms include commitment to: Use the DTUA template as outlined in the Agreement (and Pilot FAQs) Provide contact information Participate in collection of metrics as requested Consent to the institution’s name being included in public listings of participating institutions Signed Agreements will be due back to the co-chairs by Wednesday, October 31st

18 DTUA Resources Currently Available: Coming Soon!
DTUA Glossary DTUA Guidance Chart Tool for Classifying Human Subject Data DTUA Pilot FAQs Coming Soon! Template FAQs Recording of this webinar to be posted on website DTUA 101 and Pilot slide deck With permission from Pilot Participants, we will also publish a list of participating institutions

19 Questions, Comments, Concerns, Suggestions??
Contact: Melissa Korf Associate Director, Grants & Contracts Office of Research Administration Harvard Medical School Martha R. Davis Assistant Director Brandeis University

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