Policy and Implementation Plan for Public Access to Scientific Publications and Digital Data from...

Policy and Implementation Plan for Public Access to Scientific Publications and Digital Data

from VA-Funded ResearchTom Puglisi, PhD

ORO Executive Director

January 25, 2016

VETERANS HEALTH ADMINISTRATION SLIDE 2

VA Research Results Access Plan –Federal Initiative

White House Directives• Office of Science and Technology Policy: Increasing Access

to the Results of Federally Funded Scientific Research, February 22, 2013

• Executive Order 13642: Making Open and Machine Readable the New Default for Government Information, May 9, 2013.

• Office of Management and Budget: Open Data Policy – Managing Information as an Asset, May 9, 2013, (Memorandum M-13-13)


VA Research Results Access Plan – Development Timeline

• Task Force chartered – March 2013• VHA Office of Research and Development• VHA Office of Research Oversight• VHA Privacy Office• VHA Office of Analytics and Business Intelligence• VHA Office of Ethics• VA Office of Data Governance and Analysis• VA Office of Information and Technology• Office of General Counsel

• Draft Plan approved by Under Secretary for Health and submitted to OSTP and OMB – November 2013

• Final OSTP and OMB approval – February 2015• VA/VHA review and concurrence – September 2015 • Federal Register Announcement – October 2015


VA Research Results Access Plan – Effective January 1, 2016 –Requirements Applicable to All VA Research (Regardless of Funding)

• All new proposals for VA research (regardless of funding status or funding source) must include a data management plan

• The data management plan must describe the conditions and mechanisms (see slide #9 thru slide #14) under which publications and data resulting from the research will be shared

• The plan should specifically state whether or not final data sets underlying published results will be shared with the public and, if so, include details on how, where, and the extent to which the data will be made available

• Evaluations of data management plans should include the adequacy and appropriateness of the plan relative to applicable VA and VHA research, privacy, confidentiality, proprietary information, and information security requirements

• Local SOPs should specify how and by whom the evaluation is to be performed


VA Research Results Access Plan – Effective January 1, 2016Additional Requirements Applicable Only to VA-Funded Research

• For purposes of the Access Plan, “VA-Funded” means activities funded as research by• The Office of Research Development (ORD)• Any other VHA Program Office

NOTE: Research funded and/or supported entirely by a VISN and/or Facility is not currently considered to be “VA-Funded.” Future policy is under development and will be addressed as relevant VHA Handbooks are revised.

• For purposes of the Access Plan, “Research Results” means:

• All Publications reporting the results of VA-Funded research

• Final Data Sets underlying all such publications (i.e., data underlying the published results)



In addition to the requirements on Slide #3 –

• VA-Funded research must comply with the requirements of relevant ORD or other Program Office Funding Guidelines and/or Requests for Applications (RFAs)NOTE: ORD is currently developing RFA guidelines for data management plans to be included in new submissions

• Evaluations of newly proposed research by the VA funding office must include an evaluation of the adequacy and appropriateness of the plan relative to the specific criteria established by the funding officeNOTE: ORD is currently implementing this requirement for new submissions



In addition to the requirements on Slide #3 – Data Management Plans for VA-Funded research must:

• Include a statement acknowledging that failure to implement approved data management plans may result in loss of funding and/or other restrictions

• Describe protections for individual privacy, confidentiality of data, and security of proprietary information



In addition to the requirements on Slide #3 – Data Management Plans for VA-Funded research must:

• Specify that publications and related metadata will be made available to the public through the National Library of Medicine PubMed Central website within one year after the date of publicationNOTE: PubMed Central accessibility for ORD-funded research has been required under VHA Handbook 1200.19 §5 since July 10, 2014. VA’s agreement with PubMed Central has been extended to include publications resulting from all other VA-Funded research. For submission procedures, see the ORD website at:http://www.research.va.gov/resources/policies/public_access.cfm



In addition to the requirements on Slide #3 –Data Management Plans for VA-Funded Research must:

• Specify how the final research data set(s) will be made available (if at all) in machine/computer readable form (i.e., how the final research data set(s) will be made available electronically, as opposed to on paper)

• Explain how the data available for sharing or other means of access will permit validation of results

• Specify that final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access (unless the relevant ORD or Program Office Funding Guidelines/RFAs state otherwise; e.g., as for the Cooperative Studies Program)


VA Research Results Access Plan – How to Comply

Final study data resulting from VA-Funded research may be shared in six ways:

(1) Individually Identifiable Data may be shared pursuant to valid HIPAA Authorization, Informed Consent, and an appropriate written agreement limiting use of the data to the conditions described in the authorization and consent.




(2) Individually Identifiable Data, excluding Veterans’ names and 38 USC §7332-protected information, may be shared, pursuant to a written request and IRB approved waiver of HIPAA authorization, with the approval of the Under Secretary for Health, in accordance with VHA Handbook 1605.1 §13.b(1)(b) or §13.b(1)(c) or superseding versions of that Handbook.

Note: Subject to all other listed requirements, Veterans’ names may be shared with other Federal agencies (38 USC §5701), and with non-Federal investigators who provide the names and addresses of the individual subjects.




(3) Individually Identifiable Data, including 38 USC 7332-protected information, may be shared, pursuant to the above requirements and a written assurance from the recipient that the information will be maintained in accordance with the security requirements of 38 CFR Part 1.466, or more stringent requirements, the information will not be re-disclosed except back to VA, and the information will not identify any individual patient in any report of the research or otherwise disclose patient identities.




(4) A Limited Dataset (LDS) may be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.




(5) A De-identified, Anonymized Dataset may be created and shared.

NOTE: Where practicable, ORO recommends that such sharing take place under a written agreement prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. However, it is permissible for final datasets in machine-readable format to be submitted to and accessed from PubMed Central (and similar sites) provided that care is taken to ensure that the individuals cannot be re-identified using other publicly available information.




(6) All Non-Exempt, Reasonably Segregable Data must be shared pursuant to a valid Freedom of Information Act (FOIA) request, as determined by the FOIA Officer.


VA Research Results Access Plan – Plan for the Future Due December 31, 2016

VA will –

(1) Complete a detailed analysis of mosaic effects that may result in possible identification of the individuals from whom data originated.

(2) Develop and implement standards to ensure fail-safe identity protections for VA research subjects, including mechanisms to prevent “re-identification” of subjects from “de-identified” datasets.

(3) Develop and implement standards to protect patentable intellectual property, as warranted.



(4) Complete a detailed analysis of, and determine a path forward regarding, the most viable long-term mechanisms for effecting public access to VA research data, including one or more of the following:

(a) Creating a dedicated, centralized research data archive hosted by VA (perhaps expanding upon VA’s current VINCI initiative);

(b) Relying on a group of decentralized VA research data archives; (c) Making use of components of VA’s emerging enterprise framework for

information management; (d) Using an archive hosted by another government entity but available to VA; (e) Permitting some form of public access to genomic and other large VA

datasets through the use of protected VA hardware and software that would permit data manipulation and analysis without the actual release outside VA of potentially identifiable information;

(f) Combinations of and/or other alternatives to the above.



(5) Develop and implement mechanisms for continued assessment of the long-term needs for the preservation of scientific data in fields that VA funds.

(6) Develop, and make available to the VA research community, standardized template language for voluntary informed consent, voluntary HIPAA authorization, and DUAs to support public access to VA research results.


VA Research Results Access Plan – Frequently Asked Questions

1. Does the VA Research Results Access Plan apply to ongoing VA research initiated prior to 2016? ANSWER: No. The Plan took effect on January 1, 2016, and is not retroactive. The requirement for a data management plan applies only to new VA research that was/is initiated after January 1, 2016.

2. Is there a grace period for implementing the new requirements? ANSWER: No. However, ORO will give facilities a reasonable period of time to revise their relevant policies and procedures. Facilities are reminded that requirements for results access took effect on January 1, 2016, for new studies and are not retrospective in scope.

3. Does the requirement for a data management plan apply to all VA research, including basic science research and animal research? ANSWER: Yes.

4. Does “VA-funded research” include projects that are conducted by VA but are not funded and/or projects that are funded only by the VISN or Facility? ANSWER: Not at this time. Research funded and/or supported entirely by a VISN and/or Facility is not currently considered to be “VA-Funded.” Future policy is under development and will be addressed as relevant VHA Handbooks are revised.



5. Do the “publication” and “final data set” requirements apply to data collected as part of published research projects but not contributing to the published results? ANSWER: No.

6. Do the research “publication” and “final data set” requirements apply to data included in ORD (or Program Office) final reports? ANSWER: No, assuming reports from the data are unpublished. Requirements generally apply to the stated scientific scope of the study and not to individual reports or administrative/regulatory activities completed as part of conducting the study.

7. Can data management plans be modified or amended after the study begins? ANSWER: Yes, assuming the modifications are consistent with other applicable VA and VHA requirements. For non-VA funded studies, investigators should also check with their funding source regarding any required permissions.

8. What criteria should be used to evaluate data management plans for “non-VA-funded” research? ANSWER: Currently, there is no consensus in the scientific and federal communities on these criteria. Discussions among federal agencies to date have primarily emphasized the underlying principles behind sharing results. However, it is recommended that evaluations of data management plans for “non-VA-funded” research include an evaluation of the adequacy and appropriateness of the plan relative to applicable VA and VHA research, privacy, confidentiality, and information security requirements.



9. How should the evaluation of data management plans for “non-VA-funded” research be documented? ANSWER: VA policy does not currently specify how the evaluation of data management plans for “non-VA-funded” research should be documented, so facilities are free to develop their own documentation procedures (which should be included in local SOPs).

10. What should be included in the data management plans for externally funded research (e.g., research funded by NIH, NSF, DOD, industry, private foundations)? ANSWER: Each federal agency will have its own requirements for research results access as part of its implementation of the White House Directives. Currently, there are no reciprocity agreements between federal agencies. Therefore, the data management plan should follow any requirements and/or guidance of the non-VA funding entity (federal or non-federal). There are no additional requirements relative to the VA research data access policy. Of course, the research must still comply with all other applicable VA requirements.

11. Who is responsible for evaluating the data management plans for VA-funded research? ANSWER: The relevant VA funding office is responsible for evaluating the data management plans for the research that it funds.



12. Who should evaluate data management plans for “non-VA-funded” research? ANSWER: VA policy does not currently specify who should evaluate data management plans for “non-VA-funded” research, so facilities are free to develop their own review procedures. Options include (a) the R&D Committee or relevant R&D Subcommittee, (b) the Privacy Officer and/or Information Security Officer, (c) the ACOS, and/or (d) any official or committee so designated by the Facility Director.

13. What approvals must be in place at the time an application for VA funding is submitted? ANSWER: Such requirements are determined by the relevant VA funding office. Consult the relevant Request for Applications (RFA) or document providing details on proposal submissions. ORD does not require approvals for a data management plan at the time of submission. Rather, data management plans are to be included as part of the overall application/submission for funding and will be evaluated during scientific review.

14. Does the current Records Control Schedule (RCS) relative to maintenance and destruction of research data continue to apply? ANSWER: Yes. RCS research record maintenance and destruction dates continue to apply. Additional guidance will be provided as program, regional, and/or enterprise level resources/repositories for long-term storage and data access are developed.



15. Do the research data access requirements apply to individual patient-subject data? ANSWER: Yes, but only if the data are included in the Final Data Set underlying the published results. However, all current VA and VHA research, privacy, confidentiality, and security requirements still apply and take precedence in determining how, where, and the extent to which results will be made available. This includes VHA Handbook 1200.12, Use of data and data repositories in VA Research.

16. Will templates and additional guidance be developed to assist the field in implementing requirements related to the VA Research Results Access Plan. ANSWER: Yes. Templates and guidance will be posted to the ORO web and SharePoint sites as they become available.


VA Research Results Access Plan

Links to VA Plan:

VA Open Government Websitewww.va.gov/open

ORO Website:http://www.va.gov/oro/ or

http://www.va.gov/ORO/oropubs.asp

[email protected](o) 202-632-7676, (c) 202-714-8432

http://www.va.gov/open

http://www.va.gov/oro/

http://www.va.gov/oro/



Date post:	18-Jan-2018
Category:	Documents
Upload:	lora-francis
View:	219 times
Download:	0 times

Policy and Implementation Plan for Public Access to Scientific Publications and Digital Data from...

Documents