RARE-X Research Program – Researcher Data Use Agreement (DUA), Data Access Request (DAR), Researcher Data Protection Agreement (DPA) completion requirements/guidelines

DPAs/DUAs

(1)  An Institutions that wishes to sign a DUA is a “Requestor”

(2)  DUAs must be signed by an individual at a Requestor with signing authority

(3)  Requestors can sign a Data Use Agreement (DUA) and identify a Requester Investigator

(4)  DUAs must have a purpose and an associated DPA with an addenda that defines the same purpose and security precautions

(5)  GG approved Requestor Investigators are given a RARE-X Research Account and become a RARE-X Research Account Holder

(6)  Requestor Investigators can initiate one or more Data Access Request (DAR)

(7)  If more than one DAR is initiated for a DUA, for different data and purpose, then the DPA addenda must either be amended or additional DPA addenda must be added to the DPA to correspond to the new DAR

(8)  If a Requestor Investigator wishes to collaborate with a researcher at a different institution, that institution is required to have signed DUA and DAR with the same project title and research use statement

(9)  If a Requestor Investigator leaves a Requestor, then the Requestor must notify Global Genes within ______ days

(10)  If a Requestor Investigator wishes to access the access data previously covered by a DAR from another Requestor Institution, the new Requestor Institution must have signed DUA, DAR and DPAs.

(11)  RARE-X Researcher Account Holders may be required to have IRB approval if they have access to personal identifying information for Research Participants.

(12)  The Requestor hereby assures Global Genes that, when issuing a Requestor Investigator a RARE-X Researcher Account, other institutional departments at the Requestor with relevant authorities (e.g., those overseeing human subjects research, information technology, technology transfer) have also approved such issuance of a RARE-X Researcher Account to such Requestor Investigator.

(13)  RARE-X Researcher Accounts are not transferable.

(14)  The Requestor agrees that if a RARE-X Researcher Account Holder changes institutions or leaves the Requestor for any reason during the particular RARE-X Researcher Account access period, then the Requestor will notify Global Genes and ensure that the Requestor Investigator completes the Project Close-Out process before leaving the Requestor.

(15)  Before the Data covered by such Requestor Investigator’s RARE-X Researcher Account may be re-accessed, a DUA, DAR and DPA with the new Requestor must be signed (either via submitting such DAR associated with an exist DUA/DPA or by such new Requestor agreeing to its own RARE-X DUA, DPA and issuing a RARE-X Researcher Account thereunder to such Requestor Investigator. (must be approved by the applicable DAC.????)

DARs

(i)  DARs must include

(a) a description of the data to be accessed in the RARE-X Data Use System (RDUS)

(b) purpose of the research

(c) a list of individuals and their contact information who will have access to the data

(1)  individuals must either report to the Requestor Investigator or

(2)  individuals are employees at the Requestor Investigator institution and are internal collaborators

(ii)  Changes to DARs

(a)  If an individual needs to be added to a DAR, the existing DAR must be amended or replaced

(b)  If an individual leaves a research project associated with a DAR then the existing DAR must be amended or replaced