Durham Va Medical Center

DURHAM VA MEDICAL CENTER APPENDIX F VERSION DATE: January, 2016

Data Management Plan for Public Access to Scientific Publications and Digital Data from Research Funded by the Department of Veterans Affairs

Protocol: Investigator: Date:

1. Background and Purpose: This document supports policy and implementation plans for the Department of Veterans Affairs (VA) to implement the February 22, 2013, memorandum from the White House Office of Science and Technology Policy (OSTP) directing Federal Agencies to support increased public access to the results of Federally-funded research.

2. VHA OFFICE OF RESEARCH OVERSIGHT REGARDING OSTP MEMORANDUM:

Effective December 31, 2015: All VA investigators include in their research proposals a data management plan that describes how, where, and to the extent to which they will make the data and results of their research available to the public and specifying what data will be available in machine readable formats.

Please verify the following statements and provide information requested. Yes No

1. This study is VA-funded research.

VA Funded Research: 1) funded by the Office of Research and Development (ORD); 2) any other VHA entity (e.g. VHA Program Offices)

If no, continue to signature section. If yes, continue to item 2. 2. Data Management Plan for Public Access to Scientific Publications and Digital Data from Research Funded by the Department of Veterans Affairs:

Not applicable. Results of this study will not be published. This form is complete. Continue to signature section. Not applicable. There are no current plans to publish or make publicly available the final research datasets underlying scientific publications. I will ensure that the IRB is notified via resubmission of this form if future plans are made to publish results of this study. This form is complete. Continue to signature section.

I plan to publish results of this study. Continue to item 3.

3. Results from this VA-funded project will be made publicly available through the following archive host(s) (select all that apply to your data management plan):

Publications will be made available to the public through the National Library of Medicine (NLM) PubMed Central (PMC) open public access website within one year of the date of publication. Required for all publications based on VA funded research.

Results of clinical trials funded by the VA Cooperative Studies Program (CSP) will be submitted to the Clinicaltrials.gov archive.

Other: If publications, results or final de-identified research datasets underlying publications are to be made public through avenues other than those mentioned above, the mechanism to do so and host site (URL)

INVESTIGATOR’S ASSURANCES

1. I understand that failure to implement approved data management plans may result in loss of funding or other restrictions.

2. I certify that protections for individual privacy, confidentiality of data and security of proprietary information are described in the protocol, if applicable.

3. I certify that, when possible as based on the standards of the archive host, all data will be available in machine readable formats.

4. I certify that I will make all final de-identified research datasets publicly available as required by federal policy.

Signature of INVESTIGATOR Date