DTCC Manuscript Development Procedures and Guidelines for JHS Data

Guidelines

Feasibility Test: RTRN DTCC @ JSU will serve as a facilitator for research. That is, prior to preparing manuscript proposal, investigator can ask Sr. Biostatistician at RTRN DTCC to test the study hypothesis using simple statistical methods (chi-square test, mean test, simple regression, logistic regression, etc). Based on the results of preliminary tests, investigators will decide if the study idea can be supported by the JHS data. Thus, RTRN investigators can start with only the study idea that feasible using JHS data. This in turn will minimize wasted effort and time of investigator and ensure greater likelihood of success in developing and producing scientific manuscripts using JHS data. For the feasibility test, the RTRN investigator will email the brief study concept (objective, study question, inclusion/exclusion, etc.) to DTCC Sr. Biostatistician (email:jae.lee@rtrn.net). Please submit request via theFeasibility Test Request Form.

Data and Statistical Services Request: Requests for JHS data for publication require approval of JHS P&P (link: http://jhs.jsums.edu/jhsinfo/ForResearchers/Publications/ ManuscriptSubmissionGuidelines/tabid/102/Default.aspx) Upon approval of a JHS Manuscript Proposal, initiator will request data or statistical analysis services from DTCC. To submit a request for data or analysis services, you must complete a Statistical Computing Request attached. All requests will be reviewed by the DTCC Service Core Members and will generally be reviewed within two weeks of the date of submission. Due to the complexity of a number of data requests, please give us as much notice (i.e., preferred deadline) to when the data are needed. An automated response e-mail from the data request system will be sent to the e-mail address you provide when your request has been successfully submitted. After review, you may be contacted via telephone or email to clarify questions about or details of your request.

Authorship: RTRN investigator will include at least one DTCC investigator or key personnel as co-authors, as appropriate, on any publications.

Data Sharing Plan:The proposed research will include data from subjects enrolled in the Jackson Heart Study. The final dataset will include self-reported demographic and behavioral data from interviews with the subjects and laboratory data from specimens provided. Datasets will be stripped of identifiers (de-identified ) prior to release for sharing; by doing so we believe that there is no possibility of deductive disclosure of subjects with unusual characteristics. However, in order to ensure we are providing appropriate and adequate protection of research participants' identities, we will make the data and associated documentation available to users only under a data-sharing agreement that includes a commitment to:

• The proposed research using the data will be reviewed by JHS/DTCC for appropriateness of use
• Using the data only for research purposes and not to identify any individual participant
• Not disclosing or using the data for a purpose other than that for which it was supplied
• Not transfer the data to other users
• Securing the data using appropriate computer technology
• Destroying or returning the data after analyses are completed
• Not to present or publish data prior to receipt of approval

Penalties for violating terms of the agreement are detailed in the Data Sharing Agreement, but may include the blocking of further access to the JHS data, permission denied for use of data in publications and presentations, or legal actions.

Data Sharing Agreement: TBD, jointly with JHS and DTCC. Acknowledgement and adherence to his data sharing agreement will be mandated for any investigator accessing the JHS data. Investigator will fill out the DTCC statistical computing request form. If investigator wants data only, then he/she will fill out both JHS and DTCC data sharing agreement forms. If investigator wants the statistical services from DTCC, then she/he will submit the DTCC data sharing agreement form.

Under the HIPAA Privacy Rule, de-identification of a dataset means removing the following variables: names; geographic information (including city, state, and zipcode); elements of dates such as those for birth, hospital admission and discharge, death; telephone numbers; fax numbers; electronic mail addresses; Social Security Number; medical record and prescription numbers; health plan beneficiary number; account numbers; certificate or license number; any vehicle identifier or serial number, including license plate number; any device identifier or serial number; Web Universal Resource Locator (URL); Internet Protocol (IP) address number; any biometric identifiers, including finger or voice prints; full face photographic images or any comparable images; and any other unique identifying number, characteristic, or code consisting of any segments of the previously listed identifiers.